Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.
For decades, FDA regulated dietary supplements as foods, in most circumstances, to ensure that they were safe and wholesome, and that their labeling was truthful and not misleading. An important facet of ensuring safety was FDA's evaluation of the safety of all new ingredients, including those used in dietary supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (the Act). However, with passage of the Dietary Supplements Health and Education Act of 1994 (DSHEA), Congress amended the Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result of these provisions, dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions. 1/
Warning Letter for Arthritis and Joint Support
Product’s Labeling Causes Dietary Supplement To Be Unapproved “New Drug”
On August 12, 2002, FDA’s Minneapolis District Office issued a Warning Letter to the Conklin Company, Inc., Shakopee, Minnesota. The firm manufactures various products promoted as dietary supplements. An FDA inspection of the firm on April 24 - 25, 2001, June 5 - 6, 2002, and July 8, 2002, disclosed violations of the Federal Food, Drug, and Cosmetic Act. Two of the firm’s products, Life Track Arthritis and Joint Support and Cold Season Formula, are misbranded, unapproved new drugs. The products’ labeling represents and suggests that these products are intended to be used in the cure, mitigation, treatment or prevention of disease. The products are also misbranded because the labeling is false and misleading, suggesting the products are safe and effective for their intended uses.
Several other products (Life Track Vitamin E, Multi Mineral, Vitamin C, Vitamin B-Complex, Multi Vitamin and Bone Support) are misbranded because they fail to bear the Supplement Facts Panel. In addition, these products are misbranded because their labels fail to identify the products using the term “Dietary Supplement” or other alternative descriptive term authorized by the regulation.
Warning Letter Issued for Unsubstantiated Claims
On May 30, 2002, FDA’s Seattle District Office conducted an inspection at Earth & Plant, Inc., Homer, Alaska. The inspection revealed that the firm’s labeling for the product Hydroxygen Plus was in violation of the Act. The claims included statements such as:
"Another benefit of Hydroxygen Plus for lupus is that brain cells get more oxygen since this passes through the blood brain barrier. "
"When you have a low cellular oxygenation condition in the body, as you do with lupus, it makes a lot of sense to take Hydroxygen Plus."
"I suggest taking supplements that regulate the immune system and strengthen the TH-1 cells that fight infections inside the cells.. . Directly killing them with Hydroxygen Plus... ."
" Hydroxygen Plus, taken in therapeutic quantities, can kill a significant amount of mycoplasma and viruses. It could possibly even take care of these lupus causing infections on its own."
The Warning Letter noted that “...available scientific evidence does not support the claims you are making for this product.” Therefore, the labeling statements are false or misleading. In addition, the label fails to include adequate directions for use causing the product to be misbranded. The product is also determined to be a “new drug” that could not be legally marketed without an approved New Drug Application.
Human Growth Hormone Promoted on the Internet
Firm Found Promoting HGH On the Internet For Anti-Aging Treatment
On July 30, 2002, FDA’s New England District Office issued a Warning Letter to AffordableHGH.com of Wilton, Connecticut. The Warning Letter concerned somatotropin (rDNA origin) with cyanocobalamine and pyridoxine for injection compounded by the firm. Somatotropin is also known as recombinant human growth hormone (hGH) and is currently marketed by the firm as shown on the Internet sites www.affordablehgh.com and www.buyhghdirect.com. These websites were promoting the human growth hormone product as an anti-aging treatment regimen that a consumer would self-administer with an injection through the skin.
The Warning Letter stated that:
Distribution of your hGH product violates 21 U.S.C. § 333(f) of the Act. Your hGH product is being promoted and distributed for an unapproved use. There are no recombinant hGH products that are approved by FDA for anti-aging treatment. Title 21 U.S.C. § 333(f) states that “...whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition...is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by Title 18, United States Code, or both.”
The uses promoted for the drug included claims such as “decrease in fat, increase in muscle, improved skin texture, decrease in wrinkles, increased immunity, better sleep and increased cardiac output and kidney function.” This classifies the product as a “new drug” without an approved New Drug Application.
Consumer Complaint Results in Recall
FDA’s Los Angeles District Office conducted an inspection of TriMedica International, Inc., Tempe, Arizona, on May 22 - 23, 2002, as a follow-up to a consumer complaint. The directions for use on the label included directions for sublingual application. The finished product ingredient statement declared only sodium and minerals. The complainant's physician tested the product that resulted in a pH of 10. The investigation revealed that TriMedica was the repacker and distributor of the product. The firm had packed the wrong product into the bottles. They actually bottled a product called “pH+” with a pH of 12. Both products are intended to increase the pH of water to make it more alkaline.
The “O2 Life pH neutral” was not intended for sublingual use. The "pH +" is intended to be diluted before application (2 drops per 8 ounces of water). All old labels for the “O2 Life pH neutral” were destroyed and the new labels did not include the sublingual directions for use. The firm recalled 555/2 ounce bottles of “O2 Life pH neutral,” lot number 9482, expiration date 10/03. The recall number for this Class II recall is F-500-2.
Essence of Mushrooms for Cancer
FDA Examination of Labeling Finds Essence of Mushrooms Promoted for Cancer
In December 2001, FDA’s New York District Office recommended Detention Without Physical Examination for the product, Essence of Mushrooms capsules, 400 mg. The product, manufactured by Windsor Health Products Ltd., Kowloon, Hong Kong, was shipped as vitamins via Federal Express. However, FDA examination found accompanying labeling promoting the product for treatment of cancer. In addition, the labeling also identified the manufacturer's website, which was found to be promoting the Essence of Mushrooms as an alternative therapy for cancer. FDA refused entry of the product.
Warning Letter Issued to Health Food Manufacturer
On May 7, 2002, FDA’s Chicago District Office issued a Warning Letter to the president of Optimum Nutrition, Inc., Aurora, Illinois. FDA conducted an inspection of the firm on July 25, 26, and 27, 2001. At that time, a sample of product labeled as stevia powder was collected for confirmation of identify by FDA’s Denver Laboratory. Labels and labeling of several of the firm’s products, were also collected. FDA’s laboratory confirmed the identification of stevia in the sample collected. The Warning Letter advised the firm that stevia is considered a food additive when used as an ingredient in a conventional food.
However, there is no regulation in effect that provides for the safe use of stevia, nor is there a sufficient basis to conclude that stevia in generally recognized as safe among qualified experts for its intended use in food. Therefore, stevia is an unapproved food additive that is unsafe under Section 409 of the Act.
The firm was also cited for unauthorized health claims for the firm’s product, Natural Opti-Soy 50, a soy protein product. The objectionable claims stated that soy protein, “...may play a significant inhibitory role in certain cancers and atherosclerosis development.” In addition, statements in the labeling for Natural 100% Whey Protein Dietary Supplement claimed that whey protein builds muscle mass, increases serotonin levels, and has other effects on the structure or function of the body.
Dietary Supplements Seized at Humphrey Laboratories
Internet Promotion of Dietary Supplement for Autism Results in Seizure
On October 16, 2002, FDA’s Seattle District Office assisted in the seizure of approximately 500 bottles of “Kirkman Taurine” and related marketing material which was located at Humphrey Laboratories, Inc. d.b.a., Kirkman Laboratories, Lake Oswego, Oregon. Although the article was labeled as a "dietary supplement," it was being promoted by Kirkman Laboratories on the firm’s Internet website and by accompanying product literature for autism.
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."
These claims are false and misleading in that they are not supported by scientific studies and therefore they cause the article to be a misbranded food. The article is also a drug as defined in 21 U.S.C. § 321(g)(1)(B) in that it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man. Therefore, the article may not be introduced or delivered for introduction into interstate commerce because it is a new drug and no approval of an application filed is in effect for such drug.
Dietary Supplements Seized at Sino King International
Herbal Supplement Claims to Elevate Intelligent Quotient (IQ) and Promote Growth
On October 16, 2002, FDA’s New York District Office assisted in the seizure of 578 bottles of “Brain Nutrient” a.k.a. "Intelligence Increasing Capsules" located at Sino King International Development and Management Group, Inc. (Sino King), Long Island City, New York. Sino King is an importer and distributor of various herbal and dietary supplements, including "Brain Nutrient," that are promoted and sold nationally through the firm’s Internet website.
The article, labeled as an “herbal supplement,” was being promoted on Sino King’s Internet website and by an accompanying product insert for various uses including: “to elevate the intelligence quotient (IQ) and promoting growth, and can serve as supplementary treatment of primary mental retardation, microcephalus, low intelligence accompanied with epilepsy or tinnitus, ischemic and anoxic encephalopathy, cerebral palsy, mongolian idiocy, intracranial hemorrhage, encephalopathic and toxic encephalopathic sequel, cerebral hematoma operation sequel, cretinism, and hydrocephalus patients."
These claims are false and misleading in that they are not supported by scientific studies and therefore they cause the article to be a misbranded food. The article is also a drug as defined in 21 U.S.C. § 321(g)(1)(B) in that it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man. The article is also a misbranded drug because its labeling fails to bear adequate directions for use and it is not exempt from such requirement.
Seizure and Consent Decree of Condemnation and Destruction at Spectramin, Inc.
“Forever Young,” “Forever Happy” and Other Dietary Supplements Seized
On March 13, 2002, investigators from FDA’s Florida District Office accompanied a U.S. Deputy Marshal in the execution of a seizure at Spectramin, Inc., Sunrise, Florida. Six dietary supplements, including “Advanced Form U Life,” “Arthri X Tra,” “S T O P Pain,” “Forever Young DMAE,” “Forever Happy” and “Sinuplex” were seized. The value of the seized supplements was approximately $308,719. In addition, 127 cases of printed promotional materials containing egregious drug and disease claims for the products were seized.
Previously, on November 20, 1998, the Florida District Office issued a Warning Letter to the President of Spectramin, Inc., Sunrise, Florida. The Warning Letter advised that, based on the claims made for the products, the articles were “new drugs” and therefore could not be marketed without an approved new drug application. In addition, the products were also misbranded because the labeling failed to bear adequate directions for use. The Warning Letter cited 15 products with egregious disease claims.
On August 26, 2002, a U.S. District Judge entered a Consent Decree of Condemnation and Destruction in this seizure of unapproved new drugs and misbranded drugs. Spectramin, Inc., filed a statement of interest to the seized goods. FDA inspections at Spectramin revealed that some of its products were being distributed with promotional materials claiming that the products could treat serious diseases such as cancer, arthritis, and heart disease. FDA alleged that six of Spectramin's products were unapproved new drugs that were also misbranded because their labeling failed to bear adequate directions for their intended uses.
Under the Decree, Spectramin is permanently enjoined from holding, manufacturing, processing, packing, labeling, or distributing any unapproved new drug or misbranded drug. The Decree also provides FDA with letter shutdown and recall authority.
Seizure of Aloe Vera Dietary Supplements
Dietary Supplement Claims to Treat Diabetes, Cancer, Stop Alcohol and Nicotine Cravings
On June 19, 2002, FDA’s Denver District Office assisted in the seizure of approximately 200 units of aloe vera products from Dandy Day Corp, Broomfield, Colorado. The products consisted of Crave Away, an aloe vera dietary supplement promoted to treat diabetes, lower blood sugar, alcohol and nicotine cravings, and Attention Deficit Disorder. Another product, AID CRÈME, an aloe vera cream, was promoted to treat skin cancer, yeast infections, strep throat, radiation burns, and horse ears. Master promotional audio and visual types were seized as well. The total value of the goods was estimated to be $2,100.
AMP II Pro Drops – Dietary Supplements Seizure and Consent Decree of Condemnation and Destruction
Supplement Containing Ephedrine HCl ESP Promoted for Obesity is Seized
On October 30, 2001, officials from FDA’s Denver District Office accompanied the U.S. Marshals in the seizure of finished product AMP II Pro Drops and raw material, Ephedrine HCl. The seizure was accomplished at the label distributor Biogenics, Inc., d/b/a E’OLA International, St. George, Utah, and the contract manufacturer, Nature’s Energy, Pleasant Grove, Utah. The product is an unapproved “new drug” in that it is marketed for obesity without a new drug application. The product was labeled as a dietary supplement, but did not meet the definition of a dietary supplement because it contains ephedrine HCl USP, which is not a dietary ingredient, and which was approved as a new drug in 1948. The total amount of product seized was 141,000 bottles, with a wholesale value of $2,800,000. Also seized were 500 grams of raw material, 3,200 brochures, and 1134 videotapes.
On April 12, 2002, a U.S. District Court Judge entered a Consent Decree of Condemnation and Destruction in this seizure action. [See United States v. 1009 cases, more or less, of an article of drug (D. Utah)]. The firm, Biogenics, Inc., d.b.a. E’OLA International, Inc., filed a statement of interest to the seized goods. Under the Decree, the firm is prohibited from holding, manufacturing, processing, packing, labeling, promoting, or distributing AMP II Pro Drops, any similar product containing or purporting to contain ephedrine hydrochloride, any synthetic ephedrine alkaloid, or any product that is a new drug not approved by FDA. The Decree also provides the government with letter shutdown and recall authority. On May 3, 2002, destruction of 141,000 vials of AMP II Pro Drops, more than 8 boxes of brochures, and 17 cases of video tapes previously was accomplished by incineration.
Warning Letter for Warehouse with Rodents
FDA and USDA Inspectors Find Building in Disrepair, with Rodent and Bird Infestation
In March/April 2002, FDA’s Chicago District Office conducted an inspection of a warehouse, Reserve Marine Terminal of Chicago, Illinois. The inspection disclosed numerous insanitary conditions at the facility. Inspectors observed rodent gnawed and urine stained bags of corn soy blend, rodent burrows, dog feces, building disrepair, and at least one bird in flight. On May 20, 2002, the Chicago District Office issued a Warning Letter to the president of Reserve Marine Terminals advising him of the insanitary conditions observed during the inspection.
The inspection was a joint effort, involving U.S. Department of Agriculture (USDA) and the City of Chicago. The firm voluntarily destroyed goods with a total value of approximately $42,000, including 2,880/55 pound bags of corn soy blend and 440/55 pound bags of dry milk, which were physically damaged.
Seized Goods Destroyed
On November 14 - 15, 2001, FDA’s Chicago District Office witnessed the destruction of various food products at Zarda King, Ltd., in Dolton, Illinois. The products, valued at $17,725, were destroyed pursuant to a Federal Court Decree of Condemnation. This destruction was the culmination of a previous seizure for rodent adulteration.
Coffeeconnexion Co. Mass Seizure Due to Rodent and Insect Infestation
Insect and Rodent Infestation Results in Mass Seizure
On May 9, 2002, FDA’s New Orleans District Office Nashville Branch assisted the U.S. Marshals Service in a mass seizure of all food items at Coffeeconnexion Co., Lebanon, Tennessee. FDA conducted an inspection of the facility on August 3 - 11, 1999, and found widespread insanitary conditions. These conditions included live and dead insects in and on food ingredients, unscreened windows and doors, as well as building defects that would permit pest entry. Prior to the seizure, the Nashville Branch issued a Warning Letter to the firm on September 20, 1999. The most recent inspection of the facility on February 14 - March 4, 2002, found the same evidence of widespread and active rodent and insect infestation throughout the facility. FDA’s laboratory analysis of samples collected during the inspection revealed the presence of rodent urine, rodent excreta pellets, rodent hair, rodent gnawed holes in bags, and live and dead adult insects and larvae in and around food products in the facility. The value of the goods was approximately $150,000.
Consent Decree of Condemnation and Destruction
United States v. 7/25 Pound Paper Bags (W.D. La. Alexandria Division). On October 2, 2001, a U.S. District Court Judge entered a Consent Decree of Condemnation and Destruction condemning and forfeiting seized articles of food at Cash Grocery & Sales, Inc., Alexandria, Louisiana. The articles were seized on June 13 - 14, 2001, because they were held under insanitary conditions (widespread rodent infestation) whereby they may have become contaminated with filth. Upon entry of the decree, the Claimant, Consolidated Companies, Inc., d.b.a. Cash Grocery & Sales ("Cash Grocery") must: (1) post a penal bond of $143,000; (2) pay costs; (3) notify FDA in writing that it is prepared to destroy the seized articles; (4) destroy the seized articles under FDA supervision; and (5) pay all costs incurred by FDA in supervising Cash Grocery's compliance with the terms of the decree.
Mass Seizure at Public Warehouse
Three Million Pounds of Fish, Nuts, Butter, and Milk Fat Seized Due to Insanitary Conditions
United States v. Articles of Food at LaGrou Cold Storage (N.D. Ill.). On July 2, 2002, a complaint for in rem seizure was filed in the U.S. District Court, Northern District of Illinois, alleging that certain articles of food including the frozen tilapia fish stored at LaGrou's Cold Storage, a public warehouse in Chicago, Illinois, were adulterated within the meaning of 21 U.S.C. § 342(a)(4) of the Act, because they had been held under insanitary conditions and may have become contaminated with filth. Approximately 3 million pounds of fish, nuts, butter, and milk fat, valued at over $2,000,000. were seized. The U.S. Department of Agriculture (USDA) detained approximately 14 million pounds of meat and poultry products also held in that facility.
During May and June 2002, FDA and USDA jointly conducted an inspection of LaGrou Cold Storage and documented widespread and active rodent infestation in the facility. Investigators observed live rats in the building, rodent excreta pellets on, in, and around stored lots of food, rodent nests in packaging material and equipment, rodent paw prints, and rodent gnawed food products on several floors of the building. Investigators also observed numerous building defects that would allow rodents easy access to all areas of the warehouse, as well as rodent harborage areas outside the building.
Following a hearing on July 8, 2002, the U.S. District Judge denied an Emergency Petition for relief filed by Regal Springs Trading Co., a company claiming ownership of 276,000 pounds of frozen tilapia fish seized on July 2, 2002. The Emergency Petition requested the Court to enjoin the U.S. from proceeding with the seizure against the tilapia or, in the alternative, to order FDA to inspect the tilapia immediately to determine whether to release it to Regal Springs Trading Co.
On July 16, 2002, Regal Springs Trading Co., signed a consent decree to condemn and forfeit more than a quarter million pounds of frozen tilapia fish. On July 19, 2002, Regal Springs Trading Company posted a 1.5 million dollar bond, in accordance with the consent decree, to regain custody of its product for the purpose of attempting to bring it into compliance with the law. Pursuant to the decree, Regal Springs conducted its reconditioning efforts at its own cost under FDA supervision.
United States v. Articles of Food at LaGrou Cold Storage, (N.D. Ill.). During a September 6, 2002, status hearing before U.S. District Judge Blanche Manning, Swissland Packing Company withdrew its Motion for Release of Improperly Seized Product filed in this ongoing seizure action against food stored under extremely insanitary conditions. Swissland Packing Company had argued that FDA lacked jurisdiction over Swissland's products: B calf stomachs, gullets, and tracheas B because they were not food within the meaning of the Act but "raw materials" from which foods (e.g., rennets, which are enzyme preparations used in cheese) are extracted.
FDA disagreed, based on United States v. Tuente Livestock, 888 F. Supp. 1416 (S.D. Ohio 1995), in which a court held that live hogs, prior to slaughter and ultimate consumption, are food. With respect to Swissland's products, FDA had maintained that, if a food-producing animal is food when the animal is alive, i.e., prior to extraction of the edible tissue, then the animal's food-producing stomach, gullet, and trachea must also be food prior to extraction of the rennets.
To date, the Court entered thirty consent decrees condemning and forfeiting various seized articles of food. Pursuant to the consent decrees, the thirty claimants of the food will recondition their products at their own cost under FDA supervision.
Cantaloupe Contaminated with Salmonella
Outbreaks of Salmonella Poona Linked to Contaminated Cantaloupe
On May 11, 2002, I. Kunik Company of McAllen, Texas, issued a nationwide recall of its “Susie” brand cantaloupes because of their association with outbreaks of food borne illness throughout the United States and Canada. The outbreaks of Salmonella Poona that have infected dozens of people throughout parts of the United States and Canada were linked to the Susie brand of cantaloupe which was imported from Mexico and distributed in the United States and Canada.
Salmonella Poona is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella Poona often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysm), endocarditis and arthritis. The recall number for this Class I recall is F-726-2.
As a result of this investigation, FDA took steps to prevent the importation of any other contaminated cantaloupe. FDA detained all cantaloupe imported by I. Kunik from Mexico. The agency worked with the company, states and other government agencies to investigate this matter. In addition, FDA issued a nation-wide Import Alert #22-01, Detention with Physical Examination, for cantaloupes from Mexico.