On July 5, 2023, the FDA and FTC jointly announced six cease and desist letters to alleged delta-8 product makers. You can access the letters here. Unlike prior rounds of warning letters, these letters have a new focus: harm to children.
For nearly five years, the FDA and FTC have taken the position that CBD is an unlawful additive in ingestible products. This is based largely on the so-called drug exclusion rule, which we’ve analyzed at length before (see here, for example). Essentially, because CBD is an approved drug ingredient (in Epidiolex®), it cannot be added to foods or dietary supplements.
Delta-8, however, is not an approved drug ingredient. And if it is derived from hemp, it is not independently scheduled – at least if you read the Controlled Substances Act and 2018 Farm Bill literally. But, there’s a huge controversy about whether it can be controlled, with agencies like the DEA saying it is. You can read more about that issue here or here.
But the fact that delta-8 products are in a gray area doesn’t mean the federal government’s just going to let things slide. Indeed, the FDA maintains a web page warning about the supposed dangers of delta-8 products. Knowing this, we could see that it was only a matter of time until the FDA started going after the industry.
This newest round of cease and desist letters takes an interesting turn, however. Many CBD warning letters alleged adulteration or unapproved drug concerns. These letters generally make similar allegations about adulteration. But they also claim that the products at issue are illegal because they constitute unfair or deceptive marketing. The problem: they all allegedly look like consumer foods and candies that are widely available to children. For example, here’s a blurb from one of the letters:
As noted above, your various Delta-8 THC products have an appearance and form similar to conventional candies, foods, and beverages often consumed by children. For instance, your Delta-8 Sour Gushers product is marketed in packaging that strongly resembles the packaging for Super Sour Gushers fruit snacks, including: a yellow background; brightly-colored design elements evoking liquid splotches, including green elements at the top and bottom; and the depiction of several individual fruit snacks, including a red fruit snack gushing red liquid beneath the word “Gushers.” Your Delta-8 THC Hot Cheetos are marketed in packaging that resembles the packaging for Cheetos Crunchy Xxtra Flamin’ Hot Cheese Flavored Snacks, using the same black and orange color scheme, the use of the Cheetos name and logo, and a depiction of flames at the top and bottom of the package. Your Medicated Jolly Rancher Gummies Sour are marketed in packaging that resembles the packaging of Jolly Rancher Gummies candies and Jolly Rancher Gummies Sour candies, including the use of a blue background, the use of the Jolly Rancher Gummies name and logo, and the cartoon depiction of anthropomorphic fruits.
Imitating non-THC-containing food products often consumed by children through the use of advertising or labeling is misleading. FTC Policy Statement on Deception, 103 F.T.C. 174, 176 n.9 (1984) (appended to Cliffdale Assocs., Inc., 103 F.T.C. 110 (1984)) (the nature, appearance, or intended use of a product may create an impression in the mind of the consumer, and it is deceptive if this impression is false and not corrected by the seller); 15 U.S.C. §§ 52, 55(a)(1) (under Section 12 of the FTC Act, which prohibits false advertisements for foods and drugs, the Commission must consider any consequences that may result from the use of the product under customary or usual conditions).
Children are at particular risk for mistakenly ingesting edible THC products imitating traditional foods because they are more likely to focus on similarities of product appearance and packaging, and less likely to notice or be able to comprehend labeling text. Ingesting edible cannabis products can result in serious health consequences in children.3 Given the significant number of adverse events reported in connection with ingestion of edible products containing THC, advertising and packaging your Delta-8 THC products in a manner that is likely to be particularly appealing to young children could present an unwarranted risk to health and safety.
It bears mentioning that the statements in the FTC and FDA’s cease and desist letter are just allegations. In any enforcement proceeding, the agency would have to establish that the recipient of the letter made the offending products and that they were illegal.
You may be asking what the lesson is here. For years the agencies targeted products based on health-related claims. Now they are expanding their focus, targeting products that may be marketed in other ways the agencies deem offensive. For years, this has been largely left to private plaintiffs in the form of IP claims (see here and here, for example). But it looks like the feds will now take a harder look at delta-8 products that they think kids may confuse for commercial candy or foods.
For now, stay tuned to the Canna Law Blog for more updates on FDA and FTC cannabinoid policies and delta-8 products.