In response to an editorial published online in The New England Journal of Medicine titled, “Hazards of Hindsight—Monitoring the Safety of Nutritional Supplements,” by Pieter A. Cohen, M.D., 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:
“The Dietary Supplement Health & Education Act (DSHEA), enacted in 1994, provides an extensive framework of regulation to help ensure that consumers have access to safe, high quality dietary supplements. The safety concerns identified by Dr. Cohen are troubling not only for consumers, but also for those reputable companies that follow the law and seek long-term relationships with their customers. However, the problems noted by Dr. Cohen are not an issue of the law itself, but rather the result of a chronically underfunded government agency that has yet to use the full extent of its enforcement authority and seems to lack the political willpower to prosecute even the most blatant offenders. Time and time again, FDA has issued warning letters for egregious behavior by a few outlier firms, yet not taken further action when the products—many of which are clearly not legal dietary supplements—remain on the market.
“What we have here is a tale of two industries: those companies who follow the regulations, and those who don’t. No matter what laws are put in place, if there isn’t a strong regulatory agency policing the market, those laws will be broken. There should be stronger consequences for those not following the law, rather than adding bureaucracy for those who are.
“While we believe Dr. Cohen is well-meaning, his expertise is in medicine, not dietary supplement regulation, and while he has some legitimate observations, he misses the mark in some of his solutions. Too often critics of DSHEA who are neither familiar with the nuances of the law nor the realities of the marketplace, fall back on the pharmaceutical-standard of pre-market approval as the answer. This ignores the fact that pre-market approval is not viable for the supplement industry nor is it a guarantee of safety. Even with pre-market approval for pharmaceuticals, counterfeit drugs appear in the market and phony online pharmacies sell dangerous medicines, and at the same time, some FDA-approved pharmaceuticals have reached the market, only to be recalled years later for safety concerns. As for the post-surveillance system for supplements that Dr. Cohen raises so many concerns about, he neglects to advise that this is the identical adverse event reporting system used for over-the-counter medications.
“CRN is already engaged in exploring how to strengthen FDA’s resources and how to solve problems that plague our industry, but urges attention to solutions focused on where the real problems lie, rather than adding bureaucratic layers for the vast majority of products that don’t pose safety issues. Serious enforcement of the existing law is the best way to provide consumers with meaningful assurance of the safety of these products.”