Loading…
Skull Smash LLC distributed unapproved new drug products marketed as ammonia inhalants (SKULL SMASH®, BADASS Bitch, DOUBLE BARREL, and SILVER BULLET) in violation of the Federal Food, Drug & Cosmetic Act sections 505(a) and 502(ee). The company failed to obtain FDA approval before introducing these stimulant products into interstate commerce through its website and Facebook social media account. The products were also misbranded, lacking proper regulatory disclosures required for drug products. FDA inspections conducted in November 2023 identified labeling, website, and social media claims indicating the products were intended to function as stimulants affecting body structure or function, which requires premarket approval.