Need to Know - March 2023

Past Editions—Need to Know Archives

• Connect with CRN at NACDS

• Amazon bans NMN in dietary supplements

• FDA fails consumers, industry on CBD; Congress introduces legislation to address the issue

• State age restriction proposals for supplements expected to persist

Connect with CRN at NACDS Annual

The NACDS Annual is set for April 22 to 25 at The Breakers, and CRN President & CEO Steve Mister will be there.  

• What are the latest ingredient and category trends in the supplement aisle?  

• Got questions about regulatory changes in the dietary supplement market? Worried about the future of NAC, NMN or CBD? 

• Wondering how other retailers are implementing their own third-party audit programs and product testing requirements?  

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. 

Amazon bans NMN in dietary supplements

Amazon recently alerted sellers that as of March 13 products marketed as dietary supplements that contain beta-nicotinamide mononucleotide (β-NMN) or “NMN” can no longer be sold on the platform.

• The Amazon update referenced FDA’s November 2022 letter, which announced the agency view that NMN is precluded from sale in dietary supplements because it had previously been studied for drug use. Amazon notes “if you want to sell NMN on Amazon, you must show that you are approved by the FDA for over-the-counter sales,” according to NutraIngredients-USA. [No products have received such approval.]

CRN President & CEO Steve Mister previously observed how the agency’s action on NMN “perpetuates the uncertainty around the drug preclusion issue and furthers FDA’s course of plucking individual ingredients out of the supplement marketplace without warning. Manufacturers, retailers, and consumers are left in limbo each time this happens."

“Amazon’s decision will have negative effects—for consumers, for NMN marketers and for Amazon itself—by prematurely deciding not to offer these products,” Mister told NutraIngredients-USA, recalling how the company “… behaved similarly with NAC and alienated many of its consumers before returning that ingredient to its platform.”

CRN called out the agency for stifling innovation and acting with disregard for consumer interests in response noting a similar inappropriate application drug preclusion to deny marketing of CBD in dietary supplements and to stop sales of N-acetyl-L cysteine (NAC).

• Both NAC and NMN have a history of safe use in supplements, Mister noted, as FDA has acknowledged.

• While NAC is back on Amazon, following release of a 2022 FDA guidance explaining its intent to exercise enforcement discretion, the agency’s 2020 warning letters presented a significant and lengthy disruption to the dietary supplement industry and consumers.

Yes, and CRN expressed disagreement with FDA’s overly expansive interpretation of the drug preclusion provision in the federal Food, Drug & Cosmetic Act noting “the retroactive application of the clause is misplaced and sets a dangerous precedent for the agency to remove other lawful dietary ingredients from the market based on assertions of pre-1994 drug approvals or clinical investigations.”

CRN is submitting a citizen petition to FDA on the drug preclusion issue.

FDA fails consumers, industry on CBD; Congress introduces legislation to address the issue

FDA’s CBD announcement that existing regulatory frameworks for foods and supplements are not appropriate for this ingredient along with the agency’s denial of CRN’s 2020 citizen petition is continuation of its “long exercise of kicking the can down the road while ignoring the realities of the current marketplace and offering little to show for its purported four-year review of a dietary supplement CBD regulatory pathway,” CRN noted in a statement.

CRN President & CEO Steve Mister observed:

• FDA has had ample time to consider scientific evidence and develop a regulatory pathway for CBD within the existing legal framework.

• Since 2018, when Congress enacted the Farm Bill, FDA’s inaction and indecision have frustrated consumer interest in having safe and beneficial CBD products available to them and allowed a “gray” CBD marketplace to emerge without meaningful oversight.

• The agency’s “punt” to Congress, asking it to intervene after four years, is a further disservice to consumers and responsible industry.

FDA claimed that a new regulatory pathway would benefit consumers by providing clear labels, prevention of contaminants, CBD content limits, and limits on use in certain populations, Mister pointed out that these goals can—and should—be addressed through the existing new dietary ingredient notification process once FDA creates a legal pathway for CBD in dietary supplements. “CRN offered the agency a blueprint for that pathway, and it has been ignored,” said Mister. 

• FDA’s response to CRN’s CBD citizen petition does not address why safety is a factor in drug preclusion and FDA’s exercise of its rulemaking authority to create a legal pathway for CBD in dietary supplements

• Nothing is stopping FDA from using its rulemaking authority for CBD, other than FDA itself. Instead, FDA suggests Congress must fix this issue when FDA has had the authority to address it all along.

What’s next: CRN looks forward to continuing its work with congressional lawmakers to develop a legislative solution given the absence of FDA leadership. House Bill 1629 was introduced last week to open the supplement pathway to CBD.

State age restriction proposals for supplements expected to persist

Following 2022’s legislative activity across the U.S. from California to New York, CRN expects similar proposals will be considered during the 2023 legislative session.

The New Jersey State Assembly convened in late January with the intent to discuss various bills, including legislation that would restrict the sale of “diet pills and muscle-building dietary supplements” to consumers under 18 years of age, A 3512.

• However, the bill was removed from floor consideration after multiple conversations between CRN and the sponsor’s staff, including a Zoom meeting with the primary sponsor, Assembly Health Committee Chairman Herb Conaway, M.D.

Maryland is now the latest state to introduce legislation that would place age-restrictions on the purchase of certain dietary supplements.

CRN has been successful in thwarting over-reaching and ineffective proposals to limit access to certain sports nutrition and weight loss supplements, with nuanced tactics including:

• Engaging legislators on the ground, on Capitol Hill, and in the states

• Partnering with like-minded organizations like retailers, local chambers of commerce and business associations

• Backing up our position on the safety and benefits of dietary supplements with data and educational materials

CRN will continue to take “a thoughtful and deliberate approach in finding common ground with legislators and common-sense solutions, without ignoring the principles enshrined within DSHEA nearly three decades ago,” as explained in Nutrition Industry Executive last year.

Go all in: If you would like to help us in the fight against these state bills, please contact Steve Mister.