The U.S. Food and Drug Administration (FDA) has taken significant action against White Label Leaf LLC and Flying Monkey US LLC by issuing a warning letter concerning their Delta-8 tetrahydrocannabinol (THC) products. This warning highlights critical regulatory violations and raises concerns about the safety and marketing practices of Delta-8 THC products.

Key Violations Identified by the FDA

The warning letter, dated July 11, 2024, outlines several serious violations related to the companies’ Delta-8 THC-containing products. The FDA’s review of these products was conducted through the examination of the companies’ website, revealing two main areas of concern: the use of Delta-8 THC as an unsafe food additive and unauthorized drug claims.

1. Adulterated Human Foods: The FDA determined that Delta-8 THC added to products such as Flying Monkey Mango Tango Gummies and Flying Monkey Heavy Hitter Blend Mango Gummies is considered a food additive. Importantly, there is no existing food additive regulation that authorizes the use of Delta-8 THC, and it does not meet the criteria for Generally Recognized as Safe (GRAS) status. Consequently, these products are deemed adulterated, rendering their introduction into interstate commerce illegal.
2. Unapproved New Drugs: The review also found that the Delta-8 THC gummies were marketed as drugs. Claims on the companies’ website suggested that these products could be used for diagnosing, curing, mitigating, treating, or preventing diseases, with specific references to anti-inflammatory and pain-relieving properties. However, these products have not received FDA approval for such uses, classifying them as unapproved new drugs.

FDA’s Concerns Over Cannabinoids in Food Products

The FDA has expressed significant concerns about the potential harm associated with the consumption of cannabinoids, including Delta-8 THC, in food products. The agency reiterated that no cannabinoid has been approved for use as a food additive, underscoring the serious health risks these products may pose to consumers. The lack of regulatory approval and oversight raises further concerns about the safety of these products, particularly when marketed with unsupported health claims.

Implications for the Companies Involved

The issuance of the warning letter serves as a critical reminder of the regulatory challenges faced by companies involved in the manufacture and sale of Delta-8 THC products. White Label Leaf LLC and Flying Monkey US LLC have been given 15 days to respond to the FDA’s warning letter, a standard timeframe that underscores the urgency of addressing these violations. Failure to comply with FDA regulations can result in further enforcement actions, including product seizures and injunctions.

The case of White Label Leaf LLC and Flying Monkey US LLC highlights the broader regulatory challenges associated with Delta-8 THC products. As the popularity of these products grows, so too does the need for clear and enforceable regulations to ensure consumer safety. The potential health risks associated with unregulated cannabinoids, combined with misleading marketing practices, necessitate a robust regulatory framework to protect public health.

Source: Food Safety News