FDA WARNING_LETTER - Natures Rx, LLC - February 21, 2020

The FDA issued a Warning Letter to Mr. Bhairi concerning the product "Silver Bullet" distributed via www.naturalrx.net. An FDA laboratory analysis confirmed "Silver Bullet" contains undeclared sildenafil, the active ingredient in the prescription drug Viagra, used for erectile dysfunction.

The product is deemed an unapproved new drug because sildenafil was approved as a new drug (Viagra, March 27, 1998) before being marketed as a dietary supplement or food, thus excluding "Silver Bullet" from the dietary supplement definition. It is a drug intended to affect body function and is not generally recognized as safe and effective. Its introduction into interstate commerce without an FDA-approved application violates sections 505(a) and 301(d) of the FD&C Act.

Furthermore, "Silver Bullet" is a misbranded drug under section 502 of the FD&C Act. It lacks adequate directions for use (502(f)(1)) as sildenafil is a prescription drug requiring professional supervision. Its labeling is false or misleading (502(a)) by failing to declare sildenafil, which poses serious health risks, especially for individuals taking nitrates (e.g., for diabetes, high blood pressure, heart disease), as it can dangerously lower blood pressure. The product also lacks adequate warnings for user protection (502(f)(2)).

The FDA requires prompt corrective action within fifteen working