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: 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.
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