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PRINTABLE HIGHLIGHT SHEET | JUMP TO: NAC | Vitamin D & Me! | Probiotics | Age Restrictions | CBD | DSHEA 2.0 | OWL
The CRN Daily Supplement is the newsletter for members of the Council for Responsible Nutrition (CRN), the leading trade association of the dietary supplement indusry. This quarterly digest provides non-members a sneak peek into our initiatives and industry news. Join CRN to receive your copy daily. Contact Carl Hyland (chyland@crnusa.org) for additional details.
FDA evaluation of NAC not complete; CRN continues dialog with agency, Amazon and key stakeholders
As reported in Natural Products Insider, CRN recently met via Zoom with Acting FDA Commissioner Dr. Janet Woodcock and other officials to discuss top supplement industry issues, including concerns over the agency’s position that N-acetyl-L-cysteine (NAC) cannot be lawfully marketed in dietary supplements.
FDA had responded in an earlier letter to CRN's concerns about repercussions in the retail space following the agency's July 2020 warning letters on NAC. FDA acknowledged that the issue is still under consideration at the agency and the evaluation of NAC is not complete.
As previously reported, CRN has been in contact with members marketing NAC dietary supplements who had products removed from Amazon—in addition to contacts with Amazon and FDA.
CRN's Megan Olsen said in a Natural Products Insider update that she hasn’t heard that other retailers plan to stop selling NAC-containing supplements, and she believes many traditional brick and mortar retailers are still selling the products. Olsen did note that Amazon has asked brands to remove NAC-containing supplements from its website.
CRN has shared FDA's response with Amazon to help demonstrate that the legal status of NAC reflected in the warning letters is not a final decision by FDA.
“CRN has continued to have discussions with both FDA and Amazon regarding this issue,” Olsen said. “We are very pleased that Amazon is at least continuing to talk with us, though of course they have not committed to...change their course of action.”
CRN Foundation shares unbiased research via ‘Vitamin D & Me!’ consumer education website
The CRN Foundation announced the launch of "Vitamin D & Me!"—a consumer education website on vitamin D and COVID-19. The Vitamin D & Me! website presents research, expert video interviews, news, and education in a user-friendly format, focusing on U.S. consumers 55 and older.
“Worse outcomes from COVID-19 and other respiratory infections are seen with increasing age, which is one of the reasons why the site is dedicated to the 55+ community. The site will also provide helpful information for all adults,” CRN's Luke Huber, ND, MBA, explains.
CRN Associate Member Nutrasource developed the scientifically-supported content for Vitamin D & Me! The initiative tracks and summarizes clinical studies on vitamin D and COVID-19.
Vitamin D & Me! also includes:
- Media reports on vitamin D and COVID-19
- Educational content about vitamin D
- “Meet the Experts” video interviews with researchers and clinicians
“We have been fascinated over the past year at the amount of research being conducted examining the potential relationship between vitamin D and COVID-19,” CRN's Steve Mister said. “The CRN Foundation is delivering unbiased education on the latest science, which helps people make smarter decisions to maintain their health.”
Contact Kendall Ridley with questions.
'Probiotics: What's Inside is Alive!' retailer education campaign provides need-to-know info on identity, quantity, viability, and more
It is critical that retail buyers understand probiotics' unique properties in order to provide customers with safe, high quality, and beneficial products. CRN's new retailer education campaign, Probiotics: What's Inside is Alive, explains the importance of probiotic identity, quantity, and viability—and properly labeling these attributes.
The campaign's Retail Buyer's Guide, infographic, and video include tips for:
- Curating probiotic offerings for sale
- Proper handling of probiotics
- Educating customers about probiotics' health benefits
In addition, the campaign offers:
- Scientific White Paper
- Ten Questions to Ask Your Vendors About Probiotic Supplements
- Infographic for consumers
- Educational video for consumers
“CRN is an industry leader for advancing education around dietary supplements,” said CRN's Andrea Wong, Ph.D., in Nutritional Outlook's coverage of the campaign launch. “As these live organisms continue to grow in popularity, CRN will expand educational resources for the retail community to ensure consumers have access to high quality and beneficial probiotics.”
Skillful government relations key to protecting supplement status in the states—an update on age-restriction proposals
Skillful government relations, including productive engagement with opponents, is key to protecting supplements’ status in the states. CRN's Government Relations Committee and State Subcommittee are working together to oppose state age restriction proposals, including California AB 1341 and Massachusetts H 2331 and S 1525.
“CRN has a unique understanding and depth of knowledge on age restriction proposals,” CRN Government Relations State Subcommittee Chair Ingrid Lebert of Pharmavite noted. “CRN’s team is careful to respectfully engage those stakeholders we aim to educate, which takes strategic relationship building to ensure an open dialogue. When opposition assertions are delivered without consideration of stakeholder perspectives, it creates an additional hurdle for arriving at solutions to best serve consumers, retailers and industry.”
At a California Judiciary Committee hearing in May, Tatum Ackler, with CRN California lobbying consultant Samson Advisors, emphasized appreciation for ongoing discussions with legislators and a commitment to work together, testifying in accord with comments from the American Herbal Products Association.
In contrast, other opposition comments drove Rep. Lorena Gonzalez (D-San Diego) to express astonishment, noting they did not demonstrate adequate research into the eating disorder issues driving the proposal and prompting her to emphasize that, in her view, the legislation does not go far enough. “I don't appreciate the misinformation campaign,” Rep. Gonzalez added, referring to assertions that the proposal would affect all supplements.
CRN Massachusetts consultant Robert Rodophele testified during a hearing of the Massachusetts Joint Committee on Public Health. He emphasized CRN’s support of FDA cracking down on dangerous adulterated products at the federal level and drew a clear line separating these from legitimate dietary supplements marketed by responsible companies.
See CRN's video “4 Things to Know About Age Restriction for Dietary Supplements” with president & CEO Steve Mister.
Mister: 'It's time to rally around H.R. 841' for CBD, other hemp-derived cannabinoids
The suggestion that FDA set a pre-market safe use level for CBD flies in the face of DSHEA, said CRN President & CEO Steve Mister in a recent bylined article for Natural Products Insider. Companies in the supplement space, whether they market products with CBD or not, should be aware of the dangerous precedent that would be set by that approach.
“No other dietary ingredient is subject to FDA’s setting a safe serving level before it can be lawfully marketed,” Mister noted. “Rather, the law places on FDA the burden to demonstrate a lawful dietary ingredient is not safe to remove it from the market.”
It’s time for companies that want a pathway forward for CBD and other hemp-derived cannabinoids to rally around H.R. 841 and help build support, Mister urged.
The bipartisan Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (H.R. 841) would:
- Exclude hemp-derived CBD and other cannabinoids from drug preclusion language in the definition of a dietary supplement in the federal Food, Drug & Cosmetic Act (FDCA). This would allow CBD-containing dietary supplements into the market legally.
- Require products containing hemp-derived CBD and other cannabinoids to be marketed as dietary supplements and mandate these products comply with supplement regulations—meaning all requirements and restrictions for dietary supplements imposed by the FDCA and the Fair Packaging & Labeling Act would apply.
“The question is really not about the safety of the ingredient,” said Mister in an interview with NutraIngredients-USA. “It's about the legal obstacle that's in the FDCA in the very definition of a supplement, which created this race to market. If a drug company gets there first, they get a monopoly over the article.”
H.R. 841 is the best way to eliminate that obstacle, Mister emphasized in the interview. Opponents of H.R. 841 on safety grounds "have gotten the order of things backwards," he observed.
Check out the full interview for more on DSHEA 2.0—beyond CBD—and access CRN's webinar, now available on demand.
Plus, Whole Foods Magazine recently discussed three ways the industry is being called to action by the Dietary Supplements Quality Collaborative, of which CRN is a member, quoting CRN's Vice President Government Relations Julia Gustafson:
New ‘Supplement OWL’ website enhances industry transparency; advisory board encourages full participation
“Transparency has never been more important and the Supplement OWL is a demonstration of this industry’s commitment to candor and honesty with our regulators, retailers and consumers,” said members of the Supplement OWL Advisory Board in a recent letter to fellow dietary supplement trade associations. The advisory board urged associations to alert their members to the OWL and encourage them to place their labels in the registry.
Highlighting the Supplement OWL's growth over the past three years, the letter detailed exciting developments and important improvements recently made to the registry, including:
- A more user-friendly label entry page and interface
- “Export results” feature
- “Save search” feature and an associated notification feature
- Multi-version product tool
- Bulk upload capability
- Supplier feature
- Video guide for brand owners
The SupplySide 365 Network (SSN 365) recently hosted a session on updates to the Supplement OWL with CRN’s Luke Huber, N.D., MBA—now available on demand. Contact Luke Huber with questions.
The CRN Daily Supplement is the newsletter for members of the Council for Responsible Nutrition (CRN), the leading trade association of the dietary supplement indusry. Join CRN to receive your copy daily. Contact Carl Hyland (chyland@crnusa.org) about membership. Learn more: www.crnusa.org/join