Groups urge FDA to regulate plant-derived CBD, not synthetic, as dietary supplements and food, to issue final rule, and to exercise enforcement

July 18, 2019

Advocacy groups are urging FDA to issue an interim final rule that would permit the lawful use of the hemp-derived cannabinoid cannabidiol (CBD) in dietary supplement and food products. Many submitted public comments to FDA this week following FDA’s May 31 open hearing on the issue of CBD regulation and call for public comment.

Hemp advocacy group Vote Hemp (Washington, DC) shared comments it submitted to FDA. Notably, Vote Hemp says that its arguments for legalizing CBD in food and dietary supplements pertain to plant-derived CBD only, such as full-spectrum hemp extracts that contain a full range of phytocannabinoids found in the hemp plant, as opposed to a singular cannabinoid isolate. Synthetically produced CBD ingredients are different from whole-plant extracts and should not be considered dietary ingredients, it says. It wrote: “If FDA eventually approves synthesized cannabinoids for human consumption and these synthetic products are deemed safe, the public needs full transparency in labeling to distinguish whole-plant, naturally derived CBD from synthetic CBD.”

Vote Hemp also urged that natural, plant-derived hemp extracts be eligible for organic status under USDA’s National Organic Program.

If plant-derived CBD products are to be regulated like food and dietary supplements, they should be subject to all of the regulations pertaining to these categories, Vote Hemp wrote, including food facility registration, compliance with current Good Manufacturing Practices (cGMPs), reporting of serious adverse events, submission of new dietary ingredient notifications, and compliant labeling. “Hemp-derived herbal extracts are no different than other herbal supplements and should be treated by FDA the same as any other herb. Thus, existing federal regulations for food and dietary supplements must apply to hemp-derived extract products, including those containing CBD, to assure consumers of the same production safety and integrity of ingredients met by other FDA-regulated supplements,” it said.

The Natural Products Association (NPA; Washington, DC) also submitted comments to FDA and noted that, based on a Freedom of Information Act request NPA submitted, the association found that only four CBD firms have so far been inspected by FDA, with three of those firms receiving a 483 letter from FDA indicating GMP infractions.

“Four inspections when there are an estimated 1,500 CBD products on the market is in no way adequate,” the association wrote, adding, “These numbers do not send a message of a willingness to engage on enforcement regarding CBD products and especially those that could possibly contain levels of THC [tetrahydrocannabidiol], which is still a Schedule I substance. More testing and inspection of firms making CBD should be top priority for the agency with a proliferation of products on the market.”

Vote Hemp said FDA should require CBD products to be labeled transparently to disclose extraction and manufacturing methods, use of additives, ingredients, cannabinoid concentration, and serving size.

It wrote: “To this end, Vote Hemp urges FDA to quickly issue an Interim Final Rule with an accelerated effective date authorizing the sale of hemp-derived dietary supplements and foods containing CBD, which: 1) have a CBD concentration of no more than 50 mg/ml, and 2) meet existing FDA requirements for the manufacturing and marketing of dietary supplements and foods.” Vote Hemp pointed out that the 50 mg/ml concentration is still half of the concentration found in the CBD pharmaceutical drug Epidiolex, meaning that there is still a lot of room to play in for higher-concentration CBD products in the pharmaceutical space.

FDA should not only limit the allowable amount of CBD in food and dietary supplement products, but it also should require listing recommended serving sizes to avoid any concerns such as the potential for liver injury at CBD doses of 20 mg/kg body weight per day, Vote Hemp wrote. Luckily, the group says, the serving size of most “if not all” CBD products on the market is much below this.

Like the association the American Herbal Products Association (AHPA; Silver Spring, MD), Vote Hemp is urging FDA to move quickly to authorize the lawful use of hemp-derived CBD in food and beverages, either by issuing an interim final rule or, at the least, issuing guidance indicating that the agency will exercise enforcement discretion for these products. At FDA’s May 31 meeting on the topic, AHPA president Michael McGuffin urged FDA to take action on either of these two pathways.

The need for an interim final rule is urgent, as more CBD products come to market. According a recent report from Vote Hemp and Hemp Business Journal, hemp-derived CBD product sales are expected to exceed $646 million by 2022.

Vote Hemp wrote: “FDA issuance of an Interim Final Rule would help to ensure uniform federal standards are applied to hemp-derived foods and dietary supplements, including those with CBD. The need for prompt action by FDA is magnified because the USDA is currently promulgating regulations for hemp cultivation and is expected to complete those within the next few months. These USDA regulations will inevitably result in the increased cultivation of hemp for CBD production.” USDA is expected to issue an interim final rule this August to implement the hemp-related provisions in the 2018 Farm Bill.