fda cbd congressDecember 15, 2021
“CRN is extremely disappointed to learn that FDA rejected NDI notifications for full-spectrum hemp extract containing CBD submitted earlier this year by supplement manufacturers Charlotte’s Web and Irwin Naturals. Ultimately, it seems that the agency engaged these supplement companies in a months-long process unnecessarily.
“Since we first urged the agency to act two years ago, consumer interest in CBD has grown, sales have multiplied, and product innovation has expanded. Individual states have grown impatient and begun devising their own inconsistent patchwork of regulations. Meanwhile, FDA has turned its back on the safety of millions of Americans by refusing to take action on a legal pathway to marketing CBD. While most supplement companies follow good manufacturing practices (GMPs), bad actors do exist; FDA’s refusal to regulate the CBD marketplace opens the door to CBD products that may be poorly manufactured or illegally marketed. FDA demonstrated today it will lean on bureaucracy to kick the can down the road, and Congress should take notice.
“FDA also claimed the full-spectrum ingredients containing CBD and Epidiolex should be considered the same ‘article,’ a term used for purposes of determining what substances are eligible to be dietary supplements under the Federal Food, Drug and Cosmetic Act. However, Epidiolex, manufactured by GW Pharma, is a highly concentrated CBD isolate that contains 10 times more CBD than either of the full-spectrum hemp ingredients and plainly is not the same article supplement companies are producing, as CRN has argued for several years.
“CRN has publicly endorsed HR 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 and is actively lobbying Congress to do what FDA has refused to do—create a legal pathway to market CBD as a dietary supplement.
WASHINGTON–( BUSINESS WIRE )–The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today denounced FDA’s rejection of two new dietary ingredient (NDI) notifications for full-spectrum hemp extract containing cannabidiol (CBD)—and urged Congress to act on pending legislative proposals that require the agency to address the lack of regulation of hemp-derived products.
“FDA continually asked the companies for meetings and safety data about their products containing full-spectrum hemp extract. After complying with FDA’s requests, these companies saw FDA reject their NDI notifications—disregarding published peer-reviewed toxicology studies and years’ worth of real-world safety evidence.
The following is a statement from CRN President & CEO Steve Mister:
“Despite very clear direction from Congress when it removed hemp from the Controlled Substances Act in 2018, FDA seems to have made up its mind not to support CBD in supplements and is now trying to justify it. That’s the only logical conclusion to draw from FDA’s actions—and its continued inaction. These mixed messages from FDA are unacceptable, and Congress must exercise leadership by stepping in to end it.
“CRN has publicly called for FDA to act on CBD for more than two years to provide consumers with a safe, regulated market for these products. In June 2019, CRN submitted comments to FDA with scientific data and information on CBD. In December 2019, CRN and FDA met to discuss these issues. With still no action from FDA, CRN filed a citizen petition with the agency in June 2020, calling on FDA to clarify when a substance is considered an ‘article’ and to regulate CBD as a legal dietary supplement. More than a year later, FDA has failed to provide a meaningful response. In fact, FDA leaders refused to discuss CBD during a May 2021 meeting with CRN leadership.
“FDA has wrongly mischaracterized these products as the same article as a prescription drug and has ignored, dismissed, and downplayed ample evidence that these full-spectrum hemp products can be marketed in a manner that is reasonably expected to be safe. Meanwhile, the agency has done little to protect consumers from the unregulated marketplace it has created from more than two years of inaction.
“FDA is failing America’s hemp farmers, supplement manufacturers, retailers, and most importantly—170 million supplement consumers. Congress must take action now.”
The federal Food and Drug Administration (FDA) just released a report to Congress regarding the agency’s progress toward comprehensive regulation of hemp-derived cannabidiol (CBD). The report echoes the hard-line approach to CBD safety that the agency took on November 25, 2019, when it announced that CBD is not “generally recognized as safe” (GRAS) among qualified experts for use in human or animal food,” but, importantly for CBD businesses, also confirms agency interest in developing a risk-based enforcement approach in order to keep up with the burgeoning market for CBD products.
The report confirms the FDA’s already-expressed skepticism as to CBD safety, but offers hope that the agency seeks to take expeditious, clarifying regulatory action given market growth and uncertainty. The report reiterates that until the FDA obtains more data resolving its concerns about CBD contaminants, mislabeling, and lack of scientific research regarding side effects or adverse health effects, it cannot consider CBD safe as a food additive (a position the agency has already made clear). But the report also emphasizes the FDA’s willingness to develop a “risk-based enforcement policy that would provide greater transparency…while FDA potentially engages in…a rulemaking.” Promisingly, the agency recognizes not only the “vast proliferation of CBD consumer products,” but also the “significant interest in the development of therapies and other consumer products derived from cannabis and its components, including CBD,” and “the potential opportunities that CBD may offer,” all of which outstrip “limited FDA [enforcement] resources.”
In all, the report offers little new insight to CBD industry watchers, but it does offer some hope that the FDA will move quickly on a risk-based enforcement policy that will clarify agency expectations and ways manufacturers and marketers can mitigate the risk of commercializing CBD products. Unfortunately, the report is insufficiently detailed to inform short-term strategies for avoiding FDA warning letters or more serious enforcement action. Otherwise, however, the report does not offer meaningful new insights or clues about the agency’s timeline or anticipated policy changes. Additionally, the report’s reference to notice and comment rulemaking is frustrating because this process—which the FDA has not even initiated here—typically takes approximately two years to complete.
When Congress passed the Consolidated Appropriations Act of 2020 (H.R. 1158), it directed $2 million to the FDA for “research, policy evaluation, market surveillance, and issuance of an enforcement discretion policy and appropriate regulatory activity” for hemp-derived CBD. This appropriation further required the FDA to produce a report on its progress toward obtaining and analyzing data to help determine (1) a policy of enforcement discretion and (2) a process in which hemp-derived CBD will be evaluated for use in products. The report was due 60 days after the bill’s enactment, but the FDA belatedly issued it this week.
The report summarizes the FDA’s current positions as to the following categories:
The report covers several issues, albeit at a high level. The list below summarizes the primary points of interest from a CBD business perspective. Of particular note, the FDA expressed desire for product-specific information, consistent with the agency’s interest, expressed in the report, for a more nuanced, discretionary approach to enforcement. Along those lines, the FDA stated that it is trying to develop ways for companies to share proprietary and trade secrets, in the interests of providing data that the FDA can use in evaluating CBD enforcement.
What CBD Businesses Need to Know.
Until the FDA issues new guidance or rules, manufacturers, distributors, and retailers should approach CBD responsibly. Marketing and labeling should be scrupulously accurate, and we continue to recommend strongly against making extreme or unsupported health claims (the FDA’s history of warning letters provides a useful practical delineation of what is unacceptable).