The U.S. Food and Drug Administration has established a final rule that states that over-the-counter antibacterial soaps containing some specific active ingredients can no longer be legally marketed. This is as a result of manufacturers being unable to clearly demonstrate the safety and effectiveness of the ingredients, especially in terms of preventing the spread of illness and infection.
There are 19 active ingredients, and the final rule applies to products which contain one or more of these. The list includes triclocarcon and triclosan, the most frequently used ingredients in wash products which are designed to be mixed with water and washed off. Wipes, hand sanitisers and antibacterial products used in medical settings are not affected by the final rule.
Although consumers have been led to believe that products which contain antibacterial ingredients are more effective at minimising the spread of infection, there is no scientific proof that this is the case. Most products are actually no more effective than using simple soap and water. This is according to the Managing Director of the Center for Drug Evaluation and Research (CDER), Janet Woodcock.
Long-Term Negative Effects
In addition, there appears to be some worrying data which suggests that using such products could actually be harmful in the long term. Research points to the potential health risks long-term exposure to ingredients such as triclosan and triclocarbon could pose. These include hormonal effects and bacterial resistance.
Manufacturers Taking Steps
The FDA works to protect the health of the public, helping to ensure the effectiveness, safety and security of vaccines, drugs, medical devices and biological products for both human and veterinary use. In addition, they work with the Department of Health and Human Services to regulate and protect the food supply, dietary supplements, cosmetics and tobacco products.
Manufacturers will now have a year to comply with the ruling, although many began phasing out the use of the listed ingredients back in 2013, when a proposed rule was issued. Companies can turn to Paid Medical Trials that are offered through companies such as trials 4 us offer paid medical trials in order to have their products marketed as medically graded.
The advice for customers is that washing with running water and plain soap continues to be the most effective step to avoid the spread of germs. If there is no access to soap and water, a hand sanitiser containing a minimum of 60% alcohol should be used.
