Utah senator Orrin Hatch introduced a new piece of legislation Wednesday called the FDA Cosmetic Safety and Modernization Act.
The bill amends the Federal Food, Drug and Cosmetic Act of 1938 by introducing new measures meant to regulate ingredients, monitor adverse reactions associated with cosmetics and establish good manufacturing practices.
One main component of the bill is that manufacturers or distributors must submit a report to the FDA on a “serious adverse event” associated with the use of a cosmetics product. The bill defines a “serious adverse event” as “death, life-threatening experience, in-patient hospitalization, a persistent or significant disability, incapacity or disfigurement, a congenial abnormality or birth defect and a permanent alteration of appearance.”
The bill also authorized reviews by the FDA on the safety of cosmetics ingredients, established mandatory manufacturing registration for domestic and foreign facilities and allowed the FDA to suspend registration of a facility that has reasonable probability of causing a serious adverse health consequence through a cosmetics product.
Sen. Dianne Feinstein, who proposed an updated version of her Personal Care Products Safety Act in May, showed her support for the bill in a statement issued to WWD: “Legislation to update 80-year-old safety rules for personal care products should include the strongest possible health protections and be supported by both companies and consumer groups,” she said. “I look forward to working with senator Hatch to move this issue forward.”
The Personal Care Products Council also issued a statement in support of the bill: “We greatly appreciate senator Hatch’s leadership in introducing legislation to update the regulatory system for the cosmetics and personal care sector,” said Lezlee Westine, president and chief executive officer of the council. “Our commitment to reform remains strong. We look forward to continuing to work with senator Hatch, members of the Senate Health, Education, Labor and Pensions Committee, sponsors of similar legislation, including senators Feinstein and Collins and other interested stakeholders to create a more modernized regulatory system for the personal care products sector.”
Procter & Gamble’s associate director of scientific communications, Scott Heid said: “For a number of years, P&G has advocated for stronger federal cosmetics regulations. We support the legislation previously introduced by senator Feinstein and Collins to strengthen and modernize FDA oversight of the cosmetics industry while continuing to meet consumer needs for new and innovative products. As members of the Personal Care Products Council, we will continue to work with PCPC, legislators such as senator Hatch and other important stakeholders to find enough common ground to move bipartisan cosmetics reform legislation forward.”
While many have shown support for the bill, the Environmental Working Group showed concern over the legislation.
“While we agree with senator Hatch that the time to reform cosmetics law is long overdue, we are strongly opposed to the bill he introduced yesterday,” said Scott Faber, senior vice president for government affairs at the Environmental Working Group, on Thursday. “In particular, the Hatch bill would not require FDA reviews of cosmetics chemicals, instead allowing third parties to review chemicals. It would not require the industry to substantiate the safety of its own chemicals, would create a weak and untested safety standard and would fail to provide the FDA with any resources to oversee a $60 billion industry that impacts the health of every American.”
The Environmental Working Group also noted some key differences between the Hatch bill and the Feinstein-Collins bill. For instance, Feinstein-Collins requires that companies share ingredient information with the FDA for agency scientists to understand how consumers are exposed to cosmetics chemicals. Hatch’s bill does not include this requirement.
Another key difference is that Hatch’s bill preempts state action to protect consumers once the FDA identifies a chemical for review instead of after the review, meaning that the bill prevents states from taking action on harmful chemicals discussed at the federal level.