C & A Naturistics

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your “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” products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Passage 2

Your “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” products are not generally recognized as safe and effective for their above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 3

The labeling for your “AK Forte” product does not declare that the product contains acetaminophen or diclofenac.

Passage 4

Your “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” and “RenaLimp” products are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes.