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:
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.
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