Washington, D.C., October 21, 2014—In response to a research letter, “Presence of Banned Drugs in Dietary Supplements Following FDA Recalls,” published today in the Journal of the American Medical Association (JAMA), the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:
Statement by Steve Mister, president & CEO, CRN:
“Any time adulterated health products get to consumers or remain on the market after the FDA has determined they are potentially unsafe illustrates a weakness in the enforcement of the nation’s food and drug laws. Responsible manufacturers and marketers of dietary supplements applaud strong enforcement measures by FDA to address illegal products that contain undisclosed, active pharmaceutical ingredients (APIs). We have zero tolerance for this problem and welcome not only recalls, but also criminal enforcement against companies that put consumers at risk.
However, the promotion of a new study in JAMA grossly misrepresents the extent of the situation and understates the success of FDA’s efforts. We agree with the authors that FDA must increase the aggressiveness by which it enforces the drug laws targeted to illegal products. But the study found that of the 274 products that were recalled over the three-year period, only 27 remained on the market—meaning that FDA’s action successfully rid consumers of 90 percent of the implicated products. Of the 27 remaining, 18 of the products were identified as containing APIs after being recalled; the other nine had been reformulated. In other words, the FDA’s recall efforts had a more than 93 percent success rate (256 out of 274).1
We note also, that once these products were identified by FDA as containing undisclosed APIs, they were recalled under FDA’s ample authority for regulating adulterated drugs—because they are just that, adulterated drugs, regardless of how they were marketed. Increased resources to enforce the nation’s drug laws would more directly address the problem and help reduce the number of unrepentant products to zero. Yet the researchers jump to the recommendation that changes in the law to increase FDA’s powers over dietary supplements are needed, illustrating their call to action is a ‘solution in search of a problem.’
The value of this study does not lie in its sensational captions or distorted figures, rather in its demonstration of the positive outcome that can occur when the law is properly enforced. We urge FDA to continue using its recall authority to eradicate adulterated products and, like the responsible industry, put consumer safety first. As we observe the 20th anniversary of the passage of the Dietary Supplement Health and Education Act (DSHEA), it seems that some are still more committed to rewriting that law than to promoting full implementation of DSHEA to protect consumers with the ample authority already given to FDA to appropriately regulate these products.
Additionally, we encourage consumers to be smart when purchasing dietary supplements, to avoid products that make drug-like claims for supplements or claim to be natural alternatives to prescription medications, and to seek the advice of their doctor or other healthcare practitioner to ensure that they choose quality, safe and beneficial products.”
1. The study identified 274 products marketed as dietary supplements but recalled by FDA for the presence of APIs between January 2009 and December 2012. The inclusion criteria of the researchers required that the product must still be available for purchase in July or August 2013 either from retailers or from the marketer’s website. Only 27 products met that requirement—the other 247 had been withdrawn following the recall. Of the 27 analyzed, 18 were found to still contain an API. 18/274 is 6.57% of the total products recalled.