FDA WARNING_LETTER - Healthwest Minerals, Inc. dba Mt. Capra Products - April 30, 2024

The FDA issued an Amended Warning Letter to Mt. Capra on September 11, 2024, following a review of their websites (mtcapra.com and facebook.com/mtcapra) in March and April 2024. The FDA determined that Mt. Capra's "Goat Milk Formula Recipe Kit" met the definition of an infant formula under section 201(z) of the Federal Food, Drug, and Cosmetic Act (the Act) due to representations on their websites, such as mimicking breast milk and being a substitute for commercial baby formula.

The product was identified as a "new infant formula" under section 412(c)(2)(A) of the Act because Mt. Capra had not previously manufactured an infant formula. A violation of section 412(c)(1)(B) of the Act and a prohibited act under section 301(s) of the Act occurred because Mt. Capra introduced a new infant formula into interstate commerce without making the required submission to the FDA at least 90 days prior to marketing.

The FDA acknowledged Mt. Capra's voluntary recall of the product distributed between May 1, 2023, and May 1, 2024, and their efforts to inform customers and the public that the product should not be used as infant formula. Mt. Capra also removed the product from their website