December 13, 2018
Amid the champagne corks popping and footballs spiking as hemp becomes legalized thanks to the 2018 Farm Bill that sailed through the U.S. Congress this week, questions remain over whether the FDA will maintain its conservative interpretation of statutes and somehow reel in the booming CBD market.
The FDA, after all, was able to successfully eliminate the billion-dollar ephedra market in 2004. It also nipped in the bud the burgeoning red yeast rice market in 1998—this is the closest analogue to the CBD market today because red yeast rice contained the lovastatin molecule, which is active ingredient in the $19 billion-dollar pharmaceutical market of statin drugs. There, the FDA ruled that red yeast rice manufacturers were concentrating levels of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin. This, by law, made the supplements into illegal patented drugs.
Hemp-derived CBD players assert that they are not concentrating CBD within the hemp plant, only growing hemp plants that naturally exude high levels of CBD with less than 0.3 percent levels of THC. And that may be true. The FDA still asserts that CBD is a drug: This past June, the FDA approved GW Pharmaceuticals’ Epidiolex CBD isolate.
According to FDA, CBD was first authorized for investigation as a new pharmaceutical drug and the subject of substantial clinical investigations that have been instituted and made public. If a drug comes first, it cannot then later become a supplement. However, a supplement can then later be made into a drug, as with the Lovaza brand pharmaceutical fish oil concentrate. Pharma trumps supplements.
More to the point, the 2018 Farm Bill that just passed both houses of Congress explicitly stated that while the law will remove hemp from the Controlled Substances Act and thus remove the Drug Enforcement Agency from any regulatory action around hemp or CBD, the FDA remains the federal regulatory authority in charge of the market.
The bill’s language reads, to wit: “However, nothing in this subtitle shall affect or modify the authority granted to the Food and Drug Administration and the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262), including for hemp-derived products.”
“This removes hemp from the purview of the Controlled Substances Act,” wrote United Natural Products Alliance senior political advisors Peter Reinecke and Trisha Knight. “Reports that the language would ‘legalize’ CBD sales are erroneous.”
Attorneys representing supplement companies assert that the FDA’s position is not accurate—that the research into Epidiolex was not significant, that the drug gained approval only through the Investigational New Drug process, which is not the typical way drugs gain FDA approval, and that Epidiolex is a CBD isolate, thus any other type of supplement that is not a 100 percent pure CBD isolate is therefore not the same agent and thus good to go as a supplement.
Some assert that the FDA could easily eliminate the remaining legal cloud over CBD by virtue of a rule-making process that would create three “swim lanes” that hemp and CBD backers say is the way forward—one lane for pharma CBD, another for supplement CBD, a third for marijuana-derived CBD available in marijuana dispensaries for the medical and recreational markets.
“We believe this is something the agency can do and that they should do as a matter of public health,” said Steve Mister, president of the Council for Responsible Nutrition industry trade group that represents large supplements manufacturers, “because allowing these products to be sold as dietary supplements creates an immediate regulatory framework around the products.”
That framework would be the same for all other supplements—they would be subject to Good Manufacturing Practices (GMPs), they would have to report significant adverse events, they would be subject to review of their claims, and would have to file structure/function claims with the FDA.
“All of these things would immediately allow these products to be part of a regulatory framework rather than what you have now,” said Mister, “which is FDA saying they’re illegal, not doing a lot of enforcement, and it’s just a free for all.”
The U.S. Hemp Roundtable, a lobbying group that has been quite successful in educating and helping to pass pro-hemp/CBD laws in both Congress and state legislatures, believes the way forward is to engage the FDA.
“We applaud the agency’s continued efforts to crack down on bad actors who undermine the industry through misguided marketing claims,” said Jonathan Miller, the Roundtable’s general counsel. “And while we are concerned about non-binding statements made by the FDA that have led some state and local officials to question the legality of the retail sale of hemp-derived CBD, we are hopeful that we can work with the agency to clarify that CBD – which their own scientists concluded has no abuse potential and does not pose a risk to public health – should not be withheld from Americans who count on it for their health and wellness.”
It remains anybody’s guess what the FDA will do. The agency announced this week that it is going to be more aggressive in policing the larger supplements market—likely the only industry subject to greater federal government regulations in the Trump administration.
At the same time, the sheer breadth of the consumer market buying into CBD is a wide swath indeed—from mothers with seriously debilitated young children to military veterans trying to recover from war wounds both physical and psychological, stressed-out office workers to elderly people dealing with aches and pains.
It’s true that the FDA was successful in dismantling the ephedra-based weight-loss market because a couple high-profile athletes died with ephedra in their bodies. But consider: What would this emerging broad base of U.S. consumers do if told their life-changing supplement was removed from the market—not because of safety issues (the FDA as well as the World Health Organization both agree it’s safe) but because of some statutory technicality?
“FDA could in its discretion allow the two to be co-marketed as both supplements or food and as a drug, but that requires an exercise of FDA discretion that they have not done,” said Mister.
“We are very interested in working with the agency to find a legal path to market for CBD products.”
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