FDA WARNING_LETTER - Wave Miami LLC - January 28, 2020

The FDA issued a Warning Letter to Mr. Rivera regarding the "Lipro Dietary Capsule" product, marketed on his website and Facebook pages. The FDA determined the product is an unapproved new drug and a misbranded drug. Laboratory analysis confirmed the presence of undeclared tadalafil, a PDE-5 inhibitor and the active ingredient in Cialis, used for erectile dysfunction.

This undeclared ingredient poses serious health risks, particularly for individuals taking nitrates for conditions like diabetes, high blood pressure, or heart disease, as it can dangerously lower blood pressure. The FDA had previously issued a public warning and recommended a recall, which the firm has not yet completed.

The product is deemed an unapproved new drug because tadalafil was approved as a drug (Cialis, 2003) before being marketed as a dietary supplement, thus excluding it from the dietary supplement definition. It is also considered a new drug because it is not generally recognized as safe and effective for its intended uses, which include preventing, treating, or curing disease conditions. The marketing and sale of this product without an FDA-approved application violate sections 505(a) and 301(d) of the FD&C Act.

Furthermore, "Lipro Dietary Capsule" is misbranded under sections 502 and 301(a) of the FD&C Act. It lacks adequate directions for use, as tadalafil is a prescription drug requiring professional