Inspections, Compliance, Enforcement, and Criminal Investigations

Center for Food Safety and Applied Nutrition 2001

Chapter 4

Last Update: August 07, 2003

Allergens

In 2001, the FDA's Center for Food Safety and Applied Nutrition increased its activities on food allergen awareness. A major goal of the initiative was to provide guidance to industry and regulators on how to manage allergens through appropriate manufacturing and labeling practices. Numerous food recalls were conducted in Fiscal Year 2001, based on the presence of an undeclared food allergen in a product.

In Food Allergen Awareness: an FDA Priority, New Initiatives Focus on Allergens in 2001, authors Kenneth J. Falci, Ph.D., Kathy L. Gombas and Elisa L. Elliot Ph.D., Series Editor: Catherine Kitty Bailey, M. Ed., discuss food allergens.

For sensitive individuals, the presence of allergens in food is potentially life-threatening. Currently, there is no cure for food allergy. The only successful method to manage food allergy is avoidance of foods containing the allergen. Fortunately, most consumers are aware of their specific sensitivities and can avoid foods that might result in a life-threatening situation. For example, a person with a peanut allergy may find it easy to avoid whole peanuts. Formulated foods, however, present a separate challenge. In such cases, the individual relies on accurate ingredient labeling. The FDA, food manufacturers and special interest groups are working to increase public awareness of the seriousness of allergic reactions and to assure that allergens are appropriately labeled in food products. For example, one of the U.S. Department of Health and Human Services "Healthy People 2010" initiatives for the coming decade is to reduce the number of deaths due to anaphylaxis caused by food allergens.

The number of allergic individuals in the U.S. is unknown. Estimates suggest, however, that 1.5% of the adult population and 5% of children younger than three years old have some form of food allergy. One estimate of the number of fatal food anaphylaxis cases in the U.S. is 125 per year.

The Ingredient Label: Alert for the Allergy-Sensitive Person

The FD&C Act requires, in virtually all cases, a complete listing of all ingredients of a food on the food label. In certain cases, such as with allergens, public health concerns have been noted as FDA took steps to require particular wording in an ingredient statement. For example, 21 Code of Federal Regulations (CFR) 102.22 requires the food source identification for protein hydrolysates, e.g., hydrolyzed wheat gluten, and hydrolyzed soy protein. Failure to list an ingredient on the food label, particularly an allergen, has resulted in product recalls. A recent review of FDA food recall actions for undeclared allergens such as peanuts, egg, or milk revealed an increase in recalls in the last decade. Recall activity increased from an average of 35 per year at the beginning of the last decade to an average of 90 per year during the last four years of the same decade.

Bakery Products

Undeclared Eggs in Italian Rolls Result in Recall

In August 6, 2001, Bella Napoli, located in Troy, New York, recalled a product labeled as Italian Rolls because it possibly contained undeclared eggs. Dinner rolls, which contained eggs were inadvertently packaged in bags and labeled as Italian Rolls, which did not contain eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

Rolls were distributed through Price Chopper stores in Troy, Latham Cohoes and Watervliet. Product was packaged in a 16 ounce, uncoded clear plastic bag, containing twelve rolls. The recall was initiated when the New York State Department of Agriculture and Markets laboratory analysis disclosed that the dinner rolls contained eggs.

Chocolate Chip Cookies Recalled Due to Undeclared Pecans and Almonds
FDA Assists Firm in Class I Recall of Cookies With Undeclared Nuts

On August 21, 2001, Publix Super Markets Inc., voluntarily recalled Publix Bakery Chocolate Chip Cookies purchased between August 13 and August 20, 2001, in Jacksonville, Florida division stores. The product possibly contained undeclared pecans and almonds. People who have an allergy or severe sensitivity to these products run the risk of serious or life threatening allergic reaction if they consume these products.

Publix Spokesman Lee Brunson said, "We are working very closely with the Food and Drug Administration and our manufacturing facility to resolve this situation with accuracy and expedience." The company received no customer complaints regarding this product.

Recall of Animal Crackers with Undeclared Milk and Egg
FDA Analysis Reveals Low Levels of Calcium and Phosphorous in Rice Beverage

On June 11, 2001, the FDA's Philadelphia District Office received notice that Stuaffer Biscuit Co., York, Pennsylvania, was initiating a voluntary recall of 8,163 cases of Jungle Jammers Animal Crackers because of undeclared milk and egg products. The product was packaged in a 13-ounce retail box for Save-A-Lot Food Stores and was distributed in the following 12 states: Kentucky, Georgia, Michigan, Tennessee, Missouri, Texas, California, Florida, New York, Ohio, Maryland and Indiana, under the Save-A-Lot Food label only. The firm issued a press release on June 11, 2001. The district followed up at the firm to collect recall information.

Class 1 Recall of Hamburger Buns

On September 12, 2001, Flowers Bakeries of Thomasville, Georgia, initiated a recall of select codes of Cobblestone Mill seeded 8-pack hamburger buns because the buns possibly contained undeclared egg as an ingredient. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products. The Cobblestone Mill seeded 8-pack hamburger buns were distributed to supermarkets and other food stores in West Virginia, Kentucky, North Carolina, South Carolina, Tennessee, Ohio and Virginia.

The firm initiated the recall after it was discovered that product containing egg was distributed in packaging that did not reveal the presence of egg. Subsequent investigation indicated the cause of the problem was a temporary breakdown in the company's production and packaging processes.

Beverages

Warning Letter Issued for Low Levels of Nutrients

On July 25, 2001, the FDA's New Jersey District Office issued a Warning Letter to Parmalat/Farmland Dairies, Wallington, New Jersey, for their Westbrae Natural Rice Beverage. FDA conducted an inspection of Farmland Dairies from November 16 - 21, 2000. During the inspection investigators collected a sample of the beverage. FDA analysis revealed that the levels of calcium and phosphorus in the product were found to be well below the declared amount of calcium on the label. FDA laboratory results disclosed results of 16.1%, 9.64% and 21% of the declared amount of calcium. In addition, laboratory analysis disclosed 31.6%, 23.5% and 39.2% of the declared amount of phosphorus.

Infant Formula Class I Recall

In July 2001, the FDA's Detroit District Office received notice from Mead Johnson Nutritionals, Evansville, Indiana, of a new formula recall. The firm distributed sample packs [originally intended for distribution to physicians] at retail stores without an ingredient statement or nutritional labeling. The FDA's Center for Food Safety and Applied Nutrition conducted a health hazard evaluation and concluded that one of the three products, Enfamil LactoFree infant formula, represented a Class I health hazard for infants allergic to milk protein.

The single serve containers, which did not declare milk protein, could become separated from the outer pack, which stated "the goodness of milk protein without the lactose." The firm determined that 19 sample packs had been sold in one or more Babies 'R Us stores located in the following nine states: Colorado, Iowa, Kansas, Minnesota, Missouri, Oklahoma, Tennessee, and Texas. A press release was issued on July 28, 2001.

Damaged Evaporated Milk From Canada Detained
FDA Supervises Reconditioning and Destruction of Detained Product

On March 19, 2001, the FDA's San Juan District Office detained a shipment of canned evaporated milk, manufactured by Nestle, Canada. The product consisted of 129,696 cases of 24 cans of 13 ounces each, valued at 1 million dollars. The evaporated milk had been damaged due to bad weather conditions while in transit to Nestle, Inc., Puerto Rico. The FDA's San Juan District Office supervised a reconditioning process conducted by Nestle Inc. The product was found to be unfit for human consumption was destroyed under the FDA and U.S. Customs supervision.

Firm Recalls Packaged Drinking Water
Sanitizer Found in Bottled Drinking Water

On August 17, 2001, Bareman Dairy, Holland, Michigan, announced that, in cooperation with the FDA, it was conducting a recall of 19,700 Gallons of Bareman Dairy Crystal Clear Drinking Water Packaged in One Gallon Containers. The Gallon Containers were coded with a sell by date of Dec 8 JD. Bareman Dairy determined that a portion of this lot possibly contained an equipment sanitizer.

This sanitizer was made of a mix of peroxiacetic acid and hydrogen peroxide. Consumption could cause irritation or burning of the throat and stomach. The company advised consumers that if you experience irritation or burning, immediately dilute by drinking several glasses of water and contact the proper medical authority, do not induce vomiting. The recall was instituted after company testing revealed the problem pursuant to a customer complaint. The product, run under the Bareman Dairy label, was distributed in Michigans Lower Peninsula, Northwestern Indiana, and Illinois. Consumers who purchased the Drinking Water dated December 8 were urged to discontinue use of the product immediately and return to the place of purchase for a full refund.

“Carnation Follow-Up Formula Recalled Due to Possible Health Risk
Excessive Levels of Magnesium Found in Follow-Up Formula

On September 14, 2001, Nestlé, Glendale, California, initiated a recall of 120 cans of Nestlé Carnation Follow-Up Formula, 32-fluid-ounce Liquid Ready to Feed, due to excessive magnesium in these cans. Long term extended use of the product could have the potential to cause severe adverse health effects, such as low blood pressure and irregular heart beat.

Symptoms to look for in children would include poor feeding, unusually pale color and weakness. There were no reports of illnesses associated with this product. The product was distributed only to Wal*Mart stores in the following Texas cities: Crockett, Hempstead, Lewisville, Denton, Plano, Garland, Murphy, Corsicana, Sulphur Springs, Humble, The Woodlands, Longview, Katy-Houston, Center, Irving, Bedford, Grand Prairie, Lancaster and Arlington.

No other Nestlé Carnation formula products or forms (such as powder or concentrate) were involved. The recall was limited to 120 cans of Nestlé Carnation Follow-Up Formula, 32- fluid-ounce Ready To Feed with the following production code stamped on the top of cans: 1203EWFR3551. The code appeared under the "use by" date, 22 Jan 2003, and may or may not be followed by one additional letter. The recall was the result of routine quality assurance sampling by the company which revealed that one batch of the formula had a high magnesium content.

FDA Supervises Destruction of Moldy Tomato Juice

On June 22, 2001, the FDA's San Juan District Office witnessed the destruction of 459 cases of 24/12 ounce cans of Tomato Juice manufactured by Productos Del Tropico, C.X.A., Dominican Republic, valued at $3,442.50. The product was sampled, and laboratory results revealed the product contained excessive rot and mold. The product was consigned to Empresas La Famosa, Toa Baja, Puerto Rico, who voluntarily chose to destroy the product.

Candy and Sweeteners

FDA Warns Consumers About Candy That Poses Choking Hazard
"Konjac" Jelly Cups Imported from Asia Cause Choking in Children

On August 17, 2001, FDA issued a warning to consumers of a potential choking hazard posed by konjac jelly cups imported from Asia. After consultation with the Consumer Product Safety Commission, the FDA issued a second warning on October 5, 2001. Some of the candy had warning labels, suggesting that it not be eaten by children or the elderly. Other labels warned of a choking hazard and said to chew the candy thoroughly. Some of the candy was sold with no warning label at all. Local authorities reported three children deaths from choking in the United States associated with conjac jelly candy. There were also reports of deaths in other countries.

The candy was sold in several fruit flavors. It was found in small sealed plastic cups that may or may not contain a chunk of fruit. Each jelly cup is about the size of a single-serve coffee creamer. The candy is sold in retail stores and on the Internet under a variety of names.

FDA Sampling Results in Recall of Candy
FDA Lab Analysis Discloses Lead in Candy as High as 4.60 ppm

On August 17, 2001, Villarreal Distributors of San Antonio, Texas, recalled over 20,000 candy containing clay pots of JARRITOS brand Tamarindo candy. The recall was initiated because the candy had been found to contain excessive levels of lead. Lead is very toxic and dangerous to humans, especially children, women of childbearing age, pregnant women and their unborn children. Although people with lead in their blood often do not exhibit the symptoms of lead toxicity, such symptoms include the following: stomach aches, colic, nausea, vomiting, abnormal irritability, and insomnia. Lead can also permanently damage the central nervous system, resulting in learning difficulties in school children as well as cause other long-term health problems.

The JARRITOS brand Tamarindo candy was distributed in Illinois, Ohio, Wisconsin, New Jersey, Mississippi, Iowa, Missouri, Montana, Indiana, Tennessee, Kentucky, Nebraska, South Carolina, Alabama and Maryland, through retail sites, especially ethnic markets, stores and bakeries that cater to Latinos. The product was imported from Mexico, manufactured by La Barca II Dulceriain Jalisco, Mexico. The product was sold as 12 candy containing clay pots per labeled package. The label stated JARRITOS and Tamarindo 100% Natural with a picture of a boy. Each pot was also individually packaged in an unlabeled clear plastic bag.

The recall was the result of a routine sampling program by the FDA that revealed that the candy had levels as high as 4.60 ppm. It is believed the lead had leached from the clay pots into the candy.

FDA Alerts Public to Possible Health Risk Associated with Candy Lollipops from Mexico
Excessive Lead in Lollipops From Mexico Leads to Recall

On April 25, 2001, FDA issued an alert to consumers of a possible Health Risk associated with Tamarind Candy from Mexico. FDA warned consumers to avoid purchasing or consuming tamarind candy lollipops labeled Dulmex brand Bolirindo because of high levels of lead that may be associated with the product - especially its wrapper. People, especially children, who consume high levels of lead can suffer serious damage to their central nervous systems - sometimes leading to permanent neurological damage.

Routine lead level testing of children conducted by the California Department of Health Services revealed at least three cases where 2 year old children may have suffered elevated lead levels as a result of contact with this candy. These findings led the California Department of Health Services and FDA to analyze this product for lead contamination. Although sampling and analyses of this product continues, preliminary findings indicate that at least the lollipop wrapperÂ’s exterior may have exceedingly high concentrations of lead (21,000 parts per million).

In light of these preliminary findings and reported injuries, FDA urged consumers not to consume these lollipops and to keep them out of children's hands. Eating the lollipops may expose them to dangerously high levels of lead, especially if the candy becomes damp or if the wrapper is chewed or eaten. Anyone who suspects they or their child may have consumed these lollipops may want to consult their doctor about having their lead level checked. The product is a soft, dark brown, tamarind fruit candy lollipop on a white or orange stick. It is wrapped in an orange-red wrapper with BOLIRINDO in white lettering and picture of a brown tamarind fruit. The product is known to be distributed in California, but may also be present in other parts of the country, particularly in Southwestern states.

Allergy Alert Issued for Undeclared Dairy in Candy Bar

On August 7, 2001, Golden Temple, Inc, Vashon, Washington, the manufacturer of BumbleBar products, determined that milk had been unintentionally added to 1.6 ounce BumbleBar's Chocolate Crisp bar. Therefore, BumbleBar, Inc., voluntarily recalled its 1.6 ounce Chocolate Crisp BumbleBars (UPC 7-60590-10072-5). People who have allergies or severe sensitivities to dairy were urged not to consume the affected product. The problem was isolated to 86 cases, manufactured between March 31, 2001, and July 25, 2001. The lot codes were printed on the case exterior near the label, on the carton, or inside flap of the carton. The lot codes affected were: 21802, 22302, 31402, 31702, 32202, 32402, 32902, 40602, 41202, 41902, 42302, 42602, 51602, 52302. These lots were distributed in the states of Washington, California, Colorado, Florida, Indiana, and Arizona. The problem was discovered in the ingredient purchasing specification for the organic chocolate used in the bars. Specifications had been changed and production had resumed with a non-dairy chocolate. The recall notice was issued to the distributors who returned product and put dairy free product back into distribution.

Consumer Complaint Results in Recall
FDA Inspection Finds Candies with 10,000 ppm of Undeclared Milk Protein

In March 2001, the FDA's Minnesota District Office initiated an inspection of Eileen's Candies, a candy repacker located in Green Bay, Wisconsin. The inspection was conducted as a follow-up to a consumer complaint. Analyses of a sample of Mills Fleet Farm Butterscotch Chips detected 10,000 PPM of undeclared milk protein. The inspection found that the bulk Butterscotch Chips and Ivory Chips (white chocolate chips) were both improperly labeled by Eileen's Candies when they were repacked into retail size packages. Both bulk products were manufactured by Clasen Coatings, Middleton, Wisconsin, and were properly labeled, but the "model" retail label supplied to Eileen's Candies by Clasen Coatings lacked declaration of Non-Fat Dry Milk and Whey Powder. Eileen's Candies recalled the affected products.

FDA Assists U.S. Customs in Seizure of Candy
FDA Investigation Discloses Substitution of Candy With Candy Contaminated with Filth

On March 13, 2001, the Southwest Import Division [SWID] Consumer Safety Officer accompanied U.S. Custom's officials in Laredo during a seizure of 176 cases of Chorreada hot candy. This seizure was the result of an investigation conducted by SWID's Laredo resident post that indicated the cases of candy had been largely substituted for an entry of candy refused admission by FDA because of contamination with filth.

In addition to the seizure, SWID recommended that liquidated damages be assessed for the importer's failure to redeliver the merchandise actually refused admission by FDA. This seizure represents the culmination of a cooperative effort between SWID's Investigation and Compliance Branch and U.S. Custom's Office of Investigation and Office of Fines Penalty and Forfeitures.

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