Time for DSHEA 2.0?

It may be time to discuss what DSHEA 2.0 could look like, according to a new opinion piece published in The Journal of Nutrition by a former industry association expert.

Heather Granato, VP, Partnerships & Sustainability

June 16, 2015

3 Min Read
Time for DSHEA 2.0?

In the 20 years since the Dietary Supplement Health & Education Act (DSHEA) passed, the law has remained fairly untouched, with new regulatory requirements related to steroid precursors (via the Designer Anabolic Steroid Control Act, DASCA), adverse event reporting and the like imposed via different bills. However, in a new piece published in The Journal of Nutrition, Taylor Wallace, Ph.D., a former senior scientist and regulatory expert at the Council for Responsible Nutrition (CRN), suggests it may be time to begin a dialogue on how supplement regulation could be improved with a “DSHEA 2.0".

Wallace holds that DSHEA has had major successes, among them establishing the Office of Dietary Supplements, implementing dietary supplement cGMPs (current good manufacturing practices) and adopting a standard Supplement Facts panel. However, he also suggests that “dietary supplements are not regulated appropriately in the United States," and that as the market has expanded and evolved, the regulations should as well. He focuses on four primary areas that could beneficially affect ease of access and safety of products: premarket approval, label claims, GMPs and adverse event reporting (AERs).

Delving into one of the most controversial areas of discussion, Wallace notes that while premarket approval doesn’t prevent illegal sales of pharmaceuticals into the United States, it does provide regulators with authority to act on a perceived health threat. With dietary supplements, FDA relies on a postmarket surveillance system and places the burden of safety on the regulators. But he also notes that implementing a premarket approval process for supplements could significantly burden FDA to ensure proper enforcement. Instead, he points to the GRAS (generally recognized as safe) notification program as a possible model for dietary ingredients, citing the uncertainty around the NDI (new dietary ingredient) draft guidance.

“GRAS notification has served, in my opinion, as an effective process for which a food ingredient is generally recognized among qualified experts as being safe," Wallace stated in an email to INSIDER. “Adopting this process for dietary supplements would mean a full safety review for a dietary ingredient regardless of whether it was present in the food supply before DSHEA. … If a finished product contained dietary ingredients that had a GRAS determination with no question from FDA, then notification would not be needed."

He also suggests FDA should have more statutory authority to enforce specific requirements on the types of levels of scientific evidence needed to substantiate a structure/function claim. Wallace noted there would first need to be some consensus among experts around how to evaluate evidence for that scientific substantiation, as randomized controlled trials (RCTs) are not necessarily positioned to evaluate long-term health effects. Instead, he looks to the European Commission, which has shown inclination toward reliably measured biomarkers related to general health. “I’m suggesting multiple types of data be considered when substantiating structure/function claims," he stated in his email, pointing to how the DRIs for dietary fiber were developed with data from many types of studies. “While I’m not suggesting the same immense numbers of studies are needed, I think the key is having consistent, reproducible, reliable evidence."

The topic of further industry regulation is not far from the minds of industry or its associations. “We’re always open to more discussion about industry regulation and how to ensure that consumers are best protected while still allowing for industry innovation," said Duffy MacKay, N.D., senior vice president, scientific and regulatory affairs, CRN. “These types of discussions are ongoing, and have been for years.  That’s how we move forward with new laws such as DASCA. The key is not just changing the legislation to bend to the will of critics, but rather finding ways to help solve the biggest problems faced by our industry.  Having more resources for FDA is key, and we’d like to see the agency implement the current regulations—such as finalizing the NDI guidance—so we can truly evaluate what new regulations, if any, might be needed."

About the Author(s)

Heather Granato

VP, Partnerships & Sustainability, Informa Markets, Food EMEA division

Heather Granato is a 30-year veteran of the natural products industry, currently serving as vice president, partnerships & sustainability, in the Food EMEA division of Informa Markets. She is based in London, and leads efforts related to industry partnerships and broader sustainability initiatives for the Vitafoods and Food ingredients brands. She has been a presenter at events including SupplySide, Vitafoods, Food ingredients, Natural Products Expo, the Natural Gourmet Show and the Folio: Show. Her publishing experience includes Natural Products Insider, Food Product Design, Vitafoods Insights, Country Living's Healthy Living, Natural Foods Merchandiser, Delicious Magazine and WomenOf.com. Granato serves as the founding president of Women In Nutraceuticals, a global non-profit founded in 2022 focused on empowering women in the nutraceutical industry; she is also on the board of directors for the Organic & Natural Health Association. From 2016 to 2022, she was a vice president on the national governing board of Kappa Alpha Theta women’s fraternity. Granato was named to the FOLIO: 100 list of top media professionals in 2018, and was selected as a 2015 Top Woman in Media by FOLIO:. She received the 2014 Visionary Award and the 2018 Journalistic Excellence Award from the American Herbal Products Association (AHPA); and was honored with the CEO Merit Award for Content from Virgo in 2014. Granato graduated magna cum laude from the University of Richmond, Virginia, in 1992 with a bachelor’s degree in journalism.

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