In the article titled “Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements,” Cohen says the current system of reporting adverse events is inadequate, citing the case of liver injury adverse events in Hawaii connected with a sports nutrition product called OxyElite Pro manufactured by USPlabs that was recalled in late 2013. These serious adverse events, which dietary supplement companies are required by law to pass on to authorities, are collected in a database called MedWatch.
“MedWatch suffers from significant underreporting and incomplete reports, which hamper its ability to detect harms even from prescription medications. It is even less effective in detecting adverse effects of supplements,” Cohen wrote.
“Sweeping changes would be needed to create an effective surveillance system capable of rapidly detecting supplement-related adverse events in the United States,” Cohen wrote. He advocated for an interdisciplinary team to be established to evaluate adverse events reports made up of expert clinicians, toxicologists, pharmacologists, and chemists. And in conclusion, Cohen repeated a call he has made in the past for a form of premarket approval.
“Every supplement ingredient should undergo rigorous safety testing before marketing. Until that happens, consumers and physicians cannot be assured that the pills, powders, and potions labeled as dietary supplements are safe for human consumption,” he wrote.
In responses to Cohen’s argument, both the Council for Responsible Nutrition (CRN) and the American Botanical Council (ABC) said that new laws are not needed; what is called for is better enforcement of existing laws. Cohen views the issue of products being on the market with ingredients whose safety is unclear as demonstrating fundamental gaps in dietary supplement regulations; the industry associations and other experts say that lax enforcement is the primary point of concern.
“Cohen is incorrect in saying that the law allows dangerous new ingredients to get on the market,” Steve Mister, executive director and CEO of CRN told NutraIngredients-USA. “If you have a new ingredient you have to notify FDA 75 days before going to market and you have to show in a New Dietary Ingredient notification that your ingredient is reasonably expected to be safe. The law is very clear; you may not market these products unless you’ve done an NDI notification. The law does provide a mechanism. If the agency is not enforcing that mechanism, that is not the fault of the law.”
Illegal outliers vs. responsible core
FDA enforcement may have increased in recent years, but it has a long way to go, Mister said. In a written response to Cohen’s article, Mister called for a more stringent application of existing law.
“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,” Mister wrote.
Mark Blumenthal, founder and executive director of ABC, echoed that sentiment, saying, “Criminals who are currently intentionally breaking the law will not stop their illegal activities just because well-intentioned people might create new barriers to entry, i.e., premarket approval regarding the safety of the ingredients in their products.”
In a statement, ABC said the principal point of concern lies with products that are not properly categorized as supplements at all.
“The case [Cohen] makes for a reform of the current ‘woefully inadequate system for supplements’ is in large part based on the numerous adverse event reports related to products containing unlabeled prescription drugs illegally masquerading as dietary supplements,” ABC wrote.
Adverse event reporting
Cohen’s call for an interdisciplianry team to review adverse events is perhaps worthy of further consideration, Mister said. Blumenthal sees Cohen’s failure to call for the inclusion anyone with specific dietary supplement industry experience on the team as troubling. ABC's statement quoted supplement safety expert Rick Kingston, PharmD, President of Regulatory and Scientific Affairs at SafetyCall International and Clinical Professor of Pharmacy at the University of Minnesota.
“While a quicker alert system for adverse event reports may be in the public interest, it is not sensible to restrict a proposed reporting system solely to dietary supplements, especially if it leaves responsible manufacturers out of the process,” Kingston said. Manufacturers should be in the loop, he said, and unscrupulous manufacturers who would presumably ignore such communications would in so doing provide enforcement leverage for FDA.
For ABC, as for CRN, the bottom line is more action, not more words: “ABC believes that neither a revamped adverse event reporting system just for supplements, nor the requirement of a pre-market safety assessment for dietary supplements will deter unscrupulous manufacturers and marketers of fraudulent products from attempting to sell intentionally adulterated products, including illegal prescription drugs disguised as dietary supplements. What is needed is more robust enforcement on the part of the FDA, and fortunately, FDA has significantly increased such enforcement in this area in the past few years.”