FDA Makes Good on Threat to Raid Pro-Biotics Manufacturer

Federal law requires that any statement made with regard to medications or medical products must be investigated and approved by the FDA before being publicly broadcast. This is to protect consumers from unscrupulous companies seeking to make money from promises not proven to be truthful. As well, FDA approval ensures that products available on the American market are safe and will not cause harm to consumers and patients. Any manufacturer making medical statements of fact about certain products will certainly be reprimanded by the FDA followed by a search and seizure of the production facility.

Tuesday morning, the FDA made good on one of these threats as it raided UAS laboratories in search of certain “probiotic” products that had not been evaluated by the FDA. The FDA claims that not only did UAS flout its warnings but it continued to make non-medical statements about its products. The CEO of the corporation assured its consumers that “[its] products are safe and effective and they need not worry about the probiotics they are taking. That is not at issue with the FDA.” “What is at issue with FDA are statements made on our website that FDA believes expand our labeling and make ‘drug-like’ claims for our probiotics. So like nutritional supplements, we cannot make claims beyond describing general health benefits even though the medical and scientific literature may be suggestive of certain more specific health benefits.”

This is not UAS’s first run-in with the FDA over labeling concerns. In 2005, the manufacturer faced FDA scrutiny for placing promises on its label that the probiotics could inhibit ulcers and prevent against e. coli poisoning. It also promised its products could protect women from uncomfortable vaginal and yeast infections.

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