Native Salts LLC
FDA issued a warning letter to Native Salts LLC (Chicago, IL) on February 28, 2024, concerning its 'N, Native Salts' smelling salts product marketed as an OTC stimulant. The agency found the product to be an unapproved new drug under FD&C Act section 505(a) because it contains ammonium as a reflex stimulant ingredient — a use FDA determined not to be generally recognized as safe and effective in a 2008 proposed rule — and does not conform to OTC Monograph M011, which permits only caffeine as an active stimulant ingredient. The product was also found to be misbranded under section 502(ee). FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (6)
When Should I Use Native Salts? They are most commonly used during sports games or at the gym for strenuous exercise and to aid in getting that last rep up. The great part about Native Salts is that it can be used in a variety of settings outside of lifting and intense workouts. In most scenarios, it can give you a quick jolt of energy when you're tired while avoiding caffeine. Its other usages can vary from waking up in the morning, before a yoga class, a work meeting, a big exam, or even while out at a bar with friends.
Instant Alertness[:] Native Salts provide a quick and easy way to regain focus, improve energy, and get back to things that matter most to you.
Is Native Salts healthy? Native Salts are composed of simple organic ingredients to provide a natural, refreshing, & alert sensation. They are an invigorating way to stay alert without caffeine. …. We take pride that our smelling salts are all-natural, aromatic, while keeping you alert!
Is Ammonia in Native Salts dangerous? …Smelling salts, like Native Salts, contain a heavily diluted form of ammonium, which gives off ammonia gas. Think of it like this, inhaling pure ammonia is like doing a belly flop off of an Olympic high dive. It's going to hurt a lot. Inhaling Native Salts is like doing a cannonball off the side of the pool. It's going to wake you up and give you a tiny boost of adrenaline.
When you want a pick-me-up, but don't want a caffeine crash.
Native Salts is an all-natural, handmade smelling salts that you can actually use everyday and does not only produce an energizing and alert sensation but also smells pleasant and aromatic.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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