CIR Panel Unsure About Safety Of Formaldehyde-Releasing Pro Hair Smoothers

The Cosmetic Ingredient Review Expert Panel re-examined formaldehyde and methylene glycol March 4, recognizing the need for a prompt ruling in light of recent reports of adverse events associated with professional hair-straightening products and concerns about the chemicals' safety in other cosmetics.

“There are numerous complaints about harms associated with this, and consumers understand there are problems with the safety of this product,” Rachel Weintraub, a non-voting expert panel member and director of product safety and senior counsel at the Consumer Federation of America, noted during the meeting.

“I think it’s important to get the word out to consumers as soon as possible so that consumers understand the risks they are taking by using this product," she said.

The panel members agreed, issuing a tentative final report with a three-part conclusion, based on the preservative ingredients' different applications in personal care.

The group reaffirmed its 2005 determination that formaldehyde and methylene glycol are safe in cosmetic products “when formulated to ensure use at the minimal effective concentration" and not in concentrations exceeding 0.2%.

However, the panel could not conclude that formaldehyde/methylene glycol are safe in cosmetic products intended to be aerosolized, or when the vapor or gas of the ingredients is produced under conditions of use, as is the case with many keratin-based hair-straightening products.

Additionally, the expert panel determined that current data on the safety of formaldehyde and methylene glycol in nail-care products were insufficient. CIR seeks information regarding nail-salon exposure levels and looks to clarify FDA’s position on permissible levels of the ingredients in nail products.

On its website, FDA says that "in the past, [it] has not objected to [formaldehyde's] use as an ingredient of nail hardeners," provided that the concentration does not exceed 5% and the consumer is given adequate directions for use, warned about potential safety issues and equipped with nail shields "which restrict application to the nail tip."

Consumer Safety Mission Spurs Panel Forward

While there was discussion among panel members about tabling review of formaldehyde/methylene glycol until additional data are available, the group decided to push ahead with the tentative final ruling, mainly due to aerosol and vaporized safety concerns.

“We wanted to move this ahead in the interest of hopefully protecting the consumer from products that we feel would be considered unsafe because not only is its concentration greater than 0.2% methylene glycol, but because of vaporization in the heating process,” panel member and Kansas City dermatologist Donald V. Belsito explained.

Taking into consideration the panel's conclusions, the Personal Care Products Council issued a statement March 9 urging consumers to “exercise caution” in using professional hair-straightening products "until the review is completed and regulatory authorities have had the opportunity to assess it and come to their own conclusions."

The trade association points out that "the panel did not evaluate any potential mitigating effects of ventilation in salons in which the treatments are given."

Panel member Ronald A. Hill, associate professor of medicinal chemistry at the University of Louisiana at Monroe, suggested during the meeting that CIR's decision regarding formaldehyde and methylene glycol in professional hair-smoothing products should take into account the various conditions that might affect their safety.

“We know people are having reactions, and we probably have some idea why, but I don’t think we can conclusively say right now based on the science that [professional hair straightening] isn’t safe and that it shouldn’t be used under [any] circumstances.”

Bailey remarked that it is “possible to envision circumstances for properly ventilated and properly trained individuals to use these hair-smoothing products in a safe way” and said it is up to the panel to make a distinction if needed.

Panel members emphasized that the rulings on formaldehyde and methlyene glycol could be modified or changed before they are made final.

In the meantime, the Council is pressing FDA "to work expeditiously with [the U.S. Occupational Safety and Health Administration] and appropriate state and local organizations to objectively determine if salon hair-smoothing products emit levels of formaldehyde gas that are unsafe for consumers or salon workers."

Because sufficient ventilation and properly trained application are such important factors in the safety of hair straighteners that contain formaldehyde or formaldehyde-releasing chemicals, the Council "strongly advises" against use of the products in the home.

The Consumer Federation of America is taking a harder line on the products, recommending that consumers and stylists stop using the products altogether.

The group suggests in a March 9 release that keratin-based hair-smoothing products have the potential to expose users to levels of formaldehyde even if formaldehyde is not listed on product labeling, since there are formaldehyde-releasing preservatives, such as methylene glycol, that may have unfamiliar names.

“The CIR Panel review clarifies how formaldehyde can be formed from heating up a ‘keratin-based’ hair-smoothing product and how consumers and stylists can be at risk from formaldehyde exposure during the application of this product," Weintraub states. “We urge consumers and stylists to stop using this product until manufacturers can verify that these products do not emit dangerous levels of formaldehyde."

Both the Federation and the Council urge consumers and stylists to notify FDA of adverse effects from use of keratin-based hair smoothing products.

Panel Grapples With Its Regulatory Role

During the meeting, panel members questioned the expert panel’s role and the extent to which its work should inform regulation of formaldehyde and methylene glycol. The panel is reviewing the ingredients at the request of both FDA and the Council.

“Although we certainly know about the adverse events that are occurring now, the question is: Are we the right body right now to move forward and address this?” asked panelist James G. Marks, Jr., dermatology department chair at Pennsylvania State University's College of Medicine.

Linda Katz, director of FDA’s Office of Cosmetics and Colors, said the agency is doing some of its own research on professional hair-smoothing products, but is counting on CIR's help.

“We are in the process of doing the research that we need to on the products specifically for which we’ve received complaints, but there are missing pieces,” she said. “And part of the missing piece is really the safety issue for what one could expect or one should look for in a product, and that was part of the reason that we asked for [CIR’s] help.”

Plant Fatty Acid Oils, Alkyl Benzoates Are Safe

Also at the March 4 meeting, the CIR expert panel came to final “safe as used” rulings for plant-derived fatty acid oils as well as C12-15 alkyl benzoates and related alkyl benzoates (see chart). Diethanolamine (DEA) and related DEA-containing ingredients garnered a tentative final “safe as used” ruling, with the condition that they be formulated to be non-irritating.

The panel issued insufficient data announcements for silylates and surface modified sioxysilicates as well as acrylate cross polymers. For acrylate cross polymers, the panel identified a need for data regarding benzyne toxicity.

The group opted not to re-open reviews of disperse blue 1 and quaternium 15.

The next panel meeting is slated for June 27-28 in Washington.

By Lauren Nardella