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Skull Smash

FDA sniffs out unapproved claims company's smelling salts increase alertness, focus, and more.

Skull Smash uses some colorful language in the marketing of its ammonia inhalants, commonly known as smelling salts.

“Don’t be a basic bitch…be a badass bitch,” reads the Badass Bitch product label, which carries the company’s slogan “sniff—lift—dominate.”

Skull Smash explains on its about page that:

Smelling salts are common in strength sports to help mentally stimulate and ‘psych up’ the lifter on competition day or in training to give them a boost on their competitive lifts. They are also popular in combat, contact and team sports to increase alertness and focus.

But as the FDA recently informed the company, smelling salts have not been approved for these uses. Specifically, the FDA wrote in a March 13 warning letter to the company that several of its products, including Badass Bitch, are subject to a proposed rule that determined that:

ammonia and any other ammonia ingredient in a drug product that is labeled with claims or directions for use as a reflex stimulant are not generally recognized as safe and effective (GRASE) or are misbranded.

Put another way, Skull Smash’s marketing of its ammonia inhalants as “reflex stimulants” violates FDA law, according to the warning letter.

The FDA gave the company 15 working days to respond to the letter. With that deadline nearing, found that the company has yet to address several of the claims cited in the FDA’s letter.

This includes “sniff—lift—dominate,” which in addition to product labels appears prominently on the Skull Smash homepage; the section of the about page noted above (along with numerous other problematic claims on the page flagged by the FDA); and the following statement in an October 2023 Skull Smash Facebook post:

This potent, mint scented edition is sure to get your attention, amp up your alertness and aggression, and deliver a punch, like an ice cycle [sic] straight to your brain.


Company responds

In response to a request for comment, Skull Smash owner Steve Welch, to whom the letter is addressed, said:

My lawyers have made an initial response to the FDA regarding their letter and allegations. We will need more time than the small amount they gave to address their claims, as well as to propose our own information and argument to them. [W]e are currently working on addressing the issues, and will give it our best attention.

Of note

In a May 2023 press release warning consumers not to purchase unapproved smelling salts sold by Nose Slap, which also sold a product called Soul Slap, the FDA noted that inhaling ammonia can quickly lead to eye, nose and throat irritation, as well as coughing and airway constriction.

Find more of our coverage on inhalants marketed as providing health benefits here.

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