FDA Warns Cannabis Companies Against Illegal Marketing of delta-8 THC Products

Cannabis business owners should take note of recent action the Food and Drug Administration (FDA) has taken against five companies for marketing products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

What is delta-8 THC?

Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis stavia L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects.

Products containing delta-8 THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tincture, and infused beverages.

Why did the FDA issue warning letters?

The FDA issued warning letters to the companies which address the illegal marketing of delta-8 THC products being sold online and in stores. 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.

In addition, the FDA issued warnings because it is observing an increase in adverse event reporting related to delta-8 THC, including those involving minors. The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners, and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment. The agency is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.

The letters also cite violations related to drug misbranding and the addition of delta-8 THC in foods, such as gummies, chocolate, caramel, chewing gum, and peanut brittle. Misbranding is a term under the FD&C Act to describe the lack of information on a product’s label about its proper usage, side effects, dosage, and other considerations. Examples of the FDA language viewed as illegal include:

  • “Whether you have a hectic mind or suffer from an anxiety disorder, delta-8 THC gummies can provide relief to calm down the mind;”
  • “Many are turning to consume CBD oil for anxiety, depression, and bipolar disorder;”
  • “CBD could help remove dementia from brain cells;” and
  • “Delta-8 is known to be successful in many cancer treatments.”

Help is available

Cannabis companies should carefully review the FDA’s guidance. The business attorneys at O’Reilly Rancilio are available to assist you. Please call 586-726-1000 or visit our website.

Categories: Business