Media Reports Highlight FDA Failures

Larisa Pavlick
May 12, 2022

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In April, a pair of media outlets – Politico and CBS News – published features critical of the U.S. Food and Drug Administration (FDA) and its “food failures.”

This Politico article is 32 pages long and includes information obtained from more than 50 interviews with former FDA staff and industry leaders. Ultimately, the message is that the FDA staff is failing at its mission, which is to ensure public health and safety specifically related to its activities regulating food.

The story provides specific examples of how the FDA has failed to act (in a timely manner) during recent outbreaks and emergencies. Although this article is long and includes several highlights, in the interest of adult attention span, I will bullet the best information and my favorites takeaways.

Although dietary supplement regulation falls under the FDA Center for Food Safety and Applied Nutrition, it does not specifically mention dietary supplements. It’s important to remember, however, dietary supplements remain a subgroup within food at the agency.

Examples of perceived FDA food failures

  1. Contaminated infant formula (2022)
    1. Four babies hospitalized and two died.
    2. September: First hospitalization reported.
    3. January: FDA (for cause) inspection.
    4. February: Recall initiated.
  1. Multiple produce safety outbreaks, including spinach, romaine lettuce, and cantaloupe. The contributors point out that several of these outbreaks related to fresh produce and were potentially caused by preventable foodborne pathogens in agricultural water. They suggest the FDA staff is partially responsible because of their failure to establish or finalize guidance and standards.
    1. 2011 Cantaloupe: Sickened 147 and hospitalized 143.
      1. Per the CDC, the cantaloupe contamination was Listeria monocytogenes, resulting in 33 deaths. But the FDA didn’t issue a recall until a month after the first reported case.
      2. Agricultural water quality is found within the FSMA-Produce Safety Rule. However, the FDA staff issued a notice of enforcement discretion for this section of the Rule.
    2. 2018 romaine lettuce: “Of those who fell ill, 96 hospitalized, 27 suffered kidney failure, and five died.”
  1. Failure to establish limits for heavy metals in baby food and infant cereal.
    1. Between 2017 and 2021, the media published multiple accounts of contamination.
    2. In 2022, the FDA released its “Closer to Zero” action plan.
  1. Failure to establishing an action plan to lower sodium in the American diet. Specifically, referred to as the slow-moving killers in the American diet.
    1. 1978: “…first petitioned FDA to crack down on sodium.”
    2. 2021: FDA finalized the policy with short-term targets and food companies are “encouraged to help cut salt across the food supply by 2024.”
  1. The glacial pace the FDA moves in modifying or establishing standards of identity for specific food commodities. Some of these modifications have taken centuries. Examples in the Politico article include:
    1. The yogurt industry requested an update regarding the standard of identity to address current manufacturing and ingredients; however, it’s been 40 years since they petitioned the agency. When industry leaders heard there weren’t enough resources, they lobbied for a budget increase. In June 2021, the agency released an update and the industry “hated it.” It appears the agency doesn’t have the necessary skill set or industry experience to this technical task. The issue remains open and is not finalized.
    2. Bakery industry asked for definition of “fresh” so the term could be used on packaging in 1992. They’re still waiting.
    3. “Frozen cherry pie” standard of identity hasn’t been finalized after 15 years since its initial petition.
    4. French Dressing? In 1998, the dressing and sauces trade group asked for an update to “overly restrictive decades-old standard of identity.” The FDA updated it in January 2021. If you’re counting, it was 23 years after the petition.

Other highlights

The Politico article is filled with statistics regarding what the author sees as preventable illness and specifically as it relates to the FDA staff delays in taking regulatory action or to establish guidance.

“This government dysfunction has a real impact on people’s lives. The CDC estimates that more than 128,000 people are hospitalized and 3,000 people die from foodborne illness each year – a toll that has not lessened after sweeping updates to food safety a decade ago.”

All of this despite a $1 billion food budget, two-thirds of which is earmarked for the Office of Regulatory Affairs to pay for inspections.

While critics typically blame a lack of budget and resources, former FDA Commissioner Scott Gottlieb told the author that “…inadequate staffing and budget are the division’s biggest problems,” while adding that the agency simply can’t keep up with an increasingly complex food system.

The author also suggested that a lack of leadership at FDA is part of the problem including the fact that it’s been run by five commissioners in three years. Additionally, the report reveals internal turf battles plague the agency, led by Frank Yiannas, deputy commissioner for food policy and response, and Susan Mayne, director of CFSAN. Even the newest commissioner recognized the staff’s lingering discontent.

The report’s already drawn the attention of Congress.

“I’m deeply concerned about a new report into longstanding, significant delays and dysfunction across food safety efforts at the FDA,” U.S. Sen. Patty Murray, D-Washington wrote in a letter following shortly after publication. “Americans rely on the FDA to ensure the food they are eating and feeding their families is safe. The FDA’s failure over decades 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’m calling on you to make these issues a priority and take immediate action to ensure the FDA is doing all it can to fulfill all aspects of its mission to protect the health and safety of the American people.”

Larisa Pavlick is VP of Global Regulatory & Compliance at the United Natural Products Alliance (UNPA). Pavlick has more than 20 years of combined experience working within the dietary supplement industry, including nearly eight years as an investigator at the FDA.