|
Source: FDA, 3/22/21 The
U.S. Food and Drug Administration has issued warning letters to two companies
for selling products labeled as containing cannabidiol (CBD) in ways that
violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically,
the warning letters address the illegal marketing of unapproved drugs labeled
as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs
containing CBD, and none of these products meet the requirements to be legally
marketed without an approved new drug application. The letters explain that, as
CBD has known pharmacological effects on humans, with demonstrated risks, it
cannot be legally marketed as an inactive ingredient in OTC drug products that
are not reviewed and approved by the FDA. Additionally, the letters cite
substandard manufacturing practices, including failure to comply with current
good manufacturing practices.“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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “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.” The
FDA issued warning letters to: =
Honest Globe Inc. =
Biolyte Laboratories LLC The
products that are the subject of the warning letters issued today have not gone
through the FDA drug approval process and are considered unapproved new drugs.
There has been no FDA evaluation of whether these unapproved drug products are
effective for the uses manufacturers claim, what an appropriate dose might be,
how they could interact with FDA-approved drugs or other products or whether
they have dangerous side effects or other safety concerns. The
FDA has previously sent warning letters to other
companies illegally selling unapproved CBD products that claimed to prevent,
diagnose, mitigate, treat or cure various diseases, in violation of the
FD&C Act. Under
the 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 body of humans, is a drug. OTC drugs
must be approved by the FDA or meet the requirements for marketing without an
approved new drug application under federal law, including drug products
containing CBD, regardless of whether CBD is represented on the labeling as an
active ingredient or an inactive ingredient. The
FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of
seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome
and Dravet syndrome in human patients. The
FDA has requested written responses from these companies within 15 working days
stating how they will address these violations or providing their reasoning and
supporting information as to why they believe these products are not in
violation of the law. Failure to adequately address the violations promptly may
result in legal action, including product seizure and/or injunction. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
|