With two major health retailers announcing that theyâ€™re bringing non-THC cannabis-derived products to shelves nationwide this year, the inevitable battle between the FDA and CBD proponentsÂ has reachedÂ new heights.Â
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. Â 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 CVSâ€™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 theyâ€™re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimerâ€™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, theÂ FDA goesÂ onÂ toÂ warn companies thatÂ 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.
FDA is staking its turf on CBD regulation â€” and Congress, which legalized it along with hemp production in December, isnâ€™t too happy about it. “This has just created a problem that we didnâ€™t need to have,â€ť Maine Democrat Chellie Pingree says: https://t.co/nQ8eBu6sdD
â€” Sarah Owermohle (@owermohle) March 26, 2019
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.Â In making this announcement, the FDAÂ makes known its awareness of the popularity of CBD productsâ€”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 youâ€™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.
CBDÂ as a dietary supplement
Separate from CBDâ€™s popularity is the question of its safety and efficacy. Writing for Harvard Health Publishing, Dr. Peter Grinspoon argues,Â â€śWe need more research but CBD may be prove to be an option for managing anxiety, insomnia, andÂ chronic pain,â€ť while also noting that â€śWithout sufficient high-quality evidence in human studies we canâ€™t pinpoint effective doses, and because CBD is currently is mostly available as an unregulated supplement, itâ€™s difficult to know exactly what you are getting.â€ť
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 FDAâ€™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 oversightâ€”especially if the Affordable Care Act gets thrown out entirely.
Dietary supplements are largely unregulated, as federal law â€śdoes not requireâ€ť them â€śto be proven safe to FDAâ€™s satisfaction before they are marketed,â€ť nor does the sellerâ€™s claim have to be proven â€śaccurate or truthful before it appears on the product.â€ť By refusing to bestow CBD with the dietary supplement label, the FDA is hampering the marketâ€™s development and patient access to these products.
Theyâ€™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 Nationsâ€™ Commission on Narcotic Drugs, in which they recommended, among other things, that
While the recommendations would still leave THC and marijuana an internationally scheduled substance, the recommendation to de-schedule CBD is a huge victory. (The UNâ€™s Commission on Narcotic Drugs is expected to make a ruling by 2020.)
â€” 420 Cyber, Inc. (@420Cyber) February 1, 2019
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 conferenceÂ when I interviewedÂ him about his first-hand, very personal experienceÂ getting access to medical marijuana.Â 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 aÂ clinically-tested drug.
Already, patient access to cannabis products isÂ progressingÂ more quickly in Mexico than in the United States. Canadian company CannaOne TechnologiesÂ recently announcedÂ signed an agreement with Manna Health Services SA de CV of Mexico City,Â to build an online CBD product purchase and delivery marketplace for the entire Country of Mexico.Â But we’re talking about a political culture that’s turned so cannabis-progressive the official Twitter account for the nationâ€™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 FDAâ€™s position on CBD in February. A New York City Department of Health spokesperson told The Atlantic that â€śUntil cannabidiolâ€¦is deemed safe as a food additive, the department is ordering restaurants not to offer products containing CBD.â€ť
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.
â€” RH Magazine (@RH_restaurant) February 8, 2019
While your CBD-shampoo may still be safe, consumption is one of the most popular ways to partake in CBD, and the FDAâ€™s crackdown represents a threat to many peopleâ€™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. â€śSuch 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,â€ť 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 â€śbetter side effect profileâ€ť 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 CBDâ€™s classification. For Schroeder, who supports CBD being regulated as a dietary supplement, the main difference comes down to access. â€śIf 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,â€ť Schroeder told me.
But that doesnâ€™t mean heâ€™s for a strictly laissez-faire approach. In his view, heâ€™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. â€śI think that youâ€™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. Thereâ€™s a lot of opportunities out there, but thereâ€™s a lot of education that needs to be done as well.â€ť
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.
Disclosure:Â I have no financial interest or positions in the aforementioned companies.Â This information is for educational purposes and does not constitute financial and/or legal advice.