FDA to Step Up Oversight of Cosmetics, Assess 'Forever Chemicals''

 US regulators this year will begin to demand reports from cosmetics manufacturers about the ingredients used in their products. They are also preparing to assess potential risks of so-called forever chemicals in these products.

The US Food and Drug Administration (FDA) last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.

"On average, consumers in the US use six to 12 cosmetics products daily. But, until recently the FDA didn't have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced," said Namandjé Bumpus, PhD, FDA's chief scientist, in an August 7 press release.

In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through September 7.

"Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency," Bumpus said.

The products, according to the FDA statement, include makeup products, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skincare products.

MoCRA "represents a sea change in how FDA regulates the cosmetics industry," wrote attorneys Frederick R. Ball, Alyson Walker Lotman and Kelly A. Bonner, in an article for the Food and Drug Law Institute published in spring 2023.

The FDA has called the MoCRA law "the most significant expansion" of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.

The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins October 1, seeks $5 million for work needed to implement MoCRA.

PFAS, or "Forever Chemicals"

Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.

MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.

The FDA's website says that so far, the available research doesn't allow for "definitive conclusions about the potential health risks of PFAS in cosmetics."

The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.

PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.

PFAS are known as "forever chemicals" because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn't have the tools to process.

This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That's why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.

But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told Medscape.

"Nothing will naturally eat it because when you break the bond, it's like eating celery," he said. "You use more calories to eat the celery than you gain back from it."

Interest From a US Senator

Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.

In the article, Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.

Sen. Susan Collins (R-ME) cited Peaslee's article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.

"The findings of this study are particularly alarming, as many of these products are subject to direct human exposure," Collins said. "For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts."

In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Collins said. In 2021, she introduced legislation seeking a ban on PFAS that re intentionally added to cosmetics. That legislation did not advance through the Senate.

But the Senate Appropriations Committee, on which Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.

The Senate Agriculture Appropriations subcommittee, which oversees the FDA's budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform "regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics," the subcommittee said.

https://www.medscape.com/viewarticle/995955