Lawsuit Alleges FDA Ignored Petition For Breast Cancer Warning Labels On Cheese

A non-profit research organization has filed a lawsuit against the U.S. Food and Drug Administration (FDA), alleging the agency illegally ignored a petition calling for cheese manufacturers to be required to add breast cancer warnings to product labels.

The Physicians Committee for Responsible Medicine filed the lawsuit on September 22, naming FDA Commissioner Stephen Hahn, MD and the U.S. Department of Health and Human Services (DHHS) as defendants, after no response was provided to an October 2019 petition requesting dairy cheese manufacturers be required to add warnings that the products contain reproductive hormones which may increase breast cancer mortality risk.

The petition cited the Life After Cancer Epidemiology study funded by the National Cancer Institute, which compared the diets of women with breast cancer diagnosis to those without breast cancer. Findings from the study indicated those who consumed the most American, cheddar, and cream cheeses had a 53% higher risk for breast cancer.

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Furthermore, the study found women who consume one or more servings of high-fat dairy products such as cheese, ice cream, whole milk per day had a 49% higher breast cancer mortality rate.

Supporting research cited in the petition included a study published in the International Journal of Epidemiology, which warned women who consumed two to three cups of cow’s milk per day had an 80% increased chance of breast cancer.

Among all of the studies presented, researchers collectively suggested the exposure of insulin-like growth factor and other growth hormones may be among the reasons for higher breast cancer mortality rates in women.

The Physicians Committee for Responsible Medicine submitted a petition advocating for the FDA to require manufacturers to include a warning on the product packaging and labeling of all dairy cheese products indicating “Dairy cheese contains reproductive hormones that may increase breast cancer mortality risk.”

As a result of the FDA’s failure to respond, the organization filed a lawsuit alleging the agency failed to fulfill its responsibility to respond to a citizen petition within 180 days, claiming nearly a year has passed and the unreasonable delay is unlawful under the Administrative Procedure Act.

The organization has also claimed DHHS failed to respond to two Freedom of Information Act appeals, which requested records pertaining to conflicts of interest and financial disclosures of members of the 2015 Dietary Guidelines Advisory Committee (DGAC).

The U.S. Centers for Disease Control and Prevention (CDC) has stated breast cancer is among the most common causes of death in women. In 2020, an estimated 275,000 new cases of invasive breast cancer are expected to be diagnosed in women, and experts project approximately 42,000 women will die from the cancer.

According to the American Cancer Society, breast cancer diagnosis rates have been trending upward for the last several decades. Currently, experts project there is a one in eight chance a women in the United States will be diagnosed with breast cancer at some point throughout their life.


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