APG SEVEN, INC – FDA Warning Letter, May 7, 2024

The FDA issued a Warning Letter to Alpagi, LLC, after reviewing their website (www.alpagi.net), Facebook page (Productos naturales Alpagi | Facebook), and samples/labeling of their dietary supplement products “BioMoringa” and “BioDiabetin.” The FDA determined that 14 of Alpagi's products, including BioMoringa, BioDiabetin, Maca Plus, and BioProstate, are unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. This is based on claims made on product labels and social media, such as "Anti-fungal – Antiviral," "Antidepressant," "Anti-inflammatory" for BioMoringa, and a Facebook post stating BioMoringa can "prevent pathologies such as diabetes, cholesterol, cancer."

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their intended uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(