What happened
Original notice title
White Label Leaf, LLC/Flying Monkey US, LLC MARCS-CMS 681493, July 11, 2024
From the archived source record
FDA has determined that your products, Flying Monkey Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the Act [21 U.S.C. 331(a)]. This letter is to inform you that your firm markets Delta-8 THC containing products that may pose a serious health risk to consumers. Adulterated Human Foods According to your product labeling, your Flying Monkey Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies are foods to which Delta-8 THC has been added. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the Act, 21 U.S.C. § 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act, 21 U.S.C. § 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a). Some of the available data raise serious concerns about potential harm from Delta-8 THC. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the Act. Therefore, your Flying Monkey Heavy Hitter Blend Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies and other gummies or foods that contain Delta-8 THC are adulterated within the meaning of section 402(a)(2)(C)(i) of the Act because they bear or contain an unsafe food additive.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- b71ddaac9f68
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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