Industry stakeholders respond to request for information from Congress on hemp-derived CBD market

On July 27, 2023, a bicameral committee of legislators that include House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), as well as Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA) published a Request for Information (RFI) asking industry stakeholders for their input on the hemp-derived CBD market as Congress assesses the potential for a regulatory pathway. The request seeks input on a range of factors, specifically: current market dynamics, pathways, scope, safety, quality, as well as form, packaging, accessibility and labeling. The deadline for submitting input was August 18, 2023.

Numerous stakeholders submitted comments to Congress in response to the RFI. A common thread across many comments was criticism of the U.S. Food and Drug Administration’s (FDA) interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and its subsequent inaction with regard to properly regulating the products that have proliferated since the 2018 Farm Bill made hemp legal to grow.

“Congress initially anticipated that, with the removal of hemp and its non-THC constituents from scheduling, FDA would immediately provide pathways for the marketing of hemp-based products under its existing legal jurisdiction. FDA has ample authority to regulate these products as food, dietary supplements, cosmetics and over-the-counter and prescription drugs with the prescribed authorities in the current federal Food, Drug, and Cosmetic Act (FDCA) and related regulations,” stated The Council for Responsible Nutrition (CRN; Washington, D.C.), in its letter. “Even though Congress and industry have requested that FDA use this authority there has been no substantive action. As a result, the CBD industry has since languished. We believe that if FDA had worked expeditiously on a regulatory pathway to legally market CBD when the 2018 Farm Bill was enacted, the questions raised in this RFI would have already been addressed. Instead, FDA has spent the past five years metaphorically wringing its hands about this authority, ignoring Congress’ directive, watching from the sidelines as a sizable, but unpredictable CBD marketplace evolved without meaningful enforcement of legal requirements, and ignoring (even denying the existence of) credible, well-conducted research that was presented to the agency to demonstrate the safety of well-made CBD products.”

FDA does not recognize CBD as a dietary supplement because of the drug preclusion clause. Because of this, the agency believes that existing regulatory pathways cannot apply to hemp-derived CBD. CbdMD, a manufacturer of hemp-derived CBD products, disputes this interpretation in its letter to Congress.

“This opinion is flawed and unsupported as it does not account for the fact that Extract of Cannabis (a Full Spectrum Tincture product) is an old dietary ingredient as it was legally marketed in the United States from the mid 1800s thru the time when Cannabis prohibition began, and is clearly documented as such in the published United States Pharmacopeia (USP) during the relevant time periods,” explains the company. “Time, and the fact it was prohibited and scheduled as a controlled substance, has hidden this from the public domain. Despite Extract of Cannabis, and by extension extract of hemp, being an old dietary ingredient and not subject to Drug Exclusion, the looming specter of potential impending regulatory action by FDA and a constant flow of misleading information has persisted since the 2018 Farm Bill, suffocating the market and stifling growth. The FDA’s continued comments in combination with its unwillingness to act have caused big box stores, large retail chains, and major food and beverage brands to reject the sale of products containing CBD and other hemp extracts. Stalled growth of the market has led to an oversupply of hemp biomass and crude oil, driving prices down and negatively impacted hemp farmers. Many of those impacted were minority farmers who had turned to hemp as a lifeline to save their livelihood when other crops like tobacco had experienced a significant decline in demand.”

All the while, the market continues to grow, and FDA’s enforcement has been limited to warning letters when brands make illegal claims. Responsible companies have taken steps to ensure consistent quality of their products, and some have even invested in GRAS (generally recognized as safe) dossiers as well as New Dietary Ingredient Notifications (NDINs) that require toxicological studies that demonstrate the products’ safety. FDA does not recognize hemp-derived CBD as GRAS and has not acknowledged NDIN notifications, citing drug preclusion, but also continues to raise questions of CBD’s safety and calling the current evidence provided insufficient.

While industry has begun to demonstrate the safety and effectiveness of CBD products for sleep and pain, industry largely acknowledges the need for more data. The Natural Product Association (NPA; Washington, D.C.), for example, has long advocated for FDA to implement testing of hemp-derived CBD.

“Currently, through the United States Department of Agriculture, there are 37 hemp analytical testing laboratories. Any laboratory testing hemp for THC must be registered with the Drug Enforcement Agency through these facilities. Unfortunately, the combined volume of hemp produced, and the lack of facilities has led to industry-wide concerns. This is why we have proposed to establish a national testing center and corporate stewardship program for manufacturers of CBD products at the National Center for Natural Products Research at the University of Mississippi,” wrote NPA. “This program would provide an independent verification program for product analysis. The program would randomly select 1,000 products per year that would purport to contain hemp/CBD. These products would be tested using known standards for their content of impurities, THC, CBD, and other cannabinoids. The data generated from this program would be provided to the FDA and published in a public-facing database for anyone to access.”

NPA has also advocated for setting a daily consumption level, which the association says FDA has the authority to do. “Specific to foods and dietary supplements, under current authorities, the FDA can set a daily consumption level (which would address the major public health concerns) in foods and dietary supplements,” explains NPA. “Establishing such a level would trigger other authorities dealing with labeling and product quality through good manufacturing practices (cGMP), which the agency can use to regulate the marketplace and analyze facilities and analyze products effectively. FDA can do this either through enforcement discretion (which has precedence for dietary supplements as recently as 2022 with N-Acetyl Cysteine) or through notice-and comment rulemaking (an option that was written into statute in 1994 but has never been used by FDA). Once this pathway is established, it would be viable for the other cannabinoids.”

While FDA continues to question the safety of hemp-derived CBD, stakeholders are point to other jurisdictions that have determined CBD to be safe and are currently regulating these products. The United Kingdom is one example.

“A large body of evidence is available on the safety of CBD and CBD-containing hemp extracts. In fact, other government bodies have established recommended maximum upper intake levels of CBD based on the available safety data,” explains CRN. “In 2020, the UK Food Standards Agency recommended an upper limit of 70 mg per day CBD for healthy adults, based on a review of evidence by the UK Committee on Toxicity. Later that year, the Australian Therapeutic Goods Administration also released their safety assessment with the overall conclusion that ‘cannabidiol presents a good safety and tolerability profile at the low dose range of under 60 mg/day.’ In 2022, Health Canada’s Science Advisory Committee on Health Products Containing Cannabis issued a review of CBD, stating that ‘CBD is safe and tolerable for short term use (a maximum of 30 days) at doses from 20 milligrams per day (mg/day) to a maximum dose of 200 mg/day via oral administration for healthy adults provided they discuss the use of all other medications and substances used with their pharmacist.’”

Unfortunately, FDA is largely relying on safety data related to pharmaceutical grade products rather than dosages associated with dietary supplement consumption as demonstrated by a recent review of CBD’s oral toxicity, published in April of 2023. FDA’s view is that a new regulatory framework is necessary while stakeholder contend that the current regulatory framework provides FDA with sufficient authority to regulate these products. Additionally, cbdMD argues that industry self-regulation and third-party certification add a layer of safety for consumers.

“We believe the current market conditions for Dietary Supplements/Foods/Cosmetics are robust and provide adequate safeguards. We believe that industry self-regulation can complement federal and state regulation. Further, with clear regulations the market will regulate itself as retailers will look to responsible suppliers who can document their cGMP compliance and those who cannot will be naturally excluded from the market,” wrote cbdMD. “By way of example, in 2019, NSF began certifying CBD and hemp products. NSF certifies products to NSF/ANSI 173/455 (Dietary Supplements Contents Certified), NSF 229 (Functional Foods), NSF 306 (NSF Certified for Sport®), and NSF 527 (Personal Care Contents Certified). NSF’s certification program helps ensure products do not contain unacceptable levels of contaminants, including those specific to hemp, like THC and certain solvents and verifies the validity of label claims.”

According to a joint letter to Congress from The American Herbal Products Association (AHPA; Silver Spring, MD), The Consumer Healthcare Products Association (CHPA; Washington, D.C.), and the United Natural Products Alliance (UNPA; Salt Lake City, UT), FDA provided some members of Congress "technical assistance" on how a regulatory pathway can be drafted legislatively in the context of a "harm reduction" program. The letter explains that this is a flawed approach because, "Attempting to regulate all CBD products under one scheme would engender unnecessary delay and cost."

"Substantial authority for CBD dietary supplements already exists," the letter goes on to explain. "That authority could be amplified upon or adjusted, if necessary (for example, to address intoxicants or set requirements for limited duration use labeling), but existing authority is largely applicable to CBD products. Similarly, Congress just last year enacted a new regulatory paradigm for cosmetics, which could serve as a basis for CBD containing cosmetic products. There is no more need to 'reinvent the wheel' to create a CBD paradigm across product categories than there is, for example, in regulating caffeine."

The group also argues that people consume CBD to be healthy, and therefore treating CBD like carcinogen such as tobacco through a "harm reduction" paradigm is not appropriate.

It's unclear what Congress’s involvement will lead to. While FDA petitions Congress for a new regulatory pathway, a number of bills have been introduced that would direct FDA to regulate CBD under the Food, Drug and Cosmetic Act. In the meantime, it’s business as usual.