PUBLIC HEALTH
June 13, 2011

Probiotics Seized for False Health Claims

The FDA directed US Marshals to seize several varieties of probiotics because their labels made false treatment claims.

The U.S. Food and Drug Administration (FDA) requested that U. S. Marshals seize probiotic products manufactured by UAS Laboratories, Inc. of Eden Prairie, Minnesota because the company claimed the products could treat or prevent colds, the flu, respiratory infections, urinary tract infections, yeast infections, ulcers, as well as high cholesterol.

The claims on dietary supplement products cannot refer to a reduced risk of disease. In fact, the claims must be worded very carefully to avoid mentioning any specific disease. Thus claims such as "improves memory," or "slows aging" are typical.

The company had previously been issued a warning by the FDA, but continued to make disease claims for their products. The products that were seized included DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS. The products were in capsule, powder, and tablet forms.

The Federal Food, Drug, and Cosmetic (FD&C) Act restricts the use of disease claims to approved drugs or to drugs that are otherwise legally marketed. The FDA said the seized products were misbranded because their labeling did not have adequate directions for use. The FD&C Act, passed in 1938, authorized the FDA to demand evidence that new drugs are safe to use.

Consumers need to be savvy when purchasing dietary supplements and understand the claims that can legally be made by manufacturers. Structure/function claims describe the role of a nutrient or dietary ingredient on a structure or function of the body, such as the claim that calcium helps build bones. The claims on dietary supplement products cannot refer to a reduced risk of disease. In fact, the claims must be worded very carefully to avoid mentioning any specific disease. Thus claims such as "improves memory," or "slows aging" are typical. More specific claims that refer to specific diseases, such as "prevents osteoporosis," require the manufacturer to meet strict requirements.

Dietary supplement manufacturers are responsible for ensuring the accuracy of their claims. Consumers must understand that these claims are not pre-approved by the FDA. If a dietary supplement label includes a structure/function claim, it must provide a disclaimer that states that the FDA has not evaluated the claim and that the product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.

For a company to make a claim that a product prevents, treats, cures, or relieves a disease, they must submit a New Drug Application and provide evidence to the FDA that the product is safe and efficacious for the claim being made. UAS Laboratories did not file or receive approval of a new drug application, and the products that were seized are not generally recognized as safe or effective for the uses that were recommended, according to the complaint filed by the FDA.

Consumers who use dietary supplements should educate themselves about the benefits and risks involved. The FDA provides a fact sheet on their website to help consumers understand dietary supplements and make informed choices.

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