FDA Under Pressure to Establish CBD Rules

The agency may limit the amount of CBD in food and drinks; public hearing is set for Friday.

May 30, 2019

WASHINGTON—On Friday, the U.S. Food and Drug Administration will hold its first public hearing on how the federal government should regulate cannabidiol (CBD)  products, and it may end up limiting how much of the cannabis compound can be added to foods and beverages, according to a Bloomberg report.

CBD is a rapidly growing wellness trend resulting from the legalization of hemp in the U.S. this past December. CBD shops are popping up around the country, and even mainstream retailers, such as CVS, are offering CBD creams, sprays and lotions. Sheetz last week announced the launch of CBD products at more than 140 convenience store locations across Pennsylvania. The line includes topical rubs and patches, tinctures, vape pens, oral pouches, capsules, pet products and more, Sheetz said in a press release.

Although such products are on the market, CBD hasn’t yet been approved for use in food and drinks by the FDA.

Unlike THC, CBD doesn’t give users a high. Instead, it reportedly serves as a natural way to fight ailments, including insomnia, inflammation and anxiety. But there has been minimal enforcement, and various businesses, including burger chain Carl’s Jr., have sold CBD-infused foods.

CBD companies are pushing forward in order to gain market control, said Robert DiPisa, co-chair of the cannabis law group at Cole Schotz of New Jersey. “As an attorney, I try to read everything that the FDA is putting out,” he said. “I try to gather as much information as possible to guide them in the best direction I can, but the truth of the matter is everyone is running blind right now.”

The FDA is under pressure to act quickly, but the agency has expressed concern that allowing CBD in food, beverages and supplements will reduce the incentive for pharmaceutical companies to conduct clinical research into CBD’s health benefits.

Former FDA Commissioner Scott Gottlieb has said that there are “open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug-approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”

This indicates that the FDA will set a limit on how many milligrams of CBD can be incorporated into food and drinks, according to DiPisa. “What they might end up doing is reserve the higher dosages of CBD for pharmaceutical drugs and only permit lower dosages to be incorporated in food and drinks,” he said. “That in itself would hopefully keep an incentive for the pharmaceutical companies to continue to invest in clinical research.”

Regulating CBD is in the best interest of companies and consumers, said Bruce Linton, chief executive officer of Canopy Growth Corp., a Canadian pot company now in the process of building a large CBD extraction and manufacturing facility in Kirkwood, New York.

The market implications are huge. Analysts at Piper Jaffray & Co. estimated that the U.S. CBD market could be worth as much as $15 billion in five years.

NACS has prepared a fact sheet (for members only) to help you navigate what’s legal and what’s not for CBD retailing. A Federal Cannabis Legislation Tracker covers leglislation introduced in Congress in 2019 pertaining to marijuana legalization that may affect convenience retailers.

In addition, each week NACS Daily brings you a roundup news and information on cannabis and CBD. For more on how the legalization of recreational marijuana may affect the c-store industry, see the February 2019 issue of NACS Magazine.