Native Salts LLC

Warning LetterOpen

Andrew J. Pickens Native Salts LLC 515 N. Noble St. Chicago , IL 60642 United States wakeup@nativesalts.comIssued Feb 28, 2024Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateFeb 28, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Native Salts LLC
Location: Andrew J. Pickens Native Salts LLC 515 N. Noble St. Chicago , IL 60642 United States wakeup@nativesalts.com
FEI Number: N/A
Country: United States
Issue Date: February 28, 2024
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Native Salts LLC distributed "N, Native Salts," an unapproved OTC stimulant drug product in violation of federal law. The FDA identified two primary violations: the product was an unapproved new drug introduced into interstate commerce under section 505(a) of the FD&C Act, and it was misbranded under section 502(ee) of the FD&C Act. The company's website and social media marketing made claims demonstrating intended use as a stimulant, including statements that the product provides "instant alertness," improves focus and energy, and produces an "energizing and alert sensation"—all of which positioned the product as a drug requiring FDA approval before distribution.

Native Salts LLC FDA Warning Letter, February 28, 2024