Are Smelling Salts Bad for You? What the FDA Actually Says
Part of our series: Smelling Salts — The Complete Guide.
Why we are the ones writing this
We sell smelling salts, and this article tells you what a federal regulator has said against the category we sell in. That is deliberate. Anyone searching this question has already been told the answer is fine by people with something to sell. The useful version cites the documents and lets you read them.
Nothing here is medical or legal advice.
The short version
The FDA has publicly warned consumers not to buy or use unapproved inhalant products marketed for alertness and energy. There is no approved product for that use. The agency's position is not that ammonia is exotic or that possession is a problem — it is that products sold with those claims are unapproved drugs.
That distinction runs through everything below, and it is worth holding onto: the enforcement has been about marketing, not about molecules.
What the FDA actually said, and when
On 6 August 2024 the FDA issued a consumer alert on unapproved inhalant products marketed for alertness and energy. It stated that manufacturers "have not demonstrated these products to be safe or effective for their intended uses," and warned that failure to correct violations "may result in legal action without further notice, including, without limitation, product seizure and injunction."
The alert listed adverse events reported in the category:
- shortness of breath
- seizures
- migraines
- vomiting
- diarrhoea
- fainting
That is the agency's own list. We are not going to soften it or put a "but" after it.
The legal spine: a proposed rule from 2008
The alert did not appear from nowhere. It rests on a 2008 proposed rule — Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients, 73 FR 34895, published 19 June 2008, Docket FDA-2008-N-0297. That rule determined that ammonia, and any other ammonia ingredient in a drug product labelled with claims or directions for use as a reflex stimulant, is either not generally recognised as safe and effective, or is misbranded.
One detail matters and is usually left out: it is still a proposed rule. It has not been finalised. Finalisation would be the single biggest change the legal picture could undergo, and it is the first thing on our regulatory watch list.
The enforcement record
Between April 2023 and April 2024 the FDA issued warning letters to seven companies in this category, all for marketing unapproved drugs:
| Company | Letter no. | Date |
|---|---|---|
| Nose Slap LLC | 654566 | 24 Apr 2023 |
| Innovative Formulations LLC (Insane Labz) | 672952 | 22 Feb 2024 |
| Native Salts LLC | 674277 | 28 Feb 2024 |
| Spirochaete Research Labs (Scitus Laboratory Products) | 674278 | 08 Mar 2024 |
| Skull Smash LLC | 672714 | 13 Mar 2024 |
| Ammonia Sport Inc. | 672196 | 19 Mar 2024 |
| Ward Smelling Salts | 672166 | 30 Apr 2024 |
Every one turned on claims and intended use — how the product was sold, not that it was sold. As of our most recent scan, no further warning letters or alerts on ammonia inhalants had surfaced in 2025 or 2026, and the 2024 alert remains the current federal statement.
"Listed with the FDA" is not approval
You will see ammonia inhalants described as FDA-listed, NDC-listed, or appearing in the DailyMed drug directory with wording like "for temporary stimulation of the senses to restore alertness."
Listing a product in the drug directory is a registration step. It is not approval, and it does not immunise the marketing. Several of the companies above had listed products. The gap the FDA enforces is exactly the gap between a listed product and an approved one, and any seller pointing at a listing as though it were a clearance is telling you something that is technically true and practically misleading.
So — are they bad for you?
The honest answer has three parts, and none of them is "no".
There is no approved product for this use, and the FDA has said the safety and effectiveness case has not been made. That is the regulator's position and we are not going to argue with it on our own product page.
The mechanism is irritation. Ammonia gas acts as an irritant on the mucous membranes of the nose, throat and airway. That is not incidental to how ammonia inhalants work — it is how they work. A product whose mechanism is irritation carries the risks of an irritant, and more exposure means more irritation, not a different effect. What Are Smelling Salts and How Do They Work? covers the chemistry.
Some people should not use them at all, and the risk is concentrated there: anyone pregnant, anyone with a respiratory condition including asthma, anyone allergic to a listed ingredient, and anyone dealing with a head injury, suspected concussion or fainting.
What we can tell you is what is in the bottle, what the regulator has said, and how to use one correctly if you choose to. What we will not tell you is that it is safe. That word does not belong in copy written by the seller.
What separates a compliant product
If you are going to buy in this category, these are the things worth checking — of us as much as anyone:
- A full ingredient list, not a proprietary blend or a mystery formula.
- A stated ammonia content. Spinto bottles contain 0.35 g of ammonia each.
- Correct-use and safety information that is specific — distance, duration, who should not use it — rather than a generic "use as directed".
- No alertness, energy, performance or focus claims. This is the exact language the seven warning letters cite. A seller still leaning on it in 2026 has either not read them or has decided to risk it.
- Intact tamper evidence on arrival.
The full safety information
- Keep out of reach of children.
- For external inhalation only. Do not ingest. Avoid contact with eyes, skin and mouth.
- Do not use during pregnancy.
- Not for use by anyone with a respiratory condition, including asthma.
- Not for use to treat or assess a head injury, concussion, fainting or any medical event.
- Consult a physician before use if you have any medical concern.
- Correct use: hold away from the face, brief inhale, recap immediately.
- Store capped, upright, dry and away from heat and flame. Dispose of responsibly.
Full technique in How to Use Smelling Salts Safely.
FAQ
Has the FDA banned smelling salts? No. The FDA has issued a consumer alert and warning letters over products marketed with alertness and energy claims. Ammonia inhalants are not scheduled by the DEA and no federal ban on sale is in force.
Are smelling salts FDA-approved? No. There is no approved product for the alertness or energy indication. Some products are listed in the drug directory, which is registration and not approval.
What side effects has the FDA reported? Shortness of breath, seizures, migraines, vomiting, diarrhoea and fainting.
Who should avoid them entirely? Anyone pregnant, anyone with a respiratory condition including asthma, anyone allergic to a listed ingredient, and anyone dealing with a head injury, suspected concussion or fainting.
Is it true the NFL banned them? In 2025 the NFL instructed clubs that they may no longer administer ammonia in any form to players. The NFLPA clarified that teams cannot supply them; players may still use their own. Covered in Smelling Salts in Powerlifting and Strength Sports.