First take on NDI comments: Guidance will stifle innovation without increase in safety

First take on NDI comments: Guidance will stifle innovation without increase in safety

Comments on FDA’s NDI guidance have flooded in, and several themes have emerged. Commenters observed that the guidance will stifle competition, is overburdensome and will contribute little to the overall safety of dietary supplements.

The comment period closed yesterday, and at that time FDA reported having received more than 7,400 comments, which did not include comments with multiple signees (one, left over from the first comment period in 2011, had more than 30,000 signees). FDA also redacts comments and avoids posting redundant comments on the public docket.  Of the roughly 1,900 comments posted on the public docket, about 260 pertained to the most recent version of the draft guidance, with others having been posted in 2011 and 2012 in response to the first draft of the guidance.

More comments received in the past few days as the deadline wound down are likely to be posted on the docket in the coming days. NutraIngredients-USA will take a deeper dive into the main points of the comments in the coming days, but an initial overview of public reaction reveals some common skeins of thought.

Many comments that came in from what appear to be consumers mention FDA’s perceived bias toward drugs. 

“Supplements are not drugs. Please stop treating them as such,” was a comment sentiment.

A number of comments echoed the sentiment that there is plenty regulation already, and what lacks is a willingness on the part of FDA to enforce existing laws. Along those lines, there were questions about how FDA is planning to implement this regulation if it stands in current form.

“This will create more work for the already overburdened FDA ,” one commenter said.

Health care professionals split on guidance

A number of comments came in from people who identified themselves as health care professionals. These generally broke along the lines of training and experience; commenters identifying themselves as chiropractors or alternative health care professionals were generally in favor of the supplement industry and against the guidance with MDs generally taking the opposite view.

Many of these negative comments echoed concerns about the supplement industry that have been reported in the popular press, that there is insufficient quality control making these professionals loathe to recommend them to their patients if they can’t be sure what’s in the bottles. "When we recommend prenatal vitamins, or supplements for prevention of neural tube defects or even nausea--how are we to know if we are really recommending sugar pills when NO ONE is verifying them?” was one representative comment.

One commenter was prominent industry critic Dr Pieter Cohen MD from Harvard.  Cohen had this to say: "While the guidance cannot correct important flaws in DSHEA, overall, it serves as an advance in respect to clarifying many areas of controversy and, if industry compliance is high and FDA enforcement is aggressive, it would lead to safer dietary supplements for American consumers.”

Cohen went on to say that he believes the safety information (not proprietary manufacturing details) provided to FDA should be made public. He also suggested that synthetic ingredients, when and if allowed, should be disclosed as such on product labels.

Comments filed by Canadian dietary supplement manufacturer Atrium Innovations echoed many of those by industry, when the company said: "Substantial and unprecedented premarket regulatory process for New Dietary Ingredients (“NDIs”) that is tantamount to obtaining FDA approval for dietary supplement products, contrary to both the letter and Congressional intent of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). We question why, after 17 years, FDA has promulgated such stringent guidelines, as we do not believe that a consumer safety crisis exists to merit such action by the Agency.”

Innovation buzz kill

A number of comments focused on how the draft guidance’s provisions, especially its call for multiple NDI filings, could throw a wet blanket on innovation. One commenter opined that more than 90% of phytonutrients that could be beneficial to human health remain to be discovered. The commenter referenced a 1992 Congressional Dietary Supplements Task Force report that concluded that while keeping safety in mind, “freedom of choice for these products should be allowed as much as possible.” The commenter concluded the guidance in its current form undercuts this principle.

Another commenter focused on the potential effect the guidance could have in squelching competition. "Please revise the guidance to make it easier, not harder, for competition in the consumer market to produce innovation and choice with many providers and companies producing product,” his comment read.

A number of commenters, led in by comments filed on behalf of the American Chiropractic Association, called for a 120-day extension of the comment period, which would put the deadline at February 11, 2017.

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