INSIGHT: FDA Considers Pathway for Legalizing CBD

The Food and Drug Administration held its first public hearing on May 31 concerning products containing cannabis or cannabis-derived compounds (in particular, cannabidiol (CBD), a popular additive to food, beverages and supplements). This new focus reflects the burgeoning popularity of CBD as an additive to consumables, driven by the compound’s much-touted health benefits.

Although FDA Deems CBD ‘Unsafe,’ There Has Been No FDA Enforcement

The FDA currently classifies all products containing CBD (including those derived from hemp, in accordance with the 2018 Farm Bill) as “unsafe” under the Federal Food, Drug, and Cosmetic Act (FDCA). Despite this designation, the agency’s general approach to CBD enforcement suggests that it does not believe the substance should face outright prohibition and that CBD has gained widespread acceptance.

Under the FDCA, a substance must be generally recognized as safe by relevant experts, which has not happened yet with respect to CBD. Consequently, the FDA has not approved CBD as an additive.

Nevertheless, CBD-infused food and beverage products continue to multiply in the marketplace, and the FDA has taken no action to remove such products from the shelves. Affected industries have been demanding clarity, especially because hemp-derived CBD products are legal at the federal level, and so has Congress.

Unfortunately, the FDA’s policy regarding CBD marketing claims is murky: While the agency has scrutinized companies making unapproved therapeutic claims, which the FDA states are illegal, the agency has not taken any enforcement action to date.

From 2015 to date, the FDA has sent 22 warning letters to companies for deceptive marketing regarding the therapeutic qualities of CBD (e.g., “contains CBD oil to alleviate anxiety”). This activity has been toothless. The warning letters targeted only egregious offenders that made putatively extreme and unsupported specific claims regarding the health benefits of CBD. The FDA has not initiated any enforcement actions against any company marketing CBD-infused products.

Acknowledging this ambivalence, the FDA scheduled the May 31 hearing to gather the information it needs to work out a coherent, informed and comprehensive approach to the substance. Outgoing FDA Commissioner Scott Gottlieb explained that the hearing would “give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient.”

What We Learned at the Hearing

FDA Acting Commissioner Dr. Norman Sharpless opened the meeting with brief, but illuminating, remarks. Sharpless acknowledged the great interest in CBD products but also noted that CBD raised important health-care concerns requiring further research and clarity, including safe dosages, drug interactions and tolerance among populations such as children, the elderly and pregnant women.

The core challenge of regulating CBD, he explained, arises because the FDA’s regulatory apparatus was designed to treat drugs and food/beverage additives separately. Thus, the FDA needs to consider thoughtfully how to regulate this substance, which is already being used widely in both categories. He also emphasized that marketing claims regarding CBD health benefits are an ongoing concern for the FDA, especially unproven claims, such as its ability to treat serious diseases.

Sharpless ended by stating that the FDA is focused on taking a science-based approach to resolving this concern, and to that end, the agency has established an internal working group.

Following these comments, a panel of agency officials received concise briefings from speakers representing primarily the academic, agricultural, manufacturing, health, retail and distribution, and public safety communities. Several consistent themes emerged from these diverse perspectives.

The FDA is lagging behind the marketplace. There is a surging demand in the marketplace for CBD products. Commenters consistently acknowledged regulatory guidelines’ importance in keeping the industry on track and noted that such guidelines will also help focus research efforts (which are necessary to protect consumers), ensure responsible labeling and help the industry understand where the risks and priorities are. Lack of regulation, commenters clearly indicated, is creating a proverbial “Wild West,” in which consumers cannot trust that products are accurately labeled, pure and safe.

Market participants, as well, are hampered by lack of clarity as to what they can and cannot do. Several commenters suggested that the market cannot afford to wait through an extended, years-long rulemaking process.

There are health benefits, but also concerns. Most commenters agreed that available data and anecdotal evidence point to health benefits of CBD, especially for pain management and to treat specific afflictions, such as anxiety, insomnia and epilepsy. Commenters generally agreed, however, that additional product testing and clinical research into efficacy, adverse effects and drug interactions are necessary. A small minority expressed skepticism or caution. The FDA’s questions indicated there is strong interest on the agency’s side, as well, in obtaining substantive additional data on these questions.

There is clinical data, but more research is needed. Some commenters pointed to a new and slowly growing body of clinical data, but almost all commenters agreed that additional research is necessary for clarity, both for the FDA to properly regulate CBD and for consumers to make safe, informed choices.

Labeling integrity is a particular challenge. Academics and health professionals, in particular, cited the need for clear standards regarding how CBD products are labeled. For example, CBD products may contain undesirable substances, such as synthetic cannabinoids, or high levels of THC (tetrahydrocannabinol, the primary psychoactive ingredient of cannabis). Without enforceable guidelines, there is a great potential for misleading consumers and health patients. (For example, commenters indicated, a large percentage of CBD extract is under-labeled, over-labeled or mislabeled.)

CBD purity remains a challenge. Many commenters expressed concern that existing studies reflected the presence of heavy metals, pesticides and pollutants, and bacteria in CBD products, a result of the products’ current unregulated status.

Speakers consistently welcomed the rigor of FDA scrutiny. Commenters agreed that FDA attention and regulation would establish the guardrails necessary to make the CBD market safer, more understandable to consumers and more consistent—all qualities that will fuel, not hinder, continued growth.

Next Steps

The FDA’s Principal Deputy Commissioner, Dr. Amy Abernethy, distilled the FDA’s focus going forward on Twitter following the hearing:

For companies that seek to do business in the exploding CBD market, the FDA hearing raises a number of important issues.

First, manufactures, distributors and retailers should approach the product 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).

Second, it is clear that the FDA, as an institution, understands the widespread acceptance of CBD (among other cannabis-related products) and presumably the need for oversight in order to provide useful guardrails for businesses, consumers and researchers alike.

Third, unfortunately, those guardrails may not be available for some time. The FDA appears to be working towards generating thoughtful guidelines regarding CBD and cannabis-related food, beverages, drugs and supplements, but the agency has not publicly set any deadlines for itself in this regard.

Given the time-consuming process generally required by federal government rule-making, it may take a while for the FDA to generate regulations to help promote clarity in the CBD marketplace.

This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.

Author Information

Barak Cohen is a partner in Perkins Coie’s White Collar & Investigations practice, and the Litigation Lead in the firm’s Washington, D.C., office. He is a former Department of Justice prosecutor, and now represents companies and individuals in international and U.S.-based internal investigations and high-stakes government investigations involving various regulatory bodies.

Michael C. Bleicher is an associate in Perkins Coie’s Privacy & Security practice. He focuses on matters involving the application of the Electronic Communications Privacy Act, intersections between privacy and national security matters, and general counseling for companies ranging from startups to blue chip firms.