FDA Recalls & Seizures of Dietary Supplements

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Modified on 2009/12/16 21:34 by Angus Hinson
The US Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services. The FDA is in charge of protecting the public from health issues that are caused by dangerous or unregulated medications, cosmetics, and food products. If the FDA believes that a product under its jurisdiction has been having negative health effects on the population, the FDA can request that the product’s manufacturer recall the product from the market. A number of factors can trigger a review--the severity of the adverse events, the number of adverse events received, and how conclusively the product can be linked to the condition are all key facets. It is a common misconception that the FDA can “order” all of its recalls. In most cases, the FDA is limited through the Federal Food, Drug, and Cosmetic Act (FD&C Act) to simply request that a company recall its product. Most companies voluntarily carry out the recalls requested by the FDA, and so legal action is not usually necessary.

The only situations in which the FDA can seek legal action to force a company to recall its product is when the product poses a serious risk to human health, and its manufacturer refuses to recall it voluntarily. In these circumstances, the FD&C Act authorizes the FDA to seek legal action against the company. The FDA is then allowed to seize the product in question and/or order an injunction against the company.

There are three different categories of recalls, which are sorted by the level of danger involved. Class I recalls involve products that have a high likelihood of causing health issues or death, such as food that contains botulism or life-saving drugs that are mislabeled. Class II recalls involve products that will only likely cause temporary health problems, such as an under-strength drug used to treat mild medical situations. Class III recalls are for products that will probably not cause any health issues, but violate FDA labeling and manufacturing regulations, such as products that have an off-taste, or products that are encased in delaminating plastic.

Here are just a few examples of FDA recalls, dealing with a variety of products and problems.

March 2002 - Kava: Consumers were warned about supplements containing Kava because of a link to severe liver injuries including hepatitis, cirrhosis and liver failure. There had been over 25 reports of adverse events reported in other countries and the U.S.

February 2003 - Ephedra: In February 2003, the FDA wrote a letter to Powerhouse supplements of Cincinnati, Ohio over Ephedra for making false and misleading claims. Under the Federal Food, Drug and Cosmetic Act, products labeled as dietary supplements can make health claims, (such as "x product enhances the immune system"), but they cannot make structure and function claims without adequate scientific evidence for substantiating the claims. The labeling of dietary supplements must be truthful and not misleading. The FDA maintains there is an inadequate scientific basis for claims of enhanced athletic performance for ephedra-containing dietary supplements, hence the letter to Powerhouse supplements requiring them to change their product claims.

February 2004 – Ephedra:
Marshals seized ephedra-containing dietary supplements Betatrim, Thermbuterol, and Stacker 2. The maker claimed the supplement enhanced athletic and muscle performance without adequate scientific basis said FDA regulators.

November 2004 - Ephedra:
In perhaps the case most similar to to the use of the controversial St. John’s Wort, the FDA acted to remove dietary supplements with ephedrine alkaloids marketed as a treatment for serious disease. It was an adulterated food as well as unapproved, said the US Attorney for the Southern District of Texas in charging VITERA-XT. 

U.S. Marshalls seized more than 2.1 million VITERA-XT capsules in the Houston offices of Asia MedLabs,Inc. Ephedra, also called Ma Huang, is a source of ephedrine alkaloids that are regulated as drugs when chemically synthesized.

December 2005 – Ephedra:
Again in December 2005, the FDA forced Nature’s Treat Energy Inc. to forfeit its dietary supplement Nature’s Treat Energy Plus #1. Marshalls seized more than 2,600 bottles of capsules from a Gainesville, Texas and more than 350 bottles from a distributor with a retail value of approximately $150,000 because of ephedra.

August 2007 – Red Yeast Rice:
Consumers were told not to buy or eat three red yeast rice products sold on the Web Sold as a dietary supplement for treating high cholesterol, FDA testing revealed these products contained lovastatin, the active pharmaceutical agent in the prescription drug, Mevacor, marketed for treatment of high cholesterol. The red yeast rice threatened health by causing severe muscle problem and kidney impairment and reacted with other drugs. The FDA sent warning letters to Swanson and Sunburst Biorganics to stop selling the products.

April 2009 – Hydroxycut Weight Loss: Hydroxycut has been recalled by the FDA due to the fact that it has been linked to 23 liver injuries. Several variations of the product have been recalled, including “Hydroxycut Carb Control”, “Hydroxycut Hardcore Liquid Caplets”, and “Hydroxycut Regular and Caffeine-Free Drink Packets”. While the FDA did not say what ingredients or dosages of the products made them dangerous, they predicted the health issues may be linked to an ingredient called hydroxycitric acid, which has been linked to liver problems in at least one medical journal study.

May 2009 – Steroids, Unapproved Ingredients: The FDA seized $1.3 million in body-building supplements. U.S. Marshals seized more than 23,000 bottles of three supplements distributed by LG Sciences LLC of Brighton, Michigan charging they contained unapproved additives and or ingredients including steroids. Reports Consumer Reports. Ingredients include Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL.

October 2009 – Silver
The FDA issued a warning on the dietary supplements containing silver or colloidal silver warning it may cause permanent discoloration of the skin turning a user blue. Although argyria is not dangerous to physical health, it can have serious negative effects on one’s emotional and social health.

November 2009 – Undeclared Weight Loss Drugs: This November, GMP Herbal Products, Inc. issued a voluntary nationwide recall for its weight loss supplement, Pai You Guo, found to contain undeclared drugs. An FDA lab found to contain undeclared sibutramine, an FDA-approved appetite suppressant and phenolphthalein, a solution used in chemical experiments and a suspected cancer causer. The products were sold on the Internet.

November 2009 – Steroids: Also in November, the company Bodybuilding.com LLC announced it was voluntarily recalling its dietary supplements sold through the company’s Web site. www.bodybuilding.com, after the FDA warned that the products may contain steroids. The company said it was acting in “an abundance of caution” but had not received any reports of adverse events in connection with the recalled products thought to contain “Superdrol” “Madol” Tren” “Androstenedione” and /or “Turinabol”

November 2009 – Steroids: IDS Sports announced it was voluntarily recalling five dietary supplements sold around the country with names of Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR. Acute live injury is known to result from the use of products containing steroids. Other problems can include, shrinking of the testes and male infertility, masculinization of women, breast enlargement in males and short stature in children.
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