FDA warns company over Delta-8 THC product violations

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

White Label Leaf LLC/Flying Monkey US LLC
Tampa, FL

The U.S. Food and Drug Administration (FDA) has issued a warning letter to White Label Leaf LLC/Flying Monkey US LLC, for significant violations related to their Delta-8 tetrahydrocannabinol (THC) products. The letter, dated July 11, 2024, describes a review of the companies’ website, https://flyingmonkeyusa.com, conducted in May 2024. The FDA determined that the companies’ Delta-8 THC-containing products, including Flying Monkey Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies, are adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they contain an unsafe food additive.

Key Violations:

Adulterated Human Foods:

1. Unsafe Food Additive: The FDA found that the Delta-8 THC added to the Flying Monkey products is considered a food additive. There is no food additive regulation authorizing the use of Delta-8 THC, and it does not meet the criteria for Generally Recognized as Safe (GRAS) status. As a result, the products are adulterated, making it illegal to introduce these adulterated foods into interstate commerce.

Unapproved New Drugs:

2. Unauthorized Drug Claims: The FDA also determined that the Flying Monkey Delta-8 THC gummies are being marketed as drugs due to claims on the website that suggest the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Examples include claims that Delta-8 THC has anti-inflammatory and pain-relieving properties. The products are not approved by the FDA for these uses, making them unapproved new drugs.

The FDA also noted that the companies sell other food products containing cannabinoids and reiterated that no cannabinoid, including Delta-8 THC, has been approved for use in food as a food additive. The agency expressed serious concerns about the potential harm from the consumption of cannabinoids in food products.

The full warning letter can be viewed here.