K & Care Organics
1 extracted findings
FDA source excerpt, selected passage
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).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.