For 77 years the Food and Drug Administration (FDA) has regulated the cosmetics and personal care industry under the Federal Food, Drug, and Cosmetics Act of 1938. The fewer than a dozen pages of instructions served as the only guide on how to regulate the millions of lipsticks, moisturizers and other cosmetics sold each year.
On April 20th, 2015 Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (Sen. 1014) strengthening the FDA’s authority. The bill would provide streamlined federal standards so brands and manufactures know what to expect and can plan for the future with certainty.
The Personal Care Products Safety Act Would
- 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.
- Authorize the FDA to collect user-fees from personal care products manufacturers similar to what is done for medications and medical devices to fund the new oversight rules.
- Require the FDA to evaluate a minimum of five ingredients per year to determine their safety and appropriate use
Understanding the Ingredient Process
The review process would provide companies with clear guidance on whether an ingredient should continue to be used by consumers and if so, what the concentration levels should be and whether consumer warnings are needed. The first set of chemicals for review include:
- Diazolidinyl urea used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion
- Lead acetate used as a color additive in hair dyes
- Methylene glycol/formaldehyde used in hair treatments
- Propyl paraben used as a preservative a wide range of products including shampoo, conditioner and lotion
- Quaternium-15 used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers
The introduction of the bill marks a major milestone as the industry and the FDA were at a standstill on negotiations regarding the best way to move forward with updating the outdated law. Likewise, every congressional session over the last several years (at least 6 years) has seen the introduction of a cosmetics safety bill. This bill is the result of numerous discussions with stakeholders and extensive consultation with the FDA and is supported by the following companies and consumer groups:
- 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)
- Environmental Working Group
- Society for Women’s Health Research
- National Alliance for Hispanic Health