The FDA published a Federal Register (FR) notice today declaring that 19 ingredients for use in consumer antiseptic wash (use with water to wash off) are not generally recognized as safe and effective (GRAS/GRAE). The Agency has however deferred a decision on three additional ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) for this use as additional studies and data are being reviewed at this time to support an Agency finding.
The final rule covers only consumer antiseptic washes and FDA notes the effectiveness and systemic exposure of the 19 ingredients has not been demonstrated. FDA notes that “[T]he minimum data needed to demonstrate safety for all consumer antiseptic wash active ingredients falls into three broad categories: (1) Safety data studies described in current FDA guidance (e.g., nonclinical and human pharmacokinetic studies, developmental and reproductive toxicity studies, and carcinogenicity studies); (2) data to characterize potential hormonal effects; and (3) data to evaluate the development of bacterial resistance”. FDA has found that “[T]he available information and published data for the 19 active ingredients considered in this final rule are insufficient to establish the safety of long-term, daily repeated exposure to these active ingredients used in consumer wash products.”
“For the 19 active ingredients included in this final rule, either no additional data were submitted since the 2013 Consumer Antiseptic Wash PR, or the data and information that were submitted were insufficient to support GRAS/GRAE findings. Therefore, these ingredients are not included in a monograph at this time.”
The 19 ingredients (I somehow count 20 but I am guessing that two of the iodophor complexes are considered the same) are:
- 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
- Triple dye
The Final Rule will be effective one year after its publication in the FR after that date any consumer antiseptic wash containing one of the 19 ingredients listed above will be considered misbranded unless marketed under an approved new drug application. The one-year effective date is to give marketers time to reformulate their products and exhaust inventories of existing products.
The final Rule (here) is another long one, 90 pages, and will make good bedtime reading. It provides a nice history of the rule making for this specific class of products. Also it works better for sleep than Ambien!