The Center for Drug Evaluation and Research (CDER) has indicated that among its’ enforcement priorities, CDER will take special aim at the manufacturers of dietary supplements found to be spiked with pharmaceuticals. Echoing the sentiments of FDA Principal Deputy Commissioner Josh Sharfstein, CDER has indicated that the areas identified within the industry as having the highest number of offenses are “weight loss, sexual enhancement, and bodybuilding,” with over 200 tainted products discovered by FDA. CDER’s newly formed Division of New Drugs and Labeling Compliance urges the supplement industry to stay vigilant and hold itself accountable for the products they sell by remaining informed about the materials they buy, the suppliers they are buying from, and what is added to the products.

 CDER was recently involved in the voluntary recalls initiated by several firms that marketed “aromatase inhibitors.” The Center suggested that these ingredients posed a serious “health hazard” to consumers, an allegation refuted by the companies that marketed those products, citing a lack of adverse event reports that would support such a risk. CDER is also often consulted by Customs Enforcement and FDA Compliance Officers when evaluating dietary ingredient imports. The message to supplement firms is that dietary supplements are a priority for FDA and enforcement may come from a variety of branches.