With worries over antibiotic-resistant “super bugs” on the rise, many consumers may assume that antibacterial soaps would help protect against unwanted bugs: not so fast, says the FDA.  Amongst growing concerns that the active ingredient in many of these soaps, triclosan, could be linked to hormonal effects and bacterial resistance, on December 17th, FDA published a proposed rule that would require makers of antibacterial soaps and body washes to prove that their products are safe and effective.  This proposed rule, if finalized in its current form, would require manufacturers to either spend a great deal of time and money on safety and efficacy studies, with no guarantee that the studies will show the product to be safe and effective, or reformulate their products in order to avoid the risk of FDA enforcement.

Here is what you need to know about the proposed rule:

What products are affected?  This rule only applies to consumer antiseptic washes that are intended to be used with water.  This means soaps, hand washes, and body washes.

What products are excluded?  Hand sanitizers, antibacterial wipes, antiseptic first aid supplies, and antiseptic washes intended for use by health care professionals or in the food industry are all excluded.

What do manufacturers have to do to keep their products on the market and avoid reformulation?

  1. Prove Efficacy:  Companies will have to provide studies that show that the active ingredient used in the antibacterial soap doesn’t just kill bacteria, but is more effective at reducing infections than washing with plain soap and water or not washing at all.
  2. Prove Safety:  Companies will have to prove through scientific studies that active ingredients like triclosan and triclocarban are safe for long-term, repetitive use by the wide variety of populations that use these types of products.  These tests will have to show not just a lack of toxicity, but that there are not unreasonable developmental, reproductive, or carcinogenic risks, and that these products do not pose an unjustifiable risk of contributing to the problem of resistant bacteria.

How fast do they have to do it?  FDA has proposed a 180-day comment period and a 12-month implementation period starting from the date the final rule is issued.  Given that this rule is fairly controversial, with interested and passionate parties on both sides, there is likely to be a large number of comments for FDA to address before the rule can be finalized.  Even barring an extension to the comment and/or implementation periods, we anticipate that this rule will not go into effect for at least two years (if at all).

What’s next?  While this rule is limited to antibacterial washes intended to be used with water, antimicrobial products not covered by this rule run the gamut from other personal use items, like hand sanitizers and wipes, to cleaning supplies, and even paint.  FDA’s jurisdiction is limited to the regulation of foods, drugs, cosmetics, and medical devices.  However, the proposal of this rule on the heels of a recent action by FDA to curb the use of antibiotics in the raising of livestock indicates that the problem of drug-resistant bacteria may be an evolving priority for the agency. Even so, what, if any, further action FDA will take on this issue is unknown at this time.