GAO pushes FDA for final NDI guidance to improve enforcement efforts

WASHINGTON — The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients. Those two guidelines will help the agency use adverse event reports in overseeing dietary supplement products, the GAO stated. "With final guidance in place, firms may be able to make more informed product development and marketing decisions, which could ultimately reduce FDA's enforcement burden in these areas," the GAO reported. 

“We believe that the recommendations from the GAO report are reasonable and open the door for further dialogue with FDA as to how industry and government can continue to work together," stated Steve Mister, president and CEO for the Council for Responsible Nutrition. "Our association has engaged in industry education since the law was passed, and most recently, CRN — along with the American Herbal Products Association, the Consumer Healthcare Products Association, the Natural Products Association and the United Natural Products Alliance — partnered on an educational webinar for the supplement industry with participation from [the] FDA, to further advise the industry on complying with serious adverse event reporting." 

"From 2008 through 2011, the Department of Health and Human Services' Food and Drug Administration received 6,307 reports of health problems — adverse event reports — for dietary supplements," the GAO reported. As many as 71% of these were serious adverse events reported by the industry as required by law, and most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA's product categories. 

However, the GAO cautioned the FDA that it may not be receiving information on all adverse events because consumers and others may not be voluntarily reporting these events, though they may be contacting poison centers about some of them. From 2008 to 2010, poison control centers received more than 1,000 more reports of adverse events linked to dietary supplements than the FDA did for the same period. 

With that disparity, the FDA had stepped up inspections of supplement firms to help ensure compliance with AER reporting requirements. Specifically, the FDA increased firm inspections from 120 in 2008 to 410 from Jan. 1 to Sept. 30, 2012. Over this period, the FDA took the following actions: three warning letters, one injunction and 15 import refusals related to AER violations, such as not including contact information on the product label or submitting a serious AER.

The industry supports the increased scrutiny. "We certainly support transparency for consumers with regard to adverse event reporting to the extent that consumers will benefit from that transparency and that industry will not be made the victim of frivolous lawsuits because of it," Mister said. "However, along with transparency, there must be context and education so that consumers are not misled and clearly understand that just because a consumer may have taken a product at the same time they experience an adverse symptom, it may not translate into a causal relationship between a product and the adverse event itself."