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FDA 2019

FDA wants $5 million for cannabis regulation

While FDA has proposed $5 million in its FY2021 budget request to continue regulating cannabis-derived products, at least one industry trade group—the Natural Products Association—said the request doesn’t go far enough.

FDA has requested $5 million to continue regulating cannabis-derived substances, including CBD, as part of the Trump administration’s FY2021 budget request.

For the above activities, the agency requested $2 million for the Office of Regulatory Affairs (ORA), $2 million for the Center for Food Safety and Applied Nutrition (CFSAN), $0.5 million for FDA headquarters and $0.5 million for the Center for Veterinary Medicine (CVM).

“New funding will enable FDA to better regulate the usage of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food additives,” the agency stated in its proposed budget. “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.”

Among the activities that would be supported under FDA's FY2021 budget request: inspections of facilities manufacturing cannabis-derived products. 

For several years in warning letters, the agency has flagged non-FDA-approved products, including products labeled as dietary supplements, that purport to treat diseases like cancer and epilepsy.

“FDA must support oversight of increasing numbers of marketed FDA-regulated products containing cannabis-derived substances that may put the public at risk,” FDA stated in its budget request.

Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), which is based in the nation’s capital, described the request as “a step in the right direction” and “indication” that FDA “has the resources to regulate the industry.”

“However, this does not go far enough to specifically address the issue of setting a safe level of daily consumption for CBD products,” Fabricant, a former FDA official who oversaw the dietary supplements division, added in a press release. “Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers.”

FDA has opined CBD cannot be marketed in conventional food and supplements because it was first studied as a drug. While the agency has been looking into the feasibility of a rulemaking to authorize CBD in food and supplements, FDA in late 2019 expressed safety concerns about CBD, including risks of liver injury, drug interactions and male reproductive toxicity.

Supplement trade groups have expressed differing views on how FDA should proceed as it eyes a regulatory framework for CBD.

NPA supports legislation passed last year in the House of Representatives that would earmark “$100,000 for FDA to undertake a process to make lawful a safe level for conventional foods and dietary supplements containing cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations.” According to the trade group, the process would follow a precedent involving red yeast rice, allowing a natural product to contain a level of a drug ingredient that FDA has determined to be safe.

Another supplement trade association in Washington—the Council for Responsible Nutrition (CRN)—asserted FDA must first address a definitional issue identified by FDA: namely that CBD is excluded from the definition of a dietary supplement because, in essence, the compound or “article” was first studied as a drug by GW Pharmaceuticals plc, whose drug Epidiolex is marketed to treat severe forms of epilepsy.

What many supplement trade groups seem to agree on is that FDA isn’t doing enough to actively regulate the CBD market.

Language in the FY2021 proposed budget “uses the phrase ‘continue to support’ and ‘continue to regulate’ throughout, but this misses the mark,” Fabricant said in NPA’s news release. “Enforcing on label claims alone does not go far enough. Instead, we encourage the FDA to use this new funding to move on to the next phase of enforcement and establish a safe level or threshold of CBD.”

Congress in late 2018 removed hemp and its derivatives from the Controlled Substances Act (CSA), fueling an explosion of CBD-containing products on the market. 

"In many cases, product developers make unproven claims to treat serious or life-threatening diseases," FDA stated in its FY2021 budget request, "and patients may be misled to forgo otherwise effective, available therapy and opt instead for a product that has no proven value or may cause them serious harm."

In a FY2020 appropriations package signed into law, Congress earmarked $2 million for FDA to conduct research, market surveillance, issuance of an enforcement discretion policy and proper regulatory activities for hemp-derived CBD products.

Sen. Chuck Schumer, Democrat from New York who supported the funding, said the absence of FDA guidance and clarity was creating chaos for consumers and industry, according to a Dec. 17 press release from his office.

“CBD is brimming with potential to be a billion-dollar industry across New York State, bringing along countless jobs and truly meaningful economic development with it,” Schumer said in the release. “But before that can happen, we need to be 100% sure we understand the ABCs of CBD—its impact on human health, and how best to regulate it at the federal level.”

 

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