December 3, 2019

FDA is raising new safety concerns about products containing cannabidiol (CBD), particularly CBD-containing foods, and last week sent warning letters to 15 companies the agency said are illegally marketing CBD products.

Resource guide: Marijuana in the health system

Background: CBD products on the rise

CBD is the second most abundant component of the cannabis plant after tetrahydrocannabinol (THC). Unlike THC, CBD does not get users high, but there is some limited evidence suggesting that it might have anti-anxiety, anticonvulsant, and anti-inflammatory effects.

That early-stage evidence—combined with the recent popularity of anti-anxiety products and the growing movement to legalize marijuana—has given rise to a big CBD industry. CBD products brought in about $600 million in the United States in 2018, and a recent industry study projected the global CBD market would swell from $311.7 million in 2019 to $1.25 billion by 2024.

However, CBD research has been restricted because the Drug Enforcement Administration classifies it as an illegal substance, and researchers in the United States are required to have a license to possess and study the compound.

To date, FDA has approved one drug containing a highly purified form of CBD, Epidiolex, based on clinical trials that showed the drug reduced seizures in children with two rare forms of epilepsy. From that clinical trial, researchers also know CBD can trigger adverse side effects, such as diarrhea and fatigue. Patients who participated in the trials had higher rates of infection, sleep problems, and depressed appetite.

Beyond that, it is generally accepted that CBD is not habit-forming, and it does not produce the same high one gets from marijuana with THC. Further, animal studies have found that CBD might have anti-inflammatory effects that can treat chronic pain or inflammatory diseases in animals, and other, limited research indicates CBD could help treat psychological disorders.

But experts warn that most of the available data is early stage, and very little is known about CBD's medicinal effects or potential hazards. Earlier this year, the Federal Trade Commission warned three companies for advertising that their CBD products could treat medical conditions without having evidence to support those claims.

FDA updates CBD safety concerns

FDA last week revised a Consumer Update outlining new concerns the agency has about CBD products, and particularly foods containing CBD.

FDA in the update said it "recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD."

FDA said most CBD products currently sold in the United States are unregulated and untested. The agency noted that its own testing has shown some products do not contain the amounts of CBD they claim to contain, while some CBD products contain toxic metals, pesticides, and THC.

FDA also noted that some available data has sparked concerns about potential harms associated with CBD products, including changes to male fertility, diarrhea, drowsiness, liver injury, mood changes, and possible interactions with other drugs.

Overall, FDA said it has not been able to conclude that CBD is safe for use in animal or human foods, and noted that selling food or drinks containing CBD is illegal in the United States. FDA Principal Deputy Commissioner Amy Abernethy said, "We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD 'can't hurt.' Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD's safety … and there are real risks that need to be considered."

But Stuart Titus—CEO of Medical Marijuana, which is involved with CBD products across the United States—raised concerns about FDA's update, saying it conflates the side effects of Epidiolex with general CBD products. "FDA has mistakenly substituted the adverse effects of Epidiolex, a refined, isolated and semi-synthetic form of CBD, as being the same form of CBD that is being sold by those in the nutritional supplement industry," Titus said. He continued, "Nothing could be further from the truth. There is no evidence to show that botanical forms of CBD have more much 'drug interaction' than normal foods or that the natural botanical form of CBD confers the 'toxic liver effects' that the FDA mentions in its statement."

FDA warns companies for illegally marketing CBD products

In addition to revising the Consumer Update, FDA last week sent warning letters to 15 companies the agency said are illegally marketing CBD products. FDA sent the letters to:

  • Apex Hemp Oil;
  • Bella Rose Labs;
  • Daddy Burt, which is conducting business as Daddy Burt Hemp;
  • Healthy Hemp Strategies, which is conducting business as Curapure;
  • Infinite Product Company, which is conducting business as Infinite CBD;
  • Koi CBD;
  • Natural Native;
  • Noli Oil;
  • Organix Industries, which is conducting business as Plant Organix;
  • Pink Collections;
  • Private I Salon;
  • Red Pill Medical;
  • Sabai Ventures;
  • Sunflora/Your CBD Store; and
  • Whole Leaf Organics.

FDA in the letters warned the companies for "marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals," as well as "marketing CBD products as dietary supplements and adding CBD to human and animal foods." The agency ordered the companies to respond to the letters within 15 days and detail how they intend to correct the issues.

Jason Wilson—a research and banking expert at ETFMG, which runs the ETFMG Alternative Harvest ETF—said some companies are releasing "marketing ads saying [CBD is] good for pain, anxiety, sleep disorder, and muscle pain. … However, the FDA is pointing out that you can't advertise it as a cure-all" or "start putting it in food."

But Brad Ridenour, CEO of Koi CBD, said he was surprised by the warning letter Koi received. "It came out of the blue. We were just at a CBD show last week, and there were hundreds of similar products and websites," he said.

Ridenour said CBD companies have been waiting for direction from FDA on how to label and market their products. "They keep telling us they're going to come out with guidance, and they don't," Ridenour said, adding, "They just tell us what not to do. We're ready to comply with anything they throw at us."

Similarly, Steve Mister—president of the Council for Responsible Nutrition, which is a trade association representing the dietary supplement industry—said, "It's time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements."

Abernethy in a release said FDA is working to update its regulations on CBD products and will continue monitoring the market in the meantime. "As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we'll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns," she said (Carrel, Forbes, accessed 12/2; Cara, Gizmodo, 11/26; Reiley, Washington Post, 11/27; FDA release, 11/25).

Resource guide: Marijuana in the health system

Despite the legal and clinical ambiguity surrounding marijuana policy and use, health systems should devise a strategy for managing marijuana in their facilities. Use these resources to inform and develop your system's strategy.

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