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Congress did give the agency a nudge with new funding for
research and a call for the agency to develop an enforcement
discretion policy, but stakeholders are still waiting to hear FDA's
timetable for action. FDA, however, has shown no signs it will be
rushed into finding a regulatory route for CBD foods and
supplements.
The agency has repeatedly said CBD cannot be added to foods or
sold as a supplement because it was approved 2018 as the active
ingredient in Epidiolex, a drug used to treat childhood epilepsy.
The agency says that permitting such uses would require it to carve
out an exception under the Federal Food, Drug, and Cosmetic Act
(FDCA), a regulatory process that would take several years to
complete. That timeframe is frustrating for supplement
manufacturers and food companies eager to cash in on the booming
market for CBD products. US consumers bought more than $200 million
CBD supplements, ointments and infused foods and beverages last
year, and the market is predicted to top more than $1.5 billion by
2025.
Nearly 25% of American adults - more than 60 million - have
tried CBD and found it effective for pain, anxiety and other
ailments, according to a 2018 survey by Consumer Reports. The
position prohibits interstate sales of CBD foods and supplements,
but several states - including Colorado, Maine, and Oregon have
legalized CBD as a food and supplement ingredient - while others
are following the federal agency's lead and prohibiting such uses
or turning a blind eye. Food and supplement manufacturers see
federal rules as critical to the future of the CBD industry,
arguing the existing patchwork of rules is encouraging bad actors,
endangering consumers and precluding them from a lucrative market.
"There is clearly consumer confusion - there is a lot of
uncertainty all around and that looks likely to continue," said
Brian Ronholm, senior director of regulatory policy at Wilson,
Sonsini Goodrick & Rosati. "The heavy lifting is going to be
done by FDA and who knows how long that will take."
No special rules
FDA officials have repeatedly said the bar for an exemption to
allow CBD use in foods and supplements is high and contend they
need more data before moving forward with a potential rulemaking.
"There's still much we don't know - about the consequences of
long-term use, about the risks to vulnerable populations, and lots
more," FDA Principal Associate Commissioner Lowell Schiller, the
co-chair of FDA's CBD working group, said in Nov. 7 remarks at the
Council for Responsible Nutrition's (CRN) annual conference in
Carlsbad, Calif. "As we continue to work as rapidly as possible to
figure out how to address this popular ingredient that until very
recently was a controlled substance, it's important to remember
that there are no special rules for CBD."
"Congress didn't put CBD in a special new class of products,
subject to a special set of rules," Schiller added. "Under the
framework recognized and preserved in the Farm Bill, we look at an
FDA-regulated product containing CBD the same way as we would look
at an FDA-regulated product containing any other substance. We
apply the same tools and authorities and statutory provisions." But
critics say FDA's approach ignores the threats to consumers and
problems for manufacturers from a patchwork of rules. "Right now,
different states have different rules and there is inconsistency,"
said Jonathan Havens, a partner with Saul Ewing Arnstein &
Lehr. "I understand FDA's challenge. The FDA is not a public
pressure agency, they are a public interest agency charged with
protecting the public health. But the reality is this is a really
big market and from a safety perspective, you want uniform
standards."
The agency has effectively ignored the vast majority of CBD
supplements and foods on the market and has only sent warning
letters to CBD companies making overt therapeutic claims. The
agency sent out 15 warning letters in late November, reiterating
its concerns about the lack of CBD safety data and its policy that
CBD is not Generally Recognized as Safe (GRAS) for use in human or
animal food. FDA has also stepped up its warnings about the
potential risks from CBD, telling consumers in a November alert
that the limited data it has reviewed show "CBD has the potential
to harm you, and harm can happen even before you become aware of
it." FDA seems to be signaling to consumers "that they really view
this product as unsafe, that they don't have enough data to make
confident of its safety," said Jessica Wasserman, a partner in the
Cannabis Law Group at Greenspoon Marder LLP. "Therefore, they can't
bless it in any way, even at a certain dosage.
It seems like things are going to continue as they are." "I'm a
little critical of FDA on this," Wasserman said, adding the agency
is "scaring consumers" but ignoring the booming market for CBD
products. "They always say 'safety first,' but this current
situation is unsafe and they aren't showing any urgency," she said.
Wasserman added that FDA's current policy also precludes supplement
manufacturers from submitting New Dietary Ingredient notifications,
but suggested the agency may have a more favorable view CBD as a
supplement rather than a food ingredient.
The restatement that CBD is not GRAS "signals they are very
uncomfortable with CBD in food," she said. Havens echoed the view
that FDA may ultimately look more favorably on CBD supplements than
foods, noting the agency's policy is that adding CBD to foods is a
"prohibited act." By contrast, the agency says that CBD currently
"doesn't meet the definition of a supplement," he said, and that
the companies it has issued warning letters to have made
"exaggerated health claims" on their products.
If the agency went after a company for "merely selling a CBD
supplement, I question whether FDC could win in a court case,"
Havens said. FDA's policy does not appear aligned with the booming
CBD market as "consumer demand for CBD continues to grow rapidly
despite the lack of regulatory clarity," said Peter Matz, director
of food and health policy for the Food Marketing Institute. Matz
said his group's members - food retailers - are "confused about
which CBD products can be sold legally and where" and also unsure
about labeling requirements and quality standards.
"However, the bigger concern here is public health and safety in
an unregulated CBD market," Matz said. "The absence of a clear
pathway to market for these products means consumers currently face
a variety of risks, from unsubstantiated health and benefit claims,
to a lack of standardization in product labeling and packaging, to
products that may not contain the ingredients they purport to
contain." Another option for FDA would be to follow the advice of
former FDA Commissioner Scott Gottlieb, who suggested FDA needs to
put the onus on manufacturers to petition the agency to prove CBD
can be safely added to foods through the submission of NDIs or food
additive petitions, which would include reviews of toxicity
studies. "These are the same standards any new food ingredients are
held to," Gottlieb explained in an July 31 opinion piece published
by The Washington Post. "Congress can help by passing language
saying that the FDA doesn't need to issue a broad regulation on CBD
and can instead rely on petitions filed by individual, prospective
producers." In the interim, the FDA could exercise enforcement
discretion to allow CBD to be marketed in food so long as the
products meet certain conditions, Gottlieb suggested.
Pressure on Congress
Whether Congress has the appetite for Gottlieb's plan is unclear
but pressure from stakeholders did result in a move in late
December by lawmakers to push FDA to act more quickly. The FDA
spending bill approved by Congress in December includes $2 million
for the agency to study hemp-derived CBD and to begin work on an
enforcement discretion policy for food and dietary supplements that
contain the non-psychoactive cannabis ingredient. Language in the
bill earmarks the funding for "research, policy evaluation, market
surveillance, issuance of an enforcement discretion policy" of
hemp-derived CBD product. Within 60 days of enactment of the
appropriations bill, FDA is tasked with providing the Senate and
House Appropriations Committees with "a report regarding the
agency's progress toward obtaining and analyzing data to help
determine a policy of enforcement discretion and the process in
which CBD meeting the definition of hemp will be evaluated for use
in products."
Lawmakers are also directing FDA "to perform a sampling study of
the current CBD marketplace to determine the extent to which
products are mislabeled or adulterated" and report to the
committees within six months. But the language falls far short for
many stakeholders and is unlikely to quell demands for lawmakers to
intervene again. Wasserman said the directives from Congress are
"all items FDA is doing anyway", adding that language in prior
versions of the spending bill went further and mandated quicker
action and immediate enforcement discretion. Supplement
manufacturers were clearly hoping Congress would take a more
aggressive approach. A coalition of supplement makers led by the
Council for Responsible Nutrition (CRN) and the United Natural
Products Alliance (UNPA), have urged lawmakers to amend the FDCA to
craft an explicit regulatory pathway for CBD supplements.
In a memo released after the spending bill was finalized, UNPA
officials said apparently FDA "was not supportive of the industry's
language recommending an NDI pathway" for CBD dietary supplements
and "insists on evidence that would support a dosage level."
Wasserman suggested FDA's position that it lacks the needed safety
data makes it unlikely Congress will force the issue and require it
to take specific action to open the door for CBD foods and
supplements. "IF FDA says this isn't safe, you don't want to push
them too hard," Matthews said. Ronholm agreed that lawmakers are
likely to be cautious about heaping too much pressure on FDA and
meddling with its review of CBD. "FDA is just in a really tough
spot," Ronholm said. "They have no safety data whatsoever but are
being pressured to put together regulatory scheme. It is not fair
to a public health agency."
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US food and supplement manufacturers, keen to take advantage of
booming consumer interest in cannabidiol (CBD), remain frustrated
by a patchwork of state regulatory regimes and the lack of FDA
rules that would legitimize the market and allow for interstate
sales of hemp-derived CBD foods and supplements.
