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# Halodine Marketing Covid-19 Unapproved New Drugs: FDA
- URL: https://www.fdaweb.com/halodine-marketing-covid-19-unapproved-new-drugs-fda/
- Published: 2021-07-13T12:00:00.000Z
- Updated: 2026-09-14T17:05:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149700

FDA says its review of Web sites and social media sites maintained by Halodine, Miami, FL, found that the company is marketing non-alcohol-based antiseptic products for sale in the U.S. to mitigate, prevent, treat, diagnose, or cure Covid-19 and other conditions in people. A 7/7 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/halodine-llc-611150-07072021?ref=fdaweb.com) says the products are unapproved new drugs that are sold in violation of the Federal Food, Drug, and Cosmetic Act. They also are misbranded.

The firm was told to take immediate action to correct the violations cited in the letter and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with copies of related documentation.

The firm’s products have been listed by the agency at a Web site advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are misleadingly represented as safe and/or effective for treating or preventing Covid-19.