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Minnesota company reacts with surprise to FDA seizure of products

Federal marshals seized probiotic products made by UAS Laboratories Inc. and charged that while the company was selling nutritional supplements, it was marketing the products as drugs without getting FDA approval.

A company executive at Eden Prairie-based UAS Laboratories Inc. expressed surprise Wednesday that U.S. Marshals at the behest of the U.S. Food and Drug Administration had seized some of its products.

On Tuesday, federal marshals seized several probiotic products in powder and capsule form made by the company and charged that while UAS Laboratories was selling nutritional supplements, it was marketing these products as drugs on its website without getting a new drug approval from the FDA. The agency alleges that UAS Laboratories claim the products could treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers and high cholesterol, which qualifies them as drugs that require approval.

UAS Laboratories’ director of marketing Connie Falkenstein said the FDA recently audited the company’s plant and the results were “fine.” She added that the language on the website may have crossed the line in terms of what is appropriate for nutritional supplements and that the company is “working with the FDA” to be in compliance. Still, she expressed surprise that the FDA ended up seizing the company’s line of probiotics products. (The wellness company also has some nonprobiotic products that weren’t seized, she said.)

“We were surprised,” Falkenstein said. “We thought we were doing everything we were supposed to do. Our products are fine. They are effective.”

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But if the FDA complaint filed in a Minnesota court that asks for permission to seize the products is true, then Falkenstein’s surprise is misplaced. In the complaint filed June 1, 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 — — 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 was founded in June 1979 and is a profitable company, Falkenstein said, but declined to provide financial details. She did not know exactly how many employees work at the firm. She also declined to make the founder and president Dr. S.K. Dash available for an interview.

A cached version of the now static website says: “While working as the director of the Food and Drug Administration for South Dakota, from 1973 to 1979, Dr. Dash discovered that a probiotic product was approved as a drug in the 1950′s by the U.S. Government.” An FDA spokeswoman said the agency could not confirm a Dr. Dash working there and that the FDA has field and regional offices, but no state offices as is implied in the statement.

The spokeswoman, Siobhan DeLancey, said that the agency historically has taken action against companies that represent dietary supplements as drugs.