With the persisting uncertainty surrounding the next iteration of the Farm Bill and its treatment of hemp-derived consumable products, perhaps it should come as no surprise that legislators on Capitol Hill have proposed alternative approaches to regulating certain intoxicating varieties of such products. Yesterday, Senator Ron Wyden (D-OR) introduced the Cannabinoid Safety and Regulation Act (“CSRA”), which proposes a national framework for the regulation of consumable cannabinoid products, with the principal goal of protecting consumers – in particular, children. The CSRA would define “cannabinoid product” as, essentially, a natural (non-synthetic) product (including an inhalable, food, beverage or dietary supplement) made or derived from hemp that contains some form, type or amount of cannabinoid(s) and/or tetrahydrocannabinol (“THC”), that is intended for ingestion by, or use in or on the body of, human or animal.
As an initial matter, the CSRA would amend the Federal Food, Drug and Cosmetics Act (“FDCA”) to outlaw both “adulterated cannabinoid products” and “misbranded cannabinoid products.” With respect to the latter category, any finished cannabinoid product that does not comply with strict new labeling, promotion and advertising rules will be considered misbranded under the FDCA. The CSRA would also, for the first time, create a national registry for manufacturers and distributors of cannabinoid products in the county. Specifically, it would require the registration of all facilities that engage in the “manufacturing, preparing, propagating, compounding, processing, packaging, packing, importing, labeling, or holding of a cannabinoid product for commercial distribution in the United States.” In addition, the CSRA would direct FDA to promulgate regulations “regarding the promotion, sale, and distribution of cannabinoid products intended for human consumption and that contain detectable levels of any tetrahydrocannabinol that occur through means other than a direct, face-to-face exchange between a retailer and a consumer, to prevent the sale and distribution of cannabinoid products to individuals who have not attained the age of 21, including requirements for age verification” (emphasis added).
Other key provisions of the bill would:
- Prohibit the marketing, sale or distribution of a cannabinoid product to anyone under the age of 21;
- Establish a Center for Cannabinoid Products within FDA;
- Authorize FDA to establish, by order, requirements for tamper-evident and child safety packaging for cannabinoid products intended for human consumption;
- Require FDA to promulgate regulations imposing Good Manufacturing Practices (“GMP”) standards upon all manufacturers of cannabinoid products;
- Require FDA to promulgate regulations imposing rigorous testing requirements for all cannabinoid products, including testing for pesticides, chemical residues, residual solvents and heavy metals and also potency testing for the total THC content and THC concentration of a finished product;
- Require FDA to promulgate cannabinoid product standards that are “appropriate for protection of the public health and that distinguish different cannabinoid product types”; and
- Require FDA, the Department of Agriculture, Attorney General’s Office and the Alcohol and Tobacco Tax and Trade Bureau to jointly develop and publish recommendations for regulating cannabinoid beverages that contain THC.
Critically, the CSRA would also permit states to continue to regulate consumable hemp products. On that score, it includes an express non-preemption clause that would reserve to the states authority “to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to cannabinoid products that is in addition to, or more stringent than, requirements established under this chapter” (emphasis added).
Of course, this newly introduced legislation is likely just a starting point, and the House is expected to introduce a companion bill soon addressing many of the same issues. The House and Senate bills would ultimately need to be reconciled before any core concepts described above have a viable pathway to becoming law. That is to say - even though there is some consensus that Congress needs to act, there is still a long road ahead. The CSRA also does not resolve the existing uncertainty surrounding the next iteration of the Farm Bill and whether the existing definitional gap in the law that enabled the proliferation of intoxicating hemp products across the country will continue to exist. In short, there is a lot to consider in this bill and how it may or may not dovetail with the next version of the Farm Bill. We will continue to monitor and report on significant developments with this bill and any related legislation.
