Loyola University Chicago School of Law, JD 2017
The Food and Drug Administration (FDA) issued a final rule on September 2, 2016 establishing that certain over-the-counter (OTC) consumer antiseptic wash products (i.e. antibacterial hand and body soaps) containing certain active ingredients can no longer be marketed as they are not generally recognized as safe and effective and are, therefore, misbranded. The impact of the rule on manufacturers is expected to be quite significant.
The FDA finalized the consumer antiseptic wash proposed rule, originally published on December 17, 2013, due to concerns that consumers believe antibacterial washes to be more effective at preventing the spread of germs than plain soap and water. The FDA also considered data that suggests that long-term exposure to certain antibacterial ingredients may pose health risks such as bacterial resistance or hormonal effects.
As a result, effective September 6, 2017, manufacturers will no longer be able to market antibacterial washes with any one or more of the 19 specific active ingredients evaluated by the FDA.
After reviewing well over 1,800 comments from various stakeholders, the FDA found that manufacturers failed to demonstrate that 19 of the evaluated 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. However, the FDA has deferred rulemaking for one year for three additional ingredients: benzalkonium chloride, benethonium chloride, and chloroxylenol.
This rule does not apply to consumer hand “sanitizers” or wipes or antibacterial products used in health care settings. However, the FDA issued a Proposed Rule requesting additional scientific data to support the safety and effectiveness of topical consumer antiseptic rubs (including hand sanitizers) on June 30, 2016 as well as a Proposed Rule for health care antiseptics on April 30, 2015.
The impact of the final rule will certainly be significant. In fact, a 2001 physician-performed survey of national chain, regional grocery, and internet stores found that 76 percent of liquid soaps and 29 percent of bar soaps that were marketed contained the active antibacterial ingredients triclosan or triclocarban, two of the 19 reviewed by the FDA.
The FDA also conducted an impact analysis assessing the costs and benefits of the Final Rule.
According to a 52-week 2009 sales survey of drugstores, supermarkets and mass merchandisers, the FDA identified 725 antibacterial hand or body soaps containing antiseptic ingredients. The sales from the 725 products totaled $286 million. However, noting that the survey did not account for warehouses, the internet and other specialty outlets, the 725 products were multiplied by a factor of 3.1. The adjusted estimated sales for one year totaled and estimated $886.1 million.
The analysis estimated the issuance of the Final Rule would reduce exposure to antiseptic ingredients by 2.2 million pounds a year. However, with limited data on the health effects of widespread, long-term exposure, this benefit could not be reduced to monetary equivalents
Over the next year, manufactures will have the option to do one of the following to become compliant: 1) remove the antiseptic active ingredient and relabel the product (involving relabeling costs, reformulation costs, increased used of other ingredients and potential for reduced sales due to the loss of “antibacterial” claim), 2) discontinue the product (resulting in reduced sales), 3) relabel without reformulation (involving relabeling costs and the potential for reduced sales due to the loss of “antibacterial” claim), or 4) relabel the product as a health care antiseptic without reformulation (involving relabeling costs and the potential for reduced sales due to the loss of “antibacterial” claim, risk of need to relabel following Proposed Rule regarding health care antiseptics). Manufacturers may also seek approval of a new drug application.
For relabeling alone, the FDA estimates the cost per universal product code (UPC) will range from $18,695 to $39,738 for branded labels and from $22,030 to $44,875 for private labels. While some manufactures may be able to relabel their products in conjunction with their routine voluntary label changes, the total estimated cost of a one-time label change is estimated to be in the range of $42.1 to $88.1 million.
In addition to relabeling costs, manufacturers must consider costs associated with reformulating their products. Based on estimates of the reformulation costs of OTC cough-cold products, the FDA estimates the cost of reformulating may be anywhere from $70.2 to $280.6 million.
The Final Rule issued by the FDA a few weeks ago is certainly going to have a significant economic impact on consumer antiseptic manufacturers, relabelers, repackers and distributors despite the fact that the health risks and long-term financial gains for consumers is still mostly unknown.
While some manufacturers have already started removing the ingredients from their products, those who have yet to start have one year to comply with the Final Rule. Those manufacturers, particularly the smallest entities, should start by conducting a thorough analysis of their company’s financials, marketing strategy and other product lines. Choosing the right path for the company, be it removing products all together, relabeling, reformulating or reformulating and relabeling, will determine long-term success or failure.
The FDA has many resources regarding regulatory compliance including resources specific to drug compliance programs. Although many of the resources such as Drug Manufacturing Inspections, OTC Drug Monograph Implementation or Over-the-Counter Guidances are intended for FDA personnel, understanding the enforcement process may help individual entities maintain compliance.
Finally, manufacturers may look to Warning Letters issued by the FDA for guidance on enforcement policies and procedures. For example, on April 18, 2011 JD Nelson and Associates was issued a Warning Letter after the FDA determined there was insufficient scientific evidence to support the claims made about the company’s Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant.