U.S. Food and Drug Administration is facing criticism from lawmakers over its regulation of hemp-derived cannabidiol products, which were legalized in a 2018 farm bill.
On Thursday, the House Committee on Oversight and Accountability’s Health Care and Financial Services Subcommittee held a hearing to address concerns around the languishing now five-years long legal industry.
Hemp farmers have found themselves mired in a money-losing crop as hopes for a multimillion industry have faded.
Earlier this year the FDA decided it was not going to act on rules surrounding hemp-derived CBD to be sold in dietary supplements or foods. That sent prices for hemp lower than what it costs the farmers to produce hemp.
Instead, the FDA punted back to Congress arguing that it needs better legislation and guidance from lawmakers.
At the same time, Douglas W. Stearn, an FDA director said, “The accumulating evidence about CBD suggests that there are considerable safety concerns with its potential use as a dietary supplement, and it is not apparent from your petition or the available evidence how a CBD product would be able to meet the applicable safety standard that the law provides for dietary supplements.”
The agency said that existing policies governing food and dietary supplements were insufficient to manage the risks it said were associated with CBD, a nonpsychoactive compound that can be derived from marijuana and hemp, and that Congress would have to step in.
Democratic Rep. Katie Porter from California, the subcommittee’s ranking member, defended the FDA, emphasizing that new legislation is required to give the agency a clear mandate for CBD regulation.
Porter warned against the paradox of criticizing the FDA for its cautious approach while simultaneously criticizing potential overreach.
“Today, Republicans have convened this hearing because they believe, apparently, that the FDA doesn’t need any more authority from Congress to properly regulate hemp-derived products,” she said. “The problem is that some of the same lawmakers who want to do ‘oversight’ of the FDA for being cautious about its existing powers would turn around and blast the agency if they ever felt like it went too far beyond its legal authority.”
She added, “Look, we can’t have it both ways here.”
Even though hemp and CBD are legal, the market hasn’t grown as much as it could have. The FDA said it won’t allow CBD in dietary supplements or foods, because it’s not clear how much CBD is safe to consume and for how long.
That lack of regulation has led to a gray market where CBD-infused products are sold, but mostly those that don’t make health claims or are targeted towards kids. There’s also concern about some companies turning hemp supply into intoxicating substances like delta-8-THC that can have effects similar to marijuana.
Richard A. Badaracco, a former DEA agent, highlighted the safety concerns associated with unregulated CBD products and stressed the necessity of federal regulation.
Meanwhile, Gillian L. Schauer, executive director of the Cannabis Regulators Association, pointed out that without federal rules, states are starting to make their own policies.
The regulatory framework to address hemp-derived cannabinoid products is urgently needed, whether through the farm bill or another legislation, she added.
“When compared to state-regulated marijuana markets, the current cannabinoid hemp market is effectively an alternative unregulated market for intoxicating cannabinoids, with lower barriers to entry and access due to a complete lack of consumer safety and public health regulations,” Schauer said.
The problems are compounded by the diverse range of hemp-derived products. They exist in various forms with differing active ingredients, functioning in the same way whether derived from hemp or marijuana. Although states like Oregon are taking steps to limit the THC levels in these products, the absence of a federal definition of “low-THC” could inadvertently lead to the legalization of more potent marijuana products.
Currently, the production and sale of hemp-derived products aren’t federally regulated. That stands in stark contrast with state-regulated marijuana, where safety regulations, product testing, ingredient disclosure, and compliance requirements are firmly in place.
Schauer recommended the adoption of comprehensive federal regulatory framework addressing all hemp-derived cannabinoids, as well as establishing a federal regulator, similar to the FDA, with a background in public health and consumer safety needed to oversee hemp-derived products, including CBD. She added that that regulator should be promptly identified, authorized, and funded, and given a clear mandate to establish regulations, ensure compliance, and conduct consumer education about legal products.