FDA WARNING_LETTER - Herbs America, Inc. - April 30, 2018

The FDA reviewed Herbs-America.com, Chuchuhuasi.com, Lepidium.com, Chanca-piedra.com, and the Maca Magic store on Amazon.com in April 2018. The review determined that products including Chanca Piedra, Jatoba, Boldo, Copaiba oil, Chu Chu Huasi, and Maca (Lepidium meyeneii) are marketed with claims establishing them as 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)] due to their intended use in the cure, mitigation, treatment, or prevention of disease.

Examples of drug claims include: Chanca Piedra for gallstones, kidney stones, detoxification, and antispasmodic effects; Jatoba for diarrhea, parasites, stomach issues, coughs, and nail fungus; Boldo for digestive disorders and dyspepsia; Copaiba oil as an antiseptic, expectorant, anti-inflammatory for respiratory and urinary tracts; Chu Chu Huasi for rheumatism, tuberculosis, bronchitis, stomach ache, fever, arthritis, Parkinson's, MS, and alcoholism; and Maca for immuno-stimulating qualities, hormonal balance, sterility, impotence, erectile dysfunction, and combating serious malignant illnesses. Testimonials also support these intended uses.

These products are considered "new drugs" under