Pharma rolls back government PFAS regulations

In January 2025, a Minnesota law regulating PFAS, a class of synthetic chemicals used to make products that are resistant to heat, grease, oil, and water, went into effect. The law, one of the strongest of its kind in the United States, bans the use of chemicals in 11 categories, from cookware to textile furnishings.

Starting in July 2026, the state will also require manufacturers to do so Report the presence of PFAS In their products, and starting in 2032, companies will be prohibited from selling any product that contains intentionally added PFAS. With some exceptions. The goal, according to the state Pollution Control Agency, is For protection “Human health, the environment and taxpayer dollars” by reducing the use of PFAS.

But a coalition of drug and device makers and distributors, the Pharmaceutical PFAS Working Group, or PPWG, disputes that, arguing that Minnesota’s sweeping restrictions place a burden on these companies, which use PFAS (short for perfluoroalkyl substances) in manufacturing and packaging. Even some medications, including Prozac and Lipitor, can be considered PFAS under some definitions. Although FDA-regulated medical devices and drugs are exempt from the final sales ban, companies will still need to disclose detailed information about each product and the amount and purpose of each PFAS compound.

The comprehensive strategy taken by Minnesota and Maine, which also includes a reporting component, constitutes “a very practical, straightforward and very reasonable approach to a very large problem.”

-Anna Reed, Natural Resources Defense Council

“The unprecedented scope of the Minnesota law — which applies to all products entering the Minnesota market — effectively imposes nationwide restrictions on PFAS and a risk-based reporting obligation, imposes requirements with unenforceable deadlines, and contains provisions that conflict with federal law,” the group, which represents major pharmaceutical companies including Merck, Pfizer, and Roche, wrote in a lawsuit. letter To the Ministry of Justice.

Additionally, the presence of different regulations in each state creates a regulatory patchwork for businesses, “as companies often must modify operations to comply with more restrictive state laws,” PPWG wrote. It concluded that federal law should override state mandates. The comment, which was made public in September, was in response to… call From President Donald Trump’s administration to limit burdensome state laws.

However, environmentalists are not convinced that the patchwork of regulations — or Minnesota law, which… It will not be banned PFAS in FDA-regulated medical products represent a significant burden on companies.

The overall strategy taken by Minnesota and Maine, which also has Reporting element“This approach is very practical, very straightforward and reasonable to solve a very big problem,” said Anna Reid, director of PFAS advocacy at the Natural Resources Defense Council, an international environmental advocacy group. “It is being portrayed as a radical ban on all products containing PFAS, which is not really the case.”

“The industry may be trying to avoid potentially broader state regulation of PFAS,” said Albert Lin, a professor at the UCLA School of Law who specializes in environmental and natural resource law.

PFAS — known as forever chemicals because they can persist in the environment for 1,000 years or more — are increasingly associated with a range of… Health concernsincluding cancers, delayed growth, and Hormonal disorders.

In the mid-2010s, the prevalence of PFAS in the environment and in everyday products began to become apparent. “This was already viewed as a public health emergency,” said Eve Gaertner, director of cross-toxic strategies at Earthjustice, a nonprofit that litigates environmental issues. States, which could be more nimble than federal agencies, are beginning to tackle PFAS regulations in batches, addressing individual product sectors such as firefighting foam and packaging, Gartner said. “Recently, state legislation has focused products in multiple sectors in a single bill,” she wrote in an email.

Today, 30 states have adopted policies to regulate PFAS, according to a tracker maintained by Safer States, a coalition of environmental health organizations and alliances across the United States. Colorado, for example, bans the sale and distribution of oil and gas products and some textiles that contain intentionally added PFAS chemicals. But several states, including Minnesota and Maine, have gone further, moving to ban the sale of a long list of products that contain intentionally added PFAS, and requiring companies to report the presence of the chemicals where their use is unavoidable.

“The unprecedented scope of the Minnesota law — which applies to all products entering the Minnesota market — effectively imposes nationwide PFAS restrictions and a risk-based reporting obligation, imposes requirements with unenforceable deadlines, and contains provisions that conflict with federal law.”

– Pharmaceutical PFAS Working Group

In addition to keeping communities safe from toxic chemicals, these measures are “pushing brands to recognize the PFAS problem and realize it’s not worth the risk,” said Katie Belch, a senior scientist at the Natural Resources Defense Council.

But for pharmaceutical companies, the growing list of laws “vary in scope, definitions, exemptions, and compliance deadlines,” the PPWG commented. Tracking and reporting all PFAS used in complex global supply chains will pose an increasing burden on the industry, the group said.

Gartner said this process is necessary to achieve transparency in the industry, especially pharmaceuticals, which by 2024 He studies It has been found that they contribute significantly to the presence of PFAS in Wastewater. “Knowing whether PFAS are in pharmaceuticals seems to be something that many consumers want to know, and companies should want to know.”

Undark reached out to all companies in the PPWG, as well as the group’s advisor who wrote the letter. Only a Roche representative responded, declining to comment; Other companies did not respond.

While it is true that countries have Different regulationsState policies are not as diverse as they seem, said Reed, director of PFAS advocacy with the Natural Resources Defense Council. Most target unnecessary use of PFAS in consumer products where there is a safer alternative on the market. “There is a little bit of difference, of course, in the legislative process, but the goals are all very similar,” Reed said. Additionally, she noted that most states with PFAS regulations on the books have consistent definitions, and those that differ are weaker, making them easier to adhere to, not more difficult. “At this point, many, many states have almost identical laws on the books,” Gaertner said. “It should not be a compliance nightmare for well-resourced organizations.”

Today, 30 states have adopted policies to regulate PFAS. Colorado, for example, bans the sale and distribution of oil and gas products and some textiles that contain intentionally added PFAS chemicals.

But the PPWG emphasized in its letter that federal requirements should take precedence over state laws — a legal principle called federal preemption — to ensure standard regulation across the country. The safety of drugs, biologicals, medical devices, animal medicines and their packaging has already been evaluated by the Food and Drug Administration, the group said. That’s why state laws shouldn’t be enforced, he added.

This legal argument may not hold up, Lin said. Federal preemption applies when a state law conflicts with federal law or when federal law expressly prohibits state regulation, but federal oversight is limited when it comes to reporting requirements. “The FDA regulates whether you can sell your product or use your product as well as the packaging that must come with it,” Lin said. “But it doesn’t really regulate reporting requirements regarding PFAS in products.” (Under the Toxic Substances Control Act, the EPA requires manufacturers and importers of PFAS between 2011 and 2022 to submit detailed data to the agency, but Which has been postponed Through April 2026. EPA Recently suggested Some exceptions to this rule, according to agency Director Lee Zeldin, “to help fight PFAS pollution without placing ridiculous requirements on manufacturers.”)

“It’s been spun as a radical ban on all products containing PFAS, and that’s not what it really is.”

-Anna Reed, Natural Resources Defense Council

In August, a judge blocked Minnesota’s reporting rules, saying, among other things, that the rules were “not rationally relevant” to the intent of the Minnesota Pollution Control Agency, which proposed the PFAS rule, and that they exceeded the agency’s authority. The judge made recommendations for the agency to make corrections and reintroduce the rules. The MPCA declined to respond to PPWG’s comment, but pointed to a statement saying that removing and destroying PFAS in Minnesota’s wastewater would cost between $11 billion and $25 billion over 20 years, and thus, Minnesota is prioritizing pollution prevention by reporting PFAS use and phasing out unnecessary use in products.

For advocates, state regulation fills an important gap in PFAS tracking, helping consumers and agencies identify sources of potentially harmful chemicals and effectively limit PFAS exposure for their populations, Reed said, and doesn’t really represent a compliance hurdle for pharmaceutical companies.

“If you look at the core of what’s happening, it’s very plausible,” she said. “And given the impact that PFAS are having right now and will continue to have for generations, frankly, it’s not enough right now.”

This article was originally published on Under the darkness. Read Original article.

Claudia López Lloreda is a freelance science journalist covering life sciences, healthcare and medicine. She is a major contributor to Undark.