Past Editions—Need to Know Archives
In this edition:
- Mister on melatonin: Advice for retailers
- FDA Drug Preclusion Clause interpretation threatens innovation, consumer choice
- CRN responds to FDA's review of the oral toxicity of CBD
How should retailers respond to JAMA melatonin letter?
“The sky isn’t falling. And sales of melatonin shouldn’t either,” CRN President & CEO Steve Mister observed in a recent Drug Store News article:
Melatonin is a trending ingredient these days, Mister noted, citing one estimate of segment sales at about $437 million in 2022.
“That figure represents a lot of people sleeping more soundly, as well they should, content in knowing that the trusted, gentle sleep aid is safe if used as directed,” Mister observed.
- CRN previously responded to a JAMA research letter that raised false alarm over levels of melatonin in gummies, noting the authors’ method of analysis was flawed and confused adult and pediatric products.
How should retailers respond? Mister advises retailers to keep doing what they do:
- Curate your supplement aisle with trusted brands and seek routine assurance that products are made to Good Manufacturing Practices (GMPs) and tested for potency, purity and uniformity by their makers or a reputable third party before landing on the shelf.
- Remind customers looking for sleep solutions for their children to reach for age-appropriate pediatric strength products.
- Remind parents supplements are not candy and shouldn’t be referred to as such—or stored where young kids can accidentally get into them.
Keeping kids safe from accidental ingestion of supplements is an issue CRN’s members take seriously, Mister emphasized. “But making parents who are responsibly using pediatric versions of melatonin products second guess themselves with a protocol on adult strength products is a meritless distraction for busy parents who know that melatonin works for their families.”
FDA interpretation of ‘Drug Preclusion Clause’ threatens innovation, consumer choice and health
CRN has submitted a Citizen Petition to FDA, calling for the agency to reconsider its interpretation of the Drug Preclusion Clause.
Why it matters: Under FDA’s current interpretation of a provision in the 1994 Dietary Supplement Health and Education Act (DSHEA), a supplement company has no way of knowing if a drug company has started the process of preclusion because the date that triggers preclusion is confidential, CRN noted in a statement, perpetuating a “race to market” situation that leaves supplement marketers effectively blindfolded.
- When dietary supplement companies attempt to see if the ingredient is being investigated as a drug, they can’t—a drug company may have already put a stake in the ground and set the wheels in motion for that dietary supplement ingredient to be precluded from the market.
What we’re saying: “We don’t believe this is about any one ingredient,” CRN SVP and General Counsel Megan Olsen said in Nutraceuticals World, explaining that CRN’s petition aims to address broad changes to the precedent FDA has set in several recent decisions, including CBD, NAC, NMN, and others. “The way FDA is reaching inconsistent and surprising decisions leaves us unable to know what could even be vulnerable right now. We believe that this is harming consumers because it’s being used to remove ingredients from the marketplace that consumers have come to rely on, even if those ingredients are safe and may have health benefits.”
- “Without a reexamination of FDA’s position, and guidance that lends clarity and predictability to the process, manufacturers are discouraged from continued innovation of new ingredients,” CRN President & CEO Steve Mister observed “and retailers are not sure whether they should, or are able to, continue to make these products available to the public for fear of selling ‘illegal’ supplements.”
FDA’s interpretation does not reflect what Congress intended when DSHEA was written, CRN’s Citizen Petition noted.
Go deeper: Nutritional Outlook discusses CRN’s Citizen Petition in detail
FDA review misses the mark: Agency overlooks or minimizes research that supports the safe use of CBD
FDA is not properly considering all the evidence on CBD, CRN observed in a letter to the agency, responding to the recent publication, “Review of the Oral Toxicity of Cannabidiol (CBD).” CRN further explained:
- FDA has access to safety data that is relevant to the ingredients intended for use in dietary supplements at levels that would commonly be used in supplement products, but has repeatedly disregarded this evidence, continuing to rely heavily on safety concerns related to high dosage prescription Epidiolex.
- Determination of safety must include consideration of the totality of relevant evidence—data on substances that reflect the ingredients intended for use and at the levels that will be consumed.
Industry stakeholders have responded to FDA’s call for scientific evidence on the safety of CBD by investing in research on their ingredients, which encompass a range of CBD-containing hemp extracts, as well as CBD isolate, CRN further noted in the letter.
- This research, conducted under regulatory test guidelines, provides evidence to support the safe use of various CBD-containing ingredients for their intended uses in dietary supplements.
- The studies have been published in peer-reviewed literature, submitted to the public docket that FDA opened to facilitate submission of CBD data, or shared with the agency.
Identifying potential hazards without consideration of exposure levels does not serve public health interests, CRN stated. Other government bodies, including the United Kingdom’s Food Safety Authority, Health Canada, and the Australian Therapeutic Goods Administration have established recommended maximum upper intake levels of CBD, the association further noted.
Creating a legal pathway for CBD is a policy priority for CRN in 2023. CRN applauded introduction of the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 earlier this year, with Mister quoted in a Hemp Roundtable statement, “While FDA delays, a sizable market has grown for CBD—legal or otherwise. Americans know these products are safe because they have been taking them for years. Consumers don’t need a new regulatory scheme that will potentially limit consumer choice.”