Past Editions—Need to Know Archives
YES, FDA allows sale of dietary supplements containing NAC
Retailers can breathe easier now that FDA has released final guidance on N-acetyl-L-cysteine (NAC) indicating it will exercise enforcement discretion regarding the sale and distribution of products labeled as dietary supplements containing NAC.
“This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of ‘dietary supplement’ and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” the guidance states.
This finalizes the draft guidance from April 2022 that addressed the controversy over the legal status of the ingredient. CRN filed a citizens petition to reverse an earlier announcement that NAC may not be sold as a dietary supplement. While the ultimate legal status is still under review, this guidance will give retailers reassurance that FDA will not enforce its earlier determination. See the Federal Register Notice for additional information.
Read more on NAC and the potential for further FDA rulemaking in coverage from Nutritional Outlook and CRN’s website: www.crnusa.org/NAC.
Connect with CRN at Total Store Expo
Attending the NACDS Total Store Expo in Boston later this month?
Connect with CRN President & CEO Steve Mister and members of CRN’s Retail Relations Forum on site.
Steve would be happy to touch base to answer your questions on dietary supplements and functional food and update you on industry news to inform your offerings.
Curious about:
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What are the latest ingredient and category trends in the supplement aisle?
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How do regulatory changes affect the dietary supplement market?
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What are other retailers doing to implement their own inspections and establish product testing requirements?
Get in touch: Contact Steve via email—smister@crnusa.org—or connect on LinkedIn if you would like to schedule a time to meet.
Vitamin D still VITAL, CRN’s Dr. Wong explains
“The fact remains that vitamin D is an essential nutrient that supports numerous biological functions. Dietary studies have repeatedly shown many people still fall short of obtaining adequate levels of vitamin D and may be missing out on health benefits,” said CRN Senior Vice President Scientific and Regulatory Affairs Andrea Wong, Ph.D., in response to results of an ancillary study of the Vitamin D and Omega-3 Trial (VITAL) published last week in the New England Journal of Medicine.
Vitamin D is a nutrient of public health concern, as identified by in the most recent Dietary Guidelines for Americans, noted Dr. Wong, adding:
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It is a disservice to public health to advise that people to stop taking vitamin D supplements when natural food sources of this nutrient are scarce and sun exposure may not be feasible for those who are most vulnerable.
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Vitamin D and calcium work in tandem to support bone health—calcium helps build and maintain bones, while vitamin D helps your body effectively absorb calcium. “These secondary study results are not surprising since VITAL was designed to assess vitamin D supplementation alone and did not include or control for calcium supplementation and intake,” explained Dr. Wong. “It seems obvious that investigating one without the other would produce disappointing results.”
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The study focused only on generally healthy midlife or older adults instead of individuals with vitamin D deficiency, low bone mass, or osteoporosis who may be more vulnerable to fractures and derive a benefit from vitamin D supplementation.
Bottom line: “People should discuss with their health care practitioner whether testing their vitamin D levels or supplementing with vitamin D is appropriate.”
More information on the prevalence of vitamin D deficiency as well as a library of scientific research on vitamin D is available on the CRN Foundation’s “Vitamin D & Me!” website.
Age-restrictions avoided in several states, while CA and NY move closer finalizing legislation
Efforts to block age-restriction proposals for select dietary supplements in several states have succeeded as legislatures adjourn for 2022. Bills of concern now dead include:
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Rhode Island, RI SB 2613, which would have placed significant age restrictions on all dietary supplements, including weight loss and muscle building products. “CRN is pleased to see that the Rhode Island House recognized the proposal passed by the Senate was overly burdensome and declined to consider it,” said Steve Mister, president and CEO of CRN in a NutraIngredients article. “We worked closely with a coalition of retailers and other stakeholders to ensure that this draconian approach was not enacted.”
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Massachusetts HB 4271 died when the legislature adjourned. CRN is pleased legislators recognized the proposal for its burden on industry and misguided intentions. Tufts University’s Jeffery Blumberg, Ph.D., professor emeritus at the Friedman School of Nutrition Science and Policy, recently opposed the legislation in a Boston Business Journal opinion piece.
CRN continues to monitor active bills in California and New Jersey:
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In California, CRN and our Sacramento-based lobbyist have engaged with the bill sponsor, Rep. Cristina Garcia (D-58th District), and have removed our opposition to the newly revised version of CA AB 1341. We will follow the bill as it advances through the legislative process before the legislature adjourns later this summer.
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New Jersey bill NJ A 3512 continues to be considered in the Health Committee, which is chaired by the bill’s sponsor, Rep. Herb Conaway, Jr., M.D. (D-7th District). Rep. Conaway’s staff were receptive to learning more about the industry’s concerns with the legislation when CRN and member representatives met with key contacts. CRN will continue to advocate for its members’ priorities on this bill. Unlike other states of interest, New Jersey’s legislature stays in session through December and the legislation carries over to 2023.
In New York, the legislature-passed bill, NY S16D, awaits advancement to Gov. Kathy Hochul’s desk. Once received, Gov. Hochul (D) will have 10 days (not including Sundays) to act. In the case of no action, the bill would become law. With prospects of a veto being highly unlikely, CRN is engaged with Gov. Hochul’s health staff to create a more palatable bill for the industry via chapter amendments.
Mandatory product listing negotiations remain in play
Negotiations on Capitol Hill remain active regarding mandatory product listing for dietary supplements. The provision is included in the comprehensive “must pass” legislation to reauthorize drug user fees, and CRN remains optimistic the reauthorization bill is the best pathway forward for enactment.
CRN strongly supports mandatory listing, as CRN President & CEO Steve Mister made clear most recently in a NutraIngredients-USA article, as well as Nutrition Industry Executive. “FDA cannot regulate an industry if it can’t see it. And FDA can’t see the breadth and range of the industry now. Mandatory listing provides the transparency that a responsible industry should want and consumers should expect.”
CRN continues to influence discussions around mandatory product listing. If it becomes clear that the proposed legislation does not address industry’s concerns, CRN is prepared to oppose the language and advocate for the “stripped down” user-fee-only bill in its place.
Learn more in the video, “4 Things to Know About Mandatory Product Listing.” Stay updated on the legislation: www.crnusa.org/MPL.
Join dietary supplement and functional food stakeholders in Phoenix for knowledge, networking
CRN’s Now, New, Next event, taking place Oct. 12–14 at the Arizona Biltmore in Phoenix, features top speakers including:
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Margaret Brennan Moderator of CBS News’ “Face the Nation” and CBS News Chief Foreign Affairs Correspondent
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Dex Hunter-Torricke Former Head of Communications at SpaceX, Executive Communications Manager at Facebook, and Executive at Google
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Marci Rossell Expert Economic Forecaster, Former CNBC Chief Economist and Co-Host of “Squawk Box”
CRN’s Now, New, Next takes place in tandem with Science in Session, a day-long symposium presenting research on optimizing health through nutrition, taking place on Oct. 11.
CRN’s events offer insightful speakers to enhance your knowledge on the timeliest topics affecting the supplement industry.
The opportunity to connect with colleagues in a collegial setting among conversations that move the industry forward is another reason attendees keep coming back.
Learn more and register today.