CBD sellers have been hoping for clarity from the FDA over product legality. Instead, several companies recently received warning letters concerning the "illegal marketing of unapproved drugs labeled as containing CBD."
The companies are Honest Globe, Inc. and BioLyte Laboratories LLC.
FDA Principal Deputy Commissioner Amy Abernathy stated on March 22:
"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.”
As in the past when the FDA has singled out offending companies, the main issue is promoting CBD's health benefits, which according to the FDA are unfounded, except for GW Pharmaceuticals' FDA-approved Epidiolex.
The letter to Honest Globe, based in Santa Clara, Califiornia, dated March 15, "summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," and states, "Because your methods, facilities, or controls for manufacturing, processing, packing or holding do not conform to CGMP, your drug products are adulterated."
The letter cites the following Honest Globe products: Elixicure Original Pain Relief with CBD and Elixicure Lavender Pain Relief with CBD.
"Your Elixicure Pain Relief with CBD products are labeled to contain cannabidiol (CBD) and are made available for purchase by consumers without a prescription.
"Your Elixicure Pain Relief with CBD products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Furthermore, your Elixicure Pain Relief products are misbranded drugs introduced or delivered for introduction into interstate commerce n violation of sections 502(a), 502(ee), and 301(a) of the FD&C Act, 21 U.S.C. 352(a), 352(ee), and 331(a).
"Currently, a nonprescription drug product containing CBD cannot 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. As explained below, nonprescription drug products that include CBD as an active ingredient are not generally recognized as safe and effective (GRASE) and are new drugs which require an approved application to be legally marketed.
"Furthermore, even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements for nonprescription drug products."
FDA: "Currently, a nonprescription drug product containing CBD cannot 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."
The section on Unapproved Drug Charges reads, in part:
"Based on our review of your product labeling, including your website, www.elixicure.com, your Elixicure Pain Relief with CBD products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or because they are intended to affect the structure or any function of the body.
"Examples of claims on your product labeling, including your website (where your products can be purchased) that provide evidence of the intended uses (as defined by 21 CFR 201.128) of your Elixicure Pain Relief with CBD products... New drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA."
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The FDA letter to Honest Globe concludes:
"Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction."
Honest Globe has since rebranded the products minus references to CBD.
The letter to BioLyte, based in Grand Rapids, Michigan, also dated March 18, takes issue with their Silver Gel products, which have since been removed from the company's website.
U.S. sales of hemp/CBD products declined 2% in 2020 to $803 million. Sales doubled from 2019 to 2020. Hemp/CBD products are regularly sold over-the-counter by drug stores and other retailers.
