K & Care Organics

Selected passages from the FDA letter

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

Passage 1

Thus, even if your products were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not new drugs under section 505G(a)(1), they do not comply with the requirements under section 505G. Accordingly, “BOTAÓ Kids Mineral Foam Spray,” “BOTAÓ Baby Mineral Foam Spray,” and “SUN & SHINE Sunscreen Mousse” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).