Washington, D.C.—In response to a bicameral Request for Information (RFI) regarding Food and Drug Administration (FDA) regulation of cannabidiol (CBD), several industry associations and stakeholders have submitted responses. The call for information came from House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA). Experts and stakeholders were asked for comments addressing:
- FDA's concerns related to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics), and FDA’s view that there is a need for a new regulatory pathway for CBD products.
- How has the absence of federal regulation has created a market for intoxicating, synthetically-produced compounds, such as Delta-8 THC, THC-O, THC-B, HHC-P, and others.
- How a new framework for CBD products could balance consumer safety with consumer access.
- Precedents in foods, dietary supplements, tobacco, and cosmetics for requirements of labeling to present risks to special populations (e.g., children, pregnant and lactating women, consumers taking certain drugs, etc.).
- Amount and type of evidence that has been required to support requirements of such labeling.
(Background: FDA: Existing Regulatory Frameworks for Foods & Supplements Not Appropriate for CBD)
NPA Submits Proposal to Regulate CBD
The Natural Products Association (NPA) shared its response. Daniel Fabricant, Ph.D., President and CEO of the NPA, outlined the association's position: “For more than five years, Americans have been asking the FDA to make a safety determination for CBD. In that time, NPA has worked with Congress and the states to establish appropriate measures and even petitioned the FDA to exercise enforcement discretion in a specific and selective manner consistent with the premarket safety review of a new dietary ingredient notification.
“Instead of using existing regulatory authority, FDA has resisted fulfilling their mandate for years and is now chasing the fantasy of a ‘center’ for hemp and cannabis products that would mimic the Center for Tobacco Products. Through DSHEA, Congress has provided the FDA with broad authority to review safety data for new dietary ingredients like CBD to enter commerce. Our proposal demonstrates that putting a clock on FDA to use existing authority is the most efficient and straightforward pathway for public health and to stabilize a robust marketplace for dietary supplements and foods containing CBD. We look forward to working with Congress and the FDA to finalize a reasonable regulatory approach that protects Americans and provides certainty to industry.”
CRN Says FDA is Failing Consumers
In its responses and recommendations, the Council for Responsible Nutrition (CRN) noted that the market for CBD products has grown into a multi-billion dollar one since the passage of the 2018 Farm Bill, but a lack of national standards from FDA inaction is a prime culprit in the industry languishing. This, CRN says, has hurt "American hemp farmers, CBD manufacturers, and the millions of consumers who use CBD and experience a variety of health benefits from these products."
CRN added: FDA has spent the past five years ignoring not only Congress' directive to regulate CBD, but also the credible, well-conducted research that demonstrates the safety of well-made CBD products. FDA's failure to establish a regulatory pathway for CBD has forced states to enact their own disparate policies to protect consumers. This has resulted in a patchwork of laws that is detrimental to the industry and should be unified by federal intervention.
“Congress is asking the right questions, because they created in DSHEA a framework that could accommodate CBD, and their reasonable expectations for the FDA around this ingredient were not met,” said CRN President and CEO Steve Mister. “Meanwhile, despite an overwhelming amount of safety data the industry has already presented to FDA, the agency continues to place an entire industry in innovation-stifling limbo, and consumers at continued risk in a needlessly unsupervised environment.”
AHPA, CHPA & UNPA Urge Action
The American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA) and United Natural Products Alliance (UNPA) also submitted comments. The associations outlined how existing statutes and regulations are sufficient for FDA to effectively regulate CBD dietary supplements, thus making the congressional development of a new regulatory pathway for CBD dietary supplements unnecessary.
“FDA could today, under its current authority and in the existing regulatory framework, move CBD containing dietary supplements out of the shadows and into the bright light of regulatory compliance,” said AHPA President Michael McGuffin. “AHPA remains committed to advocating for FDA's prompt initiation of rulemaking to grant an exception to the exclusionary clauses for CBD as a dietary supplement, with appropriate controls, under the existing regulatory framework.”
The associations urged the committee leaders for to encourage FDA to “get to a yes” and establish the procedures by which CBD-containing dietary supplements can be marketed under current law.
cbdMD Calls for Fair Treatment of CBD Products
cbdMD's Sibyl Swift, Ph.D. and Lance M. Blundell, Esq., also noted in their comments that FDA has the tools to regulate hemp-derived products using the existing regulatory framework. "We are respectfully submitting a response today to ensure Congress receives the requisite information from a top hemp brand that has taken the necessary steps to be fully compliant with the Food, Drug and Cosmetic Act (FD&C Act)," they wrote, adding:
"We are not asking for special treatment; we are asking to be treated like every other dietary ingredient or cosmetic and apply the regulations within the FD&C Act to our industry. The American people deserve access to naturally derived products for everyday health and wellness."
