At the end of last year, the U.S. Food and Drug Administration (FDA) banned 24 ingredients commonly used in over-the-counter (OTC) topical antiseptics. These active ingredients – which are now no longer ‘generally recognized as safe and effective’ – include triclosan, an antibacterial and antifungal agent found in many consumer and health care products.
Products covered by this rule include hand washes, rubs, and scrubs used by health care professionals (both in and out of hospital), as well as patient antiseptic skin cleansers for both pre-operative and pre-injection purposes.
Components of these products were first assessed several decades ago, when an advance notice of proposed rulemaking was published in the Federal Register in 1974 (39 FR 33103). Examination of data since revealed that “systemic exposure to these active ingredients was higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure was now available.” Further to this, it was stated that “widespread antiseptic use could have an impact on the development of bacterial resistance.”
In September 2016, many of the 24 ingredients were found not to be generally recognized as safe and effective in “consumer antiseptic hand washes” in a Final Rule that took effect in September of last year (81 FR 61106). In this ruling, the FDA prohibited the sale of consumer antiseptic hand washes containing triclosan or 18 other ingredients marketed as antimicrobials due to FDA findings of lack of efficacy in these products.
“Generally recognized as safe and effective”
‘Generally recognized as safe and effective’ – commonly abbreviated to GRAS/GRAE or GRASE – is a designation for certain old drugs that do not require prior approval from the FDA in order to enter the U.S. market, because they are (generally) considered to be safe and effective by medical professionals.
A drug is not considered to be a new drug only when it is deemed to be GRAS/GRAE. In order to conclude a GRAS/GRAE determination, a drug must satisfy the following:
- It must have been subjected to adequate and well-controlled clinical investigations that establish the product as safe and effective.
- The investigations must have been published in the scientific literature available to qualified experts.
- The experts must generally agree, based on the published studies, that the product is safe and effective for its intended uses. As a bare minimum, the general acceptance of a product as GAS/GRAE must be supported by the same quality and quantity of scientific and/or clinical data necessary to support the approval of a New Drug Application.
Triclosan – which was developed in the 1960s – is an ingredient added to many consumer and health care products intended to reduce or prevent bacterial contamination. It is used in antibacterial soaps and body washes, toothpastes, and some cosmetics, as well as clothing, kitchenware, furniture and toys.
Triclosan’s efficacy as an antimicrobial agent, the risk it poses for the development of antibiotic resistance, and its possible role in disrupted hormone development remain controversial, and additional studies are currently being carried out in an attempt to assess the safety of the chemical, and to understand its potential effects on organisms and environmental health.
What does the ban mean for these 24 ingredients?
In its Final Rule (82 FR 60474), the FDA found that these ingredients were not generally recognized as safe and effective. This applies to the 24 ingredients where they are present in non-prescription or OTC antiseptic products “intended for use by health care professionals in a hospital setting or other health situations outside the hospital setting”.
All products containing these ingredients must now go through a pre-market review, and the FDA will consider these as new drugs – requiring manufacturers to gain approval through New Drug Applications.
Which 24 chemicals have been banned?
The 24 chemicals which are no longer GRAS/GRAE are as follows:
- Chlorhexidine gluconate
- lodophors (Iodine-containing ingredients)*
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)*
- Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)*
- Iodine tincture USP
- Iodine topical solution USP
- Nonylphenoxypoly (ethyleneoxy) ethanoliodine*
- Poloxamer—iodine complex*
- Undecoylium chloride iodine complex*
- Mercufenol chloride
- Methylbenzethonium chloride*
- Secondary amyltricresols*
- Sodium oxychlorosene*
- Triple dye*
- Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
- Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol
(Those noted with * were also covered in the September 2016 consumer hand wash determination)
When does the Final Rule take effect?
The FDA have given manufacturers one year to reformulate or remove products with these ingredients from the market. The new status of the 24 no longer GRAS/GRAE chemicals takes effect on December 20, 2018, and preparations containing these active ingredients will require approval prior to marketing after this date.
If you are a manufacturer or importer of any of these 24 banned chemicals, it is important to be aware of this ruling, and how it may impact your business in the future.
UL’s global Regulatory Assurance Team have a wealth of worldwide expertise, and are constantly monitoring the legislation to ensure that our solutions are fully up to date, and to help thousands of companies sustain chemical regulatory compliance. Contact us to find out more.