Native Salts LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

“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.” [from your product’s website at https://www.nativesalts.com/]

Passage 2

“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.” [from your product’s website at https://www.nativesalts.com/]

Passage 3

“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!” [from your product’s website at https://www.nativesalts.com/faq]

Passage 4

“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.” [from your product’s website at https://www.nativesalts.com/faq]

Passage 5

“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.” [from your product’s website at https://www.nativesalts.com/faq]

Passage 6

“When you want a pick-me-up, but don’t want a caffeine crash.” [from a post on your Facebook webpage, dated 8/21/2023, at https://www.facebook.com/nativesalts1]

Passage 7

No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your firm’s “N, Native Salts” drug product.

Passage 8

“N, Native Salts” is a reflex stimulant drug product subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this reflex stimulant drug product falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), because it is subject to a determination to be not GRASE in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.

Passage 9

Even if “N, Native Salts” was not marketed as a reflex stimulant drug product and was only marketed as a more general stimulant drug product, your product would still not meet the requirements under section 505G, under which it would be deemed to be GRASE and not a new drug.

Passage 10

However, your “N, Native Salts” stimulant drug product does not conform to the conditions of use specified in Monograph M011 because your nonprescription product is formulated with the active ingredient ammonium***5*** and labeled with directions for intranasal administration, neither of which comply with the applicable conditions of use specified in M011, as set forth in the final administrative order OTC000025.

Passage 11

In addition, the FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “N, Native Salts” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.

Passage 12

Lastly, “N, Native Salts” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.