Enforcement by the Food and Drug Administration (FDA)
against cannabidiol (CBD)-containing products continues through the
issuance of two new warning letters. On March 22, 2021, FDA
published a press release cautioning companies against illegally
selling over-the-counter (OTC) CBD products for pain relief. In the
warning letters, FDA cited products listing CBD as an inactive
ingredient for unapproved drug and misbranding violations.
Regulatory Background of CBD Products
We have previously blogged about the regulation of CBD
products by the FDA and provided updates to the government’s actions
to create a comprehensive regulatory framework for CBD. But as a
brief refresher, FDA does not permit adding CBD as an ingredient of
food products or dietary supplements. And while the Agriculture
Improvement Act of 2018 (the Farm Bill) legalized the
production of industrial hemp and products derived from
hemp, it did not legalize all uses of and products containing
hemp derivatives (such as CBD).
Under the Federal Food, Drug and Cosmetic Act (FD&C Act),
any product intended to diagnose, cure, mitigate, treat or prevent
a disease, and any product (other than a food) that is intended to
affect the structure or function of the human body is a drug.
This definition includes articles and components of drugs, which
are regulated as drugs. OTC drugs must be approved by the FDA or
meet the requirements for marketing without an approved new drug
application under federal law; this includes drug products
containing CBD.
Currently, nonprescription drug products containing CBD may not
be legally marketed without an approved new drug application,
regardless of whether the CBD is represented on the labeling as an
active ingredient or an inactive ingredient. To date, no
CBD-containing drug has met applicable FDA requirements to be
legally marketed for nonprescription use. However, as noted in a
prior blog post, the FDA has approved one
CBD-containing prescription drug product for the treatment of
seizures associated with tuberous sclerosis complex, Lennox-Gastaut
syndrome, and Dravet syndrome in human patients.
FDA’s primary concerns pertaining to CBD use in products
include a lack of safety data and the quality of the CBD products
on the market. Currently, there is insufficient safety data to
establish cumulative exposure to CBD (and THC), impact on
vulnerable populations, or impact on drug development. There are
also concerns about contaminants such as heavy metals, microbials,
pesticides, and THC. In addition, FDA is concerned that there is a
lack of appropriate processing controls and practices regarding the
quality of CBD products, which puts consumers at additional
risk.
Analysis of OTC CBD Warning Letters and Potential
Implications to Industry
To date, FDA’s CBD enforcement has focused on disease or
health claims as well as the products’ intended use. FDA
commonly determines a product’s „intended use” based
on: claims in the labeling, advertising, or promotion; consumer
perceptions; and ingredients with well-known therapeutic uses.
Products with unsubstantiated or misleading claims may result in a
change to the intended use and consequently, a change to the status
of the product causing it to become an unapproved drug or
adulterated product under the FD&C Act. A product is
adulterated if it fails to conform to FDA’s standards of
quality, strength, or purity.
FDA’s recently issued warning letters to Honest Globe, Inc. and BioLyte Laboratories, LLC are no
different with the exception that these warning letters address OTC
CBD drug products claiming to provide pain relief. Honest Globe and
BioLyte, both manufactured and marketed OTC CBD products that
allegedly provide pain relief. Although CBD is labeled as an
inactive ingredient on the products, the labeling of these products
represent CBD as an active ingredient due to the frequent and
prominent placement of CBD claims on the products’ labeling and
advertising on the companies’ websites. The labeling and
advertising may lead consumers to the conclusion that the product
provides benefits due to the CBD contents. To add insult to injury,
CBD is not an active ingredient in any applicable final monograph
or TFM, for purposes of establishing eligibility for lawful
marketing without an approved application under the FD&C Act.
Even if CBD was considered an „inactive ingredient” in
these nonprescription drug products, the products would still
require approval through a new drug application in order to be
legally marketed since CBD has no known functional role as an
inactive ingredient in a finished product.
In addition, Honest Globe issued a press release on its
Instagram page that stated the „Did you know that
Elixicure [product in question] was the first
over-the-counter CBD-infused topical pain cream product to receive
FDA certified registration” (the company made several
similar claims identified in the warning letter). FDA noted that to
state the product is „FDA registered” is inaccurate.
Drugs are subject to listing with FDA, not registration. Moreover,
registration of an establishment or listing of a drug does not
denote approval of the establishment, the drug, or any other drugs
of the establishment, nor does it mean that a product may be
legally marketed. FDA stated that „[a]ny representation that
creates an impression of official approval or that a drug is
approved or is legally marketable because of registration or
listing is misleading and constitutes misbranding.”
Aside from the labeling and advertising claims and an assessment
of the products’ intended use, both companies displayed
significant violations of current good manufacturing practice
(CGMP) regulations for finished pharmaceuticals demonstrating
FDA’s concerns over safety data and quality control. The
companies’ methods, facilities, and controls for manufacturing,
processing, packing, and holding did not confirm to CGMP making the
product adulterated within the meaning of the FD&C Act.
Neither of the company’s products have been subject to the
approval process, nor have there been any evaluation of whether
they are effective for the claims used, appropriate dosage,
interaction with other drugs or products, or dangerous side effects
or other safety concerns.
FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.
stated that: „The FDA continues to alert the public to
potential safety and efficacy concerns with unapproved CBD products
sold online and in stores across the country. . . It’s
important that consumers understand that the FDA has only approved
one drug containing CBD as an ingredient. These other, unapproved,
CBD products may have dangerous health impacts and side effects. We
remain focused on exploring potential pathways for CBD products to
be lawfully marketed while also educating the public about these
outstanding questions of CBD’s safety. Meanwhile, we will
continue to monitor and take action, as needed, against companies
that unlawfully market their products — prioritizing those
that pose a risk to public health.”
Over the past several years, FDA has continued to issue warning letters to
companies that market unapproved new drugs that allegedly contain
CBD at an increased rate. These new warning letters are unique in
that they address OTC CBD pain relief. As noted, demonstrating a
product’s intended use and making disease and health
claims are common pitfalls for companies selling CBD products. The
rise of OTC CBD pain relief products make this an area to watch. As
this area will no doubt continue to be a hot enforcement
area for the FDA, we will continue to update our readers of
any important regulatory activity.
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.