# FDA WARNING_LETTER - Applied Nutriceuticals - Unknown Date

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> FDA WARNING_LETTER for Applied Nutriceuticals on Unknown Date. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Applied Nutriceuticals
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: This FDA Warning Letter, dated September 13, 2017, addresses Applied Nutriceuticals, Inc. regarding their product HG4UP, marketed as a dietary supplement. The core violation is the inclusion and labeling of Picamilon (also known as pikatropin, nicotinyl-gamma-aminobutyric acid, or nicotinoyl-GABA) as a dietary ingredient.

The FDA asserts that Picamilon does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)]. It is not a vitamin, mineral, herb, botanical, amino acid, or a dietary substance for supplementing the diet, nor is it a concentrate, metabolite, constituent, extract, or combination of these. Instead, Picamilon is described as a unique chemical entity synthesized from niacin and gamma-aminobutyric acid.

Consequently, declaring Picamilon as a dietary ingredient misbrands the product under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling is false or misleading. The letter also states that Picamilon is not approved as a food additive, prior sanctioned for use in dietary supplements, nor is there a basis to conclude it is Generally Recognized

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Company: https://www.keypedia.com/companies/applied-nutriceuticals/9f497e86-5a4c-46bb-9ba9-03272bd71f40

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