FDA Issues Warning Letter to Maker of Scent Inhalant ‘Nose Slap’ Products

The US FDA is warning consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy. The agency issued a warning letter to the Boise, ID-based maker of the products in late April.

The products of concern are inhalants and primarily contain ammonia, according to the agency. Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction.

FDA has received reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers after using the Nose Slap or Soul Slap products. The products may have been purchased online through the Nose Slap website.

In its April 24, 2023 warning letter to Nose Slap LLC, FDA said the products were unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act. 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.

FDA isencouraging 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:

The warning letter was sent to Daniel Schofield of Nose Slap LLC.

Warning Letter Details

The letter also cited another over-the-counter (OTC) stimulant drug products called Soul Slap. It too, says the agency is unapproved new drugs.
FDA cited cxamples of the claims from the products’ labeling, including product labels and website (https://www.noseslap.com), that incuded, but were not limited to, the following:
“NOSE SLAP! THE WAKE UP STICK . . . SMELLING SALTS INFUSED W/ ESSENTIAL OILS . . . We are on a mission to wake up the world one slap at a time. . . . CAUTION: Product releases ammonia gas. [from the “NOSE SLAP” label]

“NOSE SLAP! . . . Immediate Energy . . . Caffeine Alternative . . . Nose Slap will give you the energy boost you need to get through your day . . . With Nose Slap by your side, you are always second (sic) away from slapping the tiredness away and tackling whatever the day throws at you. . . . FAST ACTING FOR INSTANT ENERGY. . . With Nose Slap on-hand, you’re always just seconds away from a clear head and feeling prepped to crush whatever it is that’s in front of you . . . Rejuvenate your mind, refresh your senses, and increase your focus… all without sugary energy drinks . . . Nose Slap was created to fill a void of and provide a product that could provide instant alertness . . . We offer a safe alternative to energy drinks and provide a product that can provide instant alertness when waiting for energy isn’t an option. . . .” [from your website at https://www.noseslap.com]
“Nose Slap will give you the energy boost you need to get through your day, without keeping you awake later! . . . Smelling Salts have been a “thing” for years, but have never been combined with the unique properties of essential oils, creating the boldest concoction of instant energy the world has ever seen. . . . Smelling salts have been used thousands of years to provide alertness and an increased flow of oxygen to the brain. 

“What is Nose Slap?. . . Nose Slap is Maximum Strength Smelling Salts with Essential Oils…Nose Slap is a mixture of sodium carbonate, ammonium chloride, and peppermint essential oil . . . What do smelling salts do? . . . The stimulant effect of smelling salts is due to the ammonia, which provokes someone’s nasal and lung membranes once they inhale through the nostrils. The end result is that the person involuntarily inhales and begins to respire quicker, which sends extra oxygen to the brain.” 

“SOUL SLAP! NOSE SLAP WAKE UP STICKS . . . HARDEST SLAPPING SMELLING SALTS IN THE WORLD . . . We are on a mission to wake up the world one slap at a time. . . . CAUTION: THESE SMELLING SALTS ARE EXTREMELY POWERFUL! Product releases ammonia gas.” [from the “SOUL SLAP” label]
“SIZE MATTERS . . . SOUL SLAP! IS BIGGER AND OVER 10X STRONGER . . . If you like Nose Slap!, you’ll love what Soul Slap! does to wake up your senses and deliver laser-like focus. It’s the meanest blend of smelling salts and essential oils on the planet. . . . The body’s reaction to our unique energy blend will cause increased airflow, created [sic] an instant sense of rejuvenation and feeling of well-being. And unlike caffeine, it won’t keep you up at night.” [from product website at https://www.noseslap.com/products/soul-slap]

According to the agency, based on the above labeling claims, Nose Slap and Soul Slap products contain ammonium chloride, sodium carbonate, and essential oil,  and are intended for use as both reflex stimulants (i.e., smelling salts, ammonia inhalants) and, more generally, as stimulants to help restore mental alertness or wakefulness.

The Agency also noted:  “Even if “NOSE SLAP” and “SOUL SLAP” were not marketed as reflex stimulant drug products and were only marketed as more general stimulant drug products, your products would still not meet the requirements under section 505G, under which they would be deemed to be GRASE and not a new drug.”
In addition, the FDA said it is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that Nose Slap and Soul Slap are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling. Moreover, there is no evident basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section and 301(d) of the FD&C Act, 21 U.S.C. 331(d).

The letter was sent by Tina Smith, Acting Office Director, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, at FDA.