[8/6/2024] FDA is warning consumers to not purchase or use certain inhalants, which are unapproved drugs marketed to promote alertness and boost energy.
These products primarily contain ammonia. Inhaling ammonia can quickly lead to coughing, airway constriction, and eye, nose and throat irritation.
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.
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
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.
FDA encourages health care professionals and consumers to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Resources
- Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry: ToxFAQs for Ammonia
