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UAS Labs defends safety, efficacy of probiotics following FDA seizure

By Stephen Daniells

- Last updated on GMT

Related tags Fda Urinary tract infection

Minnesota-based UAS Laboratories, Inc., has defended the safety and efficacy of its products following a US Marshalls-led seizure, adding that it is working with FDA to ‘remove and/or modify the language’ of alleged disease claims on the labels of its DDS probiotics range.

At the request of the U.S. Food and Drug Administration (FDA), US Marshalls seized products including DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS, in capsule, powder, and tablet forms.

According to FDA, the company made claims that the products could treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers, and high cholesterol. Such claims are in violation of the Federal Food, Drug, and Cosmetic Act.

UAS response

In a statement from the company’s president, Dr S.K. Dash, UAS said it is diligently working with the FDA to correct the information provided on its product labels and website.

“In the interim, it is important for our customers, vendors and colleagues to understand the facts,”​ said Dr Dash.

“Our product is not under question. Our facilities were recently inspected by the FDA and our products are safe and effective. People do not need to worry about the probiotics they are taking.

“What is at issue with the FDA are certain statements made on our website that the FDA believes expand our labeling to imply that our products can be used to treat or cure certain health conditions.

“We are removing and/or modifying this language to be in compliance with FDA requirements and are working with the FDA to resolve this issue. We are in contact with our FDA representatives and expect to resolve this matter very soon.

“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,” ​he added.

FDA’s view

According to FDA documents, a warning letter was issued​ to UAS Labs in 2005 about the language of the claims being made on its products and website. The letter warned UAS Labs that claims on its products labels caused the products to be drugs, according to the Federal Food, Drug, and Cosmetic Act.

Following this warning letter, UAS Labs “promised to fully correct its violations”​, reads the Complaint for Forfeiture filed in the US District Court for the District of Minnesota.

Subsequent inspections in September 2007 and March 2011 led FDA investigators to note that claims continued to be “very similar to the claims that were cited in the 2005 Warning Letter”​.

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