The US Food and Drug Administration (FDA) issued a warning on May 1, 2023, against unapproved inhalants called “Nose Slap” and “Soul Slap” that are marketed to promote alertness and boost energy. The agency reported that several unapproved inhalants contain mostly ammonia, a toxic gas that can cause severe symptoms when inhaled. These inhalants, which are called smelling salts, contain ammonia that irritates the mucous membranes of the upper respiratory tract, triggering an inhalation reflex. The reflex alters breathing, increases oxygen flow and gas exchange in the lungs, and potentially increases alertness. However, the FDA warns that inhaling ammonia can quickly lead to eye, nose, and throat irritation, coughing, and airway constriction.
The agency has received reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers who used these unapproved stimulants. According to the FDA, inhaling ammonia frequently or in high doses is harmful. While smelling salts are considered relatively safe, the FDA can’t vouch for the quality or safety of these unapproved inhalants.
The FDA issued its consumer safety warning after sending a letter to the products’ maker, Nose Slap LLC, on April 24. The warning letter named the two stimulants being sold on the company’s website, neither of which is FDA approved. Nose Slap and Soul Slap are advertised as energy-boosting alternatives to sugar and caffeine. Both inhalants contain ammonia, which is toxic and potentially harmful when inhaled.
Ammonia can cause various symptoms, depending on the dose inhaled. It can burn the tissues of the nose, throat, and windpipe and cause swelling and an accumulation of fluid in the lungs. It can also cause airway destruction resulting in respiratory distress or failure, and those who survive inhaling high concentrations of ammonia can experience long-term lung damage. If the chemical enters the eyes, it can damage the cornea and sometimes lead to blindness.
Smelling salts were once used to prevent or treat fainting, but they are no longer regularly used by doctors. However, athletes use them in an effort to improve performance, although there’s little evidence to support this use. In general, smelling salts work by using ammonia to irritate the mucous membranes of the upper respiratory tract and trigger an inhalation reflex.
The FDA encourages healthcare professionals and consumers to report adverse events or quality problems with Nose Slap or Soul Slap to the agency’s MedWatch Adverse Event Reporting Program. The agency reminds the public that these products have not been demonstrated 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.
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