Other safety alerts
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| The United States: FDA warns consumers to not purchase or use unapproved inhalant products marketed for alertness and energy boosting |
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The US Food and Drug Administration (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 the following 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 and 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-unapproved-inhalant-products-marketed-alertness-and-energy
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 2 May 2023.
Ends/Wednesday, Aug 7, 2024
Issued at HKT 15:30
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