FDA Does Not Require Menstrual Product Ingredients on Labels
Tens of millions of Americans use menstrual products, and while manufacturers contend they are safe, most disclose little about the chemicals they contain. Now, amid calls for more disclosure and research into the health effects of these products, some states require more transparency.
The manufacture and sale of period and related products is a big business, with revenue expected to top $4.5 billion in the United States this year. On average, a person uses up to 17,000 tampons or pads in their lifetime, and they might also use rubber or silicone cups, or absorbent period underwear.
The FDA regulates and classifies menstrual products as medical devices, meaning they are not subject to the same labeling laws as other consumer items. But companies can voluntarily disclose what’s in their products.
Now, some states are stepping into the breach. In 2021, New York became the first state to enact a menstrual product disclosure law requiring companies to list all intentionally added ingredients on packaging. California’s governor signed a similar law that took effect this year, but it gives manufacturers trade secret protections, so not all ingredients are necessarily disclosed. At least six other states have introduced legislation to address safety and disclosure of ingredients in these products.
Advocacy groups studying the effects of the New York law say the new labels have revealed commonly found ingredients in menstrual products that may contain carcinogens, reproductive toxicants, endocrine disruptors, and allergens.
Shruthi Mahalingaiah, an assistant professor of environmental, reproductive, and women’s health at Harvard T.H. Chan School of Public Health, evaluates endocrine disruptors in personal care products and studies menstrual health. She said the health risk depends on the dose, duration, and sensitivity of a person to the ingredients and their mixtures.
Harmful chemicals could come from manufacturing processes, through materials and shipping, from equipment cleaners, from contact with contaminants, or from companies adding them intentionally, said Alexandra Scranton, director of science and research for Women’s Voices for the Earth, a Montana-based nonprofit focused on eliminating toxic chemicals that affect women’s health.
Vaginal and vulvar tissues are capable of absorbing fluids at a higher rate than skin, which can lead to rapid chemical exposure. Scranton said scarcity of clinical studies and funding for vaginal health research limits understanding about the long-term effects of the ingredients and additives in period products.
“We think manufacturers should do better and be more careful with the ingredients they choose to use,” Scranton said. “The presence of toxic and hormone-disrupting chemicals in menstrual products is unsettling. We know that chemicals can cause disease, and exposures do add up over time.”
Scranton’s organization advocates for labels to include the chemical name of the ingredient, the component in which the ingredient is used, and the function of the ingredient.
K. Malaika Walton, operations director for the Center for Baby and Adult Hygiene Products, a trade industry group, said in an email, “BAHP supports accurate and transparent information for users of period products and many of our member companies list ingredients on their packages and websites.”
In a written statement, Procter & Gamble, a major manufacturer of menstrual products, said that ingredients it uses go through rigorous safety evaluations and are continuously tested, and that all fragrance components are added at levels the industry considers safe.
Even though manufacturing of scented tampons for the U.S. market has mostly stopped, companies still use fragrances in other menstrual products. Laws protecting trade secrets keep details about fragrances in pads and tampons confidential so competitors can’t copy the formulas. The Children’s Environmental Health Network lists phthalates, a group of chemicals commonly called plasticizers that are suspected hormone disruptors, as an ingredient found in fragrances.
Manufacturers follow regulatory guidance issued in 2005 by registering with the FDA and submitting a detailed risk assessment of their products’ components and design, and a safety profile, before being cleared to sell in the U.S.
Pads and menstrual cups are considered exempt from regulatory guidance and do not require premarket review, according to FDA spokesperson Carly Kempler. While tampons do require review, the FDA “does not clear or approve individual materials that are used in the fabrication of medical devices.”
“There’s an understanding that the FDA is regulating these products, and they are; it’s just not very adequate,” said Laura Strausfeld, an attorney and a co-founder of Period Law, an organization working to advance state and federal period-equity policies that would stop taxation of products and make them freely available in places like schools and prisons. “The consumer is supposed to trust that when these products are put on shelves they’ve been vetted by the government. But it’s basically a rubber stamp.”
In a 2022 report, a congressional committee directed the FDA to update its guidance for menstrual products to recommend that labels disclose intentionally added ingredients, such as fragrances, and test for contaminants. The FDA is reviewing the directives outlined by the House Appropriations Committee and will update the 2005 guidance as soon as possible, Kempler said. “We will share additional details when we are able to.”
At least one period product company makes disclosure of its ingredients a selling point. Alex Friedman, co-founder of Lola, said a lack of knowledge is a problem, and more action and awareness are needed to keep people safe.
“The hardest part to swallow is why this is even up for debate. We should all know what’s in these products,” Friedman said.
New York’s law requires companies to disclose all intentionally added ingredients no matter how much is used, with no trade secret protections for fragrances. Though it applies only to products sold in that state, similar detailed labeling is appearing elsewhere, advocates said.
“We’re also seeing similar or identical disclosure on packaging in other states outside of New York, which is a testament to the power of the law,” said Jamie McConnell, deputy director of Women’s Voices for the Earth.
Manufacturers have 18 months from the passage of the New York law to comply, and some products on shelves in New York still list few ingredients other than “absorbent material,” “surfactant,” “ink,” and “adhesive.”
“We’re like, ‘OK, what is that exactly?’ ” McConnell said.
Her organization is calling for a federal law at least as strong as New York’s. Previous federal legislation failed to advance, including the most recent, the Menstrual Products Right to Know Act, introduced in 2022.
BAHP, the trade group, supported the federal legislation and the California law. McConnell said she opposed both bills because they didn’t require companies to list all fragrance ingredients.
“I think what it boiled down to at the federal level was the support of corporate interests over public health,” she said.
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