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.