US FDA Final Rule Categorizes the Safety and Effectiveness of 28 Hand Sanitizer Active Ingredients
05/13/2019

FDA releases final rule on safety and effectiveness for 28 ingredients used in consumer hand sanitizers.

Online PR News – 13-May-2019 – Geneva, Switzerland – The US Food and Drug Administration (FDA) has published a final rule on the safety and effectiveness of 28 active ingredients used in consumer hand sanitizers.

These 28 active ingredients are considered Category II - not generally recognized as safe and effective or misbranded. They include:
1. Benzethonium chloride
2. Chloroxylenol
3. Chlorhexidine gluconate
4. Cloflucarban
5. Fluorosalan
6. Hexachlorophene
7. Hexylresorcinol
8. Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
9. Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
10. Methylbenzethonium chloride
11. Nonylphenoxypoly (ethyleneoxy) ethanoliodine
12. Phenol (equal to or less than 1.5 percent or greater than 1.5 percent)
13. Poloxamer iodine complex
14. Povidone-iodine 5 to 10 percent
15. Secondary amyltricresols
16. Sodium oxychlorosene
17. Tribromsalan
18. Triclocarban
19. Triclosan
20. Triple dye
21. Undecoylium chloride iodine complex
22. Polyhexamethylene biguanide
23. Benzalkonium cetyl phosphate
24. Cetylpyridinium chloride
25. Salicylic acid
26. Sodium hypochlorite
27. Tea tree oil
28. Combination of potassium vegetable oil solution, phosphate sequestering agent, and triethanolamine

The FDA believes the nonmonograph status of these ingredients means they affect less than 3% of consumer antiseptic rubs, otherwise known as hand sanitizers, currently in the marketplace.

The FDA has also deferred making a final rule on the following three substances to allow the development and submission of new safety and effectiveness data. They are:
• Ethanol
• Isopropyl alcohol
• Benzalkonium chloride

In addition, the statistical analysis used for efficacy has been updated. It now requires bacterial log reduction studies to continue as a demonstration that an active ingredient is effective. The rules also require substances to participate in a randomized three-arm study containing:
1. Test
2. Active control
3. Negative control

The statistical analysis related to the log reduction criteria for classifying consumer antiseptic rub active ingredients is also to be considered Generally Recognized as Effective (GRAE).

The FDA has also updated the following requirements for testing efficacy:
• The test product should be non-inferior to an FDA-approved antiseptic rub as active control with a 0.5 margin (log10 scale)
• Requiring the test product should be superior to the negative control by a margin of 1.5 (log10 scale)
• A minimum sample size of 100 subjects per treatment arm
• Two adequate and well-controlled clinical simulation pivotal studies for the consumer antiseptic rub indication at two separate independent laboratory facilities by independent principal investigators must be conducted

Stakeholders are now advised to make sure their products comply with the latest regulations before offering hand sanitizers onto the market in the US.

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