On April 20, U.S. Senator Dianne Feinstein (D-California) and U.S. Senator Susan Collins (R-Maine) introduced the Personal Care Products Safety Act, which they say will protect consumers and streamline industry compliance by strengthening the U.S. Food and Drug Administration’s authority to regulate ingredients in personal-care products.
The introduction of the 98-page bill is the first step in a lengthy legislative process—one that has seen bills affecting personal-care products and their manufacturers fail in past years.
One trade association in the beauty business—the Independent Cosmetic Manufacturers and Distributors—has stated its opposition to this bill as it is.
“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 [such as] product registration and ingredient reviews. I am pleased to be introducing this bipartisan legislation with Senator Collins that will require [the] FDA to review chemicals used in these products and provide clear guidance on their safety.”
Senator Collins added, “I am pleased to be working with Senator Feinstein on legislation to modernize [the FDA's] regulation of cosmetics and personal-care products, which are widely used by consumers—often on a daily basis. 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.”
If passed, the bill would require the FDA to evaluate a minimum of five ingredients per year to determine their safety and appropriate use. The first set for review includes:
- Diazolidinyl urea
- Lead acetate
- Methylene glycol/formaldehyde
- Propyl paraben
The review process detailed in the bill would provide companies with guidance about whether ingredients should continue to be used and, if so, what the concentration levels should be and whether consumer warnings are needed.
The 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 for professional-use only. Complete label information, including ingredients and product warnings, would also be required to be posted online
- 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—as written now—would authorize the FDA to collect user fees from personal care-product manufacturers, similar to what's done for medications and medical devices.
ICMAD opposes the bill as currently drafted because it "places too large a burden on small business, stifles innovation in the cosmetics and personal-care industry, and does not provide appropriate and significant national uniformity," according to ICMAD officials.
Pam Busiek, ICMAD CEO, stated, “ICMAD has a long track record of working with federal regulators to promote product safety, honor the best science in our industry, and advance small businesses that innovate and provide jobs. We admire Senator Feinstein’s sincere efforts toward these goals, and we welcome her partnership. However, the approach taken in this legislation is in conflict with these goals.”
As an organization of small-business entrepreneurs, ICMAD officials noted that they plan to continue to collaborate with its sister organizations—the Professional Beauty Association and the Personal Care Products Council—and the FDA to modernize federal laws and ensure that consumers get safe, high-quality, innovative products that help them look and feel their personal best.
As of the end of business on April 21, the PBA hadn't issued a statement nor taken a position on the legislation. The entire bill wasn't made available until April 21, and the PBA wants to thoroughly review the legislation in its entirety, officials from the PBA have told Beauty Store Business. The PBA also looks forward to continuing to work with its sister organizations as well as Senator Feinstein's office in the legislative process, they added.
Lezlee Westine, president and CEO of the Personal Care Products Council, said, “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. 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 [the] 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.
“Given this history and the complexities of both the legislative and regulatory process, we greatly appreciate Senator Feinstein’s leadership in introducing legislation to create a more contemporary regulatory system for the cosmetics and personal-care sector. The introduction of the Personal Care Products Safety Act is an important and positive step forward. Furthermore, we applaud the senator’s efforts in bringing multiple stakeholders together to address reform.
“We look forward to continuing our work with Senator Feinstein, Senator Collins, members of the Health, Education, Labor and Pensions Committee, and other relevant stakeholders to further strengthen the bill and move it forward in Congress. And, we remain firmly committed to ensuring [that the] FDA has the appropriate funding, resources and administrative authority over our products for the 21st century.”
Jennifer Abril, president of the International Fragrance Association, North America, commented, “IFRA North America thanks Senators Feinstein and Collins for their leadership to ensure that [the] FDA has the appropriate resources and information to be effective and efficient in implementing a new cosmetic-registration scheme. We are committed to working with Congress to safeguard the health of families and advance confidence in the industry, while encouraging innovation and growth.
“While we look forward to reviewing the bill in its entirety, we believe the fragrance provisions offer a sensible framework giving the FDA more tools to review cosmetics and their ingredients in support of consumers.
“The proposals pertaining to fragrances offer a new system that would model provisions found in the International Fragrance Association’s Code of Practice that direct fragrance houses to cooperate with authorities when investigating adverse reaction reports. This would put the FDA in direct contact with fragrance suppliers to solve any potential concerns.
“As this bill makes its way through the legislative process, IFRA North America looks forward to working with Senators Feinstein and Collins, along with all relevant stakeholders, to build a regulatory program that ensures ingredients are safe for their intended use.”
According to Senator Feinstein's office, the bill—which is the result of numerous discussions with stakeholders and extensive consultation with the FDA—is supported by these companies:
- Procter & Gamble
- Estée Lauder
- Johnson & Johnson
Also, according to Senator Feinstein's office, the bill is supported by these consumer groups:
- Environmental Working Group
- Society for Women’s Health Research
- National Alliance for Hispanic Health
[Image courtesy of the office of U.S. Senator Dianne Feinstein and the U.S. Senate]