420 FILE--A representative of the US Food and Drug Administration responded to day-long public testimony regarding the establishment of regulations governing the retail sale of CBD-infused products.
On Friday, the agency held its first-ever public hearing dedicated to issues surrounding the "manufacturing, product quality, marketing, labeling, and sale" of hemp-derived CBD-infused retail products. NORML provided written testimony ahead of the event, calling on the agency to clarify confusion among both consumers and regulators with regard to the legality of certain CBD products. NORML further recommended that the FDA move expeditiously to provide regulatory guidelines governing the products' manufacturing, standardization, and quality.
Following the conclusion of the hearing, Dr. Amy Abernethy – Principal Deputy Commissioner of the FDA – issued a series of tweets concurring with many of NORML's concerns. She agreed, "There is a need to further clarify the regulatory framework to reduce confusion in the market." She also acknowledged, "Consumers need consistent information and labeling," and further stressed the need for the objective lab testing of retail products. Recently, third-party testing of over 240 commercially available CBD-infused products reported that many of them contain heavy metals, such as lead and arsenic, and that they typically contain less-than-advertised quantities of CBD.
She concluded: "[S]peakers reinforced that regulatory pathways are unclear. We must sort this out in service of public health. ... We will work as quickly as possible to define a way forward."
In December, Congress enacted legislation removing industrial hemp (defined as cannabis containing less than 0.3 percent THC) and products containing cannabinoids derived from hemp from the federal Controlled Substances Act. The following day, the FDA stated: "Congress explicitly preserved the agency's current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act."
The agency further opined, "[I]t's unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived." This past March, outgoing FDA director Scott Gottlieb testified to Congress that it could take up to four years for the FDA to create a regulatory pathway for the retail sale of CBD-infused food products or health food supplements.
The agency continues to selectively target manufacturers who it believes are marketing CBD-infused products in a manner that violates the agency's interpretation of the law.
For more information, see the NORML fact-sheet 'FAQs About Cannabidiol.'