Statement by John Bailey, Chief Scientist, Personal Care Products Council: Industry Concerned About Safety of Ingredient in Professional Hair Smoothing Products

Background:  The U.S. Food and Drug Administration (FDA) has reported receiving adverse event reports from consumers and salons on “professional use only” hair smoothing products.  Adverse reactions to products used to smooth and straighten hair that have been reported include eye irritation, breathing problems, headaches, and rashes.

FDA has authority over hair straighteners and similar cosmetic products, including those intended for professional use only, but does not have authority over the operation of salons.  The Food, Drug, and Cosmetic Act gives FDA broad legal authority to protect the public if any personal care product is determined to be unsafe or improperly labeled. The Occupational Safety and Health Administration (OSHA) is responsible for regulating workplace safety, such as conditions in an operating salon. Salons are also subject to state and local safety guidelines, which may specify safety practices such as assuring proper ventilation.

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“The Personal Care Products Council (PCPC) and its members are concerned about recent consumer reports of adverse reactions to ‘professional use only’ hair smoothing products.  These products have been reported to contain high levels of formaldehyde1, which under some conditions of use can be sensitizing and irritating to users.  One of the specific issues to be evaluated by FDA is whether unsafe levels of formaldehyde are being released into the air once this product is applied to the hair and then heated.  When hair smoothing products that contain formaldehyde are heated, they can release low levels of formaldehyde gas. Formaldehyde and methylene glycol are sensitizing agents, and consumers may experience allergic reactions if they become sensitized.

“The Cosmetic Ingredient Review (CIR) Expert Panel, an independent, non-profit body of scientific and medical experts that assesses the safety of ingredients used in cosmetics in the U.S., last reviewed the use of formaldehyde in beauty products in 2005 and concluded that, ‘…because of skin sensitivity of some individuals to this agent, the formulation and manufacture of a cosmetic product should be such as to ensure use at the minimal effective concentration of formaldehyde, not to exceed 0.2 percent measured as free formaldehyde. It cannot be concluded that formaldehyde is safe in cosmetic products intended to be aerosolized.’

“The primary application considered by the CIR during their review was the use of formaldehyde as a preservative to prevent the growth of potentially harmful microorganisms in cosmetic products.  The CIR did not examine the use of formaldehyde in hair straightening and smoothing treatments. Therefore, PCPC has joined with FDA in asking CIR to review the safety of formaldehyde and methylene glycol in professional use hair smoothing products.

“In addition, we urge FDA to work with state and local organizations, as well as with the federal Occupational Safety and Health Administration (OSHA), which is responsible for regulating workplace safety, to objectively determine if salon hair smoothing products emit levels of formaldehyde gas that are unsafe for consumers and salon workers under their intended conditions of use. We recommend FDA take prompt and appropriate action to make sure that these products have been fully tested and substantiated for safety under the conditions of use.

“Safe and proper use depends largely  on the ventilation in the salon and the application procedure, which is why we advise consumers not to use professional hair straightening products at home, but to visit a salon for proper application by trained salon workers.  Consumers who do visit a salon to receive hair smoothing treatments should be certain that the salon is properly ventilated and that the products and application process meet the OSHA safety guidelines. The federal OSHA has established limits for safe levels of inhalation exposure to formaldehyde gas.

“We strongly encourage consumers to report any adverse reaction to FDA and to visit the FDA website for more information on this important consumer health issue http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm228898.htm.”

1Formaldehyde present in water or water-containing formulations exists mostly as methylene glycol with virtually no gaseous formaldehyde remaining. However, when heated and dried during use, it is possible that formaldehyde may be released from the product into the air and may be inhaled by the customer or salon worker.

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Activist Group Resurrects Old Allegations; Products Still Meet Established Safety Standards

The Campaign for Safe Cosmetics’ November 1 report on the safety of baby products contains nothing new or scientifically noteworthy.  Allegations made that commonly used baby products are contaminated with harmful levels of carcinogenic chemicals are false.

The U.S. Food & Drug Administration (FDA), the Cosmetic Ingredient Review (CIR) Expert Panel, an independent panel of scientific and medical experts who assess the safety of ingredients used in U.S. cosmetic and personal care products, and other authoritative bodies throughout the world have long been aware that the use of certain raw materials may result in the presence of 1,4 dioxane inadvertently, and formaldehyde at low levels in personal care products.

“The presence of these substances is well known and has been reviewed intensively and extensively by scientific experts worldwide. These reviews continue to conclude that these substances present no health concern as currently used,” said chemist and toxicologist Jay Ansell, Vice President, Cosmetic Programs at the Personal Care Products Council.  “Companies must conform with current manufacturing practices to minimize the levels of exposure,” said Ansell.

The allegations about the presence of 1,4 dioxane and formaldehyde in personal care products were made by the Campaign for Safe Cosmetics in March 2009 and September 2009, respectively.  Since then, the weight of scientific data on these chemicals has remained unchanged. When present, these chemicals would likely be found at very low levels precisely because companies have gone to great lengths in the formulation and manufacturing processes to verify that the products are safe and gentle for children and also protected from harmful bacterial growth.    

1,4 dioxane in personal care products

1,4 dioxane is a byproduct that can form during the manufacturing process for ingredients that help to ensure mildness of some personal care products such as shampoo and bubble bath.  The presence of 1,4 dioxane can be controlled and minimized, and raw materials manufacturers routinely take necessary steps to reduce its presence to the lowest feasible levels.

FDA has monitored 1,4 dioxane in cosmetic and personal care products since the late 1970s by assessing products and raw materials using sophisticated analytical methods.  FDA has stated that the 1,4 dioxane levels found in their monitoring of personal care products and cosmetics “…do not present a hazard to consumers:” http://www.fda.gov/Cosmetics/ProductandIngredientSafety/PotentialContaminants/ucm101566.htm.  The agency also has observed that the levels of 1,4 dioxane in cosmetic and personal care products have significantly declined over the years due to the “vacuum stripping” process in manufacturing.  

 

Formaldehyde from the use of Quaternium-15 or Q-15 in personal care products

Quaternium-15 or Q-15, which releases small amounts of formaldehyde, a material naturally found in the body, plays an important role in maintaining the safety and integrity of products by protecting against harmful bacterial growth. The Cosmetic Ingredient Review (CIR) and other regulatory authorities in the U.S., Europe and around the world have determined Q-15 to be safe for use in cosmetics and personal care products, including baby products.  

Q-15 has been studied extensively and its potential as an allergen is already widely understood and has been addressed in the expert reviews.  CIR has found it to be safe for use at a limit of 0.2 percent in personal care products: http://cir-safety.org/staff_files/SQ-safewithqualifications%207-11-2011%20final.pdf

FDA Regulatory Authority

Under the Food, Drug, and Cosmetic Act (FD&C), companies must substantiate the safety of all ingredients and products before they are marketed.  Federal law also requires that labeling be truthful and not misleading. The laws give FDA broad legal authority to regulate cosmetic and personal care products and provides severe penalties for the manufacturers of products that do not meet these standards, including fines, seizures, bans and prosecution.

Personal Care Products companies take the safety of their products very seriously.  Through collaboration with other medical and scientific professionals, companies understand the special needs of consumers who use their products and take into account those with sensitive skin.  Parents who notice that a product may be causing an allergic reaction in their child, should cease using the product and immediately consult with their pediatrician or health care provider.

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