FDA WARNING_LETTER - Infant Acid Reflux Solutions LLC

On February 5, 2018, the FDA issued a Warning Letter to Kira Volpi, owner of Infant Acid Reflux Solutions, regarding the product "TummyCare Max." The FDA reviewed the company's website, http://www.infant-acid-reflux-solutions.com/, and determined that "TummyCare Max" is marketed in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The product is classified as an unapproved new drug under section 201(g)(1) and 201(p) of the FD&C Act because it is intended to affect the body's structure or function and is not generally recognized as safe and effective for its advertised uses. Claims on the website, such as "TummyCare Max can be used by itself (without mixing it together with a PPI) as an antacid" and "It makes the PPI more palatable and protects them from stomach acid," indicate its drug intent. The introduction or delivery of this new drug without an FDA-approved New Drug Application (NDA) violates sections 301(d) and 505(a) of the FD&C Act.

Furthermore, "TummyCare Max" is deemed a misbranded drug under section 503(b)(1)(A) and 502(f)(1) of the FD&C Act. It is considered a prescription