In the New England Journal of Medicine editorial, “Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements,” Pieter A. Cohen, M.D. harshly critiqued the regulatory system for the monitoring dietary supplements. In his editorial, Dr. Cohen took to task FDA on its lack of oversight prior to supplements reaching the market, as well as the Dietary Supplement Health and Education Act of 1994 (DSHEA). Proposing sweeping changes to the current regulatory system, Dr. Cohen suggested the collection of all supplement ingredients in databases; pre-planned public health responses in the case of adverse events; as well as a supplement response team consisting of doctors, pharmacologists, toxicologists and chemists. Furthermore, Dr. Cohen stated that supplement creators should be required to make manufacturing details fully transparent to the regulatory system.
 
Commenting on the editorial, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C., stressed that rather than revamp the currently regulatory system the current law should be better enforced. He pointed to a lack of funding for FDA as the shortfall of the current system, rather then issues with DSHEA itself.  According to Mr. Mister, DSHEA “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.”
 
He added, “ 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 CRN found Dr. Cohen’s commentary to have good intentions, Mr. Mister explained that, “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.” Mr. Mister also pointed out that the adverse event reporting program suggested in the editorial is identical to the system used by 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,” concluded Mr. Mister.