For its new Hemp & CBD Guide 2.0, Nutrition Business Journal asked me to write a short piece on five things that should concern the supplement industry about CBD, but the list quickly expanded to ten, and it’s not so short. It’s just that complex of an issue. Here they are:
1. How will the FDA interpret the so-called "clinical investigation exclusion?"
It worries me (assuming the FDA acts at all; see #10) because of the long-term implications for future ingredients. This provision of DSHEA gives pharmaceuticals a monopoly for an ingredient if they conduct the clinical research first. GW Pharmaceuticals has done the research on CBD for its Epidiolex product and conceivably could attempt to claim that monopoly. Potential supplement ingredients may never get to market if the FDA broadly interprets the clinical investigation exclusion as giving pharma companies too much incentive to lay claim to ingredients they never commercialize. Safety concerns are not part of this preliminary decision; it’s about market economics and giving consumers access to products through different regulatory categories (drugs, supplements, food, cosmetics etc.). However, the FDA could shut down the whole discretionary process by focusing on safety before supplement companies get to conduct their own research. Who would conduct safety studies for supplements if there’s no market at the end of the process?
2. How will the FDA handle NDI notifications for CBD?
Here is where safety should be center stage. Assuming CBD is judged to be a legal ingredient, most industry members agree that CBD products must follow the requirements of a new dietary ingredient. The FDA and industry have never resolved their differences over how to determine whether an ingredient is “reasonably expected to be safe.” How much safety data will the FDA require? What if the agency objects and a manufacturer goes to market anyway? With so much about the NDI draft Guidance still unresolved, CBD will likely be the stress test to force resolution of the NDI issues—with uncertain outcomes.
3. Will CBD spell the end of GRAS self-notifications for supplements?
Some firms have long used the second prong of the NDI provision in DSHEA as a workaround for NDI notifications. By conducting a self-affirmation that an ingredient is “generally recognized as safe,” and then introducing that ingredient into the food supply first, they bring the ingredient into supplements shortly thereafter and avoid the requirements of an NDI notification. The FDA and many consumer organizations strongly disfavor this process because it avoids stringent scrutiny of the scientific data by the FDA. Given the FDA’s deep reservations about CBD’s safety, would the agency leap at this opportunity to end self-GRAS for dietary ingredients entirely?
4. A place for synthetic CBD?
While there are reputable firms producing various forms of synthetically derived CBD (from yeast mediums to chemically created versions), there are companies marketing “synthetic CBD” that is not CBD at all. Given the larger backdrop about the dangers of synthetic marijuana, and that we are still battling with the FDA over the issue of whether DSHEA permits synthetic botanical constituents at all (not to mention the fact that synthetic CBD doesn’t employ any farmers in Kentucky), we could see the FDA prohibit synthetic CBD altogether. And that decision could set precedent for whether other synthetic versions of botanical constituents can be used in supplements at all.
5. Migrant companies versus legacy manufacturers?
With most new ingredients, established supplement manufacturers and marketers introduce new products into their existing portfolios of ingredients. They already know how a dietary supplement company is supposed to behave, what legal labels and structure/function claims look like and how to observe GMPs. The CBD market is different. It’s filled with firms that have migrated to the dietary supplement category for the first time because they think it’s a viable path to market to avoid the requirements of a drug. Therefore, they don’t really appreciate the legacy of DSHEA or the culture of self-regulation and commitment to consumer safety that has developed over the past 25 years of DHSEA. Which leads me to …
6. Products labeled as dietary supplements must play by our rules.
It’s simple: If products put a dietary supplement Statement of Identity on their front label or a supplement bfox on the rear label, then they have agreed to play by the rules of this category. I worry about the products marketed as CBD supplements already on store shelves that play fast and loose with established legal requirements. Where is the contact information for reporting an adverse event? If it’s a topical product, it’s not a dietary supplement; so why is it “flavored”? Can a product labeled for pain management, containing menthol and camphor, also contain CBD and call itself a supplement? CBD product manufacturers need to pick a lane and then live by those rules.
7. Can this category withstand the media spotlight?
Given the intense media scrutiny that CBD is receiving today, any product errors or safety mishaps will have tremendous implications for the entire category. This is no time to screw up. Several market tests have revealed CBD products containing more CBD than the label states, containing no CBD at all or contaminated with heavy metals, pesticides or solvents. These manufacturing errors, and the potential for public harm they create, could spell a market crisis if we don’t weed out the bad actors, or at least teach them how to play by the rules. Imagine a headline containing “Dietary Supplement Containing CBD Kills.”
8. Does it really do everything?
CBD is already referred to as a 21st-century snake oil because of the sheer breadth of unsupported claims being made for it. Part of #6 (above) is that CBD products make blatant drug claims for everything from cancer, to migraines to autism. Even if those claims are true, products making such claims must go through the rigorous process for a new drug to give patients confidence they really work. Supplements cannot legally claim to treat, cure or mitigate diseases. I worry the reckless use of these claims on so-called supplement products will mislead consumers, will engender pushback from drug manufacturers if these products eat into their market share and will lead the FDA to limit claims across all supplements.
9. Can we keep the THC out?
I’m also troubled about the lack of attention to keeping the psychoactive constituent THC out of CBD dietary supplements. The Farm Bill legalized constituents of hemp only so long as they contain less than 0.3% THC. But some products are delivering much more. And even at the mandated level, it’s possible that habitual use of a CBD product could trigger a positive drug test for THC. Do consumers realize that? Are manufacturers being meticulous to remove the THC and alert consumers of the risks?
10. What if the FDA refuses to act?
What if the FDA’s indecision towards CBD drags on for three to five years, as former FDA Commissioner Gottlieb predicted back in March? During that time, the risk of a deadly event from poorly made products could increase while more poor-quality products continue to fill the marketplace and many responsible players stay on the sidelines. I worry that the FDA believes that it will be insulated from any blame if it does nothing and that the presumption that “no decision is better than a wrong decision” will paralyze the agency from acting. Meanwhile, our consumers are at risk. An unregulated CBD marketplace that demolishes consumer confidence in the supplement category that we have worked so long to build could be our greatest threat of all.