Posted June 21, 2011

FDA Seizes Probiotics Over Marketing Claims

On June 7, 2011, the U.S. FDA announced that, at its request, U.S. Marshals seized probiotic products from UAS Laboratories, Inc., of Eden Prairie, Minn. because the company markets the products as drugs.

The seized products include DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS, in capsule, powder, and tablet forms.

UAS Laboratories said the products could treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers, and high cholesterol. The company markets the products in the United States and internationally.

The FDA has warned UAS Laboratories that its products were in violation of federal law. During a March 2011 inspection, the agency discovered that the company continued to make disease claims for the products, despite previous warnings from the FDA.

The Federal Food, Drug, and Cosmetic Act restricts the use of disease claims to approved, or otherwise legally marketed, drugs. The seized products are misbranded under the Act because their labeling does not have adequate directions for use.

To make a claim that a product prevents, treats, cures, or mitigates disease, companies generally must submit a New Drug Application1 and demonstrate to the FDA that the product is safe and effective for the particular claim. Companies may also market an over-the-counter drug under a monograph.

UAS Laboratories’ products did not conform to any existing monograph, nor did the company file or receive approval of a New Drug Application, and the products are not generally recognized as safe and effective for their recommended uses, according to the complaint filed in U.S. District Court for the District of Minnesota.

An article on MinnPost.com (June 9, 2010) indicates that the seizure was due to claims of health benefits on the company's website. Citing the complaint filed by the FDA to request the seizure, the article states, "FDA notes how it warned UAS Laboratories back in 2005 that it was in violation of the law and was subsequently assured by UAS executives that the matter would be rectified."

"While the company removed its claims of health benefits from the labeling of the probiotics products, the online campaign continued. And in March of this year when FDA inspected UAS Laboratories, the agency once again warned that the company’s website — uaslabs.com — and a partner website in which its probiotic products are sold were violating the law."

“ 'Despite the company’s 2005 promise to fully remove the claims from its website and FDA’s repeated warnings, UAS Laboratories, Inc., continues to market the misbranded defendant articles,' the complaint notes."

UAS Laboratories probiotics are currently listed in ConsumerLab.com's Product Review of Probiotic Supplements. ConsumerLab.com requires that product labels be compliant with FDA regulations. No claims to treat, prevent or diagnose a disease appeared on the labels of the tested products.

The FDA news release is accessible from the link below.