On December 5, 2022, the Minnesota Board of Pharmacy filed a lawsuit against three affiliated Minnesota hemp companies seeking condemnation and destruction of several million dollars worth of gummy edibles. Ironically named ‘Death by Gummy Bears,’ they allegedly contained 100 milligrams of hemp-derived THC per gummy and were intentionally marketed in a manner that is appealing to children.

The lawsuit alleges Northland Vapor Moorhead, LLC, Northland Vapor Bemidjii, LLC, and Wonky Confections, LLC manufactured and sold the products in violation of Minnesota law because:

• The products exceed the established maximum THC limit for edible products of five milligrams of any THC per serving, or no more than 50 milligrams of any THC per container

• The gummy bear-shaped products and the packaging are appealing to children and resemble well-known gummy candy brands that are marketed to and consumed by children

• The products were not tested for residual solvents, pesticides, mold, and heavy metals as required by law

The lawsuit seeks to order the defendants to halt manufacturing and selling these edible products, and also seeks the destruction of all embargoed inventory that violates Minnesota law.

Minnesota state regulators began an investigation after the U.S. Food and Drug Administration (FDA) alerted them that a healthy 23-year-old unexpectedly died after he consumed the edibles. However, the official cause of death is undetermined.

Regulation of High-THC Hemp-Derived Products

Minnesota regulations are unique in setting a rather high THC limit on hemp-derived edible products: a maximum of 5 milligrams of hemp-derived THC per serving and 50 milligrams of THC per container. THC concentration levels that high are typically found in products sold in regulated cannabis dispensaries. Minnesota law does, however, set strict standards for manufacturers and sellers to keep these products out of children’s hands.

While states struggle with controlling and regulating the sale of high-THC hemp products, the FDA has been largely absent from both a regulatory and enforcement perspective, aside from making clear its position that THC and CBD are not permitted ingredients in food and dietary supplements. No federal regulatory framework sets a cap on hemp-derived THC in final form products. Nonetheless, the lack of a federally designated maximum THC limit for hemp products does not mean these products are lawful under federal law.

The Federal Food, Drug, and Cosmetic Act (FDCA), as enforced by FDA, requires that food, dietary supplements, cosmetics, and drugs meet specified safety requirements prior to introduction into interstate commerce. Specifically, the FDCA requires that any substance added to, or marketed as, a food be either generally recognized as safe and effective for its intended use (GRAS) or approved by FDA as a “food additive,” both of which require “reasonably certainty” of safety. An ingredient is automatically GRAS if it was commonly used in food prior to 1958. Otherwise, GRAS status is achieved by demonstrating through scientific procedures that the ingredient is safe under its conditions of intended use (meaning safe at a particular level in a particular type of food). Neither THC nor CBD have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food.

Standards That May Lower Consumer Risks Associated with High-THC Hemp-derived Products

In states like Minnesota, where these higher THC hemp products are lawful under state law—notwithstanding their illegality under the FDCA—incorporating certain standards to protect public and consumer health and safety may serve to lower risks associated with accidental consumption, overconsumption, and consumption by minors. These standards include:

• Requiring purchasers to be 21+. For online sales, use a third-party age and identity verification service that compares customer information against independent, competent, and reliable data sources, such as public records, to prevent the sale of THC to individuals who are under 21 years.

• Packaging and labeling should not be attractive to children. Minnesota, for example, prohibits edible products that:

  • Bear the likeness or contain cartoon-like characteristics of a real or fictional person, animal or fruit that appeals to children

  • Are modeled after brands primarily consumed or marketed to children

  • Are made by applying a hemp-derived cannabinoid to a commercially available candy or snack food

• Edible hemp products should not look like conventional food products

• Packaging should be child-resistant and opaque

• Products should be clearly labeled with cannabinoid content per serving and per container

• Products should be clearly and conspicuously labeled with certain warning statements, such as:

  • “KEEP OUT OF REACH OF CHILDREN”

  • “For use only by adults twenty-one years of age or older”

  • “This product may have intoxicating effects. Do not drive or operate heavy machinery while using this product”

  • “Activation times vary but may be up to two hours after this product is eaten or swallowed”

• Consider including a warning concerning health risks for women who are pregnant, breastfeeding, or planning on becoming pregnant. This type of consumer advisory is already required by several states

Absent a federal regulatory framework that sets a cap on THC in final form products, and in the interest of public and consumer safety, sellers of food products containing THC should adhere to standards like those set forth above, whether required by state law or not.