US FDA Issues Final Rule on Safety and Effectiveness of Consumer Hand Sanitizers
The US FDA has finalized its determination of 28 active ingredients and defers its ruling on three active ingredients.
SAFEGUARDS | Cosmetics, Personal Care & Household NO. 059/19
The US Food and Drug Administration (FDA) has issued a final rule on consumer antiseptic rubs, more commonly referred to as hand sanitizers.
As part of the final rule, the FDA finds 28 active ingredients to be Category II (not generally recognized as safe and effective or misbranded). It also believes the nonmonograph status of these ingredients affect less than 3% of hand sanitizers currently in the marketplace. The ingredients in Category II include:
|Benzethonium chloride||Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)||Secondary amyltricresols||Polyhexamethylene biguanide|
|Chloroxylenol||Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)||Sodium oxychlorosene||Benzalkonium cetyl phosphate|
|Chlorhexidine gluconate||Methylbenzethonium chloride||Tribromsalan||Cetylpyridinium chloride|
|Cloflucarban||Nonylphenoxypoly (ethyleneoxy) ethanoliodine||Triclocarban||Salicylic acid|
|Fluorosalan||Phenol (equal to or less than 1.5 percent or greater than 1.5 percent)||Triclosan||Sodium hypochlorite|
|Hexachlorophene||Poloxamer iodine complex||Triple dye||Tea tree oil|
|Hexylresorcinol||Povidone-iodine 5 to 10 percent||Undecoylium chloride iodine complex||Combination of potassium vegetable oil solution, phosphate sequestering agent, and triethanolamine|
Three ingredients were deferred from further rulemaking at this time:
- Isopropyl alcohol
- Benzalkonium chloride
These have been deferred to allow for the development and submission to the record of new safety and effectiveness data for these three ingredients.
As a final part of the ruling, the FDA officially updated the statistical analysis for efficacy to require that bacterial log reduction studies should continue to be used to demonstrate that an active ingredient is effective for use in a consumer antiseptic rub product, as well as requiring subjects to be randomized to a three-arm study:
- Active control
- Negative control
Further, the statistical analysis related to the log reduction criteria for classifying consumer antiseptic rub active ingredients is to be considered Generally Recognized as Effective (GRAE).
Other requirements updated for effectiveness testing include:
- 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
Source of Information
- Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
- FDA issues final rule on safety and effectiveness of consumer hand sanitizers
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