FDA MedWatch – FDA Warns Consumers to Not Purchase or Use Unapproved Inhalant Products Marketed For Alertness and Energy Boosting

TOPIC: FDA Warns Consumers to Not Purchase or Use Unapproved Inhalant Products Marketed for Alertness and Energy Boosting: CDER Alert

AUDIENCE: Consumer, Health Professional, Pediatrics

ISSUE: FDA is warning consumers to not purchase or use certain inhalants, which are unapproved drugs marketed to promote alertness and boost energy.

FDA has received reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers after using these types of products, possibly purchased through various websites.

Manufacturers have not demonstrated these products to be safe or effective for their intended uses. Failure of the company to promptly correct violations may result in legal action without further notice, including, without limitation, product seizure and injunction. In May 2023, FDA warned consumers to not purchase or use Nose Slap and Soul Slap products (also included in this alert) marketed for alertness and energy boosting.

For more information about this alert, click on the red button “Read Alert” below.

BACKGROUND: FDA issued warning letters to companies for marketing these unapproved products:

• Ward Smelling Salts

• Ammonia Sport Inc.

• Skull Smash LLC

• Spirochaete Research Labs, LLC aka Scitus Laboratory Products

• Innovative Formulations, LLC dba Insane Labz

• Native Salts LLC

• Nose Slap LLC

These products primarily contain ammonia. Inhaling ammonia can quickly lead to coughing, airway constriction, and eye, nose and throat irritation.

In May 2023, FDA warned consumers to not purchase or use Nose Slap and Soul Slap products (also included in this alert) marketed for alertness and energy boosting.

Resources: 

• Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry: ToxFAQs for Ammonia.

RECOMMENDATIONS: Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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