Inspections, Compliance, Enforcement, and Criminal Investigations
Center for Food Safety and Applied Nutrition 2003
Center for Food Safety and Applied Nutrition
Class I Recall of Brownies with Undeclared Peanuts
In March 2003, the FDA's New England District Office reported that Shaw's Supermarkets, Inc., West Bridgewater, Massachusetts, was voluntarily recalling Bakery Brownies Blondie 6-packs from all Shaw's and Star Market store locations in the six New England states. Shaw's issued the recall because the Brownies Blondie contained peanuts, which were not listed in the ingredient statement on the product packaging. A press release was issued on March 21, 2003.
Warning Letter Issued to Bakery for Rodent-Infestation
Serious Insanitary Conditions Result In Warning Letter to Bakery
The FDA's Cincinnati District Office issued a Warning Letter on June 18, 2003, to Variety Food Service, LLC, Cleveland, Ohio, a manufacturer of baked goods. An FDA inspection of the bakery in April 2003, determined that the firm was operating under insanitary conditions.
The FDA inspection disclosed the following filthy conditions:
- Dead rodents were observed throughout the facility, including the first floor processing area, the second floor processing area, and the warehouse;
- Rodent pellets were observed throughout the facility, including both processing areas on the first and second floors;
- Live insects were observed on one lot of peanuts and inside the proofing machine; and
- Exposed rodent bait was observed throughout the facility, including both processing areas.
In addition, the firm did not implement adequate corrective actions following the Ohio Department of Agriculture inspection conducted on February 18, 2003, and the FDA inspection conducted on April 10 and 11, 2003, even though corrections were promised during the inspections.
FDA Analysis Finds Bread Grossly Mislabeled
On April 8, 2003, the FDA's Minneapolis District Office issued a Warning Letter to Natural Ovens of Manitowoc, Manitowoc, Wisconsin, following an inspection conducted in September 2001. Based upon the past history of the firm and evidence obtained during this inspection, an undercover purchase of several bread products and a dietary supplement was arranged. An extensive nutrient content analysis of these breads was performed by Atlanta Center for Nutrient Analysis. A Warning Letter was issued based on incorrect nutrient content claims, unauthorized health claims, and use of authorized health claims which were inappropriate for the product based upon analyzed content for labeled claims.
For example, FDA analyzed 7 Grain Herb Bread, 24 ounces. The analysis of a sample of this bread for nutrient content disclosed the following:
- Analysis revealed the calorie content is 154% (original analysis) and 146% (check analysis) of the value declared in the nutrition information.
- Analysis revealed the total fat content is 246% (original) and 240% (check) of the value declared in the nutrition information.
- Analysis revealed the fiber content is 42.3% (original) and 57.3% (check) of the value declared in the nutrition information.
Cookies Recalled Due to Undeclared Milk
Cookies Found to Contain > 150 ppm Milk Protein Not Declared in the Labeling
The FDA's Baltimore District Office reported that Rhee Bros., Columbia, Maryland, issued a press release April 10, 2003, announcing a recall of Chamdel brand Korean cookies in 6.34 ounce packages. The recall was initiated as a result of a New York State Department of Agriculture and Markets laboratory analysis of the cookies, which found milk protein >150 parts per million (ppm) in the product. The product was not labeled as containing milk or milk derivatives. Rhee Bros. obtained ingredient reconciliation from the overseas manufacturer so that the imported product could be properly labeled. The District's recall coordinator monitored the recall.
Undeclared Sulfites Result in Recall
In April 2003, Forever Cheese, Inc., Whitestone, New York, reported that the firm was recalling Mitica brand Apricot Bar, net wt. 2 ounce, imported from Spain. During a routine inspection of a retail establishment, a food inspector collected a sample of the product. The New York State Department of Agriculture and Markets laboratory analysis revealed the presence of sulfites, calculated as sulfur dioxide, at a level of 1363 ppm, which were not declared on the label. People with a severe sensitivity to sulfites or asthmatics run the risk of a serious or life-threatening allergic reaction if they consume this product. The firm official agreed to initiate a voluntary recall and issued a press release. The product had been distributed in New York, New Jersey, and Connecticut. Distribution of the product was suspended until the product was properly labeled.
"Diet" Root Beer Found to Contain Corn Syrup
Corn Syrup in Diet Drink Poses Serious Threat to Diabetics
The FDA's Minneapolis District Office received notice of a recall of Mug Root Beer by the Pepsi Cola Company, Inc. The recall was initiated on February 14, 2003, and was based on the fact that some Mug Root Beer was labeled Mug Diet Root Beer. However, the product in mislabeled cans contained corn syrup and sugar, which were not declared on the cans. This poses a serious health threat to diabetics and other persons who must restrict their sugar intake. The mislabeled product was canned and labeled at the Pepsi Cola Bottling plant in Burnsville, Minnesota. Mug Diet Root Beer cans were mistakenly brought to the production line during the canning of Mug Root Beer.
FDA Finds Contaminated Infant Formula and Alerts Public
On October 7, 2002, the FDA alerted the public to the voluntary recall of powdered infant formula announced by Wyeth Nutritionals Inc., Georgia, Vermont. Certain lots of powdered infant formula manufactured between July 12 and September 25, 2002, were possibly contaminated with Enterobacter sakazakii (E. sakazakii). This is a foodborne pathogen that can, in rare cases, cause sepsis (bacteria in the blood), meningitis (inflammation of the lining of the brain), or necrotizing enterocolitis (severe intestinal infection) in newborn infants, particularly premature infants or other infants with weakened immune systems.
The powdered infant formula was distributed nationwide in retail stores and amounted to approximately 1.5 million cans. The affected products were identified by an expiration/use by date, embossed on the bottom of the can of: 07 28 05, 08 28 05 and 09 28 05. The first four characters included: K12N through K19N; L07N through L30N; and N03N through N25N. The products in various sizes included the following brands of infant formula:
Kozy Kids Infant Formula with Iron
Hill Country Fare Infant Formula with Iron
HEB Baby Infant Formula with Iron
American Fare Little Ones Infant Formula with Iron
American Fare Little Ones Soy Infant Formula with Iron
American Fare Little Ones Formula for Older Infants with Iron & Calcium
HomeBest Soy Infant Formula with Iron
Safeway Select Infant Formula with and without Iron
Healthy Baby Infant Formula with Iron
Walgreens Infant Formula
Parent's Choice Infant Formula with Iron
Contamination with this pathogen was first detected during a special sampling for E. sakazakii by FDA conducted at the Vermont facility. This special sampling and analysis was conducted at all major domestic manufacturers of powdered infant formula.
FDA Issues Advisory on “Teas”
Teas Made from Star Anise Were Associated With Illnesses Including Seizures
On September 10, 2003, FDA issued an advisory to the public not to consume "teas" brewed from star anise. FDA became aware that brewed "teas" containing star anise were associated with illnesses affecting about 40 individuals, including approximately 15 infants. The illnesses, which occurred over the last two years, ranged from serious neurological effects, such as seizures, to vomiting, jitteriness and rapid eye movement.
Although the labeling of the "teas" containing star anise did not make any claims for the product, FDA understands that these products are popularly believed to help against colic in infants. FDA is unaware of scientific evidence to support benefits from "teas" brewed from star anise. Given that fact, FDA advised consumers not to use them or give them to infants and children.
FDA has not identified the specific type of star anise associated with the illnesses. For this reason, the Agency issued an advisory as an interim measure while it continued to gather additional information.
The advisory noted that FDA’s concern that the commonly available Chinese star anise (Illicium verum), a product considered by FDA to be generally recognized as safe (GRAS), may contain Japanese star anise (Illicium anisatum). Japanese star anise has long been recognized as toxic in many countries and should be used for decorative purposes only.
Until FDA is able to differentiate between Japanese and Chinese star anise, the Agency has advised the public not to consume "tea" brewed from any star anise. As part of the FDA’s ongoing efforts to protect consumers from unsafe products, FDA will monitor imports of star anise entering the United States from various countries to ensure that any imports of Japanese star anise are not labeled or otherwise indicated for use as a food.
The initial reported illnesses were identified retrospectively through a record review by a resident physician from Miami Children’s Hospital who was treating an infant with seizures. The physician was able to associate the ingestion of a star anise-containing tea with the illness. He reported his findings to the Florida Poison Information Center (FPIC). FPIC then reported the findings to the FDA.
All the affected individuals, including infants, involved in these reported cases recovered without complications. FDA has learned of similar reports from Florida, Illinois, New Jersey, Texas, and Washington as well as the Netherlands, France, and Spain.
Candy Platters with Undeclared Peanuts Recalled
On March 18, 2003, the FDA posted a Press Release advising consumers of a recall of chocolate candy platters containing undeclared peanuts. The FDA's New York District Office was notified by the FDA's New England District Office that Stop & Shop supermarkets stopped sales of Candy Assortment Platters, 28 ounce, containing chocolate with undeclared peanuts manufactured by J & D Fine Foods, Brooklyn, New York.
The problem was discovered by a Stop & Shop supermarket employee who found the platter containing undeclared chocolate covered peanuts, which was labeled as chocolate-covered raisins. According to the FDA's New England District Office all the Stop & Shop supermarkets in Massachusetts and Connecticut removed this product from their store shelves. J & D Fine Foods decided to voluntarily recall this product. This product was manufactured as a special order for Stop & Shop supermarkets in the New York, Massachusetts, and Connecticut areas.
Mass Seizure of Chocolate and Confectionary Products
FDA Inspection Reveals Rodent-Infested Food Storage and Processing Areas
In April 2003, the FDA’s Denver District Office accompanied the U.S. Marshals Service in a mass seizure of chocolate and confectionary products located at Topographic Chocolate Co., Inc., Denver, Colorado. Topographic Chocolate Company, Inc., was doing business as Art Coco Chocolate Company, Denver, Colorado, a chocolate and confectionary manufacturer. This mass seizure included all food products in rodent susceptible containers that were located anywhere on the premises, excluding those articles in the firm's cooler.
An FDA inspection of this manufacturing facility during January 28 - February 19, 2003, revealed a widespread rodent infestation throughout the food storage and processing areas of the facility, including rodent gnawed food packages. Thousands of rodent excreta pellets were seen in food storage areas throughout the building on, in and around stored lots of food. Rodent harborage areas were noted in the facility and various building defects, including gaps under doors and holes in walls, which served as potential rodent entryways into the building.
FDA laboratory analysis of samples collected during the inspection confirmed the identity of rodent excreta pellets, rodent urine, rodent gnawed materials, and rodent hairs in foods. The value of the seized goods is estimated to be between $200,000 and $300,000.
Seizures of Honey Contaminated with Chloramphenicol
In August 2002, FDA and the U.S. Customs and Border Protection announced that they had discovered bulk imports of Chinese honey that were contaminated with low levels of chloramphenicol, a potentially harmful antibiotic and unapproved food additive. The contaminated honey was detected during an investigation into a widespread scheme to evade payment of U.S. anti-dumping duties on bulk imports of Chinese honey.
Seizure - T.W. Burleson and Son, Inc.
A seizure of honey occurred on January 15, 2003, when FDA investigators from the FDA’s Dallas District Office accompanied the U.S. Marshals Service in a seizure of imported bulk honey, at T.W. Burleson and Son, Inc., Waxahachie, Texas. The continued monitoring of food production and distribution at many levels enabled FDA to detect this adulterated honey since the Agency learned of the presence of chloramphenicol in imported honey.
A sample (FDA sample #177690) of the imported bulk honey collected by the FDA’s Dallas District Office and tested by the FDA’s Denver District Laboratory was found to contain chloramphenicol at or above a level of 1 parts per billion (ppb) by High Performance (or Pressure) Liquid Chromatography with detection by Mass Spectrometry (HPLC-MS).
Chloramphenicol is a broad-spectrum antibiotic drug used to treat life-threatening infections in humans, usually when other alternatives are not available. The use of this antibiotic is limited because of its potentially life-threatening side effect, idiosyncratic aplastic anemia. For the very small number of the population susceptible to this side effect, exposure to chloramphenicol could be serious or life threatening. Because of the current uncertainty regarding the dose-response relationship between chloramphenicol ingestion and aplastic anemia, it is not possible to define a safe level for the presence of this antibiotic in food products.
Seizure - Hoyts Honey Farm, Inc.
On February 4, 2003, FDA investigators accompanied U.S. Marshals in a seizure of adulterated imported bulk and finished product honey from Hoyts Honey Farm, Inc., Baytown, Texas. U.S. Marshals seized 266 drums of honey (each containing 639 pounds of bulk honey) and five totes (each containing a net weight of 3,000 pounds) after FDA tested and confirmed the presence of an unapproved food additive, chloramphenicol. In accordance with the Federal Food, Drug, and Cosmetic Act (the Act), food products that contain chloramphenicol, an antibiotic, are adulterated and are not permitted to be sold in or imported into this country.
This seizure is the third enforcement action against similarly contaminated honey in six months. The first such seizure occurred in August 2002 in Louisiana. The second seizure occurred in January 2003 when U.S. Marshals served a warrant on T.W. Burleson and Son, Inc., Waxahachie, Texas.
The Agency will continue to detain or seize any honey imports that contain chloramphenicol to ensure that this product is not released for human or animal consumption in the United States.
Conjac Candy Firm Signs Consent Decree
Firm Signs Consent Decree Allowing FDA to Destroy Gel Candies Causing Choking
On November 6, 2002, the FDA and New Choice Food, Inc., a distributor of conjac gel candies, entered into a consent decree which allowed the FDA to supervise the destruction of 13,000 cases of mini-cup gel candies containing the ingredient conjac. This is the latest in a series of actions that the Agency has taken to protect the public against conjac gel candies, which pose an unacceptable choking hazard. Conjac gel candies are typically packaged as individual, mouth-sized servings in several fruit flavors. Each gel cup is about the size of a single-serve coffee creamer.
Various brands of conjac candies have been associated with the choking deaths of children. "FDA has repeatedly warned consumers not to eat these candies. This warning applies especially to children," said FDA Deputy Commissioner, Dr. Lester M. Crawford. "This consent agreement is the latest step in helping to get this product off the market."
Under the terms of the consent decree with New Choice, conjac gel candies that were seized by the United States, valued at approximately $500,000, will be destroyed. New Choice has also agreed to withdraw adulterated and misbranded products like those seized that may still be on the market. The company has posted a penal bond of $800,000 as assurance that it will meet the terms of the consent decree.
The decree states that New Choice must present for FDA approval, a written product withdrawal plan. FDA will supervise the withdrawal and the destruction of the seized items. New Choice is responsible for the costs that the government may incur under the consent decree.
The decree, entered in the U.S. District Court for the Central District of California, follows the seizure of the gel candies at New Choice's Irwindale, California, facility in late May of 2002. The products are considered "unfit for food" and therefore adulterated under the Act. They also are considered to be misbranded under the Act. When New Choice refused to recall the products the FDA initiated the seizure so that the gel candies would not be distributed to consumers. Other firms voluntarily recalled similar products.
Previously, in August and October of 2001, FDA issued warnings against consuming mini-cup gel candies that contain the ingredient conjac. In October of 2001, the Agency issued an Import Alert (#33-15) to detain the mini-cup gel candy when offered for entry into the United States.
Warning Letter Issued for LACF Violations
On October 1, 2002, the FDA issued a Warning Letter to the Owner of Tropical Nutty Delight, Largo, Florida. An FDA inspection of the low-acid canned food (LACF) factory on May 21, 28, 29, and 30, 2002, revealed serious deviations from the LACF regulations. The firm produces a milk-based peanut flavored beverage. The inspection disclosed that the firm failed to comply with the mandatory requirements of Title 21, Code of Federal Regulations (21 CFR) Part 113 and 21 CFR Part 108.35 as follows:
- Failure to provide sufficient information needed for FDA to determine the adequacy of the scheduled process for the milk-based peanut flavored beverage that the firm manufactures, as requested in writing by FDA;
- Failure to process products in conformity with at least the minimum filed scheduled process recommended by the processing authority. Deviations requiring correction included;
- Failure to maintain complete records of processing and production information;
- Failure to install at least one mercury-in-glass (MIG) thermometer on each retort;
- Failure to adjust the temperature recording device (TRD) for the American retort used to process the milk-based peanut flavored beverage to agree as nearly as possible with the known accurate MIG thermometer;
- Failure to equip retorts with automatic steam controllers to maintain retort temperatures;
- Failure to record observations during visual closure examinations performed at intervals of sufficient frequency to ensure proper closure; and
- Failure to file a process with FDA for the milk-based peanut flavored beverage with information as to the scheduled process including processing method, type of retort, times and temperatures of processing, sterilizing value, critical control factors affecting heat penetration, and source and date of establishment of the process.
In addition, FDA investigators noted that the owner was not under the supervision of a person who had attended a school approved by the Commissioner for giving instruction in processing operations and who had satisfactorily completed the prescribed course of instruction.
FDA Inspection Results in Warning Letter
Insanitary Conditions Found at Catering Firm – HACCP Violations Noted
The FDA’s New Orleans District Office issued a Warning Letter to Superior Catering Service, Chattanooga, Tennessee, on March 31, 2003. An FDA inspection of the firm in January 2003, disclosed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food.
During the inspection, FDA investigators documented instances where employees handled food products in an insanitary manner, failed to wear protective outer garments while preparing meals, and wore jewelry and other objects during production. The inspection also revealed instances where foods were held at potentially dangerous temperatures inside hot boxes, and thermometers had not been routinely calibrated. Processing utensils and equipment were not properly cleaned, sanitized or maintained. In addition, serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations were noted.
Importer Voluntarily Destroys Pottery
During the week of August 20, 2003, the FDA's Southwest Import District's Otay Mesa Resident Post personnel reported witnessing the voluntary destruction of Mexican folk pottery imported from J & F De Mexico, Tijuana, Mexico, en route to Mi Casa Home Accents in San Diego, California, which were incorrectly invoiced as assorted decorative clay pieces in OASIS.
The Mexican folk pottery consisting of various mugs, dishes, and bean pots were scattered throughout the shipment of other clay pieces, and were discovered when the truck was unloaded for examination by FDA. The pieces tested presumptive positive for lead by a lead check swab test performed by the investigator. Due to the small size of the various lots, official samples would have taken most pieces in the shipment. In conversation with the broker and importer, the importer offered to voluntarily destroy all the existing pieces of dinnerware valued at approximately $1,500.
Contaminated Mascara Recalled
Pseudomonas Found in Mascara – Potential for Serious Eye Injury
On April 28, 2003, FDA reported that Neways International, Salem, Utah, was recalling approximately 8000/10 gram tubes of Leslie DeeAnn Jet Black Mascara due to Pseudomonas aeruginosa contamination. This pathogen can cause severe, eye sight threatening infections. The contamination was discovered by the New Zealand manufacturer, Cosmeceutical Creations Corporation. The product was distributed nationally through Neways' multi level marketing system.
Metal Fragments in Butter Result in Recall
The FDA issued a Press Release on July 26, 2003, reporting that Land O' Lakes, Inc., Arden Hills, Minnesota, was recalling its one-pound packages of salted stick butter because the product might contain small fragments of metal. The butter was produced at a Land O' Lakes facility in Kent, Ohio, and was sold in retail grocery stores between June 11 - 26, 2003, in the following states: Alabama, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Minnesota, Mississippi, Missouri, Montana, Nebraska, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Wisconsin, and Wyoming. The affected product had one of the following production codes listed after the date, which was located above the Nutrition Facts panel on the packaging: KE 107P, KE 108P, KE 109P. There were no reports of injuries or illness related to the product covered by the recall, according to a company spokeswoman.
Raw Milk Refused Entry
The FDA's Detroit District Office refused an entry of raw milk consigned to Liberty Milk Coop of Augusta, Wisconsin, that was detained on April 9, 2003. The milk was detained because the unlicensed Canadian producer (International Dairy Direct, Sunderland, ON) was forbidden from selling milk in Canada. The milk, valued at $6,350, was voluntarily destroyed on April 25, 2003, under the supervision of the Wisconsin Department of Agriculture.
Peregrina Cheese Corp. Recalls Queso Fresco Fresh Cheese
Cheese Contaminated With Listeria Recalled
The FDA reported on March 10, 2003, that Peregrina Cheese Corp, Brooklyn, New York, was recalling 14-ounce plastic trays of "Peregrina Cheese Brand Queso Fresco Fresh Cheese" because of possible contamination with Listeria monocytogenes.
If consumed, the product could cause Listeriosis, a disease that usually causes mild flu-like symptoms in healthy individuals. However, in immune-compromised individuals, meningitis and blood poisoning can occur. Pregnant women are also considered a high-risk group, as Listeriosis can also result in stillbirths. The cheese was distributed to retail outlets in the New York and New Jersey metropolitan area.
"Peregrina Cheese Brand Queso Fresco, Fresh Cheese" was sold in a 14-ounce plastic tray package with code "0933." The package contained a plant number of 36-8431 and a grocery sticker identifying the code "0933." The label showed the address of the plant location as 342 Ten Eyck Street, Brooklyn, New York.
The recall was initiated after routine samples taken by New York State Department of Agriculture and Markets Dairy Products Specialists discovered the product to be contaminated with Listeria monocytogenes.
Dairy Recalls Chocolate Milk Due to Excess Vitamins A and D
The FDA announced on March 21, 2003,that Reiter Dairy, Inc., Barberton, Ohio, was recalling 150 half gallon containers of Topps Vitality Fat Free Chocolate Milk because it contained a significantly higher than labeled level of vitamin A. (Approximately 44,700 International Units (IU) per quart are present in each quart of the product instead of the intended level of 2,000-3,000 IU.)
Excessive amounts of vitamin A ingestion can lead to severe health problems, including birth defects in babies born to mothers who consume excess levels of vitamin A during the first trimester of pregnancy. Among infants, the ingestion of excessive levels of vitamin A may cause an increase in the pressure of the fluid within the brain, hair loss, and abnormal changes in bone formation. For persons of all ages, excess vitamin A ingestion can cause liver damage. The same product was also recalled because it contained too much vitamin D as well (4,000 IUs instead of the intended 400-600 IUs). The consumption of excess amounts of vitamin D may result in abnormally high blood levels of calcium and phosphate, which, in rare instances, may lead to abnormal deposits of calcium in various parts of the body.
The recall was initiated after it was discovered that the product contained more than the labeled amount of vitamins due to an error by the manufacturer. The fat free chocolate milk, packed in one-half gallon containers coded "MAR 27," was distributed to retail stores in Ohio, Pennsylvania, and New York. Consumers purchased Topps Vitality Fat Free Chocolate Milk were urged to return it to the place of purchase for a full refund.
FDA Announces Significant Enforcement Initiative Targeted at Misleading Claims
On December 18, 2002, FDA announced a significant enforcement initiative targeted at misleading claims about dietary supplement-associated health benefits. Dietary supplements are used by an estimated 158 million Americans, and so misleading claims about their health benefits may have significant consequences - not only for wasting consumers' money but also for luring consumers interested in improving their health in wrong directions. While FDA's enforcement goals related to truthful and non-misleading statements about health benefits apply to all of the products the agency regulates, this initiative was especially focused on products that in recent years have been the subject of important misrepresentation.
SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin: Warning to Consumers
On June 20, 2003, FDA issued a warning to consumers not to purchase or consume SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin, manufactured by NVE, Inc., Newton, New Jersey, and distributed by Hi-Tech in Norcross, Georgia. These products, which are marketed as dietary supplements, contain a prescription drug ingredient, tadalafil, that poses health risks when taken with certain prescription drugs containing nitrates. Tadalafil is the active ingredient in Cialis, an Eli Lilly product approved in Europe to treat male erectile dysfunction. The products are being sold over-the-counter and are claimed to increase stamina, confidence and performance.
FDA's Office of Criminal Investigations, with assistance from FDA's New Jersey and Atlanta District Offices, executed concurrent federal search warrants in Georgia and New Jersey after finding these dietary supplements.
Recall of Taldalafil
On August 18, 2003, Hi-Tech Pharmaceuticals, Inc., and related firm, National Urological Group, Inc., initiated a recall of their sexual enhancement dietary supplement products because the Forensic Chemistry Center’s analysis found that their products were adulterated with the prescription drug ingredient, Taldalafil. Taldalafil is the active ingredient in Cialis®, an Eli Lilly prescription drug approved in Europe (and pending approval in the US) to treat erectile dysfunction. Consumer complaints and adverse reactions for some of the recalled products have already been received nationwide
Recall of Ancom Anti-Hypertensive Compound
On February 11, 2003, Best Life International recalled Ancom Anti-Hypertensive Compound tablets, which were represented as dietary supplements but were found by FDA investigators to contain several prescription drug ingredients, including reserpine, diazepam, promethazine, and hydrochlorothiazide. The product was sold on the Internet and at retail stores.
Recall of Viga
Responding to an FDA contact, Best Life International, Mayaguez, P.R., on May 23, 2003 issued a voluntary recall and warned consumers not to buy or consume its product called Viga. Viga, marketed as a dietary supplement, was found to contain sildenafil, the active ingredient in Pfizer's Viagra. Sildenafil can cause life-threatening lowering of blood pressure when taken with nitrates.
Ginseng with Pesticides Refused Entry
In April 2003, the FDA's Minneapolis District Office refused entry of white Chinese ginseng fiber valued at $78,800 after the FDA's Arkansas Pesticide Laboratory found pesticide residues. The importer wanted to export the product. The ginseng is from Changchun Liuhe Economic Trading Co., Ltd., Changchun, China.
Warning Letter for Trans-Dermal Products
A Warning Letter was issued to Michael Peng, President of Greenvalley, LLC located in Farmingdale, New York, on September 26, 2003 for offering trans-dermal products intended for the treatment of diabetes and prostate disease-related symptoms via a website (http://gyconline.com). Moreover, although the products were represented as dietary supplements, they did not qualify as dietary supplements since they were not intended for ingestion as set forth in the Act. Additionally, FDA had no information to indicate that the products were generally recognized as safe and effective for their intended use; and the products were misbranded because the labeling failed to bear adequate directions for use.
Warning Letter for “Lipostabil”
On July 22, 2003, FDA issued a Warning Letter to Ayoula Dublin, New York, New York, for marketing and distributing “Lipostabil”, an injectable product that claimed to break down and dissolve fat “for the person who wants to lose those last 5-10 extra pounds”. Although the product claimed to be a dietary supplement, its route of administration disqualified it as a dietary supplement (since it was not intended for ingestion). Moreover, the product’s structure/function claims and lack of substantiation to show that the product was generally recognized as safe and effective for its intended use made it a new drug without an approved drug application.
Seizure at Global Source Management and Consulting
On February 13, 2003, U.S. Marshals seized 450 bottles and 57,000 bulk capsules of dietary supplement products from Global Source Management and Consulting, Inc. ("Global Source"), Sunrise, Florida. The seizure occurred after FDA determined that these products claimed to treat a variety of medical conditions. The seizure included almost 20 different products worth nearly $19,000 that were sold under the names Vitamin Hut and RX for Health through retail outlets and by mail order.
On June 18, 2003, the U.S. District Court for the Southern District of Florida entered a Consent Decree of Condemnation and Destruction for the seized drugs. Under the terms of the Consent Decree, the Claimant, Global Source, must destroy all of the drugs. In addition, Global Source agreed to cease manufacturing, processing, packing, labeling, holding, or distributing "Vitamin Hut Scientific Cholesterol Support Program" or any similar red yeast rice product containing lovastatin or any other drug product that is a new drug unless and until an approved new drug application is in effect for such product.
Seizure of HypoAllergenic Taurine Capsules
Firm Claims Dietary Supplement can “be beneficial” for Autism
On October 17, 2002,FDA investigators accompanied U.S. Marshals in a seizure of dietary supplements making drug claims from the Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories. U.S. Marshals seized hundreds of bottles of Kirkman's HypoAllergenic Taurine Capsules after FDA determined that these products made unsubstantiated claims to treat autism, a neurobehavioral disorder that begins in early childhood. Although the article is labeled as a "dietary supplement," it is promoted by Kirkman Laboratories for autism on its Internet website and by accompanying product literature.
For example, on September 3, 2002, the company's Internet website (from which products may be ordered) stated, "Dr. Jeff Bradstreet, a physician in Palm Bay, Florida, who treats autistic patients reports good success using Taurine," "Taurine may be beneficial in developmental disorders," and "Recommended Usage: ... For individuals with autism or related conditions use the following daily [dosage]: ... According to age ... Capsules ... Younger Children ... 3-4 capsules ..."
FDA seized these products because they violate the Federal Food, Drug, and Cosmetic Act (the Act). In accordance with the Act, all dietary supplement products' labeling must be truthful and not misleading and may not make any claims that the product will cure, mitigate, treat, or prevent disease. Consequently, the claims that the capsules treat autism caused the firm's product to be a misbranded food and an unapproved new drug.
This seizure was the result of FDA's investigation of the firm's Internet site. FDA will continue to identify and take appropriate enforcement actions against fraudulently marketed dietary supplement products that make unsubstantiated medical claims in their labeling.
Gero-Vita International, Inc.
On May 27, 2003, the Federal Trade Commission (FTC) filed a complaint against Glenn Braswell and four of his corporations for making false and unsubstantiated claims that five products marketed as dietary supplements are "scientific breakthroughs" to treat or cure numerous serious medical conditions. FDA provided technical assistance and scientific support to FTC for this action.
Products identified in the complaint include: Lung Support Formula, claimed to cure or ameliorate asthma, emphysema, smoking damage and other respiratory problems; Antibetic Pancreas Tonic, claimed to treat or cure diabetes and to lower blood sugar levels; GH3 and GH3 Romanian Youth Formula, claimed to extend life and prevent or treat Alzheimer's disease and other forms of dementia; Chitoplex claimed to promote weight loss and reverse obesity without diet or exercise; and Testerex, claimed to treat erectile dysfunction.
On May 9, 2003, FDA and FTC warned Website operators, manufacturers and distributors to remove misleading or deceptive Internet claims that their products may prevent, treat or cure Severe Acute Respiratory Syndrome (SARS). A net "surf" conducted by FTC, FDA and the Ontario Consumer and Business Services, found over 40 sites promoting a variety of SARS treatment and/or prevention products. The products included dietary supplements containing ingredients such as colloidal silver, ascorbic acid, beta glucan, pycnogenol, and oregano oil.
FDA sent Warning Letters to firms promoting dietary supplement products to treat or prevent SARS on the Internet. FTC also notified violative firms that they were subject to possible civil or criminal actions under the Federal Trade Commission Act. FDA followed up to determine if the firms took appropriate corrective action.
$7 Million Worth of Seasilver Seized
On June 17, 2003, U.S. Marshals seized 132,480 bottles of Seasilver, worth nearly $5.3 million from Seasilver USA's San Diego headquarters in an action initiated by FDA. The complaint for seizure alleged that, although Seasilver USA markets Seasilver as a dietary supplement, it promotes it on the Internet and in marketing materials sent with the product as a treatment for serious diseases including cancer, diabetes, hypoglycemia, psoriasis, hepatitis, and arthritis. On June 25, 2003, the U.S. Marshals seized an additional $1.7 million worth of Seasilver from a distribution center in Parma, Ohio.
In response to a request from the Federal Trade Commission (FTC), the federal district court in the Southern District of California issued, on June 13, 2003, a temporary restraining order prohibiting Seasilver USA, Americaloe Inc., and principals in the companies from making the challenged claims, and froze their assets. FTC is seeking preliminary and permanent injunctive relief, including restitution to consumers who purchased the product.
Coral Calcium Warning Letters
On June 9 and 10, 2003, FDA issued Warning Letters to 18 firms which operate 24 Web sites marketing multiple coral calcium products as effective treatments or cures for a variety of diseases and conditions. Many of these coral calcium products also made unsubstantiated structure/function claims. Coral Calcium Supreme is promoted in nationally televised 30-minute infomercials featuring Kevin Trudeau and Robert Barefoot on cable channels such as the Discovery Channel, Comedy Central and Bravo.
Seizure of Coral Calcium Supreme
2.6 Million Worth of Coral Calcium Seized for Claiming Product Cures Cancer & Other Serious Diseases
On June 19, 2003, in an action initiated by FDA, U.S. Marshals seized $2.6 million worth of Coral Calcium Supreme. In a separate action, FTC charged the marketers of Coral Calcium Supreme with making false and unsubstantiated claims that the product can treat or cure diseases such as cancer, multiple sclerosis, lupus and heart disease. Stipulated preliminary injunctions have been entered against Trudeau, Barefoot, Shop America LLC and Deonna Enterprises, Inc. The preliminary injunctions prohibit the challenged claims and restrict the defendants' ability to use or dissipate their assets.
UPDATE: Coral Calcium Consent Decree of Condemnation and Permanent Injunction
On December 17, 2003, the U.S. District Court for the Northern District of Illinois entered a Consent Decree of Condemnation and Permanent Injunction against Shop America. The decree prohibits “Shop America and each of its directors, officers, agents, representatives … and any and all persons in active concert from directly or indirectly doing or causing any promoting, representing, or suggesting that an article manufactured, marketed, or distributed by Shop America, is safe or effective in the diagnosis or treatment of cancer, multiple sclerosis, lupus, heart disease, high blood pressure, or any other disease in man or other animals.”
Seizure of Forticel and Forticel Mix
On September 18, 2003, at the request of the FDA, U.S. Marshals seized the dietary supplements, Forticel and Forticel Mix, from Jean's Greens in Norway, New York. After an investigation of this company and its marketing practices, FDA determined that Jean's Greens was making unapproved medical claims for these herbal products. Specifically, the products claimed to treat and cure various life-threatening and serious illnesses such as cancer, although there is no scientific evidence to support these claims. The seizure included 385 bottles and 78 mix packages worth more than $4,000.
Because the Forticel and Forticel Mix products make disease claims, FDA considers these products to be unapproved new drugs. Before a new drug product is approved for marketing, it must be shown to be safe and effective. Furthermore, drug product labeling must also include adequate directions for their intended use, which the seized products' labeling did not provide.
After its investigation of the firm's marketing practices, FDA advised the firm that its products were making disease claims and were subject to be regulated as drugs. Despite the FDA's warnings, the firm failed to comply.
Misbranded Dietary Supplements Destroyed
False Claims for hGH Result in Firm Destroying $515,000 Worth of Product
On April 30, 2003, the FDA announced that Nature's Youth, LLC, Centerville, Massachusetts, completed its voluntarily destruction of approximately 5,700 boxes (each containing a 30-day supply) of its misbranded product, "Nature's Youth hGH." This destruction, which occurred at locations in Massachusetts and Florida, was recently completed and involved approximately $515,000.00 worth of product. The firm also indicated it would change the labeling for future marketing of the product in order to comply with the law.
FDA determined the product was misbranded after evaluating unsubstantiated "structure and function" claims made on the company's website, as well as a review of the labeling of the product line. Among the false and misleading claims was that Nature's Youth hGH was a "proprietary blend of amino acids and precursor nutrients which enhance the body's natural production of Human Growth Factors and Insulin-like Growth Factor-1" that would, among other things, "improve physical performance, speed recovery from training, increase cardiac output, and increase immune functions." The product also claimed to be "your body's best defense against aging."
In this case, the company claimed that an article in the New England Journal of Medicine (Volume 323:1-6, Number 1, July 5, 1990) provided substantiation for their claim. However, the New England Journal of Medicine (Volume 348:777-778, Number 9, February 27, 2003) included a clear statement that such a claim was misleading. The editor-in-chief wrote in part, "If people are induced to buy a 'human growth hormone releaser' on the basis of research published in the Journal, they are being misled."
FDA Issues Cyber Letter for “Yellow Jackets”
“Yellow Jackets” Promoted as Illicit Street Drugs – Ephedra Found in Product
On October 7, 2002, FDA announced that it had issued a Cyber Letter (a letter sent via email to notify a company of potential violations) to the operator of an internet web site for promoting and selling Yellow Jackets, an herbal product, as an alternative to illicit street drugs.
Yellow Jackets are promoted as a substitute for controlled substances. According to the promoter's web site, they contain ephedra and other herbal ingredients, including kola nut extract (a source of caffeine). There does not appear to be any legitimate drug use for this product, and its sale as a substitute for controlled substances would be illegal.
FDA is aware that some street drug alternatives are being marketed as dietary supplements. FDA does not believe that street drug alternatives are intended to be used to supplement the diet. Accordingly, street drug alternatives do not meet the definition of a dietary supplement.
Yellow Jackets, described on the web site as herbal XTC, could pose a serious risk to consumers. "Consumers should not purchase or use these or similar products available through the Internet or elsewhere," said FDA Deputy Commissioner, Dr. Lester M. Crawford. "FDA will continue its efforts to protect American consumers from dangerous and fraudulent internet companies who would sell illegal products that present risks to public health."
FDA's "cyber" letters provide foreign operators with an explanation of the statutory provisions that govern interstate commerce of drugs in the United States, as well as a warning that future shipments of their products to this country may be detained at the border and subject to refusal of entry. Copies of each "cyber" letter are sent to regulatory officials in the country in which the operator is based and to other individuals and companies involved in the operation of the web site.
Ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. While products containing natural ephedrine alkaloids have long been used to treat certain respiratory symptoms in traditional Chinese medicine, in recent years they been extensively promoted and used with the goals of aiding weight loss, enhancing sports performance, and increasing energy.
The results of a RAND Corporation study commissioned by the National Institutes of Health, as well as other recent studies, provide additional evidence that ephedra may be associated with important health risks. The Rand Corporation report also found only limited evidence of health benefits resulting from ephedra use. On the basis of new evidence in the medical literature and in adverse event reports, FDA has determined that dietary supplements containing ephedra present a unreasonable risk of illness or injury. * See UPDATE
Ephedra Warning Letters
On February 28, 2003, the FDA issued 28 Warning Letters to purveyors of ephedra products for making unsubstantiated claims about sports performance enhancement on their Internet websites. The RAND Corporation study found only minimal scientific evidence in support of such claims.
At the same time, FDA requested public comment on new evidence of health risks associated with ephedra; on whether the currently available evidence and medical literature present a "significant or unreasonable risk of illness or injury" from dietary supplements containing ephedra; and on a strong new warning label on any ephedra products that continue to be marketed. FDA has received 16,190 comments on these requests -- 14,000 were form letters and 75 were substantive comments. FDA concluded that dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may result from the use of these products.
*UPDATE: FDA Issues Final Rule Prohibiting Sale of Ephedra
On February 6, 2004, FDA issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury. The rule became effective April 12, 2004.
This action was taken under Section 402(f)(1)(A) of the Federal Food Drug and Cosmetic Act which requires evidence of "significant or unreasonable risk" of illness or injury for FDA to deem a dietary supplement product adulterated. There is no requirement that there be evidence that the product has caused actual harm to specific individuals, only that scientific evidence supports the existence of sufficient risk.
The rule applies to all dietary supplements that contain sources of ephedrine alkaloids, such as ephedra, Ma huang, Sida cordifolia and pinellia. All marketed dietary supplements that contain ephedrine alkaloids will be affected by the rule. The rule does not pertain to traditional medicine remedies or conventional foods such as herbal teas. However, Ephedra is not Generally Recognized as Safe (GRAS) for foods and not approved for use as a food additive.
The final rule is at the following URL:
Seizure of Transdermal Patches
The FDA's Florida District Office reported that on July 17, 2003, U.S. Customs and Border Protection (CBP), Miami, Florida, seized a shipment of unapproved transdermal patches and misbranded dietary supplements that were imported from ABC Farma, S.L., Barcelona, Spain, by HT Commerce and Development Inc., Coconut Creek, Florida. Previously, on May 6, 2003, CBP agents notified the FDA's Florida District Office Miami Resident Post of a shipment containing various FDA regulated merchandise (transdermal patches and dietary supplements) that were misdeclared as Machinery Parts, Skin Fresheners and Nail Polish and Enamel removers. The shipment, which was originally thought to consist of machinery parts, contained a total of 1,682 pieces of various transdermal patches and 240 pieces of KiloKal Digest Tablets. The fraudulently misdeclared shipment valued at $29,994 was seized by CBP agents on July 17, 2003.
Court Enjoins Hi-Tech Pharmaceuticals
United States v. Hi-Tech Pharmaceuticals, Inc., et.al. On September 22, 2003, U.S. District Court Judge Robert J. Vining, Jr. entered a Consent Decree of Permanent Injunction enjoining Hi-Tech Pharmaceuticals, National Urological Group, National Institute for Clinical Weight Loss, American Weight Loss Clinic, United Metabolic Research Center, and Jared R. Wheat, President of these corporations, from distributing unapproved new drugs and misbranded drugs. Despite FDA's warnings, defendants repeatedly sold dietary supplements making disease claims for the treatment of obesity and erectile dysfunction. In addition, an FDA laboratory found that certain supplements distributed by Hi-Tech contained "taldalafil," which is the active drug ingredient in Cialis®, an Eli Lilly prescription drug product approved in Europe to treat male erectile dysfunction.
Under the decree, defendants must cease distributing any dietary supplement or drug unless and until, among other things, FDA has reviewed all revised product labeling, promotional literature, and detailed inspection reports from defendants’ consultant. Furthermore, defendants shall not distribute any unsolicited drug or dietary supplement sample unless it is: (1) provided in a child-resistant and tamper-evident packaging; (2) fully labeled in accordance with dietary supplement labeling requirements; and (3) is accompanied by a postage paid response card or toll-free number permitting the consumer to opt out of receiving free product samples in the future. The decree also contains recall, letter shutdown, audit, and inspection cost provisions as well as the arbitrary and capricious standard of review.
Earlier in June 2003, FDA had issued a “Public Health Alert” warning consumers not to purchase or consume certain dietary supplements sold by Hi-Tech Pharmaceuticals, Inc. and related corporation, National Urological Group, because FDA test results found the supplements were adulterated with the prescription-strength drug ingredient “taldalafil.” An interaction between certain prescription drugs containing nitrates (such as nitroglycerin) and taldalafil may cause a drastic lowering of blood pressure. There is a danger that these supplements might be taken by patients who take nitrates, since erectile dysfunction is often a common problem in people with diabetes, hypertension, high cholesterol, heart disease, and in people who smoke.
Conviction of Jason Vale and Christian Brothers
United States v. Jason Vale (E.D.N.Y.). On July 21, 2003, a federal jury in Brooklyn, New York convicted Jason Vale, president of the company Christian Brothers Contracting Corporation ("Christian Bros."), of three counts of criminal contempt. On April 20, 2000, Judge John Gleeson entered a preliminary injunction ordering Vale and Christian Bros., during the pendency of the civil suit, not to directly or indirectly sell, distribute, package, label, or promote Laetrile, also known as amygdalin, "Vitamin B-17," or apricot pits. On November 16, 2000, Judge Gleeson ended the civil suit by permanently ordering Vale and Christian Bros. not to sell, distribute, package, label, or promote Laetrile. For years before the civil suit was brought, Vale, through Christian Bros., had sold Laetrile over the Internet in order to cure and prevent cancer, and saturated the public with a massive Internet and "spam" E-mail marketing campaign which guaranteed persons a cancer free life if they used his products.
FDA determined that Vale set up a shell corporation in Arizona through which he continued to sell Laetrile in defiance of the Court’s injunction. The jury announced the guilty verdicts on July 21, 2003, following the conclusion of a week long trial.
Seizure of Food at Korea Trading Company
On February 5, 2003, FDA investigators from the Chicago District Office accompanied U.S. Marshals in a seizure of food at Korea Trading Company, Skokie, Illinois. An FDA inspection of this food storage facility on September 11-30, 2002, revealed a widespread insect infestation throughout the facility. FDA investigators found many species of live and dead insects at various stages of development in all areas of the facility. Insects were observed flying and crawling around and on susceptible food containers and in the food itself.
In addition, FDA laboratory examination of samples collected confirmed the presence of many species of adult, larval, and pupal insects, insect eggs, insect webbing, excreta, insect gnawed holes in packaging in the samples, including the product itself. All articles of food stored at Korea Trading Company were held under insanitary conditions where they may have become contaminated with filth. An FDA inspection of this food storage facility on December 2-6, 2002, revealed that the facility continued to be infested with insects.
On March 4, 2003, a Consent Decree of Condemnation was entered by the District Court for the Northern District of Illinois. The articles of food (Asian foods stored in a warehouse) were seized because they were being held, in a warehouse, under insanitary conditions whereby they may have become contaminated with filth. The decree requires the Claimant, Korea Trading Company, to: (1) pay $78,000 in the form of a cashier's check, to serve as a rolling bond; (2) retain an outside consultant to develop an appropriate reconditioning plan; (3) recondition the articles of food under FDA supervision, in ten separate lots; and (4) pay FDA's costs incurred to date, as well as FDA's future costs of supervising compliance with the decree. The decree also bars the Claimant from receiving, preparing, packing, holding, and distributing adulterated food, and provides FDA with the arbitrary and capricious standard of review.
On April 22, 2003, the district witnessed the reconditioning of seized food products owned by Korea Trading Co., Inc., Skokie, Illinois. The reconditioning effort was conducted pursuant to the Consent Decree of Condemnation. With the exception of the firm's rice products, which will be reconditioned at a later date under a separate plan, the value of the reconditioned goods is approximately $389,000.
Seizure at Donald Chin Supply Company
On December 2, 2002, District investigators from the FDA’s Baltimore District Office accompanied U.S. Marshals to Donald Chin Supply Company and Gina Chin & Associates, Washington, D.C. to seize food items stored under filthy conditions. The facilities are adjacent to each other, and both are owned and operated by Donaldand Gina Chin. The articles to be seized included foods in permeable containers, such as paper, cloth, burlap, bags, boxes, cartons, and plastic, which are subject to penetration by rodents and/or insects or their filth. The goods were estimated at Donald Chin Supply, Co., to be worth approximately $200,000 and at Gina Chin & Associates to be worth approximately $100,000.
FDA inspections of Donald Chin Supply conducted in August/September 2002, and of Gina Chin & Associates in September 2002, disclosed a widespread and active rodent and insect infestation in the buildings. Investigators observed live and dead rodents, one live bird, numerous insects, as well as a number of rodent nests, rodent gnawed holes, and hundreds of rodent excreta pellets, were seen in various food storage areas. FDA laboratory analysis of a number of samples taken during the most recent inspection confirmed the presence of insects and rodent excreta pellets, urine, nesting material, and hairs. The seizure was accomplished and investigators completed an inventory of all items.
Seizure at Nuts and Spices, Union City, California
On May 22, 2003, the FDA's San Francisco District Office accompanied the U.S. Marshals Service in a seizure of foods at Nuts and Spices, Union City, California. Nuts & Spices is a warehouse that stores imported foods from India, and other foods, such as spices, flour, and beans. An FDA inspection of Nuts and Spice Co. on February 20, 21, 25, and 26, and on March 11 and 14, 2003, disclosed a widespread rodent, insect, bird, and feline infestation throughout the warehouse. FDA collected samples to document rodent and insect activity. The State of California Food and Drug Branch embargoed all food products inside the warehouse.
The articles were adulterated because they had been prepared, packed, and held under insanitary conditions whereby they may have become contaminated with filth. FDA requested seizure of all food products in rodent and insect susceptible containers that had been shipped in interstate commerce and that were located anywhere on the premises, including articles in a 40 foot trailer in the parking lot and a 20 foot container in the courtyard. The articles seized included foods in permeable containers, such as paper, cloth, burlap and plastic bags, boxes, and cartons. The estimated the value of the goods was approximately $164,000.
Consent Decree of Injunction at SCT d/b/e/ Jeppi Nut Company
United States v. SCT Corporation, d/b/a Jeppi Nut Company, a corporation, and Theodore Pavlos and Marina Lillie, individuals(D. Md.). On April 25, 2003, District Court Judge J. Frederick Motz entered a Consent Decree of Permanent Injunction against the above listed defendants. The Decree permanently enjoins the defendants from all food operations, including receiving, processing, preparing, packing, packaging, roasting, manufacturing, holding, and distributing at or from their plants at High Street and Low Street, Baltimore, Maryland, and from the facility located at Colvin Street, Baltimore, Maryland. Furthermore, the Decree sets out two phases in which the defendants are permanently enjoined from all food operations at their new plant in Timonium, Maryland, unless and until they are in compliance.
Phase 1 enjoins the defendants from receiving, holding, repacking, and distributing any article of food at or from their new plant unless and until: (1) the defendants submit a written sanitation standard operating procedure that is approved by FDA; (2) the defendants select a person qualified to inspect food storage and distribution facilities who then certifies whether the defendants have met the conditions of the Decree; (3) the defendants report the actions taken to ensure all articles of food will not be adulterated; and (4) FDA notifies the defendants in writing that defendants appear to be in compliance with these requirements.
Under Phase 2, the Decree permanently enjoins the defendants from processing, preparing, roasting, packaging, and manufacturing any article of food at or from their new plant unless and until: (1) the defendants satisfy all the requirements under Phase 1 and apply the requirements to all food operations; (2) the defendants pay FDA for all foregoing costs; and (3) FDA inspects and notifies in writing that the defendants appear to be in compliance with the Decree, the Act, and all other applicable laws.
The defendants are required to recondition any food, equipment, paper goods, and packing materials presently stored at the old facilities before moving them to the new facility. They are also required to pay the costs of FDA supervision, inspection, review, examination, and analyses conducted pursuant to the Decree. FDA will be permitted, when it deems necessary, to inspect the defendants' facilities without prior notice to monitor and ensure continuing compliance with the Decree.
The defendants are also permanently restrained from doing or causing any act that violates 21 U.S.C. § 331(a) by causing the introduction into interstate commerce of food that is adulterated within the meaning of 21 U.S.C. § §342(a)(3) and (a)(4), or any act that violates 21 U.S.C. § 331(k) by causing food to become adulterated within the meaning of 21 U.S.C. § § 342(a)(3) and (a)(4) after shipment in interstate commerce. The Decree also provides FDA with letter shutdown and recall authority and the arbitrary and capricious standard of review. Finally, the defendants must reimburse the FDA $16,165.05 for FDA's investigational expenses prior to the Decree.
FDA Issues Import Alert on Cantaloupes From Mexico
On October 28, 2002, the FDA issued a nationwide import alert on cantaloupes from Mexico because of insanitary conditions that have resulted in four Salmonellosis outbreaks in the last three years in the United States. These outbreaks were responsible for many illnesses including two deaths and at least 18 hospitalizations. The import alert recommends that officials detain without physical examination cantaloupe from Mexico offered for entry at all U.S. ports.
Investigations of Salmonella outbreaks between 2000 and 2002 showed insanitary conditions in the growing and packing of cantaloupe in Mexico. In addition, FDA sampling of imported produce found some samples of cantaloupe from most growing regions in Mexico tested positive for Salmonella. The samples were collected during both the fall/winter and spring/summer season. This import alert expands prior import alerts that targeted specific shippers and growers whose products were linked to outbreaks or tested positive for Salmonella.
The FDA also announced that it will continue to work with the Mexican government on a food safety program for production, packing and shipping of fresh cantaloupes. The Mexican government has proposed a certification program based on good agricultural practices and current good manufacturing practices (CGMP) that would allow FDA to identify firms that have adopted and implemented such a food safety program. This certification program is still under development.
Salmonella is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis (an infection of the lining of the heart) and arthritis.
Warning Letter Issued for Violations of HACCP Regulations
On June 23, 2003, the FDA's Florida District Office issued a Warning Letter to Indumar Seafood Corporation, Weston, Florida. An FDA inspection of the firm on April 10-15, 2003, revealed deviations from the Importer Requirements of Seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The firm failed to have written product safety specifications for their cooked ready-to-eat crabmeat or for canned pasteurized crabmeat. Also, the foreign manufacturer's HACCP plans for these products were inadequate in that they were not completely written in English, lacked a critical control point of cooking and failed to list a maximum critical limit for storage temperature. A similar deviation was previously brought to the firm's attention in an FDA letter dated January 17, 2001.
Shrimp With Salmonella Refused Entry
The FDA's San Juan District Office reported that frozen shrimp was refused entry due to Salmonella, decomposition, and filth. On June 27, 2003, the San Juan District Office refused entry to frozen shrimp as per FDA Import Alert # 16-18 "DETENTION WITHOUT PHYSICAL EXAMINATION OF SHRIMP." The shipment consisted of 2,708 cartons of 10 pounds each of frozen shrimp, valued at $88,489.
Warning Letter Issued for HACCP Violations
The FDA's Florida District Office issued a Warning Letter on June 17, 2003, to Bobbery Enterprises, Inc., Miami, Florida. An FDA inspection of the firm on January 15 - 17, 2003, revealed serious deviations from the Importer Requirements of Seafood HACCP Regulations. The firm's written product specifications for imported tuna failed to include a written product specification for histamines. Also, the firm failed to maintain records in English that documented the performance and results of the affirmative steps chosen by the firm.
Class I Recall- Importer Recalls Guacamole
The FDA's Southwest Import District reported that on April 1, 2003, AvoCo International, LLC, of Rosemont, Illinois, began a recall of 468 cases of Frozen Casa Solana brand, Western style, guacamole. Southwest Import District reported that it had detained the product on November 12, 2002, after FDA analysis revealed the presence of Listeria monocytogenes. Although a company official assured FDA that the product was intact and on hold, on March 27, 2003, Southwest Import District learned that the shipment had been distributed into U.S. commerce. The Class 1 recall was coordinated by Southwest Import District with the assistance of the FDA’s Chicago District.
Spanish Labeling of Foods Made Medical Claims
The FDA's New England District Office detained an entry due to improper labeling. An entry of food supplements was examined at the port of Highgate Springs, Vermont. The product was labeled in both English and Spanish. While the English labeling made no claims, FDA investigators observed that the Spanish labeling made unapproved medical claims including cancer "cure" claims. The entry was detained and labeling submitted for review. The products were improperly labeled and therefore refused entry. The good were returned to Canada on March 4, 2003. The value of the goods was $507,590.
Canned Vegetables Refused Entry
The FDA's Chicago District Office reported that on April 21, 2003, the district witnessed the destruction of approximately 650 cases of canned mixed vegetables imported by Indian Groceries and Spices of Skokie, Illinois. The product was manufactured by Dry Fruit Stores, Mumbai, India and refused entry for the lack of a filed process. The product was valued at $3,575.
Failure to Hold Goods Results in Warning Letter
On April 24, 2003, FDA issued a Warning Letter to Taylor Farms California, Inc., Salinas, California. The Warning Letter was issued for failure to hold an entry of 9, 588 kg of lettuce for an FDA reconciliation examination under Operation Liberty Shield. The product was entered on a Sunday with an OASIS automatic hold. The following morning, FDA staff in Laredo, Texas, requested documents and location and found that the product had gone to the Taylor Farms Texas, Dallas, Texas. An attempt to make the reconciliation examination the same day in Dallas was unsuccessful as all the lettuce had been shredded and bagged for sale and mostly distributed. The product could not be examined in its original condition as required by the assignment. In addition to the Warning Letter, a request to U.S. Customs and Border Protection (CBP) was made to demand redelivery for future assessment of liquidated damages.
The Warning Letter noted that Title 21 of the Code of Federal Regulations Section 1.90 requires the importer to hold an imported article and not distribute it pending receipt of the results of an FDA examination by the receipt of an electronic or paper release. The letter also noted that failure to prevent future premature distributions of imported produce may result in an FDA recommendation to CBP that future shipments be held in secured storage.
FDA and U.S. Customs and Border Protection Announce Steps to Streamline Collection of Information on Food Imports
On May 27, 2003, FDA and the U.S. Customs and Border Protection (CBP) announced that they will streamline the implementation of the prior notice requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 by allowing food importers to provide required information on food imports to both agencies using an integrated process.
Under the Bioterrorism Act, importers are required to provide "prior notice" about the content of their food imports to FDA, starting no later than December 12, 2003. Since the Bioterrorism Act was passed last year, FDA and CBP have worked together to find ways to modify CBP's Automated Commercial System, currently used to obtain import information required by CBP. As a result of this collaboration, importers, in most circumstances, will be able to provide the required information to FDA using this existing system, making it easier for them to comply with the new law.
Nearly 20% of all imports into the U.S. are food and food products. Congress passed the Bioterrorism Act as part of its ongoing effort to combat terrorism - in this instance, by reducing the ability of international terrorists to carry out terrorist attacks in the U.S. by contaminating imported foods. The Bioterrorism Act requires that FDA receive prior notice before food is imported or offered for import into the United States. The advance notice of import shipments will allow FDA and CBP to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies.
Created on March 1, 2003, as part of the new Department of Homeland Security, U.S. Customs and Border Protection is a combination of all of the agencies with primary responsibility for the borders, including all 18,000 customs, immigration, and agriculture inspectors at more than 300 ports of entry into the United States.
"The men and women of Customs and Border Protection are the guardians of our nation's borders," said CBP Commissioner Robert C. Bonner. "Our primary mission is keeping terrorists and terrorist weapons from entering the U.S. That is why we are partnering with the FDA to protect our nation against the potential of terrorists contaminating our imported food supply. And we are also partnering with the FDA to develop a system that will be less burdensome on the trade while at the same time fulfilling the mandates of the Bioterrorism Act."
FDA reviewed the comments submitted on the proposed rule published on February 3, 2003, and issued an interim final rule on October 10, 2003. The Bioterrorism Act requires prior notice for imported food shipments beginning December 12, 2003.
Seafood Sausage Food Firm Warned
Inadequate HACCP Plan Failed to Identify Hazard of Clostridium Botulinum
The FDA's New Orleans District Office issued a Warning Letter to Baudin's Sausage Kitchens, Inc., a seafood sausage manufacturer located in St. Martinville, Louisiana. An FDA inspection of the firm on March 17-19, 2003, revealed deviations from the HACCP regulations. The firm's HACCP plan for vacuum-packaged crawfish sausage and crawfish balls did not identify Clostridium botulinum as a hazard in those products which are labeled to store under refrigeration. In addition, the firm's HACCP plan did not require the firm to continuously monitor the freezer or cooler used to store the finished product and did not list the time of exposure for cooking the casing components.
Warning Letter Issued for Gross Insanitary Conditions
On June 9, 2003, the FDA's Los Angeles District Office conducted a routine current good manufacturing practice (CGMP) inspection on April 23- May 5, 2003, at Joy Processed Foods, Inc., Long Beach, California. The firm is a manufacturer of raw and cooked potato products. The inspection revealed gross food CGMP deficiencies. The firm failed to take the necessary precautions to protect against contamination of cooked potato products, failed to conduct adequate cleaning and sanitation operations for equipment and utensils, and failed to operate fan and air-conditioner units in a manner to control potential contamination of their cooked products. The firm's employees lacked adequate training in CGMPs and failed to maintain adequate personal cleanliness.
In all, twelve specific violations of CGMP regulations were cited in the Warning Letter. These conditions caused the products processed in the facility to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth.
Herring with Listeria Monocytogenes Recalled
FDA Inspection Finds Listeria Monocytogenes In Swabs Collected At Facility
The FDA's New York District Office reported that Schmaltz Appetizing, Brooklyn, New York, had ceased production of all products and was recalling Schmaltz Herring. The FDA conducted an inspection of the facility in July 2003. Samples collected during the inspection were positive for Listeria Monocytogenes. FDA informed the firm that the environmental swabs were found positive for Listeria Monocytogenes in 4 of 25 swabs analyzed by FDA's Northeast Regional Laboratory. As a result, the firm decided to destroy the Schmaltz Herring in stock and recall the distributed lot of this product. This product had a lot number of 8/06. The firm also decided to cease production and packaging of all products until the Listeria problem could be eliminated. This firm is a small manufacturer of various kosher fish and vegetable salads. This firm also hired a private consultant to help bring their firm into compliance.
Listeria monocytogenesis an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Almonds in Oatmeal Results in Recall
The FDA's Chicago District Office reported that Quaker Oats, Chicago, Illinois, met with FDA officials regarding a recall of its Brown Sugar Bliss cereal. The cereal was recalled because it contained undeclared almonds. The product was manufactured by Ralston Corp., Sparks, Nevada. The firm issued a press release on February 21, 2003. The recall involved Oatmeal Brown Sugar Bliss, packaged in 16-ounce boxes with the "best if used by" dates of SEP 08 03RS, SEP 09 03RS and SEP 10 03RS.
The recall may have affected approximately 23,000 cases of the cold cereal nationwide, because the product may contain almonds. People who have an allergy or severe sensitivity to almonds may run the risk of serious or life-threatening allergic reaction if they consume these products. No other Quaker cereal or food product was affected.
FDA Inspection Finds E. Coli in Crawfish
E. Coli and Insanitary Conditions Found in Fish Processing Facility
On July 10, 2003, the FDA's New Orleans District Office issued a Warning Letter to Acadiana Fishermen's Co-Op, Henderson, Louisiana. The Warning Letter was based on deviations observed during an FDA inspection of that facility conducted on April 1-9, 2003. The firm is a contractor for processing crawfish.
FDA's Southeast Regional Laboratory found a sample of crawfish tailmeat labeled under the Atchafalaya Crawfish Processor brand name was positive for Escherichia coli (E. coli). The inspection uncovered numerous deviations from the HACCP regulations and insanitary conditions. FDA notified the firm of this finding in a letter dated April 30, 2003, from FDA's Southeast Regional Laboratory in Atlanta, Georgia.
E. coli is a bacterium commonly associated with fecal contamination of warm blooded animals. In the production of commercially processed crawfish, cooking destroys non-spore forming bacteria, including E. coli. Therefore, the presence of E. coli in the finished product indicates that either the cooking was inadequate or the product was re-contaminated after the cooking step. Recontamination after the cooking step could be a result of insanitary practices by the employees in the plant. The Warning Letter advised that strict in-plant sanitation measures must be instituted to prevent the presence of the organism in the finished product.
Warning Letters for Deviations from HACCP Regulations
On July 15, 2003, the FDA's New York District Office issued a Warning Letter to Carl's Seafood, Inc., New York, New York. An FDA inspection of the firm on June 25, 26 and 27, 2003, and found serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. For example, the firm did not have a HACCP plan for vacuum packed smoked salmon to control the food safety hazard of Clostridium botulinum toxin formation.
Strict temperature control is necessary to prevent toxin formation by Clostridium botulinum. During the inspection the FDA investigator observed vacuum packed salmon, which is labeled to keep refrigerated at 38 degrees F, on street display and not covered with ice. The Warning Letter noted that, "A HACCP plan must be implemented listing the critical control points (e.g., receiving, display, storage); the appropriate critical limit (e.g., 38EF or covered with ice); monitoring procedures; corrective actions; record keeping; and verification procedures."
The FDA's New Orleans District Office issued a Warning Letter on June 27, 2003, to Interland Seafood, Bayou La Batre, Alabama. The firm is a crabmeat processing facility. The FDA inspection conducted from May 12 - 14, 2003, disclosed that the firm did not monitor the sanitation of the facility or the critical control points listed in its HACCP plan for crabmeat. FDA found serious deviations from the Seafood HACCP regulations.
For example, the firm was observed using hydrochloric acid to clean cooking equipment. In addition, numerous improper employee practices were observed, such as contacting unsanitary equipment and then handling cooked crabs without washing or sanitizing their hands. Flies were observed landing on product and equipment within the processing room. Furthermore, the plumbing of the hand washing station in the processing room drained directly onto the floor.
- The FDA's New Orleans District Office issued a Warning Letter to Sharkco Seafood International, Inc., Venice, Louisiana, on July 29, 2003. During an FDA inspection of the firm on June 23, 2003, the FDA's New Orleans District Office documented that the firm's HACCP plan for histamine-forming fish was inadequate for critical limits and monitoring procedures. The firm also did not retain records for at least one year as required.
On July 30, 2003, the FDA's San Francisco District Office issued a Warning Letter to ABS Seafood Company, San Francisco, California, based on serious deviations from the seafood HACCP regulations. The FDA conducted an inspection of the firm on May 9 - 12, 2003. The firm is a wholesale processor of various types of fresh fin fish including scombroid species, Mahi-Mahi, and salmon. The deviations included the failure to conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan to control any food safety hazards that are reasonably likely to occur.
As an example, the firm did not maintain sanitation monitoring records for the condition and cleanliness of food contact surfaces, prevention of cross-contamination, maintenance of hand washing, hand sanitizing, and toilet facilities, and exclusion of pests from the facility required for the processing of small tuna, large tuna, yellowtail, and mackerel products.
On March 20, 2003, the FDA’s Los Angeles District Office issued a Warning Letter to Imperial Chefs Food, Inc., Los Angeles, California, for continued HACCP deficiencies for their fishery products.An FDA inspection of the firm on January 21-24, 2003, disclosed that the firm had no HACCP plans for fresh mackerel to control the hazard of histamine formation or for prepared meals, including salmon and shrimp, to control pathogen survival through cooking, or pathogen growth.
Moreover, the firm did not maintain sanitation control records, and failed to monitor sanitation conditions. A number of serious sanitation deficiencies were noted during the inspection, including a refrigerator holding raw and precooked fishes including Spanish mackerel at 52 degrees Fahrenheit, poor employee practices, dirty processing equipment, and inadequate pest control.
- On April 10, 2003, the FDA's New England District Office issued a Warning Letter to Milford Seafood Corp., Milford, Connecticut, for HACCP deficiencies. An FDA inspection of the firm from March 13 - 17, 2003, disclosed that the firm had no HACCP plan for refrigerated, canned pasteurized crabmeat to control the food safety hazard of Clostridium botulinum. In addition, the firm was not implementing the monitoring and record keeping procedures listed in their HACCP plan for histamine species for the receiving and dry cooler storage critical control points.
Voluntary Destruction of Contaminated Crabmeat
On January 29, 2003, the FDA's Detroit District Office witnessed the voluntary destruction of 302 pounds of contaminated crabmeat worth approximately $4,500. The destruction occurred at Morey's Seafood International LLC, Detroit, Michigan. Previous analysis of the crabmeat revealed the presence of chloramphenicol. The crabmeat was a product of China and labeled as "Jackpot Brand JUMBO PASTEURIZED CRAB MEAT."
Crabmeat Contaminated with Listeria Refused Entry
The FDA's Seattle District office refused entry and U.S. Customs and Border Protection supervised the exportation of 3,400 pounds of cooked Dungeness crab valued at $10,200. The Dungeness crab was contaminated with Listeria monocytogenes. The crab had been consigned to Pacific Seafood Co. Inc., Clackamas, Oregon, and the importer of record was Calkins & Burke Ltd, Vancouver, B.C., Canada.
Voluntary Compliance Achieved
The FDA's San Francisco District Office's reported that a shipment of Calamari Steaks and Strips from Peru, was decomposed. The importer decided to voluntarily destroy the goods. This shipment of Calamari Steaks and Strips, imported by Deibert and Associates, Walnut Creek, California, consisted of 1,344 cartons and valued at $52,346. The foreign manufacturer was Mar Peruano Empresa Pesquera, S.A., Lima, Peru. Destruction was conducted under the supervision of the FDA and the State of California Food and Drug investigators.
Uncertified Shellfish Seized
The FDA's New York District Office visited Hall Street Cold Storage Warehouses Inc., Brooklyn, New York, for the purpose of examining a shipment of uncertified shellfish, namely, fresh frozen oysters, baby clams, and razor clams from China. Based on the label examination performed, the products were raw. The FDA's New York District Office contacted the New York State Department of Conservation (DEC) and the 760 cartons of uncertified shellfish, valued at $8,733, were seized on March 12, 2003. The New York District Office also contacted U.S. Customs and Border Protection to place criteria in their database to enable future entries to be held, examined, and possibly seized.
Seizures of Seafood with Chloramphenicol
The following list of seizures are all related in that the crabmeat came from one commingled imported shipment of crabmeat from Vietnam, by Piazza's Seafood World, L.L.C., Harahan, Louisiana.
Piazza's Seafood World, L.L.C.- New Orleans Perishables
- The FDA's New Orleans District Office accompanied the U.S. Marshals Service in a seizure on August 2, 2003, of imported frozen crabmeat from Vietnam, stored at New Orleans Perishables, Kenner, Louisiana, and owned by Piazza's Seafood World, L.L.C., Harahan, Louisiana. The value of the crabmeat was approximately $1,600. Samples of the crabmeat were originally collected on March 5, 2003, from 97 cases (24, 1 pound bags/case). Samples of the crabmeat were confirmed, including check analysis, for the presence of chloramphenicol by the Denver Laboratory. By August 2, 2003, the commingled lot had dwindled to 23 cases.
Piazza's Seafood World, L.L.C. Southern Cold Storage Company
- The FDA's New Orleans District Office conducted a seizure on August 5, 2003, of imported frozen crabmeat from Vietnam, stored at Southern Cold Storage Company, Baton Rouge, Louisiana, and owned by Piazza's Seafood World, L.L.C., Harahan, Louisiana. Two of four pallets of commingled product were on “stop order” by the State of Louisiana Department of Agriculture and Forestry. Samples of the crabmeat from the original commingled lot were originally collected at New Orleans Perishables, Kenner, Louisiana, on March 5, 2003. The samples were confirmed, including check analysis, for the presence of chloramphenicol by the FDA’s Denver Laboratory. In total, 502 cases (24 one- pound bags) were seized. The value of the crabmeat was approximately $36,000.
Richard's Cajun Food, Inc.
- The FDA's New Orleans District Office conducted a seizure on August 15, 2003, of 46 cases (24, 1 pound bags/case) of imported frozen crabmeat from Vietnam, and 625 cases (8, 12 ounce plastic bowls) at Richard's Cajun Food, Inc., Church Point, Louisiana. Samples of the crabmeat from the original commingled lot were originally collected at New Orleans Perishables, Kenner, Louisiana, on March 5, 2003. The samples were confirmed, including check analysis, for the presence of chloramphenicol by the FDA’s Denver Laboratory. The value of the crabmeat is approximately $5,700. The value of the seafood jambalaya was approximately $11,000.
Piazza's Seafood World, L.L.C. - Harahan, Louisiana
- On August 26, 2003, the FDA's New Orleans District Office accompanied the U.S. Marshals Service in a seizure of two partial cases of crabmeat, approximately 46 pounds, from Piazza's Seafood World, L.L.C., Harahan, Louisiana. The crabmeat was originally part of a commingled lot of imported frozen crabmeat from Vietnam. Samples of the commingled lot of crabmeat were originally collected on March 5, 2003, from 97 cases (24 one-pound bags/case). The final sample was confirmed, including check analysis, for the presence of chloramphenicol by the FDA’s Denver Laboratory. The two cases were not intact due to previous sampling by the State of Louisiana Department of Agriculture and Forestry. The value of the crabmeat was approximately $144.00.
Seizure of 1,666 Cartons of Raw Frozen Salad Shrimp
- On November 19, 2002, FDA investigators from the Florida District Office accompanied the U.S. Marshals Service in a seizure of 1,666 cartons of raw frozen salad shrimp located at Beaver Street Fisheries. The raw frozed salad shrimp were contaminated with chloramphenicol. The Florida Department of Agriculture and Consumer Services (FDACS) placed the article under a Stop Sale Order on July 12, 2002. A sample of the article, collected by FDACS on July 10, 2002, and analyzed in the Chemical Residue Lab of FDACS, was found to contain 1.2 ppb of chloramphenicol. FDA confirmed that another sample of the article (FDA sample 175246), collected by the FDA on July 18, 2002, and analyzed by FDA's Denver District Laboratory, contained chloramphenicol.
Consent Decrees of Injunction Involving Seafood
Blue Ribbon Smoked Fish, Inc.
- U.S. v. Blue Ribbon Smoked Fish, Inc., (E.D.N.Y.). On September 16, 2003, the district court, on remand, issued a memorandum and order to clarify the scope of the injunction in this case involving a smoked fish processing operation. The Second Circuit found too broad a provision of the district court's 2002 Order enjoining the individuals from processing and distributing smoked fish at other locations. Because there was no plan to reopen the plant, the Second Circuit held that the individual defendants should not be banned from participating in the smoked fish business.
The government submitted a proposed Amended Final Order of Permanent Injunction to clarify that the individual defendants would not be required to correct the problems at the Blue Ribbon facility if it remained closed, but that they would be subject to the other terms of the injunction if they chose to work in the fish industry in positions with responsibility for sanitation or quality control. Defendants objected to the proposed Amended Order. In its September 16, 2003, decision, the district court held that the provisions of the proposed Amended Order were appropriate, although it imposed a five year limit on the requirement that the individuals notify any new employers of the injunction.
Silver Seafood, Inc.
- U.S. v. Silver Seafood, Inc., (S.D. Ala.). On August 29, 2003, United States District Judge William H. Steele entered a Consent Decree of Permanent Injunction against Silver Seafood, Inc. The Complaint for Injunction alleged that the defendants violated the Federal Food, Drug, and Cosmetic Act (Act) by causing the adulteration of food (ready-to-eat crabmeat) while it was held for sale after shipment in interstate commerce. The defendants did not maintain sanitation in their facility nor did they adequately implement their HACCP plan, rendering their crabmeat adulterated. The Decree contains the standard provisions permitting letter shut down, reinspection authority, and reimbursement of inspection costs.
Aquidneck Lobster Company, Inc.
- U.S. v. Aquidneck Lobster Company, Inc., (D. R.I.). On August 27, 2003, United States District Judge William E. Smith entered a Consent Decree of Permanent Injunction against Aquidneck Lobster Company, Inc. The Complaint for Injunction alleged that the defendants violated the Federal Food, Drug, and Cosmetic Act (Act) by introducing adulterated food (ready-to-eat lobster) into interstate commerce and by causing food to become adulterated while it was held for sale after shipment in interstate commerce. The defendants failed to maintain sanitation in their facility and did not adequately implement their Hazard Analysis and Critical Control Point plan, rendering their lobster adulterated. The Decree contains the standard provisions permitting letter shut down, reinspection authority, and reimbursement of inspection costs.
Sushi Redi, Inc.
- United States v. Sushi Redi, Inc., (D. Colo.). On July 23, 2003, the District Court entered a consent decree permanently enjoining the defendants from causing food to become adulterated while held for sale after shipment in interstate commerce. The defendant companies and individuals processed ready-to-eat raw and cooked seafood products under insanitary conditions, violating good manufacturing practice and HACCP regulations. Additionally, some of the defendants' raw ingredients and finished products, as well as the processing plant itself, contained the bacterium Listeria monocytogenes.
- The decree requires the defendants to retain an outside expert to develop a HACCP plan, an employee training program, a sanitation standard operating procedure, and an environmental microbial monitoring program. After FDA approves the plans developed by the defendants' expert, the defendants must implement the plans to FDA's satisfaction. The consent decree contains recall and letter shut-down provisions, requires the defendants to reimburse FDA for costs incurred in ensuring compliance with the decree, and provides the government with review under the arbitrary and capricious standard.
Fish & More, Inc.
- United States v. Fish & More, Inc. On February 27, 2003, the United States District Court for the Western District of Missouri entered a Default Judgment and Order of Permanent Injunction against defendants Fish & More, Inc., Jon D. Dickerson, Terry A. Dickerson, and Jonny B. Dickerson. The Order finds that defendants violate the Federal Food, Drug, and Cosmetic Act (Act) by causing the introduction into interstate commerce of raw finfish that is adulterated within the meaning of the Act in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
The Order also finds that defendants violate the Act by causing such raw finfish to become adulterated while it is held for sale after shipment in interstate commerce. The Order permanently enjoins defendants from preparing, packing, holding, or distributing any fish or fishery product unless and until defendants, among other things: establish sanitation standard operating procedures (SSOP) acceptable to FDA; select a qualified expert to inspect their plant and certify to FDA whether the requirements of such SSOP have been met; report all actions they have taken to ensure that articles of food prepared, packed, held, and distributed by them are not contaminated with filth or exposed to insanitary conditions; and destroy, at their own expense and under FDA's supervision, all articles of food that have been contaminated with filth. Defendants must pay all costs of FDA supervision pursuant to the Order.
In addition, the Order provides FDA with immediate shut-down authority if defendants are not in compliance with the Order, the Act, or applicable regulations. All FDA decisions under the Order are subject to review by the court under the arbitrary and capricious standard.
Springfield Smoked Fish Co., et al.
- United States v. Springfield Smoked Fish Co., et al., (D. Mass.). On December 27, 2002, United States District Judge Frank H. Freedman signed a Consent Decree of Permanent Injunction against Springfield Smoked Fish Co. The Complaint for Injunction alleged that the defendants violated the Federal Food, Drug, and Cosmetic Act (Act) by introducing adulterated smoked fish into interstate commerce. The Complaint also alleged that the defendants violated the Act by causing the adulteration of the fish while it was held for sale after shipment in interstate commerce. The defendants failed to verify that their HACCP plans for vacuum-packaged smoked fish were adequate to control the hazard associated with the formation of Clostridium botulinum toxin, rendering the products adulterated. The Decree contains the standard provisions permitting letter shut down, reinspection authority, and reimbursement of inspection costs.
Northern Quality Seafood & Research Enterprises, et al.
- United States v. Northern Quality Seafood & Research Enterprises, et al., (C.D. Ca.). On October 30, 2002, U.S. District Judge Lourdes G. Baird entered a Consent Decree of Permanent Injunction against the defendants. The decree perpetually enjoins the defendants from manufacturing, processing, packing, holding, and distributing any food unless and until they bring their smoked fish processing operation into compliance with HACCP regulations and the requirements of the Federal Food, Drug, and Cosmetic Act, to the satisfaction of FDA. The decree also provides FDA with letter shutdown and recall authority and the arbitrary and capricious standard of review.
Rock Landing Seafood
- United States v. Elizabeth C. Metcalf, and Carl F. Metcalf, individuals d/b/a/ Rock Landing Seafood (N.D. Fla.). On May 12, 2003, District Court Judge Robert L. Hinkle entered a Consent Decree of Permanent Injunction against the above-listed defendants. The decree perpetually enjoins the defendants from processing, packing, holding, and distributing any crabmeat products or live raw crabs at or from their old facility at 16 Rock Landing Road, Panacea, Florida. Further Defendants are permanently enjoined from processing, packing, holding, and distributing any crabmeat products or live raw crabs from any other locations unless and until:
- the defendants establish and implement a written HACCP plan, a Sanitation Standard Operation Procedure (SSOP), and an employee training program appropriate for the processing of crabmeat products, which must each be submitted to and approved by FDA;
- an outside expert reviews the defendants' plans (or develops such plans himself/herself) and certifies in writing that the plans are appropriate for the processing of crabmeat products;
- the defendants have assigned the responsibility for implementing and monitoring these plans to an employee who is trained in crabmeat processing and sanitation procedures;
- the defendants have reported, in writing, to FDA all actions they have taken to ensure that exposure to food safety hazards at their facility is controlled and that their crabmeat products are not contaminated with filth or exposed to insanitary conditions; and
FDA has notified the defendants, in writing that their processes and controls appear to be in compliance with the decree, the Federal Food, Drug, and Cosmetic Act, and 21 CFR Parts 110 and 123.
Upon Entry of the decree and the defendants' resumption of operations at their new seafood facility FDA shall inspect the defendants' facility to ensure that: (1) the defendants have thoroughly cleaned, sanitized, and renovated their facility; (2) the defendants have rid their facility of pests and filth, and have taken actions to prevent the re-entry of such pests; and (3) the defendants have actually implemented the HACCP plan, SSOP, and employee training program discussed above. The defendants will pay the costs of FDA's supervision, inspection, review, examination, and analyses conducted pursuant to the Decree. FDA will be permitted to inspect the defendants' facilities without prior notice to monitor and ensure continuing compliance with the Decree.
The defendants are also permanently enjoined from doing or causing to be done any act that violates 21 U.S.C. §331(a) by causing the introduction into interstate commerce of food that is adulterated within the meaning of 21 U.S.C. §342(a)(4) or any act that violates 21 U.S.C. §331(k) by causing food to become adulterated within the meaning of 21 U.S.C. §342(a)(4) after shipment in interstate commerce. The decree also provides FDA with letter shutdown and recall authority and the arbitrary and capricious standard of review.
Filthy Conditions Found in Storage of Spices
On March 18, 2003, the FDA's New Orleans District Office issued to a Warning Letter to A Spicy World Company, Kenner, Louisiana. An FDA inspection of the facility on January 21, 22, and 28, 2003, documented extremely filthy warehousing conditions resulting in contaminated food products. Evidence of rodent activity (including live and dead rodents, rodent excreta pellets, rodent urine stains, and rodent gnawed food products) was observed in, on, and near several different food product packaging material including, but not limited to, poppy seeds, black pepper, and meat tenderizer.
The FDA's Southeast Regional Laboratory confirmed the findings of the rodent activity from samples taken from the facility. During the inspection, the firm voluntarily destroyed at least 250 pounds of food products.
Sage Contaminated with Salmonella Recalled
On July 5, 2003, the FDA posted a notice on its Website that William E. Martin & Sons Co., Inc., Jamaica, New York, was recalling a lot of sage after being notified of a positive sample of ground sage for Salmonella. The lot of sage was imported by this firm from Turkey. Two 50 pound bags of this lot were distributed and the firm voluntarily recalled them from their one consignee. The remainder of the lot was still in the firm's possession in Jamaica, New York, and in their warehouse, Glendale Warehouse, in Port Newark, New Jersey. The firm's recall was monitored and future importation of the spices imported by William E. Martin & Sons will be monitored.
Warning Letter Issued for Inadequate Backflow
On July 2, 2003, the FDA's Detroit District Office issued a Warning Letter to Delta Air Lines, Inc., Atlanta, Georgia. An FDA inspection on June 11-12, 2003, of Delta's watering point/service area located at the Indianapolis, Indiana Airport, revealed inadequate backflow protection on the potable water line used to fill their potable water cart. The inspection also revealed poor employee use and storage practices related to potable water and lavatory equipment. Specifically, the potable water hose was misused when servicing employees of another company were allowed to place the hose in the floor drain and used it for flushing purposes during airport maintenance of clogged drains.