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Article: Consumer advocates wary of congressional interference with FDA's CBD review

25 June 2020

This article is from our policy coverage dated 22/06/20.

Congress should not force FDA to create a regulatory pathway for CBD foods and supplements and should instead focus on strengthening the agency's authority to revamp its oversight of food and supplement safety, several consumer advocacy groups have urged federal lawmakers.

Congress should ensure review of CBD "remains in the hands of the FDA, which should not be rushed to make a judgment about CBD that may impact the health and safety of millions of consumers," the Consumer Federation of America, Consumer Reports, the Public Health Institute and the Center for Science in the Public Interest said in a letter sent last week to lawmakers. "The agency needs additional time, resources, and authorities to adequately assess the science and unknown risks involved with adding CBD to the hundreds of foods and supplements consumed by Americans."

The groups sent their letter as Congress is preparing to mark up the FDA appropriations bill, a potential vehicle for lawmakers keen to pressure the agency to act quickly to allow use of hemp-derived CBD in foods and supplements. Not just allies of supplement and food makers that want FDA action, hemp industry stakeholders see the CBD market as vital to their future success and continue to pressure lawmakers to intervene.

In January, House Agriculture Committee Chairman Colin Peterson (D-Minn.) cited the needs of the hemp industry when he introduced legislation (H.R. 5587) to effectively force FDA's hand by directing the agency to regulate hemp-derived CBD as a dietary supplement and allow national sales of approved products. Reps. Thomas Massie (R-Ky.), James Comer (R-Ky.) and Chellie Pingree (D-Maine) signed on as original cosponsors and another eight House members have added their names to the bill.

Last year Congress used the appropriations process to compel FDA to produce two CBD reports. The agency released the first report in March on the state of its effort to regulate CBD ─ FDA told lawmakers that it still lacks needed safety data and reopened the public docket for stakeholders to submit any relevant information. The second report, which is supposed to update Congress on the current CBD marketplace and detail concerns about mislabeled products, is expected this month.

The letter from the consumer advocates says Congress should resist meddling with FDA's review of the popular hemp extract.

"Forcing the FDA into rushed decisions and to prematurely implement major regulatory changes would result in an unsafe CBD market and distract the FDA from its current pandemic response and recovery efforts," the groups contend. "It is also clear that Congress is not the right evaluator of the safety of consumer products, and a political decision to legislatively override a careful and scientific evaluation of CBD safety would create terrible precedent."

Rather than forcing the agency's hand on CBD, Congress should give it new authorities and resources to improve oversight of foods and supplements, the groups argue.

"Legislative direction from Congress that would require the FDA to hastily create a pathway to legalization of CBD in foods and supplements is deeply problematic because the FDA currently lacks the needed authority and resources to effectively address the myriad issues that may arise from CBD use in supplements," they told lawmakers. "Numerous improvements in the agency's poor general oversight of supplements are needed to address such problems, including requirements for product listing and registration, improved quality controls, and more robust enforcement resources."

The letter says Congress should direct FDA to complete several rulemakings, including a revamp of the new dietary ingredients review process and revisions to its 2016 supplement guidance on Generally Recognized As Safe ingredients. It also recommends regulations to require warning labels on supplements that highlight risks of drug interactions, a mechanism for consumers to report adverse events and a mandate compelling companies to report all adverse events.

The consumer groups call for Congress to provide additional funds and legal authority to regulate dietary supplements, including stronger safety standards and recall powers as well as a premarket approval and spot audit program for "high risk" categories of supplements. FDA should require warnings on CBD products that discourage use of CBD and other cannabinoids by children and other vulnerable groups, the advocates say.

Increased inspection authority and funding are also among the recommendations laid out by the groups, who say Congress "should give the FDA the support it needs to do its job, and fix the many serious shortcomings in its existing authorities."

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