FDA Issues CBD Warning Letters; Comments on GRAS

2317

Silver Spring, MD—The U.S. Food and Drug Administration (FDA) announced that warning letters were issued to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The 15 companies that received warning letters (with links to the letters): Koi CBD LLC; Pink Collections Inc.; Noli Oil; Natural Native LLC; Infinite Product Company LLLP, doing business as Infinite CBD; Apex Hemp Oil LLC; Bella Rose Labs; Sunflora Inc.; Healthy Hemp Strategies LLC, doing business as Curapure; Private I Salon LLC; Organix Industries Inc., doing business as Plant Organix; Red Pill Medical Inc.; Sabai Ventures Ltd.; and Daddy Burt LLC, doing business as Daddy Burt Hemp Co. FDA noted that some of the products are marketed as dietary supplements, but CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.

FDA also published a revised Consumer Update detailing safety concerns about CBD products. This update, according to the news release, includes concerns related to potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood, as well as animal studies indicating potential risk to the male reproductive system, questions regarding the cumulative use of CBD, and questions regarding the impact of CBD on children and pregnant or breastfeeding women.

“Based on the lack of scientific information supporting the safety of CBD in food,” the agency said in its announcement, “the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”

Related: FDA Discusses Legality CBD at CRN Conference

“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,” FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., said in the release. “In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.”

Regarding the safety of CBD, Dr. Abernethy said those at the FDA “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.’” She added that, aside from the one prescription drug that the FDA has approved, “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.” Those questions and concerns include reports of products containing contaminants, such as pesticides and heavy metals. “We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”

Related: NPA Poll: 51% of Americans Don’t Know CBD is Illegal
Responses from the industry:

The Natural Products Association (NPA) issued a statement stressing that the CBD warning letters and the consumer update won’t protect consumers from public health crisis without real action from FDA. NPA once again called on the FDA to set a safe level for daily use. “Consumers and America’s burgeoning hemp industry are the biggest losers here because this so-called action only invites another vaping crisis where illicit and potentially lethal imported substances posing as CBD can and will proliferate,” Daniel Fabricant, Ph.D., President and CEO of NPA, said in a press release. “CBD is as common as bottled water in the U.S., and letters to a handful of companies and bureaucratic head scratching helps no one. It is well past time to bring science into the equation as federal rules require and as the U.S. House of Representatives directed. Safety and consumer protection must come first.”

NPA noted that the Senate is currently considering legislation passed by the House of Representatives that would appropriate $100,000 for the FDA to perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The process, NPA explained, would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe.

Related: NPA Submits Comments to FDA on NDIs and CBD
NJ Senate: Congress Needs to Legislate Safe Level of CBD Consumption
Industry Associations Ask Congress: “Take Quick Action to Clarify the Legal Status of CBD”

CV Sciences, maker of PlusCBD Oil, which was not one of the 15 companies issued a warning letter, release the following statement: “CV Sciences supports FDA’s recent enforcement actions against bad actors who make unsubstantiated claims that CBD-containing products can treat cancer, Alzheimer’s disease, opioid withdrawal, etc. These companies put consumers at risk, while giving responsible companies within the industry a black eye. That said, CV Sciences is disappointed that FDA’s consumer update, released simultaneously with the warning letters, used an inappropriately alarmist tone,” said Dr. Duffy MacKay Senior VP of Scientific and Regulatory Affairs at CV Sciences. “CV Sciences is concerned that FDA is creating a narrative that questions the safety of CBD to try to address the significant number of fly-by-night companies entering the CBD industry. There are more direct ways for FDA to address bad actors, while still working with responsible companies to establish the appropriate scope of hemp-derived ingredients for supplements based on sound research. However, CV Sciences continues to be optimistic that FDA has a similar goal to create a clear, regulatory path for science-based, hemp-derived CBD ingredients that provide an appropriate and safe level of CBD.”

The Council for Responsible Nutrition (CRN) also issued a statement, saying FDA’s warning “misguides consumers and undermines businesses” without “addressing real public health issues.” Steve Mister, President and CEO, said: “FDA unnecessarily alarmed consumers with a headline-grabbing announcement on the potential health risks of CBD-containing products consumed by over 20 million Americans without any plan to address it. Meanwhile, it abdicates its regulatory oversight for the subset of these products that do pose risks to consumers because they are poorly made, improperly labeled or illegally deliver THC. FDA’s inaction for the past year has facilitated an unregulated marketplace–which is bad for consumers and bad for business. 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.”

CRN’s release goes on to note that FDA “invokes potential adverse effects from CBD, but does not distinguish between the high doses delivered in the approved prescription drug and supplement levels”; that FDA “acknowledges the presence of CBD-containing products that are in serious violation of general dietary supplement regulations,” but instead of mandating recalls and seizing harmful products, is “choosing to issue tepid warning letters about CBD while the market of poorly made products continues to explode;” that FDA “has the opportunity to receive meaningful safety data in the context of new dietary ingredient notifications and GFAS submissions…[but] declines the opportunity to create incentives for that research or to give this data assurances of confidentiality;” and that “the agency has repeatedly said CBD must be treated like any other ingredient, but it has refused to do just that.”

CRN concludes by asking FDA to “do the right thing,” or that “Congress get involved.” And in the meantime, “consumers can turn to organizations such as the Council for Responsible Nutrition to help them distinguish responsible supplement companies from those who may or may not be.”

Related: CHPA Petitions FDA to Establish Clear Path for CBD in Supplements
FDA and Media Turn Attention to CBD; Industry Reacts From SSW
O&N: Amazon Sells CBD Products, In Spite of No-CBD Policy

LEAVE A REPLY

Please enter your comment!
Please enter your name here