Senators Introduce Bill to Strengthen Personal Care Product Oversight

Washington—Senators Susan Collins (R-Maine) and Dianne Feinstein (D-Calif.)  today introduced the Personal Care Products Safety Act to protect consumers and streamline industry compliance 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 this year, federal regulations on these products have not been updated in 75 years.

The bill, which is the result of numerous discussions with stakeholders and extensive consultation with the FDA, is supported by the following companies:

  • Personal Care Products Council (a trade association representing more than 600 companies in the industry)
  • Johnson & Johnson (brands include Neutrogena, Aveeno, Clean & Clear, Lubriderm, Johnson’s baby products)
  • Procter & Gamble (brands include Pantene, Head & Shoulders, Clairol, Herbal Essences, Secret, Dolce & Gabbana, Gucci, Ivory, Cover Girl, Olay, Sebastian Professional, Vidal Sassoon)
  • Revlon (brands include Revlon, Almay, Mitchum)
  • Estee Lauder (brands include Estée Lauder, Clinique, Origins, Tommy Hilfiger, MAC, La Mer, Bobbi Brown, Donna Karan, Aveda, Michael Kors)
  • Unilever (brands include Dove, Tresemme, Lever, St. Ives, Noxzema, Nexxus, Pond’s, Suave, Sunsilk, Vaseline, Degree)
  • L’Oreal (brands include L’Oréal Paris, Lancome, Giorgio Armani, Yves Saint Laurent, Kiehl’s, Essie, Garnier, Maybelline-New York, Vichy, La Roche-Posay, The Body Shop, Redken)

The bill is also supported by the following consumer groups:

  • Environmental Working Group
  • Society for Women’s Health Research
  • National Alliance for Hispanic Health
  • HealthyWomen
  • Endocrine Society
  • National Psoriasis Foundation

“I am pleased to be working with Senator Feinstein on legislation to modernize FDA regulation of cosmetics and personal care products, which are widely used by consumers often on a daily basis,” said Senator Collins. “By improving FDA oversight of the ingredients in cosmetics and personal care products, this legislation aims to protect consumers while also providing regulatory certainty for manufacturers, enabling them to plan for the future.”

“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 Senator 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 Senator 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.”

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
  • 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.
  • 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 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 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.
  • Require manufacturers to register annually with the FDA and provide the agency with information on the ingredients used in their personal care products.
  • Direct the FDA 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.