FDA Issues Warning for Certain Smelling Salts and Other Inhalants Marketed for Energy, Alertness

The US Food and Drug Administration (FDA) has issued a warning to consumers to avoid the purchase or use of unapproved inhalant products marketed for alertness and energy boosting, such as smelling salts and other products containing ammonia.

Issued on August 06, 2024, the warning highlights reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers after using these types of products. According to the agency, manufacturers have not demonstrated these products to be safe or effective for their intended uses and are in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act, with the FDA issuing warning letters to 7 different companies for marketing these unapproved products.

The 7 companies who have received warning letters and the products mentioned within those letters are listed below:

• Ward Smelling Salts
  • ”BOTTLED INSANITY XL,” “HOCKEY SMELLING SALT,” and “ASYLUM REFILL PACK”
• Ammonia Sport Inc.
  • “AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE"
• Skull Smash LLC
  • “SKULL SMASH® AMMONIA INHALANTS,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants”
• Spirochaete Research Labs, LLC aka Scitus Laboratory Products
  • “ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-“
• Innovative Formulations, LLC dba Insane Labz
  • “WAKE THE DEAD SMELLING SALTS”
• Native Salts LLC
  • “N, Native Salts”
• Nose Slap LLC
  • “NOSE SLAP” and “SOUL SLAP”

In their August 06, 2024 release, the FDA pointed out they had issued a warning in May 2023 to consumers to avoid purchasing or use of Nose Slap and Soul Slap products, which are marketed by Nose Slap LLC, based on similar violations. In the May 2023 announcement, the FDA pointed out it had issued Nose Slap LLC a warning letter on April 24, 2023 for violation of the FD&C act.

References:

1. Center for Drug Evaluation and Research. Do not purchase or use unapproved inhalants marketed for Alertness. U.S. Food and Drug Administration. August 6, 2024. Accessed August 7, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-unapproved-inhalant-products-marketed-alertness-and-energy.
2. Center for Drug Evaluation and Research. FDA warns consumers not to purchase or use nose slap and Soul Slap Pro. U.S. Food and Drug Administration. May 1, 2023. Accessed August 7, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-nose-slap-and-soul-slap-products-marketed-alertness-and.