FDA’s Report On CBD Reaffirms Status Quo – Food, Drugs, Healthcare, Life Sciences

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Consumers want answers from FDA on how it plans to regulate the
multibillion dollar market for CBD-related products—and
they’re not alone. Under the Further Consolidated
Appropriations Act, 2020 (P.L. 116-94), Congress directed FDA to
provide a report concerning the agency’s progress in
receiving and evaluating data to help inform a policy of
enforcement discretion and a process by which FDA will evaluate
cannabidiol (meeting the definition of hemp) in FDA-regulated
products.

On March 5, 2020, FDA submitted the requested report, painting a
more detailed view of its CBD-related activities than the public
has seen to date. From a high level, FDA noted that it remains
concerned about the potential safety risks posed by mislabeled or
contaminated CBD-infused products. At the same time, FDA stated
that it “is actively working to evaluate potential lawful
pathways for the marketing of CBD.”

A common refrain throughout the report highlights the minimal
amount of relevant scientific data collected and analyzed to date.
In echoing its past calls for research into CBD, FDA identified a
number of questions to which it seeks answers, including:

  1. What happens if you use CBD daily for
    sustained periods of time?

  2. What level of intake triggers the
    known risks associated with CBD?

  3. How do different methods of exposure
    affect intake (e.g., oral consumption, topical, smoking or
    vaping)?

  4. What is the effect of CBD on the
    developing brain (such as children who take CBD)?

The report discusses FDA’s current views on a range of
product categories commonly associated with CBD, including those
discussed below.

Human Drugs

FDA notes the existence of “a clear regulatory pathway for
CBD drug development and approval,” pointing to the 2018
approval of prescription drug Epidiolex. However, FDA acknowledges
that there are currently no approved nonprescription drugs
containing CBD, nor do any over-the-counter drug monographs include
CBD as an active ingredient.

Animal Drugs

As with CBD in human drugs, FDA encourages continuing research
into potential therapeutic benefits of CBD-containing products for
the treatment of animal diseases.

Dietary Supplements

As FDA has made clear in its warning letters over the past few
years, FDA repeats that CBD products cannot lawfully be sold as
dietary supplements. However, FDA acknowledges that it “has
the authority to remove this exclusion through rulemaking”
and states that it is “actively evaluating potential
rulemaking to allow CBD in dietary supplements.”

Food

Though it takes the position that CBD cannot lawfully be added
to food (for humans or animals), FDA encourages industry
participants to develop and share relevant information relating to
potential conditions under which CBD might be safely added to
food.

Cosmetics

While it recognizes that cosmetic ingredients don’t
typically require premarket approval, FDA cautions that CBD may not
be added to cosmetics if it causes the cosmetic to be adulterated
or misbranded (i.e., if it causes the cosmetic to be
deleterious or otherwise injurious to users).

FDA’s Plan: Stay the Course

Moving forward, FDA states that it will, among other things,
continue to engage with other federal, state, local, territorial,
tribal and international regulatory partners and counterparts in
developing a CBD regulatory framework. FDA will also work to
generate research data to help inform CBD-related decision making.
In terms of actions involving the current CBD market, FDA says it
is developing a plan to comply with Congress’ requested
product sampling of the CBD marketplace to ascertain levels of
product mislabeling or adulteration. Further, FDA says that it is
evaluating issuance of a risk-based enforcement policy, noting that
it “intends to continue taking action to address
violations” it identifies “that put the public at
risk.”

Taken as a whole, the CBD report provided by FDA does not
describe a major pivot in policy. Still, it is clear that FDA
appears to be pursuing workable solutions for an industry sorely in
need of direction from the federal government. 

Disclaimer: This Alert has been
prepared and published for informational purposes only and is not
offered, nor should be construed, as legal advice. For more
information, please see the firm’s

full disclaimer
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