23 Sept 2016
FDA Bans Sale of Antibacterial Hand and Body Washes
Companies will no longer be able to market over-the-counter consumer antiseptic products intended for use with water (i.e., hand washes and body washes) that contain one or more of 19 specific active ingredients, including triclosan and triclocarban, under a new final rule from the Food and Drug Administration. Manufacturers have been given until 6 September 2017 to comply with this rule by removing such products from the market or reformulating them (i.e., removing the identified ingredients), although a number of companies have already begun this process. This rule does not cover health care antiseptics, consumer antiseptic rubs (e.g., hand sanitizers and wipes), antiseptics identified as “first aid antiseptics,” or antiseptics used by the food industry.
The FDA is taking this action because manufacturers did not demonstrate that the 19 identified ingredients (i.e., cloflucarban, fluorosalan, hexachlorophene, hexylresorcinol, iodine complex (ammonium ether sulphate and polyoxyethylene sorbitan monolaurate), iodine complex (phosphate ester of alkylaryloxy polyethylene glycol), nonylphenoxypoly (ethyleneoxy) ethanoliodine, poloxamer iodine complex, povidone-iodine five to ten 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 and triple dye) are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. “In fact,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, “some data suggests that antibacterial ingredients may do more harm than good over the long term.”
The widespread consumer use of antibacterial products, the accumulated scientific information, and concerns raised by health care and consumer groups prompted the FDA to re-evaluate the data needed to classify the active ingredients in consumer antibacterial products as “generally recognised as safe and effective,” or GRAS/GRAE. A determination that an active ingredient is GRAS/GRAE for a particular intended use requires consideration of the benefit-to-risk ratio for the drug for that use. If the active ingredient in a drug product does not provide clinical benefit but potentially increases the risk associated with the drug (e.g., from reproductive toxicity or carcinogenicity), then the benefit-risk calculation shifts and the drug is not considered GRAS/GRAE.
While consumers have generally viewed antibacterial hand and body washes as effective tools to help prevent the spread of germs, there is no evidence that they are any more effective at preventing illness and the spread of certain infections than washing with plain soap and water. Moreover, some data suggest that long-term exposure to certain active ingredients used in antibacterial products (such as triclosan in liquid soaps and triclocarban in bar soaps) could pose health risks such as bacterial resistance or hormonal effects. The FDA reached this conclusion after examining the available literature, as well as data, comments and other information submitted as part of this rulemaking process.
According to the FDA, the final rule involves over 700 consumer antiseptic wash drug products formulated with one or more of the 19 active ingredients mentioned above. The total benefits derived from the rule include reduced exposure to antiseptic ingredients by 2.2 million pounds per year. On the other hand, the decision to ban the sale of the identified over-the-counter consumer antiseptic products will result in one-time costs of US$106.3 to US$402.8 million as well as total annualised costs over ten years of US$23.6 million to US$27.6 million.
The FDA is giving manufacturers a full year to comply with the new requirements so that they have sufficient time to remove from the market or reformulate their products. The agency has also deferred rulemaking for one year on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol – to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these ingredients may be marketed during this time while data are being collected.
Finally, the FDA indicates that it has not received any new information demonstrating that the following active ingredients are eligible for evaluation under the over-the-counter drug review for use as a consumer antiseptic wash: alcohol (ethyl alcohol); benzalkonium cetyl phosphate; cetylpyridinium chloride; chlorhexidine gluconate; isopropyl alcohol; polyhexamethylene biguanide; salicylic acid; sodium hypochlorite; tea tree oil; and combination of potassium vegetable oil solution, phosphate sequestering agent and triethanolamine. Consequently, drug products containing any of these active ingredients are new drugs that will require FDA approval.