The US Food and Drug Administration (FDA) on Friday published a final rule calling on antibacterial wash manufacturers to eliminate 19 ingredients from their products within one year because manufacturers did not demonstrate that the ingredients 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. 

Triclosan (liquid soap) and triclocarban (bar soap) are among the most common of the ingredients and can be found in products like Dial’s Foaming Hand Soap with Activated Triclosan Technology.

Andrea Fischer, FDA spokeswoman, told Focus: "This final rule affects a majority of the consumer antiseptic hand and body wash market, which the FDA currently estimates at about 2,100 products. Most of the products containing ingredients affected by this proposed rule will require reformulation for continued marketing, which we understand has already begun."

For these 19 ingredients, either no additional data were submitted or the data submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE), FDA said in a statement on Friday.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in over-the-counter consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) – to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.

Background

The agency first proposed the new rule in 2013 after some data suggested long-term exposure to antibacterial products’ active ingredients could pose health risks, such as bacterial resistance or hormonal effects.

Under the proposed rule, manufacturers were required to provide the agency with additional data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients, FDA said.

This included data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.

Since the proposed rulemaking, manufacturers already started phasing out the use of some of the active ingredients in antibacterial washes, including triclosan and triclocarban, FDA says. 

New Reality

But antibacterial hand and body wash manufacturers did not provide the necessary data to FDA to establish the safety and effectiveness for the 19 active ingredients addressed in this final rulemaking, which include:

• 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 o 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

An FDA spokeswoman on a call with reporters on Friday said that soap products containing these ingredients make up about 40% of the market.

"If a soap makes antibacterial claims, there’s a pretty good chance it’ll have one of these ingredients," she said. She also noted that Johnson & Johnson and Procter & Gamble have already said they will phase out triclosan in their products.

Cost to Companies

FDA says the primary estimated benefits come from reduced exposure to antiseptic active ingredients by “2.2 million pounds per year.”

“Limitations in the available data characterizing the health effects resulting from widespread long-term exposure to these ingredients prevent us from translating the estimated reduced exposure into monetary equivalents of health effects. The primary estimate of costs annualized over 10 years is approximately $23.6 million at a 3 percent discount rate and $27.6 million at a 7 percent discount rate. These costs consist of total one-time costs of relabeling and reformulation ranging from $106.3 to $402.8 million,” the final rule says.

Final Rule