Co-authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law.
Do you assume that when shopping for soaps or body washes, consumers will often times reach for products labeled “antibacterial” in hopes that those products will keep them and their families safer? If so, you would be right. The popularity of antibacterial products has grown tremendously since they first appeared on the market. According to a 1998 Gallop Study of Consumer Awareness and Perception of Antibacterial Products, 33% of those surveyed expressed the need for special antibacterial products to protect their homes from bacterial and viral pathogens. A similar study conducted by Gallop in 2010 revealed that an overwhelming 75% of those surveyed said they preferred to purchase products with antimicrobial protection.
Popular as antibacterial products may be, beginning September 2017, many of them may no longer be marketed as such, based on a Final Rule (78 FR 76444) issued by the U.S. Food & Drug Administration (FDA) on September 6, 2016. This Final Rule comes after several years of an FDA investigation into the effectiveness and potential hazards of antiseptic agents in personal care products. The most popular antiseptic agent in these products is triclosan, which, along with eighteen (18) other antiseptic agents under this Final Rule, is now banned when used for antibacterial purposes in hand and body washes.
The ban applies only to consumer soaps and washes, not to antibacterial soaps used in hospitals or other health care settings such as nursing homes (80 FR 25166). The rule also does not apply to consumer antiseptic rubs (81 FR 42912), antiseptics identified as “first aid antiseptics” in the 1991 First Aid TFM (56 FR 33644), or antiseptics used by the food industry. The new rule will take effect on September 6, 2017.
In separate rulemakings, 81 FR 42912 and 80 FR 25166 respectively, the FDA proposes conditions under which over-the-counter (OTC) consumer antiseptic rubs (products that are not rinsed off after use, including hand rubs and antibacterial wipes) and OTC antiseptics intended for use by health care professionals in hospital or other health care settings are “Generally Recognized as Safe and Effective” (GRAS/GRAE).
This 2016 Final Rule brings closure to FDA’s 2013 proposed rule, where it began to question the efficacy and safety of certain antiseptic agents it had previously (in its 1994 tentative final monograph – otherwise referred to as a TFM – for OTC antiseptic drug products), considered GRAS/GRAE. In its 2013 proposed rule, FDA solicited input from industry, thereby giving it time to submit data that proved several antiseptic agents were both effective and safe. In publishing its 2016 final ruling, FDA effectively concluded that for the nineteen (19) ingredients listed, either no additional data were submitted by industry or the data and information that were submitted were not sufficient for the agency to find that those ingredients are both safe and effective. Thus, the 2016 Final Rule also serves as an amendment to the 1994 TFM for OTC antiseptic drug products.
The Final Rule finds that the following nineteen (19) active ingredients are not GRAS/GRAE for use in OTC consumer antibacterial wash products, and are therefore considered “misbranded” in the absence of an approved new drug application.
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
- Nonylphenoxypoly (ethyleneoxy) ethanoliodine
- Poloxamer-iodine complex
- Povidone-iodine 5 to 10 percent
- Undecoylium chloride iodine complex
- Methylbenzethonium chloride
- Phenol (greater than 1.5 percent)
- Phenol (less than 1.5 percent) 16
- Secondary amyltricresols
- Sodium oxychlorosene
- Triple dye
Anticipating this FDA Final Rule, many manufacturers began replacing triclosan with one of three other chemicals: benzalkonium chloride, benzethonium chloride or chloroxylenol (PCMX). In response to comments submitted by industry, FDA has deferred rulemaking for one year on these three additional ingredients – to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.
Our TOP 6 tips for manufacturers and importers as a result of this Final Rule are:
- Evaluate your current product line to determine if any are hand or body washes, intended for consumer use, and contain one or more of the nineteen (19) chemicals listed above;
- Determine whether you currently use or have an interest in using, any of the three (3) deferred ingredients in hand or body washes;
- Assess whether you need assistance in evaluating your product line and determining the applicability of the rules to one or more of your products;
- Assess whether you have an interest in submitting additional safety and effectiveness data on the deferred ingredients to FDA;
- Asses whether you have an interest in other ongoing FDA rulemakings regarding OTC consumer antiseptic rubs and/or antiseptics, intended for use by healthcare professionals inside or outside of hospitals; and
- Consider that while manufacturers will not be required to immediately begin recalling non-compliant products, they will have one year from the date of the rulings publication in the Federal Register to comply with the Final Rule by removing products from the market or reformulating (removing certain antiseptic active ingredients) these products. This means the rule will be enforced beginning on September 6, 2017.
For consumers, FDA recommends:
- “Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the S. Centers for Disease Control and Prevention (CDC) recommends that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol.”