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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."