UNPA / NEJM -- Injecting Safety into Supplements: Modernizing the Dietary Supplement Law, by Cohen & Bass

​​Dear Colleagues --

In today's New England Journal of Medicine, a perspective article (attached) was published by Pieter Cohen, M.D., and Scott Bass, J.D. The title: Injecting Safety into Supplements -- Modernizing the Dietary Supplement Law.

A word about the authors. Pieter Cohen is well known to many of you as a thoughtful, if not frequent, critic of DSHEA and the dietary supplement industry. His focus has been on spiked and adulterated products and exploring the underlying reasons why this happens. Dr. Cohen's view is that DSHEA, now 25 years old, requires revision in order to deal with modern issues of a globalized supply chain and sophisticated technology to reintroduce discarded pharmaceuticals, steroids and other illicit agents into the dietary supplement market.

Scott Bass, no doubt well known to many of you, is one of my closest personal friends and professional colleagues, as well as a principal negotiator and architect of DSHEA. Throughout his career, Scott has been a staunch advocate and defender of the dietary supplement industry and the rights of consumers to pursue natural healthcare products of their choice.

This article (a first, given the two co-authors) offers three recommendations as part of the ongoing discussions to "modernize" DSHEA, otherwise known as DSHEA 2.0. In summary, these three points are as follows:

1. A mandatory product registration system, which would allow FDA greater insights on products in the market and therefore greater capacity to deal with emerging problems.
   
   
2. A revised approach to New Dietary Ingredients by establishing a definition of "new" that would more broadly require NDI notifications and limit the scope of manufacturing processes or changes that would be considered old for purposes of ODI recognition.
   
   
3. To achieve points one and two, FDA would need to be directed by Congress as well as funded in order to aggressively enforce the law.

OUR VIEW

I am personally well acquainted with both authors of this article and respect their sincere professional interest in assuring that consumers purchase safe, high quality, and reliable dietary supplements. I join them in this objective.

How this is achieved has been and will continue to be a matter of public discussion, both within and without the industry. As far as the three recommendations go: 

1. UNPA supports the concept of mandatory product registration as a logical step to provide a central database for FDA to know how many products of what kind are available to consumers. Concerns have been expressed about how FDA might use such a database, but we live in an age of technology where such information is readily available via company websites and otherwise, and it does not seem inappropriate for FDA to have a more convenient tool to evaluate dietary supplement products on the market.
   
   
2. Revising New Dietary Ingredient requirements is a far more complex and nuanced issue. UNPA's view is that the NDI procedure as envisioned and passed in DSHEA provides an important mechanism to evaluate the safety of "new" dietary ingredients that enter the market. This was a good idea then, as it is now. The tricky part has always been defining what is old and what is new. The safety standard for New Dietary Ingredients is a reasonable expectation of safety. Many who have filed NDIs would argue that FDA has now exceeded that statutory definition, thus making the NDI process unduly expensive and burdensome. This has led to the use of GRAS affirmation as an alternative route to market. It is my view that the authors did not intend to comprehensively lay out a new NDI mechanism but rather to point out that if there are abuses of the GRAS affirmation process, this should be addressed, as well as to reaffirm the underlying statutory requirement that ingredients that are truly new to the market should undergo FDA review. This, we have no argument with. The details, however, are far more complicated and deserve continued discussion, and ultimately resolution.
   
   
3. UNPA has long supported additional funding for the Office of Dietary Supplement programs, given the growth of the industry from 1994 to 2019 (almost 2020). We continue to support additional funding for FDA, together with Congressional directives, to assure that FDA is focusing on the mission of public health and safety, and that all program activities reflect that objective. 

As a final personal note, I again want to state my respect for the authors, both of whom I believe to be earnest in their professional commitment to a better, safer, and higher quality dietary supplement marketplace. The fact that they would co-author an article in a prestigious journal, I take as an indication of progress that, despite differences, people of goodwill and common objectives can and should find ways to encourage the public debate on these important issues.

Cordially,
LDI

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