In the midst of expanded development and marketing of products containing cannabis and cannabis-derived compounds, President Donald Trump's FY 2021 proposed budget includes an additional $5 million for the U.S. Food and Drug Administration (FDA) to undertake greater regulatory and enforcement activities regarding these products.
Specifically, the budget says, "This new funding will enable FDA to continue regulating the usage of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives. The initiative will support regulatory activities, including developing policy, and continue to perform its existing regulatory responsibilities including review of product applications, inspections, enforcement, and targeted research."
The President's budget is not self-enforcing; Congress establishes the budget for all federal agencies each year. Nonetheless, it demonstrates the administration's and FDA's priority to closely scrutinize products in this growing industry and take action against those it deems to be violating existing regulations. The budget also suggests that FDA is still developing its regulatory policy regarding CBD products.
Congressional Action
The budget comes on the heels of FDA testimony last month from Douglas Throckmorton, M.D., Deputy Director for Regulatory Programs at FDA's Center for Drug Evaluation and Research (CDER), before the U.S. House Energy and Commerce Subcommittee on Health in which he said, "At present, any food containing CBD or purported CBD dietary supplement product in interstate commerce is in violation of the [Food Drug & Cosmetic Act]." He also said that FDA is concerned with "the marketing of CBD products that put consumers at risk, such as by making unsubstantiated therapeutic claims to prevent, diagnose, mitigate, treat, or cure serious diseases, but that have not obtained new drug approvals. There are also many unanswered questions about the science, safety, and quality of products containing CBD."
As we have discussed previously, the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) exempted "industrial hemp" from the Controlled Substances Act, which has led to dramatically increased business in the CBD market. In October 2019, the U.S. Department of Agriculture (USDA) issued an interim final rule providing more details regarding the regulations around the growing and cultivating of hemp. The Farm Bill also preserved FDA's authority to regulate hemp and CBD, subject to the same authorities and requirements as FDA-regulated products containing any other substances.
Congress and stakeholders have been waiting for FDA to issue clarifying regulations about use of cannabis and cannabis-derived products in food, dietary supplements, cosmetics and animals for more than a year.
Late last year, Congress enacted legislation that required FDA to provide a report regarding the agency's progress toward "obtaining and analyzing data to help determine a policy of enforcement discretion" and the process in which CBD meeting the definition of hemp will be evaluated for use in products. Congress also required FDA to "perform a sampling study of the current CBD marketplace to determine the extent to which products are mislabeled or adulterated." These reports are due shortly.
Industry Action
In addition, in November 2019, the Consumer Healthcare Products Association (CHPA) filed a citizen's petition with FDA, calling on the agency to, among other things, establish "a regulatory pathway to legally market dietary supplements containing cannabidiol derived from hemp."
We will continue to monitor the regulatory environment as developments unfold.
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