For some time now, you may have seen stores or online advertisers selling a smokeable or edible product that contains “Delta-8 tetrahydrocannabinol” or “delta-8 THC” for short. Delta-8 THC typically comes from hemp derived cannabidiol or CBD. Delta-8 THC provides similar effects as delta-9 THC, which comes from cannabis.
The reason why these products have been selling online as well as in normal retail stores in Maine is that it is not considered cannabis under state law nor is delta-8 THC derived from Hemp a federally illicit compound.
However, the Food and Drug Administration (“FDA”) recently came out with a couple of statements about delta-8 THC, its effects, health risks and concerns with the chemicals used to manufacture delta-8 THC products. As a result, on May 4, 2022, the FDA announced that it sent warning letters to five companies who are allegedly selling CBD and delta – 8 THC products that allegedly violate the Federal Food, Drug, and Cosmetic Act. According to the FDA's announcement, this was the first time the FDA has sent letters to companies that are using delta-8 THC in its products:
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans' health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”
“The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle.”
The companies involved will get an opportunity to respond to the allegations. This is a reminder that just because the 2018 Farm Bill legalized Hemp and products derived from Hemp, does not mean the same products could violate other federal laws.
Delta-8 THC may be legal, for now, but states could begin to regulate it. In Maine, there have been some discussions on whether delta-8 THC should be regulated the same as cannabis (i.e. delta-9 THC) is regulated under Maine's Medical and Adult Use cannabis programs.
Before engaging in this activity, consult with an attorney who is familiar with FDA regulations. Just because other companies are selling delta-8 THC products online or in stores does not mean you should do the same. If you are interested in reviewing the letters sent by the FDA, click here.
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John M. Burke manages the firm's Maine cannabis law practice. Mr. Burke advises and represents the firm's clients throughout Maine in both the Medical and Adult Use cannabis programs in a wide range of Maine cannabis law matters. In addition to Mr. Burke's Maine cannabis law practice, Mr. Burke advises and assists the firm's clients in a variety of industries on various intellectual property matters throughout the United States. Learn more about John Burke by clicking here.
Caseiro Burke is a boutique law firm that specializes in intellectual property law and cannabis compliance and licensing in the State of Maine. We offer clients creative, cost-effective and reliable legal solutions in all intellectual property and Maine cannabis law matters.