AHPA urges FDA to adapt current action plan for illegal steroids products
The American Herbal Products Association sent a letter to FDA prodding the agency to adapt its ongoing and productive enforcement plan against fake 2009 H1N1 products and use it to illegal synthetic steroid products.
The American Herbal Products Association (AHPA) is concerned that the wide impression left by FDA during the recent probe on nutritional supplements spoiled with anabolic steroids is that the agency is not competent of taking any action against the widespread distribution of these nutritional supplements.
According to Michael McGuffin, AHPA’s president, AHPA differs, and thinks that FDA has all of the authority it requires to shut down the vendors of any such product.
The letter cited the current program implemented by FDA for addressing fake 2009 H1N1 influenza products. It includes issuing a Warning letter as a form of their direct enforcement process and a list of manufacturers who received warning letters from FDA, which is posted on their site. AHPA also added that the fraudulent claims have now been taken out from the FDA product list.
AHPA directed the letter to Michael Levy, Esq., director of the Division of New Drugs and Labeling Compliance at FDA’s Center for Drug Evaluation and Research (CDER) and to Roberta Wagner, director of the Office of Compliance at the Center for Food Safety and Applied Nutrition (CFSAN).
From Natural Products Insider:
The AHPA letter also noted FDA’s testimony identified “several possible enforcement outcomes” against any product that contains a synthetic steroid, and FDA did not need to identify in its testimony “a category of marketed synthetic steroids for which there is no possible enforcement outcome, because under current law, except with respect to approved new drugs, all such marketing is unlawful.”
