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It is perhaps not surprising that lawmakers on Capitol Hill are proposing alternative approaches to regulate certain intoxicating types of hemp-derived products. Yesterday, Senator Ron Wyden introduced the Cannabinoid Safety and Regulation Act (CSRA)The CSRA proposes a framework for the regulation and control of cannabinoid-containing products. Its primary goal is to protect consumers, especially children. The CSRA defines “cannabinoid products” as a natural product (non-synthetic), including an inhalable food, beverage, or dietary supplement, made or derived out of hemp, which contains cannabinoid and/or tetrahydrocannabinol (THC).

The CSRA will amend the Federal Food, Drug and Cosmectics Act (“FDCA”) in order to outlaw “adulterated cannabinoid Products” and “misbranded Cannabinoid Products”. For the latter category, any cannabinoid finished product that does comply with strict new rules for labeling, promotion and advertisement, it will be considered misbranded. The CSRA will also create a national register for cannabinoid product manufacturers and distributors in the country. It would require registration of all facilities engaged in “manufacturing” or “preparing, propagating”, “processing”, “packaging”, “importing”, “labeling”, or “holding” a cannabinoid for commercial distribution in America. Tetrahydrocannabinol levels that are detectable “that occur through other means than a direct face-to-face interaction between a retailer, and a customer, to prevent the distribution and sale of cannabinoid product to individuals who are under 21 years of age, including requirements for age confirmation” (emphasis in original).

Other key provisions would include:

• Prohibit marketing, sale or distribution to anyone under 21 years of age;
• Establish a Center for Cannabinoid Product within FDA.
• Authorize FDA to establish by order requirements for tamper evident and child safety packaging of cannabinoid product intended for human consumption.
• Require FDA regulations to impose Good Manufacturing Practices (GMP) standards on all manufacturers of cannabinoid product;
• Require FDA regulations to be promulgated imposing rigorous testing requirements on all cannabinoid product, including testing for pesticides residues, chemicals, residual solvents, and heavy metals as well as potency testing of the total THC content or THC concentration in a finished product.
• Require FDA promulgate standards for cannabinoid products that “protect the public health” and “distinguish different cannabinoid products types”.
• Require FDA to work with the Department of Agriculture Attorney General’s Office, Alcohol and Tobacco Tax and Trade Bureau, and the Attorney General’s Office in developing and publishing recommendations for the regulation of cannabinoid drinks that contain THC.

The CSRA would allow states to continue to control hemp products that are consumed. It includes a non-preemption clause which would allow states to continue to regulate hemp products. This is in addition to or more stringent requirements “Established under this Chapter” (emphasis in original).

This newly introduced legislation is, of course, just a beginning. The House is expected to introduce soon a companion bill addressing many the same issues. House and Senate bills will ultimately need to be reconciled in order for any of the core concepts described above to become law. Even though there’s a consensus that Congress must act, the road ahead is long. The CSRA does not also resolve the uncertainty that surrounds the next version of the Farm Bill, and whether or not the definitional gap in law that allowed the proliferation of intoxicating products of hemp across the country will remain. This bill is complex and has many implications for the future of the Farm Bill. We will continue to track and report on any significant developments in this bill and related legislation.