Feds Raid Local Co. Over Unproven Product Claims
The offices of Eden Prairie-based UAS Laboratories, Inc., were raided by U.S. Marshals last week at the request of the U.S. Food and Drug Administration (FDA), which says UAS made unproven claims in the marketing of its products.
U.S. Marshals seized more than 80 cases of probiotic products that the company manufactures and sells, including DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS, in capsule, powder, and tablet forms.
According to the National Center for Complementary and Alternative Medicine, probiotics are live microorganisms that are similar to beneficial microorganisms found in the human stomach. They are most often available to consumers in the form of dietary supplements and foods.
According to the FDA, UAS Laboratories claims on its Web site that its products can treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers, and high cholesterol-and such statements violate federal regulations.
The FDA sent a warning letter in 2005, stating that UAS' products were in violation of federal law, but an inspection in March revealed that the company has continued to make disease claims for its products.
To make a claim that a product prevents, treats, cures, or mitigates disease, companies must submit a new drug application 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.
However, the FDA claims that UAS' products did not conform to any existing monograph, nor did the company file or receive approval of a new drug application.
According to a complaint that the FDA filed in U.S. District Court in Minnesota-which was unsealed Monday-UAS' products are not generally recognized as safe and effective for their recommended uses.
In an e-mailed statement, UAS president Sita K. Dash said that the company is working with FDA officials to resolve the issue.
“While we respect the FDA's position, it is unfortunate that the matter could not have been resolved with a phone call or warning letter before taking action,” Dash said.