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Article: FDA report finds many CBD product labels misleading
14 July 2020
FDA's congressionally mandated report on the current CBD
marketplace adds to growing evidence that CBD products are often
mislabeled and could put more pressure on the agency to intervene
and proactively regulate the non-psychoactive cannabinoid.
The agency compiled the report at the request of Congress, as
lawmakers added language to the appropriations package approved
last December requiring FDA to provide an update on the current CBD
marketplace to "determine the extent to which products are
mislabeled or adulterated."
The sampling effort is ongoing - so far, FDA has tested some 147
CBD products including gummies, beverages, oils, tinctures and pet
products, finding many do not contain the listed amount of CBD and
nearly half contain traces of THC.
The agency reported that nearly 60% of the 102 products that
listed a specific amount of CBD contained either more or less than
the amount on the label. FDA tested 20 edible and beverage
products, finding five with less than 80% of the listed amount of
CBD and six that contained more than 120% of the CBD advertised on
the label.
Only one of the 147 products tested had levels of heavy metals
that could present a health concern, the agency said.
FDA noted that its testing results - as well as information
submitted to the agency on CBD products - have yielded useful
information but "have been limited in scope and have not provided
for a comprehensive understanding of the marketplace," the agency
told Congress last week. "These uncertainties leave questions about
how these findings should be interpreted and whether they can
accurately be extrapolated to the CBD marketplace in the United
States, which makes it challenging for FDA to determine the
variability in CBD product characteristics."
The agency said it is undertaking a "more extensive CBD product
sampling effort" that will use a sampling methodology to create a
"representative, random sample of the current CBD product
marketplace."
Action demanded
Dietary supplement makers, hemp growers and other CBD industry
stakeholders said the study provides more evidence that FDA needs
to move swiftly to rein in the marketplace for CBD products.
"There's not much news here," according to the US Hemp
Roundtable. "The FDA revealed what we already knew - while more
work needs to be done to ensure CBD products consistently meet
label claims, the majority of products do not contain unsafe
contaminant levels, specifically heavy metals."
The report shows that it is "high time for FDA to regulate CBD
as a dietary supplement and food additive," the Roundtable added.
"The agency's current public stance not only impairs hemp farmers
and small businesses - an unregulated marketplace poses real health
and safety concerns."
FDA currently contends that CBD can't be added to foods or
supplements because cannabidiol has been approved as the active
ingredient in a drug developed to treat epilepsy.
The agency says since CBD does not meet the exemption criteria
under the Federal Food, Drug, and Cosmetic Act (FDCA) that would
permit use in foods or supplements, crafting an exemption would
require a formal notice-and-comment rulemaking that could take
three-to-five years - if the agency is assured the safety data
exists to support such regulations. The last formal update from the
agency came in March and offered no timetable for
action.
FDA's position has frustrated hemp advocates, supplement
manufacturers, and food companies keen to take advantage of the
booming market for CBD and wary of a growing patchwork of state
regulations. Several states permit sales of CBD supplements while
some have adopted FDA's position and others are effectively turning
a blind eye. Disputes over CBD product labels have also caused a
wave of litigation, with more than a dozen class
actions pending in federal courts.
Dietary supplement manufacturers have petitioned FDA to carve
out an exemption for CBD under the FDCA and some stakeholders
continue to press Congress to intervene.
"This is a federal regulatory issue, FDA needs to do its job,
and they need to do it now," said Kyle Turk, director of government
affairs for the Natural Products Association (NPA). "Further delay
by FDA is not good for public health or for the CBD industry,
because the best approach is one uniform national standard based on
sound science that is enforceable."
FDA's new sampling report "further affirms the need for federal
regulatory clarity," added Betsy Booren, senior vice president of
regulatory and technical affairs at the Consumer Brands Association
(CBA). "Allowing bad actors to continue to put products on the
market, unchecked, is a threat to consumer safety everywhere. The
consumer packaged goods industry applauds FDA's efforts and urges
Congress to provide more funding and resources to FDA to move
quickly through this process."