Antimicrobials

What are Antimicrobials?

Antimicrobial ingredients are materials that protect against the growth of microorganisms in personal care products, including bacteria, viruses and fungi. Antimicrobial ingredients can also kill organisms that may be present in ingredients that may be used to make products.

Antimicrobial personal care products, which are sometimes referred to as antibacterial products, provide an important extra measure of protection for consumers at home and doctors and nurses in hospitals seeking to prevent spread of germs. These products, depending on their formulation and application, kill or inhibit the growth of bacteria that cause skin infections, intestinal illnesses or other commonly transmitted diseases. These include potentially fatal illnesses caused by bacteria such as Salmonella and E.coli. These products are regulated by the Food and Drug Administration as Over-The-Counter (OTC) drugs and have to be shown to be safe and effective for their intended use. There are several different types of OTC drug products that have been established by FDA.

Find out more about FDA regulation of Over-The-Counter drugs:
http://www.fda.gov/cder/about/smallbiz/OTC_FAQ.htm

Why are Antimicrobial ingredients used in personal care products?

Antimicrobial ingredients play an important role in making sure that personal care products are free of microorganisms during storage and after they are opened. They are effective at low levels so that it doesn’t take much of the ingredient to work. There are many different types of materials that can be used in products and they are selected based on the specific type of product. A water-based product may use a different type of ingredient (or combination of ingredients) than an oil-based product.

The same ingredients that are used to protect cosmetic product integrity may also be used in OTC Antimicrobial drug products, although the amount added may be different. For OTC Antimicrobial drug products, the amounts allowed are prescribed in the FDA OTC drug monographs to ensure they are both safe and effective (and work as intended).

What are the types of Antimicrobial OTC drug products?

Consumer preference for antibacterial protection has led to an array of antibacterial personal care products. These products are designed to enhance personal hygiene by killing or controlling bacteria that can cause odor, skin infections, intestinal illnesses or other commonly transmitted diseases. The following briefly explains how different antibacterial personal care products play a role in personal hygiene and overall good health.

Antiperspirants and Deodorants - Antibacterial protection in deodorants enhances personal hygiene by controlling the growth of embarrassing, odor-causing bacteria.

Soaps - Antibacterial hand and body washes contain an ingredient that kills or controls bacteria that can cause illnesses, odor or skin infections. Unlike plain soaps, these products leave a very small amount of the antibacterial ingredient on the skin after rinsing to help inhibit the growth of bacteria left behind. Antibacterial soaps and washes are available in bar and liquid form.

Hand Sanitizers - Antibacterial hand sanitizers kill bacteria on hands without soap and water. These products are a good choice when hand washing with soap and water isn’t possible.

Lotions - Antibacterial lotions moisturize rough, dry skin and offer added protection by controlling bacteria. As with antibacterial soaps, a small amount of the antibacterial ingredient in lotions remains on the skin for an extended period of time to help inhibit the growth of bacteria.

Dental Products - Antibacterial dental products are formulated to reduce bacteria in the mouth that may ultimately lead to gum disease. Antibacterial toothpaste and mouthwash may help prevent plaque and gum diseases such as gingivitis.

Are Antimicrobial ingredients safe?

The safety of Antimicrobial ingredients has been assessed by a number of authoritative bodies (you can search this Web site for Antimicrobial ingredients). The Cosmetic Ingredient Review Expert Panel (CIREP) has conducted safety assessments of the most frequently used Antimicrobial ingredients that are used in personal care products and have found them safe. In addition, the FDA has considered the safety of Antimicrobial ingredients as they are used in foods, drugs, cosmetics and other products regulated by the FDA, and has found no reason to dissuade consumers from using these products. In October 2005, the agency expressed concerns, which have also been voiced by some in the scientific community, about the possibility that the products might result in antibiotic resistance. To date, however, there is no convincing evidence that products containing Antimicrobial ingredients cause increased resistance to antibiotics. Moreover, other jurisdictions, such as the European Union, Japan and Canada have assessed the safety of Antimicrobial ingredients and found no basis for consumers to stop using products containing these ingredients.

What about the finding of Antimicrobial ingredients in the environment?

The United States Geological Survey (USGS) tested streams across the nation and reported its findings in 2002. The newly developed and sophisticated analytical test methods used by the USGS measured 95 different organic wastewater contaminants including, (in addition to a wide variety of pharmaceutical active ingredients) measurements of some Antimicrobial ingredients used in products regulated by the FDA. As noted in the USGS report, the selection of sampling sites was biased toward streams susceptible to contamination (i.e. downstream of intense urbanization and livestock production). The levels found in streams were exceptionally low - in most cases in the low part-per-billion (ppb) range. As noted by the USGS, “[t]he concentrations measured during this study were generally very low. Fourteen of the 95 compounds have some kind of drinking-water guidelines, health advisories, or aquatic-life criteria established. However, they were rarely exceeded. Agencies such as the U.S. Environmental Protection Agency, and the Food and Drug Administration have regulatory programs to protect public and ecosystem health, and processes are in place for licensing and regulation of new compounds that might make their way into the environment. More is yet to be learned about the potential toxicological effects of many of the compounds under investigation. The information provided by this study will be useful to future research and regulatory decision-making.” See: http://toxics.usgs.gov/regional/emc_faq/9.html
Full Report: http://pubs.acs.org/journals/esthag/36/i06/pdf/es011055j.pdf

FDA links for antibiotic resistance and environmental issues:
Antibiotic Resistance: http://www.fda.gov/oc/opacom/hottopics/anti_resist.html
FDA Non-Prescription Drug Advisory Committee Meeting Oct. 20-21, 2005: http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4184T1.pdf

Likewise, other studies have generally found that Antimicrobial ingredients pose no significant risk to the environment because only trace amounts are detectable in effluent water. Some scientists have suggested that the impact of certain Antimicrobial ingredients on the environment may pose health risks and the FDA has raised similar concerns, but no concrete evidence shows that exposure of humans to the small amounts of these ingredients that are present in the environment poses any risk of harm.

More information:

Search the FDA Code of Federal Regulations:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

Link to the European Union Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_dir.htm

US Geological Survey Hydrology Program:
http://toxics.usgs.gov/regional/emc/index.html

FDA National Antimicrobial Resistance Monitoring System (NARMS) for Veterinary Drugs:
http://www.fda.gov/cvm/narms_pg.html

Centers for Disease Control and Prevention Antimicrobial/Antibiotic Resistance Program:
http://www.cdc.gov/drugresistance/

Link to the European Union Cosmetics Ingredients Inventory
http://ec.europa.eu/enterprise/cosmetics/html/cosm_inci_index.htm