Past Editions—Need to Know Archives
Connect with Steve Mister at NACDS Annual
The NACDS Annual is set for April 23 to 26 at The Breakers, and Steve Mister, CRN’s President & CEO, will be there.
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Got questions about regulatory changes in the dietary supplement market?
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Wondering how other retailers are implementing their own inspections and product testing requirements?
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What are the latest ingredient and category trends in the supplement aisle?
Steve would be happy to answer your questions and get you up-to-date on what’s happening in the dietary supplement and functional food industry that may affect your offerings. If you would like to schedule a few minutes with Steve, please email and let us know.
Get in touch: Contact Steve via email—smister@crnusa.org—or connect on LinkedIn.
Mandatory product listing for supplements could see movement in 2022, stakeholders say
CRN has spoken with lawmakers interested in sponsoring legislation that would require mandatory product listing (MPL) for dietary supplements with FDA, as reported by Inside Health Policy (IHP).
CRN President & CEO Steve Mister clarified, “the product list idea would not give FDA any premarket authority to tell companies they can’t bring products to market—it would only allow the agency to know what products are out there so it could pursue bad actors.” Mister reiterated this caveat most recently in a blog post, “Pondering New Platforms, Straw Men, and Driver’s Licenses.”
Mister spoke to Senate healthcare staff at an internal briefing in March calling on Congress to “do what is achievable.” Mister explained:
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Both industry and consumer organizations agree that MPL is a reasonable step forward—FDA should know what products are in the marketplace.
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Larger and broader reforms of DSHEA—as proposed by either industry or consumer groups—do not have bipartisan or widespread agreement.
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MPL is requested by FDA and supported by a wide range of groups as disparate as the American Medical Association, the National Consumers League, USP, The Pew Charitable Trusts, and the Dietary Supplements Quality Collaborative (DSQC).
Responsible supplement industry leaders are vocally in favor of MPL. “If somebody is against it, I would question that company. We've been advocating in Congress for a mandatory listing requirement for several years,” said Jeff Boutelle, CEO of CRN member company Pharmavite, during the “Business Leaders’ Forum” hosted by NutraIngredients-USA earlier this year. “We believe this is part of being a responsible industry participant.”
What’s next for NAC?
“The one bright spot in the FDA’s response is that it acknowledges there are no known safety issues with NAC—which industry was already well aware of,” said CRN President & CEO Steve Mister in HBW Insight reporting following the agency’s denial of CRN’s citizen petition. The agency held out the possibility that it may open a rulemaking specific to NAC instead and, in the meantime, exercise enforcement discretion.
“The promise of enforcement discretion should give retailers the assurance they need to continue selling NAC as a dietary supplement, regardless of the legal wrangling going on behind the scenes,” said Mister. “As long as these products meet all other regulatory requirements for a dietary supplement, they should continue to be treated as lawful supplements.”
Clarification of the drug preclusion provision is needed, nonetheless, as Mister further commented, “The provision was not meant to confer monopoly status for all intended uses on dietary ingredients that were marketed prior to DSHEA, were grandfathered by the law, and for which no drug manufacturer had any expectation of exclusivity prior to the passage of the law.”
What's next: Next steps include potentially opening legal action or working with supporters on Capitol Hill to amend DSHEA’s drug-preclusion provision established in the Food, Drug, and Cosmetic Act, the article further noted.
Stay updated on CRN action related to NAC here: www.crnusa.org/NAC
GRMA advances harmonized retailer testing for supplements
The Global Retailer and Manufacturer Alliance (GRMA)—now an associate member of CRN—has convened a Product Integrity Committee focused on developing a single, voluntary marketplace testing standard for dietary supplement products.
CRN will serve in a non-voting, advisory capacity to the committee and is encouraging members to participate.
GRMA’s Retailer Roundtable provides an opportunity for qualified retailer and distributor members to collaborate and discuss non-competitive quality and safety challenges within our industry. This group also acts as a member steering committee to the GRMA. Learn more via GRMA’s website.
COSMOS results drive industry innovation
Results are in on the anticipated Cocoa Supplement and Multivitamin Outcomes Study (COSMOS), published in the American Journal of Clinical Nutrition in March:
COSMOS is a randomized, double-blind, placebo-controlled, two-by-two factorial trial of a daily multivitamin and cocoa extract for prevention of cancer and cardiovascular disease among 21,442 U.S. adults free of major CVD and recently diagnosed cancer, reporting the following outcomes:
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Signs of preventive cardiovascular effects for cocoa flavanols, including a 27% reduction in the secondary endpoint of cardiovascular death
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A 10% reduction in total cardiovascular events, the trial’s primary outcome, that was not statistically significant
“Groundbreaking research like COSMOS and future research on bioactives like flavanols are the types of science that will propel innovation for the supplement industry and push forward the possibilities in supporting consumers’ health,” said CRN President & CEO Steve Mister in a same-day statement.
“As an association, we’re proud that two of our member companies, Mars and GSK, were cornerstones in the public-private partnership that supported this research,” said Mister.