New Regulatory Pathway For Cannabidiol Products May Be Forthcoming –

Key Takeaways:

• FDA is seeking assistance from Congress to create a new
  regulatory pathway that is better designed to regulate products
  that contain cannabidiol (CBD).




• In the interim, CBD products (including dietary supplements,
  conventional foods, and animal foods) on the market are at risk of
  FDA enforcement as the agency deems “appropriate.”

The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion
that a new regulatory pathway is needed to allow for greater
oversight and to better manage risks associated with cannabidiol
(CBD) products, including products currently marketed as
conventional foods and dietary supplements as well as products
marketed for animal use. Few details were provided about the
proposed pathway. Although not discussed in the announcement,
cosmetics and/or inhalable products containing CBD could be
included in the new regulatory regime.

According to the statement, FDA intends to work with Congress to
develop a new pathway that would be better suited for CBD products,
rather than engage in rulemaking that would allow CBD to be used in
dietary supplements or conventional foods. The impetus for this
decision is in part due to concerns about the safety of long-term
use of CBD. In connection with this announcement, FDA denied three
citizen petitions requesting that the agency engage in rulemaking
to establish regulations under which CBD derived from hemp could be
legally marketed as a dietary ingredient in foods and dietary
supplements. (See, citizen petitions from Council for Responsible Nutrition (CRN), Consumer Health Products Association (CHPA),
and Natural Products Association (NPA).) If
legislation is passed, FDA’s oversight over the use of other
forms of hemp-derived cannabinoid products, such as Delta-8 tetrahydrocannabinoil (THC), in food,
supplements, and other FDA-regulated products could also be
addressed.

The new regulatory pathway could potentially include risk
management tools, such as tailored labeling requirements,
prevention of contaminants, limits on CBD content, and risk
mitigation strategies such as age limitations. Until this pathway
is developed, however, FDA will continue to enforce against CBD and
other cannabis-derived products “when appropriate.” All
CBD products on the market in the interim are therefore at risk,
but if history is a guide, FDA’s enforcement priorities will primarily focus on
products that make therapeutic claims.

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