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The bill provides a funding increase of $5 million to protect the public from cannabis-derived products that are in violation of the Federal Food, Drug, and Cosmetic Act, as well as to create a potential regulatory pathway for cannabis-derived products.
The House Appropriations Committee announced on Thursday, July 9, that it had approved the fiscal year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill by voice vote. The total discretionary funding in the legislation is $23.98 billion, an increase of $487 million above the fiscal year 2020 enacted level. In total, the bill allows for $153 billion in both discretionary and mandatory funding, an increase of $331 million above the fiscal year 2020 enacted level.
The report accompanying the full bill states FDA will receive an appropriation of $3.2 billion in new budget authority which, when combined with definite user fees, provides the FDA with a total discretionary salaries and expenses level of over $5.8 billion. The committee recommendation includes a net increase of $40,828,000, “including increases for the following programs or initiatives: Strengthening Response Capabilities for Foodborne Outbreaks; Cannabis and Cannabis Derivatives; Artificial Intelligence and Other Emerging Technologies; Transform Medical Device Safety, Cybersecurity, Review, and Innovation; Compounding; and Modernizing Influenza Vaccines.”
The accompanying language for the enforcement of cannabidiol (CBD) provides a funding increase of $5 million to protect the public from products that are in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA), as well as to create a potential regulatory pathway for cannabis-derived products.
“The Committee provides an increase of $5,000,000 for enforcing the law to protect patients and the public while also providing a potential regulatory pathway for cannabis and cannabis-derived products. The Committee maintains its concern about the proliferation of foods and dietary supplements marketed in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA), including products containing cannabis and cannabis-derived ingredients,” states the Committee on Appropriations. “Non-FFDCA–compliant products continue to pose potential health and safety risks to consumers through unsubstantiated and misleading claims such as treating a wide-range of life-threatening diseases and conditions. The Committee expects the FDA to continue to prioritize consumer safety through application of the law.”
While the new bill does provide FDA an increase in funding for enforcement and a possible regulatory pathway for CBD, FDA is not given any instruction about how funding should be directed toward these efforts, nor is the agency given any directives or deadlines by which to follow up with Congress on its progress. Compare this to the Further Consolidated Appropriations Act of 2020 that passed into law in December 2019 which set aside $2 million for “research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the Food and Drug Administration which contain cannabidiol (CBD).” This same law also gave FDA 180 days to conduct sample testing of the current CBD marketplace “to determine the extent to which products are mislabeled or adulterated.”
The current draft of the bill provides little to no indication of what FDA’s next move will be regarding the development of a regulatory pathway for CBD. However, it is possible that a future draft of this bill may contain more specific language once it makes its way to the Senate. Potential clues can also be drawn from the recently released findings of FDA’s sampling study mandated by the aforementioned Further Consolidated Appropriations Act of 2020 and may explain why the language in the new appropriations bill puts an emphasis on enforcement.
The agency’s “Sampling Study of the Current Cannabidiol Marketplace to Determine the Extent that Products are Mislabeled or Adulterated” indicates that FDA’s current activity around CBD is performing long-term sampling studies in order to gain insights into the characteristics of representative CBD products on the market. These insights will conceivably inform the agency’s approach to regulating the popular products. However, the collection and evaluation of this data will take time.
Nutritional Outlook spoke to Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, DC), who said it is unclear, in his opinion, how FDA used its previous budget of $2 million provided by the Further Consolidated Appropriations Act of 2020 for CBD-related activities. Fabricant told Nutritional Outlook it is unlikey the agency spent all $2 million on testing product samples.
The $5 million funding increase for CBD activity outlined in the new House Appropriations bill is generous, Fabricant said. But will it be enough to help FDA make progress on regulating CBD?
"Could it and should it have a substantial impact? Of course it should," he said. "For example, when I was at the Agency, we had this whole thing on energy drinks and caffeine, which is on both the food additive and supplement side of the house,” explains Fabricant, who served as FDA's Director of the Division of Dietary Supplement Programs in 2011-2014. “We had the world’s expert in caffeine do a multiyear risk assessment for about a half million dollars, so that puts it into perspective. CBD isn’t studied as well as caffeine, so in some ways the caffeine studies are a lot more extensive because you have to go through thousands and thousands of studies on caffeine whereas with CBD there are probably hundreds. But that’s enough to start throwing together some guidelines. It’s just frustrating. I think everyone is frustrated, and the agency just seems completely not compelled to move it along expeditiously.”
Read more on FDA’s report here.
Updated Thursday, July 16, 2020, with quotes from Daniel Fabricant.