FDA bans 19 antibacterial ingredients from use in bath products



The U.S. Food and Drug Administration (hereinafter referred to as the FDA) issued a ban on September 2. Antibacterial bath products containing specific active ingredients must not …

The U.S. Food and Drug Administration (hereinafter referred to as the FDA) issued a ban on September 2. Antibacterial bath products containing specific active ingredients must not continue to be sold on the market because they are no more effective than ordinary ones in preventing disease and reducing the spread of disease. Soap and water are more effective and may cause long-term health hazards.

Banning the sale of 19 types of toiletries with antibacterial ingredients

The U.S. ban applies to antibacterial bath products containing one or more of 19 specified ingredients. Antibacterial bath products containing one or more of these ingredients will not be allowed to continue to be sold on the market. The two most commonly used ingredients are triclosan and triclocarban. Product categories include liquid, foam and gel hand washes, soaps and body washes, all of which are mixed with water. However, hand sanitizer, wet wipes and antibacterial products used in hospitals are not affected by this ban.

The FDA pointed out in the statement that although manufacturers claim that these ingredients have a better antiseptic effect than ordinary soap, they cannot prove that these chemicals are safe to use every day for a long time, nor can they prove that these substances are better than ordinary soap in preventing disease, or preventing The spread of certain infectious diseases. “In fact, some data suggest that long-term use of antibacterial ingredients may do more harm than good,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Certain antibacterial ingredients may cause cancer

It is reported that the scientific community has discussed whether triclosan in toothpaste can cause cancer, but recent research results show that triclosan can cause liver cancer and liver fibrosis in white mice. The antibacterial chemical triclocarban, which is added to medicines and personal care products, may cause problems including cancer, reproductive dysfunction and infertility.

The environmental organization Natural Resources Defense Council cited an FDA research report and pointed out that three-quarters of Americans’ urine was found to contain triclosan. Some studies cited by the FDA show that long-term exposure to certain active ingredients in antibacterial products, such as triclosan and triclocarban, can affect the body’s resistance or hormone levels, causing health risks.

Involving 40% of the products in the US antibacterial toiletries market

The FDA also stated that consumer antibacterial bath products including benzalkonium chloride, benzethonium chloride and chloroxylenol can continue to be sold for the time being. It will wait for the manufacturer to submit new safety and effectiveness data and postpone it for a period of time. A final decision on whether to ban sales will be made next year. The FDA emphasizes that washing hands with regular soap and running water is still an effective way to prevent the spread of germs. If only waterless hand sanitizer is available, use one containing at least 60% alcohol.

Michel, director of the FDA’s Division of Nonprescription Drugs, pointed out that most non-pharmaceutical care products on the U.S. market contain at least one banned ingredient. About 40% of the U.S. antibacterial toiletries market, or 2,100 products, will be affected by the ban.

The FDA will give manufacturers of toiletries one year to comply with the new regulations. Manufacturers can withdraw related products from the market or reformulate them to remove the 19 antibacterial ingredients specified in the ban.

Manufacturer responds by reformulating to remove banned ingredients

Toilet and personal care product manufacturers Johnson & Johnson, Procter & Gamble and Colgate have all said that they are or have reformulated their products to remove commonly used ingredients such as triclosan and triclocarban among the 19 ingredients specified in the ban.

Colgate spokesman DiPiaza said that none of its products sold in the United States are affected by the ban, but a small amount of soap sold in Puerto Rico, which also follows FDA regulations, is being reformulated. Procter & Gamble spokesman Ross said that several products will be withdrawn before the one-year grace period.


Note 1: 19 chemical substances banned by FDA

Halocarban
Flusalen
Hexachlorophene
Hexylresorcinol
Iodine complex (ether ammonium sulfate, polyoxyethylene sorbitan laurate)
Iodine complex (alkyl aryloxy polyethylene glycol phosphate)
Benzethoxylammonium Chloride
Nonylphenol polyoxyethylene ether
Phenol (greater than 1.5%)
Phenol (less than 1.5%)
Poloxamers (iodine complexes)
Iodophor (5% to 10%)
Secondary amylcresol
Sodium oxychlorobenzene sulfonate
Tribromosalen
Triclocarban
Triclosan
Triple dye
Endidinium chloride iodine complex

According to the “Technical Specifications for Safety of Cosmetics” promulgated by the my country Food and Drug Administration, the hexachlorophenol and tribromosalen banned by the US FDA this time are both prohibited components of cosmetics, while triclocarban and triclosan cosmetics are listed as Preservatives are allowed. Among them, the maximum allowable concentration of triclocarban when used in cosmetics is 0.2%, and the maximum allowable concentration of triclosan is 0.3%. The applicable scope of triclosan is hand soap, bath soap, body wash, deodorant (not spray), cosmetic powder and concealer, and nail cleanser.

Source: Antibacterial Association

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