FDA WARNING_LETTER - C & A Naturistics - March 04, 2025

On March 4, 2025, the FDA issued a Warning Letter to Anakaren Lopez of Productos Naturales CA, following a website review from May 2024 to February 2025. The letter identifies several products sold on https://www.productosnaturalesca.com as unapproved new drugs and misbranded drugs.

The products cited as unapproved new drugs are “AK Forte,” “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” “RenaLimp,” “Miel de Abeja Para Limpiar tus Ojos,” and “Ojo Roja Para Limpiar tus Ojos.” These products are deemed drugs under section 201(g)(1) of the FD&C Act due to their intended use for disease treatment or to affect body structure/function, as evidenced by claims on the website (e.g., "Highly effective in cartilage reconstruction" for AK Forte, "treatment of cancer, diabetes" for TE DE MORONEL). Since they are not generally recognized as safe and effective, they are considered "new drugs" without FDA-approved applications, violating sections 505(a) and 301(d) of the FD&C Act.

Furthermore, “AK Forte,” “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” and “RenaLimp” are