FDA Seizes UAS Labs Probiotics

WASHINGTONProbiotic products from UAS Laboratories were seized by U.S. Marshals at the request of FDA because the government agency said the products are marketed as unapproved drugs. While an initial statement from FDA did not give the exact claims it takes issue with, FDA said the products claim to treat or prevent colds, flu, respiratory infections, urinary tract infections (UTIs), yeast infections, ulcers and high cholesterol.

The seized products include DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior and Cran-Gyn DDS, in capsule, powder and tablet forms.  The company markets the products in the United States and internationally.

In a statement released June 8, the day after FDAs announcement of the seizure, S.K. Dash, Ph.D., president of UAS Laboratories Inc. said UAS Labs is working with FDA to change its products claims. We are removing and/or modifying this language to be in compliance with FDA requirements and are working with FDA to resolve this issue, he said in the statement. We are in contact with our FDA representatives and expect to resolve this matter very soon. While we respect the FDAs position, it is unfortunate that the matter could not have been resolved with a phone call or warning letter before taking action.

Dash added UAS products safety and efficacy are not at issue. People do not need to worry about the probiotics they are taking, he said.

FDA warned UAS Laboratories in May 2005 that its products were in violation of federal law due to a number of claims including:

Following a March 2011 inspection, the agency reported UAS continued to make disease claims for the products, despite previous warnings.

During a meeting with FDA on June, 16, 2005, UAS promised to correct the violations outlined in the 2005 warning letter, according to the FDA complaint, filed May 24, 2011 in U.S. District Court for the District of Minnesota.

The complaint said FDA conducted a follow-up inspection of UAS between Sept. 11 and 19, 2007, and found the company removed the disease claims that prompted the 2005 letter. Since September 2007, FDA has conducted two more inspections of UAS, and after the most recent one, in March 2011, the agency reported UAS continued to make disease claims that were very similar to the claims cited in the 2005 warning letter. FDA also noted its May 14, 2011, review of UASs website also found similar claims.

According to the complaint, 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 GRAS (generally recognized as safe) and effective for their recommended uses.

The Federal Food, Drug, and Cosmetic Act restricts the use of disease claims to approved, or otherwise legally marketed, drugs. According to FDA, 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 Application and demonstrate to FDA that the product is safe and effective for the particular claim. Companies may also market an over-the-counter (OTC) drug under a monograph.