Senator demands answers from FDA

U.S. Senator Patty Murray (D-WA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Mr. Califf, demanding answers and immediate action after a Policy report that lays bare a culture of delay and inaction at the agency’s Food Security and Nutrition Center that has put the health and safety of families at risk. here is his letter.

April 11, 2022

The Honorable Robert M. Califf
Food and Drug Commissioner
US Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Califf:

I am deeply concerned about a new report of significant and long-standing delays and dysfunctions in the United States Food and Drug Administration (FDA) food safety efforts. Americans rely on the FDA to make sure the foods they eat and feed their families are safe. The FDA’s decades-long failure to regulate and enforce food safety standards, on issues ranging from bacteria in vegetables to arsenic in baby food, has put the health of Americans at risk. I ask that you make these issues a priority and take immediate action to ensure that the FDA does everything in its power to fulfill all aspects of its mission to protect the health and safety of the American people.

According to a recent media report based on more than 50 interviews, the FDA’s food safety efforts have received little attention within the agency and have been plagued with delays and mismanagement for decades. years.^[1] Despite overseeing nearly 80% of the US food supply, the survey found that the FDA has focused primarily on drugs and devices, while food safety issues have not been prioritized by the senior management. Over the past decade, the food safety program has languished with delays in inspections and the development and publication of food safety standards. As a former acting FDA commissioner put it, the food program is “on the back burner” at the agency. Other officials described the program as “impossible”, “broken”, “byzantine” and “a joke”.

This report highlighted several delays in regulatory measures that have endangered public health. More than a decade after the implementation of the Food Safety Modernization Act, the FDA has yet to release the safety standards required by law, and hundreds of people have fallen ill from a foodborne illness. Despite the agency’s acknowledgment of the danger of toxic elements in baby foods, the FDA has failed to enforce strict safety standards, even though report after report has identified unacceptable levels of lead, arsenic, of mercury, cadmium and other toxins in baby food. The agency hasn’t even finalized long-term voluntary sodium reduction goals in foods, despite a recommendation to do so in 2010.

I am further concerned about the agency’s failure to ensure timely inspections and recalls, which are essential to ensure foods are free of bacteria and other harmful contaminants. According to the report, the number of FDA food safety inspections has generally decreased over time. Inspections are also often delayed. For example, I requested responses from both Abbott Nutrition and the FDA regarding potential bacterial contamination of Abbott’s infant formula, which has been linked to multiple hospitalizations and deaths.^[2] The FDA first received a report of these issues in September 2021, but did not initiate an inspection of the manufacturing plant until January, before a voluntary recall in February.^[3] The FDA has since discovered serious sanitation issues at the facility.^[4] FDA inspections for facilities manufacturing other food products have also failed to identify the causes of bacteria in the products, and the agency has often waited months before issuing product recalls.^[5]

These delays actively endanger the health and safety of the American people. Each year, approximately one in six Americans becomes ill and 3,000 die from foodborne illnesses.^[6] Exposure to toxic metals and chemicals like arsenic, lead and cadmium – especially for children – has been linked to a higher risk of serious illness, permanent impairment and death.^[7] The effects of poor diet are also significant. For example, a new analysis focused solely on salt intake estimates that the FDA’s delay in finalizing sodium targets in foods could lead to more than 260,000 deaths.^[8]

You have the opportunity to address these long-standing issues and reform how the FDA deals with these long-standing food safety and nutrition issues. At your confirmation of charges hearing, you urged me to “get to work” and prioritize consumer and patient protection issues.^[9] I ask you to keep that promise and take immediate action to ensure that the FDA’s food safety efforts are robust, timely, and effective in keeping the American people healthy and safe.

In addition, I request the following information no later than April 25, 2022:

1. What steps are you taking or plan to take to improve FDA’s food safety efforts, including the timeliness and rigor of regulatory and enforcement activities?
2. The recent report highlights major years-long delays in the management of water used to grow produce, toxic substances in baby food and sodium levels in food. Has the FDA assessed the causes of these delays? If so, please provide the results or findings of this evaluation. If not, please explain why these assessments have not been conducted and if there are plans to do so.
3. The report says an organizational change made under the Trump administration may have further hampered the FDA’s food safety efforts. What steps, if any, are you considering to ensure that the FDA’s organizational structure supports timely and effective decision-making on food-related issues?
4. For each year in the last ten years, how many:
   Has the FDA performed food safety inspections? Please provide a breakdown by type of inspection;
   Have food and food packaging samples been tested by the FDA for toxic elements? Please provide a breakdown by type of food and packaging. Please provide the results of these tests for all products intended for infants or young children.

Thank you for your attention to this matter. Please direct all correspondence regarding this request to Yelena Tsilker at [email protected]

Sincerely,
Patty Murray
Chair
US Senate Committee on Health, Education, Labor and Pensions

[1] https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/

[2] Letter from Senators Patty Murray and Bob Casey to Abbott Nutrition (February 24, 2022); FDA Staff Briefing (March 16, 2022).

[3] https://www.politico.com/news/2022/02/18/fda-infant-formula-illness-four-months-before-recall-00010226

[4] https://www.fda.gov/media/157073/download

[5] https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/

[6] https://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html

[7] https://www.consumerreports.org/food-safety/heavy-metals-in-baby-food-a6772370847/

[8] https://www.ahajournals.org/doi/abs/10.1161/HYPERTENSIONAHA.121.18475

[9] https://www.help.senate.gov/imo/media/doc/Califf2.pdf