FDA Advises Consumers Not to Use Nose Slap or Soul Slap Products

In a recent press release, the U.S. Food and Drug Administration (FDA) advised consumers not to buy or use Nose Slap and Soul Slap products, which are illegal medications marketed to increase alertness and energy.

FDA Supplements

FDA sent a warning letter to Nose Slap

FDA sent Nose Slap LLC a warning letter on April 24, 2023, for violating the Federal Food, Drug, and Cosmetic Act by marketing these unapproved medications. It highlighted that there is no proof that these products are secure or useful for the purposes they are intended for. Furthermore, the company has been notified that legal action, including without limitation product seizure and injunction, may be taken without further notice if the company fails to promptly correct violations. The letter outlined the findings of the FDA investigation and provided a 15-day window for the relevant company to respond in writing detailing measures taken to resolve the issue or cite the reasons if they can’t be resolved in the provided period. The details of the letter can be found in the provided links.

Consumers are encouraged not to use Nose Slap products

FDA has encouraged consumers not to buy or use the Nose Slap or Soul Slap products in light of the adverse effects experienced by many people. Consumers who used the Nose Slap or Soul Slap products reported experiencing negative side effects like shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting. It’s possible that these items were bought online from the Nose Slap website.

As per the FDA press release, the main ingredient in these inhalants is ammonia. According to the CDC, Exposure to high levels of ammonia in the air can cause coughing, burns, lung damage, and death. Some people with asthma may be more sensitive to breathing ammonia. Swallowing concentrated solutions of ammonia can cause burns in the mouth, throat, and stomach. Splashing ammonia into the eyes can cause burns and even blindness.

The adverse events can be reported to FDA’s MedWatch Adverse Event Reporting Program

FDA has encouraged consumers and healthcare professionals to report adverse drug reactions or medication quality issues to the FDA’s MedWatch Adverse Event Reporting program.

MedWatch receives reports from the public and publishes safety alerts for FDA-regulated products such as prescription and over-the-counter medicines, biologics, medical devices, combination products, cosmetics, food, tobacco products, vaccines, animal drug, pet food, and livestock feed. These products utilize different reporting pathways, and it is recommended that reports concerning these products be submitted directly to the appropriate portals.

Consumers or healthcare professionals who want to report adverse events related to these products can either fill out the form online and submit it, or download it, complete it, and fax it to 1-800-FDA-0178. The relevant links to the form can be found in the provided links below.