It’s funny how slowly the federal government can actually move. Years ago, when I was still in college, experts were advocating the elimination of antimicrobials in over-the-counter hand-washing solutions. For years, I argued with my family that simple soap and water was all they needed to stay clean.

Now, many years later, the FDA has made news that I’m certain will make the soap companies very unhappy. On September 2, 2016 they released the following statement¹:

The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients 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. Some manufacturers have already started removing these ingredients from their products.

This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use. This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.

The manufacturing companies have one year to comply with this ruling. For healthcare providers, this is big news. Just like the general public, many of us have been led to believe that we must have various antimicrobial substances in our hand-wash in order to be clean. This announcement from the FDA puts the kibosh on that one!

For the manufacturing companies this comes as a big blow. According to the FDA’s reporting, the estimated total one-time cost for companies to reformulate, rebrand, and re-label their products will come to a whopping 106.3 to 402.8 million dollars.¹

Ouch. That’s a lot of money.

Why make this change now? Apparently the manufacturing companies were given the chance to demonstrate their products are “generally safe and effective” (GRAS/GRAE). However, companies either failed to prove this or failed to demonstrate sufficient evidence to prove their safety and effectiveness.

Talk about evidence-based medicine. That’s EBM with a vengeance!

The bottom line here is that we should not forget that one of the most effective ways to prevent the spread of disease is through simple hand washing with soap and water.

*Approved for 16 CME/CECH Credit Hours

PODIATRISTS: This activity has been planned and implemented in accordance with the standards and requirements for approval of providers of continuing education in podiatric medicine through a joint provider agreement between the New York College of Podiatric Medicine and PRESENT e-Learning Systems.

The New York College of Podiatric Medicine (NYCPM) is approved by the Council on Podiatric Medical Education as a provider of continuing education in podiatric medicine. The NYCPM has approved this activity for a maximum of 16 continuing education contact hours.

PHYSICIANS: Professional Education Services Group (PESG) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Professional Education Services Group (PESG) designates this live educational activity for AMA PRA Category 1 Credits^TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. A maximum of 16 AMA PRA Category 1 Credits^TM will be awarded.

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