FDA WARNING_LETTER - Native Salts LLC - March 05, 2024

On February 28, 2024, the FDA issued a Warning Letter to Mr. Pickens regarding the distribution of "N, Native Salts," an OTC stimulant drug product. The FDA reviewed the firm's website (https://www.nativesalts.com) on November 15, 2023, and social media (https://www.facebook.com/nativesalts1).

The product is deemed an unapproved new drug under section 505(a) of the FD&C Act (21 U.S.C. 355(a)) and misbranded under section 502(ee) (21 U.S.C. 352(ee)). The FDA cited claims on the website and Facebook, such as "Instant Alertness," "improve energy," "quick jolt of energy when you're tired," and "pick-me-up," as evidence of its intended use as a stimulant.

"N, Native Salts," containing ammonium, eucalyptus oil, peppermint oil, polymer crystals, glycerin, and water, is considered a reflex stimulant and general stimulant. It is an unapproved new drug because no FDA-approved application is in effect. Furthermore, it falls under section 505G(a)(4) of the FD&C Act (21 U.S.C. 355h(a)(4)) as it