Embracing the future: The dietary supplement industry comes of age

Related tags Draft guidance Dietary supplement Fda

Embracing the future: The dietary supplement industry comes of age
Duffy MacKay of CRN argues that there is much in FDA's newly released New Dietary Ingredients draft guidance that represents a step forward for the industry.

A year from September, my son will likely be on his way to college, where he will begin the journey from teenager to adulthood. As he makes that transition, I have an expectation that he will live his life ethically and responsibly. Similarly, with the recent release of the revised New Dietary Ingredient (NDI) Draft Guidance, the dietary supplement industry, at the ripe age of 22 years post-DSHEA, is at an analogous crossroads. As our industry comes of age, how will we demonstrate the responsibilities that go hand in hand with maturation? 

With DSHEA, our industry played a role in ensuring passage of a law that would not only protect consumers, but would also allow our industry to innovate and grow. One such provision that focused on that balance was NDI notification (NDIN), a recognition of the need for an appropriate review of the safety data for new ingredients before those ingredients went to market. Now that FDA has issued its revised NDI draft guidance, we hope that companies will recognize that, while not perfect, it provides an opportunity for industry to demonstrate its commitment to product safety—a hallmark of a mature industry.

Look to the benefits

Although CRN will continue to share concerns about some of the draft guidance document, we also are urging companies to look at the benefits. For example, this new version is certainly the best explanation the industry has received to date of FDA’s expectations about the type and scope of science needed to submit an NDIN. And, it suggests a willingness by FDA to maintain an open dialogue with the industry, including an invitation to arrange a pre-notification meeting with FDA—something that should be appreciated. It’s clear that FDA carefully considered the comments that CRN and others submitted in response to the previous draft and made thoughtful revisions resulting in clearer roadmaps that companies can use to navigate the NDIN process. 

A large percentage of the NDINs to date have been rejected, and a lot of that rejection has been because companies didn’t know what FDA’s expectations were, and consequently were submitting incomplete notifications. That should change with this new guidance.

It’s clear that FDA also heard our concerns about whether it’s necessary for a manufacturer to have to submit an NDIN on an old ingredient when the manufacturing process has changed. The answer is, it depends, however, FDA has indicated that many manufacturing changes do result in a new ingredient via its expanded explanation of what is required in this area. 

Protection via master files

Duffy MacKay, ND- Headshot
Duffy MacKay, ND

Here’s another thing we appreciate. FDA clearly took into account our concerns about the lack of protection for a company’s investment in submitting an NDIN, responding by making clear that you cannot piggyback on another company’s successful NDI submission, unless you can demonstrate that you have the identical ingredient. But it added to that protection by agreeing to lock down the master files, thereby rendering the submitted information on the new ingredient proprietary. Thus if a manufacturer is excited about the growth it sees for a new ingredient, its best option is to go to that ingredient supplier and buy that exact ingredient. This is a win for companies that invest in science and should not only encourage ingredient suppliers to submit to the process, but by providing added protection, FDA is providing an incentive, rather than the disincentive of the previous draft guidance. If FDA enforces this provision—and we hope it will—this should cut down greatly on ingredient copycats, those who skip the process of submission but seek to benefit from the investment of others.  

Price of consumer safety

For those with concerns that the process can get costly, that’s true. But you can’t put a price on consumer safety. The long and the short of it is: if you can’t afford to adequately assess safety and test your ingredients, our consumers can’t afford for you to be in this business. However, a company that can’t afford to invest in the research expected to establish safety for a new ingredient, can still manufacture products using grandfathered ingredients—those on the market prior to October 1994—or look for creative options to partner with financial backers to support new and innovative products. 

The new NDI draft guidance requires companies to uphold a sense of accountability for their products. We have an obligation to consumers to treat each ingredient with care—to closely examine what we choose to sell. As the industry matures in years, companies must mature in responsibility. 

Note on author:​ Duffy MacKay, N.D., is Senior Vice President, Scientific & Regulatory Affairs, for the Council for Responsible Nutrition, which represents the dietary supplement and functional food’s industry.

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