As the second decade of the twenty-first century comes to a close, a little time spent pondering the state of the dietary supplement industry seems well spent. The past ten years have brought the industry GMPs, the food safety requirements of FSMA, a New York attorney general challenge to product testing, and threats from sports performance supplements containing illegal and unsafe ingredients. While no similarly momentous events have touched the industry in 2019, we’ve had our fair share of challenges—not the kind that make the morning headlines or threaten an existential crisis, but ones that are more gradual, and nonetheless have the potential to fundamentally change the industry.
CBD dominates discussion
Even though FDA has yet to recognize cannabidiol (CBD) as a legal dietary ingredient, CBD has unquestionably impacted the supplement industry more than any other issue this year. Every conference has the obligatory session on it; every trade show offers CBD in new products from infused water and cookies to capsules, powders and tinctures; and most companies have at least entertained the question “Should I be selling it?”
The jury is still out as to whether CBD will be the transformative ingredient that some predict. Some market analysts say ingestible CBD could replace the multivitamin as the single most widely sold product in the supplement space with annual sales over a billion dollars; others posit that CBD will be a flash in the pan, this year’s hoodia or raspberry ketones. Regardless of who’s right, its effects on the legal framework this year are unquestionable. Even as we toasted 25 years under the legal framework of DSHEA, CBD has us asking questions about the future of the law that we wouldn’t be talking about otherwise:
- Should drug companies be able to claim a monopoly over an ingredient and completely prevent its sale, at any dosage, in supplements?
- Under what conditions should FDA exercise its statutory discretion to allow a supplement and a drug containing the same ingredient to coexist? And what will it take for the agency to act?
- Has CBD exposed a loophole in DSHEA that permits the introduction of new unproven ingredients by which companies conduct a GRAS self-affirmation and avoid sharing the safety data with FDA, as contemplated by a new dietary ingredient (NDI) notification?
- Does the threat of imported synthetic CBD give FDA the opening to foreclose synthetic botanical ingredients entirely?
- Does FDA have sufficient resources and the resolve to enforce the whole range of legal requirements for supplements on CBD marketers who don’t know the law and just want to make a quick buck?
These questions go far beyond one ingredient, and they are just the start.
Legislative fix for CBD
As the year closes, Congress has gotten into the act too. Many on the Hill believed when the 2018 Farm Bill was enacted last December it paved a clear path for CBD in supplements and a new cash crop for farmers across the country. That hasn’t happened because of FDA’s objections. So now the industry is working with Members of Congress on new legislation to assure FDA opens the supplement marketplace to CBD. Congress could direct FDA to determine that CBD is a lawful dietary ingredient and then to use the safety mechanism in DSHEA to evaluate products individually through the NDI review process.
However, some are urging FDA to conduct its own safety review and set a single dosage level for CBD that the agency considers to be safe. That would be a mistake because FDA doesn’t have sufficient data to determine a maximum level now. Whatever level FDA would set would likely be woefully lower than industry wants, and inflexible to upward modification as additional safety studies become available. Some of this research is already underway. The agency only needs to recognize CBD as a lawful dietary ingredient to provide the incentives for firms to pursue additional research on both the safety and the potential uses for health benefits of CBD. The fact that industry can’t even agree on the pathway forward exposes another lasting trend in 2019: additional factionalizing of the industry reflective of national politics—more on that in a moment.
Mandatory product listing
Another aspect of the CBD issue that makes it so impactful is considering what hasn’t been addressed this year as the industry and regulators have devoted attention to this shiny new object in the room. Last March, former FDA Commissioner Gottlieb called for a mandatory product listing for supplements. FDA even made a budget request for funding to implement the listing although Congress has not given it authority to create one. Then Commissioner Gottlieb announced his departure from FDA and the issue has languished ever since.
Mandatory product listing (a legal requirement that marketers provide a copy of their product labels to FDA as a condition of going to market) has the potential to be a game changer in the industry. Just as the passage of the adverse event reporting law in 2006, with the full support of the industry, set a new mark for collaboration and responsibility, mandatory product listing has the potential to demonstrate transparency and accountability in the supplement market.
FDA makes a compelling case for listing when it acknowledges that it doesn’t even know the size and breadth of the market it is charged with overseeing. FDA should know who’s marketing supplements and what’s in the products consumers are buying. Identifying supplements that contain potentially unsafe ingredients, locating new companies who aren’t following (or don’t know) the rules, prioritizing agency resources based on trends in the market, and monitoring compliance with NDI notification requirements would all be remarkably easier if FDA had a registry of products. CRN’s own experience with the Supplement OWL has taught us that product listing is not burdensome. As consumers are demanding more transparency from the companies they buy from, mandatory listing can strengthen trust with customers.
But as with CBD, the various associations are taking different perspectives. So as indicated above, one of the lasting outcomes of 2019 is division and disagreement on policy decisions facing the supplement industry. To Members of Congress and FDA, the multiple policy positions give them reason not to take either side as much of a threat. What’s most vexing is that, in many cases, companies are funding both sides of a debate through their association memberships. Even as we have celebrated this year the industry unity that led to the passage of DSHEA, 2019 has exposed a basic problem: the industry does not have a consensus of opinion on many of the biggest opportunities and threats facing it. And the associations reflect that divisiveness.
Even despite these concerns, opportunities abound for supplements as we enter 2020. CRN’s annual consumer survey discovered supplement usage has never been higher—77 percent of Americans say they use a dietary supplement. Outside the CBD debate, other trends like personalized nutrition regimens, retail focus on condition management, and new science that’s breathing renewed interest in ingredients like vitamin D, magnesium, choline and probiotics are all fueling growing interest in supplements. Retailers too, are recognizing the potential that supplements have in the self-care movement, and they are taking more interest in assuring the quality of the products on their shelves. So as I look forward to the next decade, I wonder about the inevitable: How soon will FDA move forward on CBD? How soon will the industry embrace mandatory listing as it did with the AER legislation? And how soon until we figure out that, while multiple associations can serve the industry, multiple policy positions do not?