New GMPs, greater regulation introduced with Personal Care Products Safety Act
WASHINGTON — Industry-supported legislation was introduced Monday that would update 75-year-old regulations governing the personal care products industry by Sens. Dianne Feinstein, D-Calif., and Susan Collins, R-Maine.
The Personal Care Products Safety Act is designed to protect consumers and streamline industry compliance by strengthening the Food and Drug Administration’s authority to regulate the ingredients in the $60 billion personal care product industry.
“From shampoo to lotion, the use of personal care products is widespread, however, there are very few protections in place to ensure their safety,” said Feinstein. “Europe has a robust system, which includes consumer protections like product registration and ingredient reviews. I am pleased to be introducing this bipartisan legislation with Sen. Collins that will require FDA to review chemicals used in these products and provide clear guidance on their safety. In addition, the legislation has broad support from companies and consumer groups alike.”
“For more than five years, the Personal Care Products Council and its member companies have worked collaboratively with members of Congress seeking to reform federal regulatory oversight for cosmetics and personal care products," the Council stated. "We support the creation of a national standard that maintains the continued safety of our products while providing the U.S. Food and Drug Administration with additional regulatory authority over our industry. While we believe our products are the safest category that FDA regulates, we also believe well-crafted, science-based reforms will enhance industry’s ability to innovate and further strengthen consumer confidence in the products they trust and use every day. The current patchwork regulatory approach with varying state bills does not achieve this goal."
Consumer and health advocates are concerned about the use and concentration of some chemicals in personal care products. For example, according to the Centers for Disease Control and Prevention, short-term exposure to formaldehyde, which is used in smoothing hair treatments, has been reported to cause a range of negative health effects. Initially, these can include headaches and shortness of breath in consumers and the professionals who apply the chemicals. However, long-term exposure to formaldehyde has been associated with increased risk of cancer, and the Occupational Safety and Health Administration requires salon owners to provide their workers with protective equipment, including masks and goggles, when applying this chemical.
In another example, propyl paraben, which is used as a preservative in a wide range of products, mimics estrogen and may be appropriate only in certain concentrations. According to scientific studies, chemicals that mimic estrogen can disrupt the endocrine system and have been linked to a wide range of health effects, including reproductive system disorders.
The bill would require the FDA to evaluate a minimum of five ingredients per year to determine their safety and appropriate use – the two chemicals mentioned above are among those to be reviewed in the first year. The review process set forth in the bill would provide companies with clear guidance about whether ingredients should continue to be used and if so, what the concentration levels should be and whether consumer warnings are needed. For example, a chemical may be deemed inappropriate for use in children’s products, or appropriate for professional application only.
The first set of chemicals for review includes:
Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion;
Lead acetate, which is used as a color additive in hair dyes;
Methylene glycol/formaldehyde, which is used in hair treatments;
Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion; and
Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers.
The bill would provide streamlined federal standards so that the personal care products industry knows what to expect and companies can plan for the future with certainty.
The Personal Care Products Safety Act would also provide the FDA the authority to order recalls of certain personal care products that threaten consumer safety, as well as provide the FDA the authority to require labeling of products that include ingredients not appropriate for children and those that should be professionally administered. Complete label information, including ingredients and product warnings, would also be required to be posted online since approximately 40% of personal care products are purchased over the Internet.
And the new legislation would require companies to provide contact information on their products for consumers and report serious adverse events to the FDA within 15 days, including death, hospitalization and disfigurement. Health effects that could have resulted in hospitalization without early intervention would also be required to be reported. Manufacturers would be required to register annually with the FDA and provide the agency with information on the ingredients used in their personal care products.
In addition, the FDA would be directed to issue regulations on Good Manufacturing Practices for personal care products.
To fund these new oversight activities, the bill would authorize the FDA to collect user-fees from personal care products manufacturers similar to what is done for medications and medical devices.
The bill, which is the result of numerous discussions with stakeholders and extensive consultation with the FDA, is supported by the Personal Care Products Council, Johnson & Johnson, Procter & Gamble, Revlon, Estee Lauder, Unilever and L’Oreal, as well as the Environmental Working Group, the Society for Women’s Health Research, the National Alliance for Hispanic Health and HealthyWomen.