Editor's Note: Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME) have reintroduced the Personal Care Products Safety Act to strengthen the FDA's authority to regulate the ingredients in personal care products. The bill would provide FDA the authority to: order recalls of personal care products; require labeling to include ingredients not appropriate for children or that should be professionally administered; require complete label information to be posted online; require companies to provide contact information on their products for consumers and report serious adverse events to FDA within 15 days; require manufacturers to register annually with FDA and provide information on ingredients used in products; and issue regulations on Good Manufacturing Practices for personal care products. To fund these new oversight activities, the bill would authorize FDA to collect user-fees from personal care products manufacturers similar to what is done for medications and medical devices.
March 11, 2017
Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) [on March 11] introduced the
Personal Care Products Safety Act
to protect consumers' health and create uniform safety rules for companies by strengthening the Food and Drug Administration's (FDA) authority to regulate the ingredients in personal care products. While the personal care products industry is projected to exceed $60 billion in U.S. revenue, federal safety rules for these products have not been updated since 1938.
The bill, which is supported by a wide range of consumer groups and companies, builds on progress made in the previous Congress by strengthening the bill's small business protections, earning the support of the Handmade Cosmetic Alliance, Handcrafted Soap & Cosmetic Guild, and Coalition of Handcrafted Entrepreneurs.
"From shampoo to lotion, everyone-women, men, children-uses personal care products every day," said Senator Feinstein.
"Despite the universal use of these products, none of their ingredients have been independently evaluated for safety. This puts consumer's heath at risk and we urgently need to update the nearly 80-year-old safety rules. In contrast, Europe and Canada have robust systems with strong consumer protections including ingredient review and product registration. Our bill is supported by companies and consumer groups alike. We hope to build on the tremendous progress we've made in putting together a broad coalition to get the Senate to pass this important bill this year."
"Americans use a variety of personal care products daily, and they should be able to know whether the products that they are applying to their hair or skin are safe," said Senator Collins.
"By updating FDA oversight of the ingredients in cosmetics and personal care products for the first time in nearly 80 years, our legislation will help increase safety for consumers, protect small businesses, and provide regulatory certainty for manufacturers."
Consumer and health advocates are concerned about the use and concentration of some of the ingredients 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 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.
This bill would require the FDA to evaluate a minimum of five ingredients per year to determine their safety and appropriate use. 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.
- 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 FDA the authority to order recalls of certain personal care products that threaten consumer safety.
- Provide FDA the authority to require labeling of products that include ingredients not appropriate for children and those that should be professionally administered.
- Require complete label information to be posted online, including ingredients and product warnings, would also be required to be posted online since approximately 40 percent of personal care products are purchased over the Internet.
- Require companies to provide contact information on their products for consumers and report serious adverse events to 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.
- Require manufacturers to register annually with FDA and provide the agency with information on the ingredients used in their personal care products.
- Direct FDA to issue regulations on Good Manufacturing Practices for personal care products.
To fund these new oversight activities, the bill would authorize FDA to collect user-fees from personal care products manufacturers similar to what is done for medications and medical devices.
The bill is supported by the following companies:
- Au Naturale
- Babo Botanicals
- Coalition of Handcrafted Entrepreneurs
- Éclair Naturals
- The Estee Lauder Companies (Brands include Estée Lauder, Clinique, Origins, Tommy Hilfiger, MAC, La Mer, Bobbi Brown, Donna Karan, Aveda, Michael Kors)
- EO Products
- Goddess Garden Organics
- Handcrafted Soap & Cosmetic Guild
Handmade Cosmetic Alliance
- Herban Lifestyle
- The Honest Company
- Johnson & Johnson (Brands include Neutrogena, Aveeno, Clean & Clear, Lubriderm, Johnson's baby products)
- Juice Beauty
- L'Oreal (Brands include L'Oréal Paris, Lancome, Giorgio Armani, Yves Saint Laurent, Kiehl's, Essie, Garnier, Maybelline-New York, Vichy, La Roche-Posay, Redken)
- Procter & Gamble (12 brands) (Brands include Pantene, Head & Shoulders, Herbal Essences, Secret, Ivory, Olay, Aussie, Old Spice)
- Revlon (Brands include Revlon, American Crew, Elizabeth Arden, Almay, Mitchum)
- Unilever (Brands include Dove, Tresemme, Lever, St. Ives, Noxzema, Nexxus, Pond's, Suave, Sunsilk, Vaseline, Degree, Axe)
The bill is supported by the following health and consumer organizations:
- American Cancer Society Cancer Action Network
- Caregiver Action Network
- Endocrine Society
- Environmental Working Group
- March of Dimes
- National Alliance for Hispanic Health
- National Psoriasis Foundation
- Society for Women's Health Research