FDA Issues a Final Rule Declaring That 19 Ingredients Are Not Generally Recognized as Safe and Effective

On September 2, 2016, the Food and Drug Administration (FDA) published a final rule determining, after a review of available information, that nineteen (19) active ingredients are not generally recognized as safe and effective (GRASE) for use in consumer antibacterial washes. Once the rule becomes effective, FDA will consider any consumer antiseptic wash product containing these non-GRASE active ingredients to be misbranded and subject to FDA enforcement action.

What Products Are Covered?

This final rule pertains only to consumer antiseptic wash products. These are products that are intended for use with water. Affected products include antibacterial hand soaps, hand washes, and body washes that are used by consumers for personal use.

The rule does not apply to consumer antiseptic "rubs" (e.g., leave-on hand sanitizers or wipes), antiseptic "first aid" products, antiseptics intended for use in a healthcare setting, or antiseptics used by the food industry.

Which Active Ingredients Are Affected?

In ruling that they are non-monograph ingredients, FDA effectively banned 19 ingredients from use in consumer antiseptic washes. The 19 ingredients include the following:

  • Cloflucarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodophors (iodine-containing ingredients)
    • Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
    • Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
    • Nonylphenoxypoly (ethyleneoxy) ethanoliodine
    • Poloxamer-iodine complex
    • Povidone-iodine 5 to 10 percent
    • Undecoylium chloride iodine complex
  • Methylbenzethonium chloride
  • Phenol (greater than 1.5 percent)
  • Phenol (less than 1.5 percent)
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triclocarban
  • Triclosan
  • Triple dye

FDA deferred a decision on three other ingredients (benzalkonium chloride, benzethonium chloride, and chloroxyenol) until after the completion and analysis of ongoing studies on the safety and effectiveness of these ingredients, or until a later date if the studies are not completed.

How Long Do Companies Have to Comply?

The effective date of the rule is September 6, 2017; therefore, companies will have one year to reformulate products or remove products from the market. Companies wishing to market antibacterial washes containing these active ingredients after this date will need to obtain approval from FDA via a New Drug Application.