Ward Smelling Salts Warning Letter Details

Summary

Ward Smelling Salts distributed three unapproved OTC stimulant drug products—"Bottled Insanity XL," "Hockey Smelling Salt," and "Asylum Refill Pack"—through its website and social media channels in violation of section 505(a) of the FD&C Act, as these products lacked required FDA approval for new drugs. The products were also misbranded under section 502(ee) of the FD&C Act, with labeling and marketing claims (such as "Energy," "Focus," and "Strength") establishing their intended use as stimulants to affect body function. The company's introduction of these unapproved drugs into interstate commerce violated sections 301(a) and 301(d) of the FD&C Act.