In response to the U.S. Government Accountability Office (GAO) report, “Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products,” the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, issued the following statement:
Statement by Steve Mister, president and CEO, CRN:
“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 to help ensure consumers are making wise decisions about incorporating dietary supplements into their health regimens.
"CRN was instrumental in helping to pass the current adverse event reporting law, and remains 100 percent committed to making the law work to protect consumers. 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 FDA, to further advise the industry on complying with serious adverse event reporting. This GAO report indicated that 71 percent of serious adverse events reported to FDA came from the industry itself—and CRN will continue to urge the supplement industry to comply and support FDA in taking enforcement action against those companies that do not.
"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. 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.
"Finally, we commend the GAO for urging FDA to finalize its draft guidance on 1) New Dietary Ingredients and 2) distinguishing liquid dietary supplements from conventional foods. In their final form, these guidance documents will provide much needed clarity to companies manufacturing and marketing dietary supplements.”