CTFA Announces that Trade Associations in U.S., Europe, Canada, and Japan Sign Agreement to Propose Forum for Global Regulatory Harmonization

The Cosmetic, Toiletry, and Fragrance Association (CTFA) announced today that the cosmetics and personal care products trade associations in the U.S.(CTFA), Europe (COLIPA), Canada (CCTFA) and Japan (JCIA)  have signed and formally proposed to their respective regulators a new forum for global harmonization of regulations for cosmetics and personal care products. The agreement was signed today at a meeting of the trade associations prior to the CTFA Annual Meeting in Boca Raton, Florida.

“Consumers want safe products that are available and consistently regulated across the globe and companies need predictable regulatory regimes in order to maintain product innovation,” said Pamela G. Bailey, CTFA President and CEO.  “This new initiative is an important step toward real global regulatory harmonization that will benefit both consumers and companies. It is time that cosmetics and personal care products have the same type of global regulatory alignment that has already been achieved for other FDA-regulated products like drugs and medical devices through processes in which industry and regulatory authorities participate.”

Global alignment and mutual recognition for cosmetics is important because manufacturers currently face country-specific regulations that significantly impact costs and market access.

The regulatory harmonization initiative is part of a comprehensive international engagement strategy at CTFA.   Over the last year, CTFA has been building a much more robust and proactive global strategies program in order to better support the important global market opportunities for CTFA members and to advance consumer protection, trade, and industry growth globally.  CTFA has expanded its proactive strategic work in China – Last summer it sent a mission to China, and last September it hosted a delegation from the Chinese Ministry of Health.

The association has also been active on issues with Russia, Korea, Japan and Latin America, collaborating with local industry associations and dealing with government officials, and regulators.   

In the U.S., CTFA has stepped up its engagement with the U.S. government, meeting regularly with members of Congress and their staffs and with USTR and Commerce Department representatives to ensure that cosmetics and personal care products issues are integrated into the U.S. trade agenda, including the U.S. Korea Free Trade Agreement and the U.S. Japan Regulatory Reform Initiative. CTFA also is active in key policy forums on trade issues, such as the U.S. Chamber, the European Institute, and the Business Council for International Understanding (BCIU).

CTFA Statement on Essential Oils

In what it called a “brief report,” the New England Journal of Medicine (NEJM) today linked prepubertal gynecomastia [breast enlargement] in young boys to the use of products with lavender or tea tree oils.  Correlating essential oils exposure to gynecomastia was first reported at the Endocrine Society meeting in June 2006. At that time, investigators reported that it was too soon to draw any firm conclusions from the observations of five boys found using topical products that listed lavender or tea tree oils among their ingredients. They concluded that “an epidemiological study would be appropriate to determine whether genetic or environmental factors might also contribute to the observed effect.”

The earlier report has now been published in the NEJM describing gynecomastia in three subjects as opposed to the five presented in the earlier report.  Authors of the NEJM’s report describe prepubertal gynecomastia as “extremely uncommon.”

It is important to note that this report does not present any information about the content of these essential oils in the products referenced; therefore it is not possible to determine accurately any measure of exposure (area and frequency of application) or if there is a correlation between content and effect. One of the patients reportedly used lavender and tea tree oil-containing styling gel and shampoo; neither product type would result in significant exposure. Another used both soap and lotion, but the lotion use was described as intermittent, and exposure from soap would be minimal since it is a rinse-off product.  None of these exposures are consistent with a cause and effect relationship.

The NEJM described in vitro results indicating that these essential oils have estrogenic and anti-androgenic effects.  However, these are not rigorous tests that are adequate to establish or confirm an estrogenic and/or anti-androgenic effect.  In fact, the authors themselves describe the estrogenic and anti-androgenic effects obtained in these in vitro studies as “weak”.  This means that the evidence is not sufficient to establish exposure to tea tree oil and lavender oil in prepubertal gynecomastia, which is a highly uncommon condition.

The cosmetic industry, in conjunction with the fragrance industry, will continue to follow the medical literature to determine whether this is more than just a clinical oddity in a very limited sample.

CTFA Statement on Dioxane

Test results recently released by several environmental activist groups state that some shampoos and bath products contain trace amounts of 1,4-Dioxane, a chemical byproduct that occurs during the manufacture of some raw materials.  According to the groups, 1,4-Dioxane was found in concentrations of 1.5 parts per million (ppm) to 23 ppm with an average of 7.4 ppm. The groups assert that some of these findings exceed a limit of 10 ppm set by FDA for cosmetic products.

The groups erroneously claim that in 1985 the U.S. Food and Drug Administration (FDA) asked the cosmetic industry to voluntarily limit dioxane to 10 ppm.  However, the FDA has set no limits for 1,4-Dioxane in cosmetics and personal care products, and the levels of 1,4-Dioxane reported in these products present no risk to consumers.  Products reported to contain 1,4-Dioxane are safe, and consumers can use them with confidence.

Dioxane is a trace level material found in some raw materials used in the preparation of shampoos and bubble baths.  The presence of 1,4-Dioxane is easily controlled, and raw material manufacturers routinely take steps to reduce the levels as low as possible.  Shampoos and bubble baths do not result in a significant exposure because they are quickly rinsed off after use. The low levels reported in these products are proof that the cosmetic industry is effectively keeping the levels far below any level that might be of concern.

FDA Authority:

The U.S. Food and Drug Administration (FDA) has broad legal authority to regulate the safety of cosmetic products.  The Federal Food, Drug, and Cosmetics Act (FD&C Act) requires that every cosmetic product and its individual ingredients be substantiated to be safe, and that its labeling be truthful and not misleading.

Manufacturers are responsible for ensuring that products comply with the law before they are marketed.  This process includes analyzing an ingredient’s testing and safety data. If the manufacturer cannot substantiate the safety of the product, then the product must carry a conspicuous warning.

The law provides severe penalties for products that do not meet FDA standards.  Specifically, the law gives FDA the authority:

  • To ban or restrict ingredients for safety reasons
  • To mandate warning labels
  • To inspect manufacturing facilities
  • To issue warning letters
  • To seize unsafe or misbranded products
  • To enjoin unlawful activities
  • To prosecute and jail violators
  • To work with manufacturers in implementing nationwide product recalls
  • To collect samples for examination and analysis as part of plant inspections, import inspections, and follow-up to complaints of adverse reactions.
  • To conduct research on cosmetic products and ingredients to address safety concerns.

In addition to the Federal Food, Drug, and Cosmetics Act safety authority, the Fair Packaging and Labeling Act authorizes FDA to require ingredient labeling of cosmetic products sold to consumers.  Detailed FDA regulations govern where and how ingredients must be listed on the package.

Cosmetics are among the safest of all consumer products sold in the United States.  Their continued safety is ensured by FDA’s authority to regulate and ongoing industry voluntary programs.