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fda cbd congress

Fda cbd congress

Yet it is equally evident that, without regulatory enforcement actions by FDA, the budding market in CBD products will flourish. Those who are producing and selling CBD products and those who seek access to them will likely endeavor to secure favorable changes in law. Even if there are sound reasons for FDA to take more time before adopting regulations for these markets, delay almost certainly will give rise to conditions that make a cautious, product-by-product determination of legality more politically difficult for FDA.

FDA regulation of CBD products faces new challenges as the market develops.

Limits on FDA’s research budget have posed problems during the time FDA has had CBD-related issues on its docket because FDA’s resources have been strained by demands associated with the COVID-19 pandemic. Even without adopting more detailed directions on many CBD-containing products, FDA has warned some companies not to market unapproved products with assertions that the products’ CBD ingredients help treat Alzheimer’s Disease or stop cancer cell growth.

FDA has explained that its delay in issuing regulations on CBD is necessary to investigate the side effects of CBD. It takes time to conduct research that could provide FDA with enough evidence to decide whether a drug ingredient should be approved for use in food products—and, at present, research on the benefits of CBD is mixed.

In March 2021, the U.S. Food and Drug Administration (FDA) issued a warning letter to Cannafyl, a cannabis product company, because it marketed its products containing cannabidiol (CBD) as products that could prevent or cure COVID-19. These products are still available for purchase, but Cannafyl’s website now contains a disclaimer noting that its CBD products “are not intended to diagnose, treat, cure or prevent any disease.”

FDA studies which CBD products fit within the current legal framework and which pose excessive health and safety risks. The growing market for marijuana-related products, however, generates financial opportunities that create pressure on Congress and states to expand options for legal sales regardless of FDA’s findings.

FDA formed a CBD Policy Working Group in April 2019. In the ensuing year and a half, FDA has issued a few non-binding guidance documents related to CBD products—but, citing the need for additional research, no regulations.

Over the past several years, CBD, one of the compounds found in marijuana that is psychoactive but does not produce a “high,” has been used in products as varied as chocolate, mascara, and lotions.

Some studies have concluded that CBD mitigates ailments, including anxiety, insomnia, chronic pain, and addiction to substances such as nicotine and heroin. FDA, however, has warned consumers that CBD can have potentially harmful side effects, such as liver injury. At a minimum, the potential for harm from CBD seems to call for balancing costs and benefits of specific products.

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.

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 summarizes the FDA’s current positions as to the following categories:

What CBD Businesses Need to Know

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 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.”

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.

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).