FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products
By Michelle Bodian, Shawn Hauser, Catie Wightman
May 5, 2022
On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products. Previously, the agency issued and updated a consumer advisory outlining consumer safety concerns relating to Delta-8 products.
Consistent with the FDA's approach to CBD and other hemp products, the agency prioritized its limited resources to enforce against companies illegally marketing by making unlawful drug claims. In the warning letters, the FDA cites violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and core consumer protection laws, such as misbranding and adulteration. Below are key takeaways from these warning letters.
The FDA Will Continue to Prioritize Enforcement Where Drug Claims Are Made
These warning letters were issued to companies that allegedly violated a number of provisions of FDCA by including Delta-8 THC as a food or dietary supplement agreement and made unlawful drug claims about their products’ efficacy in treating medical conditions. This action signals that the FDA may be taking the same enforcement approach as with CBD, by limiting enforcement to products that make egregious drug or medical claims. The following are examples of unlawful drug claims cited in the warning letters:
“Delta-8 consumers report many of the same effects as THC, such as . . . relief from some symptoms such as pain . . .. Delta-8 can also help with insomnia.”
“Delta-8 THC Syrup from Kingdom Harvest is ideal for anybody experiencing a sleeping disorder or other ailments looking to be relieved.”
“If you have cancer, rheumatoid arthritis, and migraines, Delta-8 THC can help alleviate the pain because it has immunosuppressant properties.”
Delta-8-THC benefits . . . Antitumor . . . Antiemetic . . . Appetite-stimulant . . . Analgesic . . . Neuroprotective properties . . .”
“[D]elta-8-THC was administered to eight children being treated for hematologic cancers. The children were 3 to 13 years old . . . [t]hey all experienced vomiting because of the chemo . . . they received delta-8-THC with their chemotherapy treatments, every single child stopped vomiting during and after their chemo sessions!”
“Fighting Cancer . . . Δ8 may also have cancer-fighting properties . . . [t]he researchers treated mice with cancer for 20 consecutive days with a combination of the isomer and cannabinol. The result? Tumors reduced in size.”
Within the warning letters, the FDA cited that the presence of drug claims classifies these products as unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Under the FDCA, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from the FDA. Because these products are not FDA-approved drugs, they are illegal under the FDCA.
FDA is Increasingly Concerned with Misbranding
A core component of food, drug, and consumer protection law is protection against misbranding—generally meaning labeling that contains false or misleading representations of another food, drug, device, or cosmetic. The warning letters emphasize these “unapproved new drugs” are also misbranded because they are not labeled with adequate directions for use. The FDA reasoned that because the products are offered for conditions that are not amenable to self-diagnosis and treatment, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purpose.
Adulteration: Delta-8 Products Are Not Approved for Use in Human and Animal Products and Required Safety Data is Lacking
FDA cited the legal status of many of these products as unapproved food additives—meaning none of these products followed the basic safety data submission process to be approved as a generally recognized as safe (GRAS), lawful ingredient. The FDA emphasized that based on its review of published, scientific literature, existing data and information, it did not find an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status.
The FDA’s inclusion of language deeming food products containing Delta-8 to be adulterated re-emphasizes the FDA’s existing position that any food products containing Delta-8 are not permitted to be sold in interstate commerce, regardless of any claims. Even if drug claims are not made about a product, the FDA could bring an enforcement action against any company selling a food or dietary supplement product to which Delta-8 has been added.
FDA Notes Additional Safety Concerns
The FDA is also sure to note its general concern about the growing popularity of Delta-8 THC products, the commonality of unlawful drug claims, and that these products are appealing to children. The agency notes its commitment to monitoring these products and taking action where there is a public health risk.
Notably, some of these letters also cite violations of FDCA by CBD products—consistent with prior enforcement letters. The FDA also cites particular violations of law concerning animal products. One letter cites safety concerns with CBD products marketed for food-producing animals, as well as concerns regarding human food products, such as dairy and meat products from animals that consume CBD.
These recent enforcement letters could signal the initiation of federal enforcement around Delta-8 THC and other intoxicating hemp products. Federal enforcement is likely to coincide with an increase in state enforcement as a growing number of states adopt laws banning these products in general, or only allowing them in adult-use cannabis markets where product manufacturing and safety regulations are designed explicitly for intoxicating cannabis products.
If you have questions about this topic, including how your company can remain in compliance with state and federal hemp and cannabinoid regulations, please reach out to our hemp team.
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