FDA WARNING_LETTER - Ward Smelling Salts - April 30, 2024

On April 30, 2024, the FDA issued a Warning Letter to Mr. Inglot regarding the distribution of OTC stimulant drug products "BOTTLED INSANITY XL," "HOCKEY SMELLING SALT," and "ASYLUM REFILL PACK," sold via wardsmellingsalts.com and social media. The FDA determined these products are unapproved new drugs and misbranded.

The products are considered drugs under section 201(g)(1)(B) and (C) of the FD&C Act due to their intended use as stimulants for energy, focus, strength, and adrenaline rushes, as evidenced by claims on labels, website, and social media. These stimulant products are unapproved new drugs under section 505(a) and 301(d) of the FD&C Act because no FDA-approved applications are in effect.

Specifically, as reflex stimulants (smelling salts/ammonia inhalants), they are deemed new drugs under section 505G(a)(4) of the FD&C Act, as a 2008 proposed rule (73 FR 34895) determined ammonia as a reflex stimulant is not Generally Recognized As Safe and Effective (GRASE) or is misbranded. Even if marketed as general stimulants, they do not conform to Monograph M011: Stimulant Drug Products for Over-the-Counter Human Use,