The US healthcare watchdog says that manufacturers have not been able to prove that the 19 ingredients are safe for daily use
The FDA has issued a final ruling that prohibits the marketing of over-the-counter consumer antiseptic wash products, such as hand soap, that contain specific antibacterial ingredients.
The ruling, announced on 2 September, affects products containing 19 active ingredients including triclosan (full list below).
The key reason behind the ruling is, the FDA claims, because “manufacturers haven’t proven that those ingredients are safe for daily use over a long period of time”.
Theresa Michele, MD of the FDA’s Division of Nonprescription Drug Products, said: “Following simple hand washing practices is one of the most effective ways to prevent the spread of many types of infection and illness at home, at school and elsewhere. We can’t advise this enough. It’s simple, and it works.”
The ruling impacts all of the following: liquid, foam, gel hand soaps, bar soaps and body washes, but does not cover hand sanitisers or hand wipes. It also does not have implications for antibacterial soaps that are used in hospitals or nursing homes, for example.
In its announcement, the FDA pushed home the message that, from its research, there is not “enough science” to show that over-the-counter antibacterial soaps are better at preventing illness than washing with soap and water.
It stated: “To date, the benefits of using antibacterial hand soap haven’t been proven”.
In the final rule published document, Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use, the FDA stated that "accordingly OTC consumer antiseptic wash drug products containing these active ingredients are misbranded, and are new drugs for which approved new drug applications are required for marketing".
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 5-10%
○ Undecoylium chloride iodine complex
Phenol (greater than 1.5%)
Phenol (less than 1.5%)