When Scott Gottlieb stepped down from his post as Food and Drug Administration commissioner in April, one of the biggest supplement industry disappointments was the loss of a government voice calling for a pathway for CBD to become a legal dietary supplement.
Gottlieb’s July 30 CBD op-ed piece in the Washington Post suggests such beliefs may have been a “be careful what you wish for” moment.
Many supplement industry executives watching the market in its current state would likely have trouble disagreeing with the headline, “The CBD craze is getting out of hand. The FDA needs to act.” But Gottlieb, now an investor in what the byline disclaimer describes as “biopharmaceutical companies,” offers a more questionable set of ideas in the body of the piece.
He starts with some simple statements. The former commissioner makes the true but widely disregarded observation that “much of the product is illegal under current law,” and offers the clarification that the 2018 farm bill legalized growing and selling hemp but did not greenlight putting CBD into food. He reminds readers that the “one legally available purified form of CBD” remains Epidiolex, a pharmaceutical drug the FDA approved last year.
None of that is new and much of it was probably said by Gottlieb more than once during his FDA tenure. Back then, he promised “a path” to legal CBD outside the pharmaceutical realm. What’s more clear now is what path he might have mapped out. And it’s not likely anybody in the supplement industry would be eager to go skipping down it.
While Gottlieb does propose that the FDA “can approve the sale of some CBD products immediately,” it doesn’t sound like that when you read further. The mechanism of which he speaks is new dietary ingredient notification; and Gottlieb makes it clear that one NDI would not cover the wide market. He suggests Congress pass legislation allowing the FDA to skip establishing regulation that all players could use and instead it would “rely on petitions filed by individual, prospective producers.”
Given that such petitions would have to include toxicity studies, the NDI route gets very expensive, very quickly. One could say that such a requirement will shake out the less responsible players—and the industry needs some of that—but if it pares down the industry to a very few players, we’re not sure what that does besides make the pharmaceutical companies Gottlieb is consulting for very happy.
Laced through his piece are hints that betray a pharma-first agenda. He suggests the framework be “expressly unique to CBD” to ward off “supplement makers seeking a back door to add other drugs to foods.” Does “other drugs” mean Gottlieb is calling CBD a drug?
It looks that way. He also writes, “Any path to allow CBD to be added to food products needs to preserve the incentive to study the compound in rigorous clinical trials to prove its therapeutic potential as a medicine.” “Preserve the incentive” sounds a lot like preserving CBD as a drug. Blessed with FDA’s drug-approval status, GW Pharmaceuticals could likely start suing CBD supplement makers now. If additional pharma players with patents and approved drugs come into the market, that likelihood and the firepower behind it only increases.
To be sure, not all of what Gottlieb offers sounds like a deliberate ploy to boost pharma’s fortunes. But many of his recommendations already apply to dietary supplements. When he suggests such criteria as “good manufacturing requirements, demonstrating traceability, adhering to safe levels for the purity and potency,” it should be noted that all of that could and should be enforced on all products covered under FDA’s mandate.
His other suggestion, that CBD be added to supplements and food “only in very low concentrations” is more interesting. It’s something that’s being discussed and even expected in the supplement industry. What “very low concentrations” turn out to be, of course, could be a problem. Concentrations on the market now are so much lower than the Epidiolex prescription form that the risk of the FDA imposing something of market-killing severity seems low.
Still, Gottlieb’s earlier mention of liver toxicity is worth mentioning here. The toxicity issue comes up around the prescription strength dosage, 100s of milligrams compared to the 15-20 in most CBD products. And yet, Gottlieb warns, “if you eat CBD in your breakfast, lunch and dinner, you could get a toxic dose.”
Put simply, you’d have to be a big eater.
Against all that, any nostalgia for Gottlieb’s hand at the tiller to guide the future of CBD in foods and supplements seems naïve now. To be clear, the market needs clarity. It’s disappointing that so many companies are not waiting for that clarity to come. We’ve called it a “wait and see” strategy without the “wait” part. Some of them are being careful and conscientious, but many are not.
So far, the FDA has seemed willing to kick the can down the road. CBD is largely being treated as any other supplement can be expected to be treated. Don’t make any outrageous claims and don’t skimp on GMPs and the FDA is likely to reach for lower hanging fruit.
Such enforcement might be ill-defined, but if it were consistent, that would be what the CBD market needs. Indeed, it’s what the whole supplement industry needs. But Gottlieb seems to be talking about special rules for CBD that could hold the market back in the wrong ways.
And that’s a path few in the supplement industry are likely eager to tread.