FDA WARNING_LETTER - Infiniti Creations Inc

The FDA issued a Warning Letter to Infiniti Creations, Inc. CEO/Owner Brian E. Brown, based on a review of their website, www.curadermcream.com (redirecting to www.bec5creamdirect.com). The letter states that "Curaderm BEC 5 Cream" and "Tamanu Oil" are marketed in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The products are deemed drugs under section 201(g)(1) of the FD&C Act due to intended uses such as treating non-melanoma skin lesions (basal cell carcinoma, squamous cell carcinoma, actinic keratosis, sunspots) for "Curaderm BEC 5 Cream," and possessing skin healing, anti-inflammatory, antimicrobial, and antibiotic properties for "Tamanu Oil."

These products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their stated uses. Their introduction into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the FD&C Act.

Furthermore, the products are misbranded under section 502(f)(1) of the FD&C Act because the conditions they address are not amenable to self-diagnosis and treatment, meaning adequate directions for lay use cannot be provided. This misbranding constitutes a prohibited act