Lead, arsenic and other heavy metals in tampons prompt FDA investigation

The U.S. Food and Drug Administration announced on Tuesday that it would investigate the possible risks to women from heavy metals such as lead and arsenic contained in tampons.

The FDA’s action follows the release of a small pilot study in July that found arsenic and lead in organic and nonorganic tampons. Although levels of both metals were low, there is no safe level of lead exposure, according to the U.S. Environmental Protection Agency.

The July study only detected the presence of the metals and “did not test whether metals are released from tampons during use,” the FDA said in a statement Tuesday. “Nor did it test whether metals are released during tampon use, absorbed by the vaginal mucosa, and enter the bloodstream. FDA has therefore commissioned an independent literature review and initiated an internal laboratory study to evaluate metals in tampons.”

The FDA’s laboratory study will mimic normal tampon use to find out how many metals — if any — can enter the human body when they are used. The literature review will examine all research in the area to show the potential health effects of such exposure, the agency said.

“We want the public to know that before tampons can be legally sold in the United States, they must meet FDA requirements for safety and effectiveness,” the statement said. “Manufacturers must test the product and its ingredients before, during and after manufacturing.”

“Before a product is allowed to be placed on the market, the manufacturing company conducts biocompatibility tests, which are part of the safety testing and are reviewed by the FDA before market approval.”

The Consumer Healthcare Product Association, a trade group, also noted in a statement that its products undergo “rigorous testing” to meet “strict regulatory standards.” The group said it “supports further research to ensure the safe use of these products.”

The Center for Baby and Adult Hygiene Products, an industry association also known as BAHP, said it supports FDA’s continued research into the safety of tampons in real-world use and the agency’s ongoing commitment to public health.

Heavy metals in tampons

The July study tested 30 tampons from 14 brands purchased from major online retailers and stores in the US, UK and Greece. The researchers conducted a blind study, so they did not know the brands.

The researchers tested for 16 heavy metals: arsenic, barium, calcium, cadmium, cobalt, chromium, copper, iron, manganese, mercury, nickel, lead, selenium, strontium, vanadium and zinc, said lead study author Kathrin Schilling, assistant professor of environmental health sciences at the Mailman School of Public Health at Columbia University in New York City.

“We found an average of 100 nanograms per gram of lead and 2 nanograms per gram of arsenic in the tampons,” Schilling told CNN at the time. “There were no detectable amounts of chromium and no detectable amounts of mercury, which is very good.”

The study found that organic tampons contained higher levels of arsenic, while non-organic tampons had higher levels of lead.

“The average lead concentration in tampons was about 10 times higher than the current maximum levels allowed in drinking water,” Schilling said, adding that arsenic levels were five times lower than current drinking water limits.

“It’s important to note that arsenic should not be in tampons at all and we don’t yet understand the effects of vaginal exposure because it hasn’t been studied,” she said. “There is no safe level of lead exposure and lead has been shown to cause reproductive health problems in women.”

However, the mere presence of a chemical is not an indication of a risk or harmful effect, according to the industry association American Chemistry Council.

“The Centers for Disease Control and Prevention emphasizes: ‘Measurement of an environmental chemical in a person’s blood or urine is a measure of exposure. It does not automatically mean that the chemical causes disease or an adverse effect,'” a council spokesperson previously told CNN.

Why tampons are a bigger problem

Vaginal tissue is more permeable than other parts of the body, so if studies found that heavy metals – or chemicals of concern – were entering the body from menstrual products, that could be a significant problem, Anna Pollack, an associate professor of global and societal health at George Mason University in Fairfax, Virginia, previously told CNN. She was not involved in the pilot study.

“I’m most concerned about menstrual products that are applied inside the body,” says Pollack, who co-authored a 10-year study of contaminants in tampons, sanitary pads, menstrual cups and other products.

“However, there is no reason why people should be afraid of using menstrual products at this time,” Pollack added. “I would just keep an eye on the issue and follow any research that comes out of it.”

Tampon manufacturers and the FDA recommend not using tampons at night or for more than eight hours because of a higher risk of toxic shock syndrome, a fatal bacterial infection that, if left untreated, can lead to organ failure and death.

This advice also applies to anyone concerned about heavy metals or chemicals in their menstrual products, experts say.

Other recommendations include washing your hands before and after inserting or removing a tampon to reduce the spread of bacteria, changing tampons every four to eight hours, and using the lowest absorbency possible.

“If you can wear a tampon for up to eight hours without changing it, the absorbency may be too high,” the FDA notes on its website.

Signs of toxic shock, which include sudden high fever, diarrhea, dizziness, vomiting, or a rash that looks like sunburn, require immediate medical attention.

Additionally, the FDA states: “If you experience discomfort, pain, or other unexpected symptoms such as unusual discharge or an allergic reaction while inserting or wearing a tampon, stop using tampons and contact your doctor,” the FDA says.

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