Dexterity Health, LLC DBA Zazzee Naturals

Warning LetterOpen

Eric Posnack Owner Dexterity Health, LLC DBA Zazzee Naturals 2028 E. Ben White Blvd. Suite 240, Box 67894 Austin , TX 78741 United States info@zazzeenaturals.comIssued Oct 30, 2023Center for Drug Evaluation and Research | CDER

View Letter

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

Violations2

Issue DateOct 30, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Dexterity Health, LLC DBA Zazzee Naturals
Location: Eric Posnack Owner Dexterity Health, LLC DBA Zazzee Naturals 2028 E. Ben White Blvd. Suite 240, Box 67894 Austin , TX 78741 United States info@zazzeenaturals.com
FEI Number: N/A
Country: United States
Issue Date: October 30, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Dexterity Health, LLC (DBA Zazzee Naturals) was cited for marketing Liquid MSM Drops as an unapproved new drug in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The product, sold through Amazon, made disease-treatment claims (such as healing eye damage and improving eye membrane permeability) that established it as a drug rather than a dietary supplement or cosmetic, yet it lacked required FDA approval. The violation was particularly serious because the product is an ophthalmic formulation intended for direct eye administration, a route of administration that poses greater risk of harm due to bypassing the body's natural defenses.

Dexterity Health, LLC DBA Zazzee Naturals FDA Warning Letter, October 30, 2023