Journal Article Says NDI Guidance Not Stringent Enough; CRN Argues More Law Enforcement Needed


The author of a New England Journal of Medicine article says a premarket-approval system for supplements should be instated.

The author of a New England Journal of Medicine article published online last week says that tougher FDA mandates over dietary supplements-including within FDA’s new dietary ingredients (NDI) draft guidance-are needed to ensure that products on the market are safe, and that a premarket-approval system for supplements should be instated instead. Dietary supplement association the Council for Responsible Nutrition (CRN; Washington, DC) has criticized the article, stating that more regulatory enforcement is what is needed to catch bad actors breaking the law.

In the NEJM article, author Pieter Cohen, MD, declared that dietary supplements in the United States “may be marketed without any evidence of efficacy or safety.” He said there is a large number of outstanding NDI notification submissions, without which there is little assurance that dietary supplements on the market are “reasonably expected to be safe.”

Cohen also criticized the DSHEA-mandated exception that eliminates the need to submit an NDI notification if an ingredient was sold on the market as a dietary ingredient prior to October 25, 1994. Cohen questioned whether this type of historical data would be enough to substantiate a “reasonable expectation of safety” and quoted the Institute of Medicine as stating, “even widespread historical use without documented ill effects is no guarantor of long-term safety.” Instead, Cohen wrote, companies should be required to submit actual experimental data demonstrating safety. He said that by failing to require this in the draft guidance, “I do not believe the FDA has gone far enough.”

Ultimately, Cohen called for a premarket approval system for supplements: “[E]ven if the guidance is strengthened and aggressively implemented, fundamental flaws in DSHEA, such as the lack of a preapproval review process for all supplements, will continue to limit the FDA’s ability to ensure that dietary supplements are safe.”

In response to Cohen’s article, Duffy MacKay, ND, CRN’s vice president of scientific and regulatory affairs, said in a press statement, “We are well-aware that some people share Dr. Cohen’s perspective that dietary supplements should be regulated like pharmaceutical products, and his personal call for premarket approval legislation for our industry is not new.”

However, he argued, unsafe and spiked dietary supplements are currently illegal and are the result of companies already breaking the law. These companies would likely continue breaking laws-even if stricter laws were written. Thus, he said, more enforcement of existing laws by FDA, and not more stringent new dietary ingredient guidelines, are needed to catch companies acting illegally.

“Clearly, FDA is resource-challenged-both staff-wise and time-wise-and those calling for a new regulatory system that would be unnecessarily burdensome on responsible industry, resource-exhaustive for the agency, and still provide no added protection for consumers, should consider joining CRN and other FDA-regulated industries in encouraging Congress to provide more funding for FDA to enforce the current laws,” MacKay wrote.

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