FDA WARNING_LETTER - Skull Smash LLC - March 19, 2024

On March 13, 2024, the FDA issued a Warning Letter to Mr. Welch concerning the distribution of unapproved and misbranded over-the-counter (OTC) stimulant drug products. The FDA reviewed the firm's website (https://www.skull-smash.com) on November 16, 2023, and its Facebook account on November 20, 2023.

The products in question are "SKULL SMASH® AMMONIA INHALANTS," "BADASS Bitch," "DOUBLE BARREL Ammonia Inhalant," and "SILVER BULLET Ammonia Inhalants." The FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction into interstate commerce is prohibited by sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a).

These products are considered drugs due to claims on their labels, website, and social media indicating their intended use as stimulants to increase alertness, focus, and energy. Specifically, they are marketed as reflex stimulants