With two major health retailers announcing that they’re bringing non-THC cannabis-derived products to shelves nationwide this year, the inevitable battle between the FDA and CBD proponents has reached new heights.
On March 27, Walgreens announced that it will sell CBD products in 1,500 of its stores in states across the U.S., from California to Vermont. Just days before that, CVS threw its hat in the CBD ring with a distribution deal with Curaleaf Holding Inc., which will send its products to 800 of CVS’s 10,000 stores this year.
The moves make the retailers the highest-profile targets for the FDA, which clarified that, even though industrial hemp is legal following the 2018 Farm Bill, CBD remained under heavy scrutiny from the regulatory agency.
In a press announcement last December, the FDA stated:
Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk…
Because both CBD and THC are active ingredients in FDA-approved drugs, the FDA goes on to warn companies that introducing food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived, is against the law.
So what’s all this mean?
It means some of the products on drugstore shelves and the display cases of day spas might not legally be there, and may not remain as the CBD debate grows more heated. In making this announcement, the FDA makes known its awareness of the popularity of CBD products—an enthusiasm it will be hard-pressed to control at this point.
You can find CBD in everything from coffee to shampoo to products for your pet. If you’re an economically-minded person, hemp-derived CBD represents an exciting and explosive new market. It is projected to grow from $591 million in 2018 to $22 billion by 2022, which is really, really good for an economy that shows signs of slowing down.
CBD as a dietary supplement
Separate from CBD’s popularity is the question of its safety and efficacy. Writing for Harvard Health Publishing, Dr. Peter Grinspoonargues, “We need more research but CBD may be prove to be an option for managing anxiety, insomnia, and chronic pain,” while also noting that “Without sufficient high-quality evidence in human studies we can’t pinpoint effective doses, and because CBD is currently is mostly available as an unregulated supplement, it’s difficult to know exactly what you are getting.”
It’s this fine line between safety and efficacy on one hand and the economic pressure on the other that the FDA will have to walk in the coming year. The FDA’s stance in their letter sets the terms for a war that will certainly escalate after the CVS and Walgreens announcements: does CBD move forward as a pharmaceutical or dietary supplement? The answer to this question could seriously dampen the growth of the CBD industry and restrict access for patients if CBD is relegated to pharmaceutical oversight—especially if the Affordable Care Act gets thrown out entirely.
Dietary supplements are largely unregulated, as federal law “does not require” them “to be proven safe to FDA’s satisfaction before they are marketed,” nor does the seller’s claim have to be proven “accurate or truthful before it appears on the product.” By refusing to bestow CBD with the dietary supplement label, the FDA is hampering the market’s development and patient access to these products.
They’re also out-of-step with the international stance on the issue.
Earlier this year, the World Health Organization sent a report to the United Nations’ Commission on Narcotic Drugs, in which they recommended, among other things, that
- Cannabis should be removed from Schedule IV of the 1961 Convention, the designation for the most dangerous substances;
- All forms of THC should similarly be de-scheduled;
- Any form of CBD containing less than 0.2% THC should not be regulated by international drug control conventions
While the recommendations would still leave THC and marijuana an internationally scheduled substance, the recommendation to de-schedule CBD is a huge victory. (The UN’s Commission on Narcotic Drugs is expected to make a ruling by 2020.)View image on Twitter
In 2018, Mexico moved to make CBD available as a dietary supplement, one of the first countries to do so. Raul Elizalde, president of HempMeds Latin America, was one of the people who spoke before the World Health Organization on behalf of de-scheduling CBD. I met Elizalde two years ago at an industry conference when I interviewed him about his first-hand, very personal experience getting access to medical marijuana. Speaking with him again recently, Elizalde supports broader access to the medicinal properties and effects of CBD by considering it a health supplement, as well as a clinically-tested drug.
Already, patient access to cannabis products is progressing more quickly in Mexico than in the United States. Canadian company CannaOne Technologies recently announced signed an agreement with Manna Health Services SA de CV of Mexico City, to build an online CBD product purchase and delivery marketplace for the entire Country of Mexico. But we’re talking about a political culture that’s turned so cannabis-progressive the official Twitter account for the nation’s secretary of Security and Citizen Protection, who is responsible for overseeing federal police, intelligence agencies, and prisons, shared a Twitter poll that asked citizens whether Mexico should legalize cannabis for adult use.
Back in the United States, the FDA has been cracking down on CBD products being sold for human consumption (so much for that fine line). New York City became the first major American city to enforce the FDA’s position on CBD in February. A New York City Department of Health spokesperson told The Atlantic that “Until cannabidiol…is deemed safe as a food additive, the department is ordering restaurants not to offer products containing CBD.”
Other cities from California to Maine are stepping up enforcement as well. As Restaurant Hospitality reports, restaurateurs are finding workarounds to the enforcement by allowing the guests to add the CBD to the food and drinks themselves.
While your CBD-shampoo may still be safe, consumption is one of the most popular ways to partake in CBD, and the FDA’s crackdown represents a threat to many people’s means to treat themselves.
Last summer, when the FDA approved a first-of-its-kind cannabis-derived pharmaceutical drug to treat Dravet syndrome, a rare form of childhood epilepsy, FDA Commissioner Scott Gottlieb promised the FDA would consider other forms of cannabis-derived drugs. “Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality and most importantly, that these products have been proven safe and effective for patients,” Gottlieb stated.
While that stance sounds prudent, the bulk of scientific evidence to date shows that CBD is largely safe for use, and has a “better side effect profile” than many drugs.
I spoke with Blake Schroeder, CEO of Kannaway, a leader in the hemp and CBD industry, about the fight over the fate of CBD’s classification. For Schroeder, who supports CBD being regulated as a dietary supplement, the main difference comes down to access. “If you can buy something online or in a store without having to see your doctor first, people are going to have better access to the product,” Schroeder told me.
But that doesn’t mean he’s for a strictly laissez-faire approach. In his view, he’d like patients and doctors to be educated about proper dosing, similar to daily intake amounts for things like Vitamin C.
For Schroeder, the future of CBD is bright. “I think that you’re going to see more governments the non-psychoactive components as good for people. It will cut down on medical costs and reliance on certain prescriptions. There’s a lot of opportunities out there, but there’s a lot of education that needs to be done as well.”
The demand for CBD oil and CBD-infused products is unlikely to fade as people look for natural and affordable alternatives to pharmaceuticals. By suppressing research into cannabis for decades, the FDA has now put itself in a position to try to regulate from the rearguard of the CBD movement. Hopefully, with pressure from patients and the industry, the FDA will grant CBD nutritional supplement status, while also investing in testing to discover the benefits and side effects of short-term and long-term use.