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This week, the U.S. Food & Drug Administration (FDA) posted
warning letters to five hemp companies for, in the words of the
FDA, “illegally selling products containing cannabidiol
The warning letters and additional commentary from the FDA can
be accessed for a full review here. Since the passage and enactment of the
2018 Farm Bill, which removed hemp and tetrahydrocannabinol (THC)
found in hemp from the Federal Controlled Substances Act, the FDA
has consistently asserted regulatory control over certain aspects
of the hemp industry pursuant to the Federal Food, Drug and
Cosmetic Act (FD&C Act) and its implementing regulations. Chief
among those regulatory concerns has been the FDA’s position
that it is unlawful under the FD&C Act to introduce food
containing added CBD or THC into interstate commerce, or to market
CBD or THC products as, or in, dietary supplements regardless of
whether the substances are hemp-derived. You can read more about
the background and history of this and the FDA’s prior warning
letters here, here, or on a number of other news,
regulatory, and legal sites across the internet.
The batch of letters posted to the FDA’s website this week
continues the long line of warnings sent to companies operating in
the hemp-derived cannabinoid space. It is not readily apparent why
the FDA chose to single out these companies, in particular, for
enforcement. But the letters released this week, as a group, seem
to intentionally target and address the following common
- Sale and marketing of products intended for
human consumption that contain added CBD
or THC in a form that consumers may confuse with foods.
- Sale and marketing of products that pose a risk of unintended
consumption of CBD or THC by consumers, including failure to label
CBD as an ingredient on product labels (for example, simply listing
“full spectrum hemp extract” on the product label).
- Sale and marketing of products in forms that are appealing to
children, like lollipops, gum, and candies.
- Combination of CBD with caffeine in products, because “CBD
may affect caffeine metabolism and may increase and/or prolong
- Sale and marketing of animal products
containing added CBD or THC for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in animals.
- The sale and marketing of animal foods and pet
treats that are adulterated by adding CBD and other
To date, the FDA’s prior enforcement actions have largely
centered on companies selling or marketing human- or animal-related
hemp products in connection with unauthorized claims to cure,
mitigate, treat, or prevent various diseases and health-related
conditions. But in an important departure from the FDA’s past
practice, less than all of the warning letters released this week
reference alleged FD&C Act health claim violations by the
companies. So what does that mean? Are these letters a precursor to
an onslaught of new industry warnings to come? Does this signal
that the FDA is gearing up to devote more of its enforcement
efforts and energies to regulate the use of CBD, THC, and other
cannabinoids in situations where companies are intentional and
careful not to make prohibited
health-related claims about their hemp products?
While this group of warning letters may mark a shift in the
FDA’s ongoing regulatory enforcement focus, it does not appear
to significantly change the industry’s overall legal and
regulatory risks in prior years. Much of what the FDA states in
these letters has been incorporated into its prior warnings to the
industry. But it remains important for hemp product manufacturers
and sellers to carefully and continuously monitor and consider the
FDA’s position on CBD, THC, and other cannabinoids utilized in
food and supplement products and to incorporate that position into
their internal compliance practices as they develop, market, and
sell hemp products in interstate commerce.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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