The first quarter of 2022 has already presented new challenges for the dietary supplement industry. As we continue our leadership on some of the most important and pressing issues our industry is facing, here is a summary of top examples:
Mandatory Product Listing
Big news last week, though Q2, we can't talk about MPL without acknowledging the introduction in the Senate of S 4090, the Dietary Supplement Listing Act of 2022. CRN continues to be actively engaged with Members of Congress regarding MPL legislation following the bill's introduction. Being at the negotiation table has allowed CRN to help shape the legislation, pushing for inclusion as items important to the industry and removal of those aspects that are overly burdensome or exceed the appropriate scope of the registry. We have provided pushback on arguments that uninformed stakeholders may make against MPL. CRN’s team met with Senate HELP committee staff, and has shared details from its “MPL Reality Check Deck” in many venues, including a panel discussion among trade association heads for the “Short Legal Briefs With Josh Long” program and our March board of directors meeting. In addition, MPL was addressed in the inaugural post of CRN’s new blog.
In Q1 CRN's DSHEA revision resolution was reaffirmed
While mandatory product listing tops our wishlist with Congress, CRN’s Board of Directors approved a resolution at its March quarterly meeting reaffirming CRN’s support for six areas of revisions to DSHEA:
- Support for mandatory product listing
- Addressing a gap in the definition of dietary supplements
- Establishing a legal pathway for CBD in dietary supplements
- Revising the drug preclusion provision that removes some ingredients from the market
- Authorizing GMP inspections by third party auditors
- Permitting dissemination of scientific information
CRN continues to advance all of these initiatives in meetings with FDA, congressional offices and other stakeholders.
Protecting the status of NAC…
CRN worked to protect consumer access to N-Acetyl-L cysteine (NAC) dietary supplement products and to compel FDA to provide retailers, payment platforms, and product marketers with the assurance they have been asking for—that they may continue to sell NAC-containing dietary supplements without threat of enforcement. This narrow goal was finally achieved in the agency’s April 21 draft guidance, however, clarity on the agency's broader interpretation of the drug preclusion provision is needed going forward, as noted in our press release.
… and dealing with drug preclusion more broadly.
While FDA’s announcement of enforcement discretion provides comfort for marketers of NAC, this episode illustrates FDA’s overly broad interpretation of the drug preclusion clause in DSHEA and the threat to other ingredients. CRN is already evaluating how to clarify and revise this statutory provision to protect other ingredients from similar uncertainty. We are working on legislative language and a strategy to enact these changes.
State legislation to restrict certain dietary supplements from those under 18 has continued to flare up in half a dozen states. CRN’s Government Relations team and lobbyists are on high alert for opportunities to educate legislators and defeat these bills where we can, and to mitigate the burden on industry of over-reaching and ineffective legislation where we have to find compromise with a misguided consumer movement. We will be disseminating a newly published report (just in, Q2) supporting our position.
Exports to China
CRN’s international activities in Q1 addressed a range of distinctly different trade issues for our members. Continuing efforts begun at the end of 2021, we aided companies scrambling to comply with new requirements imposed by China for importation of health foods (i.e., the dietary supplement and functional food categories) that require an attestation by a U.S. competent authority attestation, i.e., the FDA, to confirm that the responsible U.S. company is exporting safe and well-manufactured ingredients and products to China. Following a flurry of calls with FDA’s Office of International Engagement, the US Trade Representative, the Department of Commerce’s International Trade Administration, and the USDA’s Foreign Agricultural Service, we aided as the U.S. developed a portal for submitting the necessary information from existing exporters, but ongoing concerns continue to bedevil trade opportunities in 2022 for new exporters.
Meanwhile, in Europe...
European trade has been affected via renewed precautionary safety concerns that would limit the recognized upper safe levels for some nutrients. With a long expertise in defending scientifically defensible safe upper levels, CRN has begun formulating our response. Separately, CRN supported and added appropriate industry verbiage to a large coalition letter to the European Commission on front-of-pack nutrition labeling, which emphasizes our member perspectives on meal replacement and sports nutrition products.
'Supplements aren’t regulated' and other false narratives
CRN has reinvigorated our efforts to address and combat false narratives in popular consumer media stating that supplements are unregulated and/or unnecessary, with new outreach to journalists with the facts. In many cases, corrections have been made and the media relations team is opening new dialogues with reporters and editors to position CRN as a go-to source for trustworthy background on supplements.
'Science in Session' paper published
Topics presented at CRN’s 2021 Science in Session event have been published in a new Journal of Nutrition article, Sex Differences Across the Life Course: A Focus on Unique Nutritional and Health Considerations Among Women. The paper highlights women’s unique nutritional needs based on physiological and hormonal changes across the lifespan to provide a better understanding of differences between the sexes to help optimize recommendations and interventions to support health and weight management as we move into the era of precision nutrition.
CRN promoted the Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) results with a same-day statement and hands-on outreach to key press. CRN applauded its member companies, Mars and GSK, cornerstones in the public-private partnership that supported this research and noted that this kind of scientific inquiry paves the way to improved understanding of the role nutrition plays for human health and drives innovation.
Education: from protein to sustainability
CRN convened diverse groups of expert speakers on trends in protein supplementation and the science supporting them, as well as on the challenges of a more sustainable industry, for two webinars to educate our supplement industry stakeholders. Both webinars are available on demand. In addition, CRN has hosted several guest presentations on various committee calls exclusively for CRN members in which timely topics related to ingredient and packaging sustainability were addressed.
Vitamin D and me!...Part 2
The task force is honing its tactics for outreach to a new audience of healthcare practitioners—nutritionists and dietitians—for its positive messaging on the relationship between vitamin D status and the incidence and severity of COVID-19. CRN Foundation is sponsoring Shopping for Health, an annual event connecting us with dietitians from more than 65 national retailers, representing nearly 10,000 store locations across the country, which will involve sharing details of the initiative with this valuable audience. In addition, CRN is activating a digital advertising campaign to drive nutrition professionals in clinical practice to the Vitamin D & Me! website.
A Whole Different Way to Look at Wellness
CRN has released its 2021 annual report, a multimedia presentation that explores how the CRN team provided unique value to our diverse array of member companies over the past year.
CRN’s Audit Committee reported a “clean” and “unqualified” audit for FY 2021 by our independent auditing firm. In finance parlance, that means no concerns. CRN takes good governance and transparency with our members and stakeholders seriously and our track record of clean audits reflects this attention.
Heading into Q2—CRN launched a new blog, “Supplemental,” that features unique takes on dietary supplement topics, kicking off with my pushback against a common argument against mandatory product listing. Members are encouraged to submit content—editorial guidelines are available here.
If you have any questions or concerns about your company’s membership, please let me know. You can reach me at firstname.lastname@example.org or 202-204-7676.
President & CEO
Council for Responsible Nutrition
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