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NEW YORK Make no mistake, this Food and Drug Administration has shown time and time again this year that it has taken a shoot-first, ask-questions-later approach to ensuring the safety of the products it regulates. The FDA, in a news release, stated that the warning letter was posted due to an internal systems error, and in fact no warning had been sent to Procter & Gamble.
Yet. Because the letter was still written, and that fact can’t be explained away by an internal systems error.
While no Drug Store News source has stated anything either on-the-record or for attribution, this new FDA has many in the OTC industry concerned. It started with the voluntary withdrawal of the majority of Hydroxycut SKUs based on some 30 adverse event reports. Then came the highly publicized voluntary withdrawal of three Zicam cough-cold products because of some 130 cases of a loss of smell allegedly associated with the use of Zicam over the course of 10 years in a population that is predisposed to that loss of smell. Following that, the FDA announced that because of three potential adverse events in the United States, it was keeping tabs on potential liver damage around the use of the weight-loss drug alli.
The legitimate concern among OTC suppliers is simply -- can they be next?