Industry groups with a stake in how the federal government regulates products made from hemp-derived cannabinoids have responded to a request for information from Congress. The suggestions from three groups offer different takes on which agencies are best suited to protect consumers.
Following a July 27 hearing on the Food and Drug Administration’s oversight of the hemp-derived CBD market, or lack thereof, health committee leaders from both the House and Senate issued a joint RFI with 29 questions, plus sub-questions, on the topics of:
- Current market dynamics
- Pathways to regulation
- Federal-state interaction
- Safety
- Quality
- Form, packaging, accessibility and labeling
“Since hemp was descheduled five years ago, consumers, manufacturers, and policymakers have sought clarity regarding the legal status of CBD. Farmers, food and beverage groups, and state regulators have shared their policy priorities with Congress,” the RFI said. “Questions remain about the best way to provide a legal pathway to market for CBD products.”
The U.S. Hemp Roundtable, which represents hemp growers and manufacturers, and the Cannabis Regulators Association (CANNRA), which represents regulators in 45 states and U.S. territories, testified at the hearing. Both groups support stronger regulation to protect consumers and clarify rules for hemp producers and regulators, but they have different approaches on how to create a better framework and which agency should oversee it.
Their responses to the RFI were consistent with their testimony and prior commentary, but it enabled the organizations to go into greater detail in making their cases for stronger regulation.
CANNRA members are on the front lines trying to regulate a wild hemp-derived product market that spans various cannabinoids — including non-intoxicating CBD and intoxicating THC derivatives — as well as types of products — from food to inhalants. They say a comprehensive regulatory approach is “urgently needed.”
In CANNRA’s RFI response, the group said the current FDA regulatory pathways, focusing on CBD alone, are insufficient to address all the types of products on the market. “Failure to provide regulatory authority for a federal agency to address all the cannabinoid hemp products on the market will result in regulatory gaps that will be exploited at the risk of public health and consumer safety,” CANNRA wrote.
It said Congress should grant authority to a federal agency “that has a focus on regulating for public health and consumer safety (i.e., the Food and Drug Administration)” to set THC limits in products based on scientific research. But it does not want Congress itself to set limits because limits set in law would require new statutes to implement change.
“Rather, Congress should call on FDA to set limits within a specified timeframe, based on current science and current market considerations. Those limits should set a minimum standard for states,” it wrote.
Meanwhile, the Hemp Roundtable feels the necessary frameworks already exist to regulate the hemp market, although it is also open to stricter regulation of CBD. They said the FDA could continue to regulate CBD. They want to see intoxicating hemp products remain legal and be regulated by the Alcohol and Tobacco Tax and Trade Bureau.
“There should be two separate categories within existing regulatory frameworks that distinguish products by their potential to cause impairment. This currently exists with regard to alcohol and the 0.5% ABV limit under which a product like kombucha can be considered food,” the Hemp Roundtable wrote in its RFI response.
“FDA would regulate non-intoxicating hemp products, while those that may be impairing should be strictly regulated and controlled in an adult-only framework by a separate agency such as the Alcohol and Tobacco Tax and Trade Bureau (TTB), rather than prohibited or criminalized. Topical products containing CBD and other hemp-derived cannabinoids should not be part of any new framework and should continue to be regulated under the current comprehensive framework for cosmetics,” it continued.
That’s also the opinion of the Wine & Spirits Wholesalers of America (WSWA), which also threw its hat into the hemp regulatory ring. It responded to some of the RFI questions of which they felt they had some expertise.
Like CANNRA, it agrees that any proposed regulatory framework for CBD must also address intoxicating hemp-derived products, synthetics or compounds. But intoxicating products should be overseen by the TTB, which is “uniquely qualified” because of its “decades of experience” regulating alcoholic beverages.
The WSWA said the TTB’s oversight should include:
- Permitting of manufacturers, importers, testing facilities and distributors
- Reviewing and approving product formulas and labels
- Collecting excise taxes from manufacturers and importers
- Ongoing market monitoring to ensure compliance with product safety, labeling, advertising, and trade practice requirements
As part of its response, the Hemp Roundtable also submitted a white paper that supports a 5 mg per serving of THC threshold for all hemp-based products. They said the studies reviewed in the white paper showed that up to 5 mg per serving is not intoxicating and is analogous to the 0.5% alcohol by volume limit on food products before they are classified as alcohol and adulterated food.
