Tag Archives: HHS

Beltway Beat

Trump Picks RFK Jr. as Health Secretary. What can the food industry expect?

By Food Safety Tech Staff, Rick Biros
No Comments

According to the Wall Street Journal, President-elect Donald Trump is planning to nominate environmental lawyer Robert F. Kennedy Jr. to serve as Health and Human Services secretary. Kennedy’s nomination was not a surprise. Last month, Kennedy said Trump had promised him control of the department and its many subagencies, which include the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Medicare and Medicaid (CMS), and others. Trump himself pledged during the campaign to let Kennedy “go wild on health.”

To put things into context, the mission of the U.S. Department of Health and Human Services (HHS) according to it’s website is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. FDA is an agency within the Department of Health and Human Services and consists of nine Center-level organizations and thirteen Headquarter (HQ) Offices including the newly reorganized Human Foods Program headed up by Jim Jones.

Kennedy’s website, Make America Healthy Again states that Kennedy has spent nearly 40 years fighting corrupt corporations and government agencies. During his tenure at RiverKeeper, he successfully sued dozens of municipalities to force compliance with the Clean Water Act. He won cases against corporate giants, including a suit against General Electric for toxic runoff from its corporate jet hangar and a court order against ExxonMobil mandating they clean up tens of millions of gallons of spilled oil in Brooklyn, NY. As of Dec 2022, the Monsanto lawsuits to which Kennedy has devoted much of the past decade have yielded $11 Billion for farmers, migrant workers, day laborers, and families exposed to the pesticide RoundUp.

If approved, what can the food industry expect from Kennedy?

According to Make America Healthy Again, Kennedy sees Big Pharma and Big Agriculture having an undue influence on what Americans eat and how they manage their health over time.

Kennedy says the public health establishment is too focused on infectious diseases and wants to redirect resources toward issues he characterizes as the chronic disease epidemic, including obesity, diabetes, autism and mental illnesses. He blames them on corporations including food producers using harmful pesticides and additives. He traces America’s high levels of chronic disease to the widespread availability of highly processed, non-nutritious food, which he blames in part on a broken agriculture policy.

Some of his food and agriculture ideas plans share the same pseudoscience as Kennedy’s views on vaccines. Kennedy recently posted on social media that the FDA had “waged a war on public health” by “aggressive suppression” of Americans’ access to raw milk, despite raw milk’s risk of causing life-threatening diarrheal diseases and now, bird flu,

Kennedy has labeled Trump’s fast food diet as “poison” and wants to reduce the amount of ultra-processed food in the American food supply. In recent interviews, Kennedy has suggested clearing out “entire departments” at FDA, including the Center for Food Safety and Applied Nutrition.

However, if Kennedy wants to restrict the use of already-approved food additives, he needs more resources — not fewer: The process involves rigorous reviews of data, issuing public warnings, and actively monitoring the food supply. If Kennedy succeeded in closing the food safety office, that would reduce the number of people who could be dedicated to the job.

The European culture regarding food additives is generally the additive needs to be proven safe before allowed into the supply chain. Conversely, FDA’s position for years has been the additive is allowed to be used unless it has been proven harmful. Two opposite ways of regulating. Kennedy’s position on additives might move the U.S. to be more like the E.U.

Other actions could be taken by the Trump administration to reduce the amount of ultra-processed food in the American food supply, but many of them would be taken outside of HHS. The US Department of Agriculture (USDA) sets the guidelines that govern school lunch programs, which means much of what children eat is determined by that agency; Trump has not yet nominated a USDA commissioner. The USDA is also primarily responsible for overseeing farming, another industry Kennedy has heavily criticized throughout his public career and pledged to target if he were to take a role in the federal government. He would likely need to work with the USDA to follow through.

One Agency?

Kennedy is correct that food safety regulation in the US is currently a mess, says David Acheson, President of TAG. Meat, poultry, and egg plants are inspected daily under the auspices of the USDA, while every other kind of food production facility — including the farms whose produce is responsible for most of the food-borne illness in the US and the nation’s countless other industrial food manufacturers — are inspected by FDA inspectors at most once a year.

It would make far more sense to unify these functions under one agency and harmonize the frequency of food production facility inspections so none are falling through the cracks. That is the kind of organizational shake-up that could actually make a difference.

The concept of one agency is not new according to Frank Yiannas, former Deputy Commissioner for Food Policy and Response at the U.S. Food and Drug Administration. Yiannas, in his closing keynote presentation at last month’s Food Safety Consortium Conference said the idea has been proposed by the Obama and the previous Trump administration, however, it requires Congress to approve the combination of the two agencies.

It remains to be seen what impact Kennedy’s proposals will have on the food industry but they bear little resemblance to those of prior Republican administrations, which have typically favored cutting regulations, not increasing them.

 

Reagan Udall Foundation Logo

Expert Panel Recommends a New Federal Food Administration Separate from FDA

By Food Safety Tech Staff
No Comments
Reagan Udall Foundation Logo

On December 6, the Independent Expert Panel for Human Foods submitted its Operational Evaluation of FDA’s Human Foods Program report to Dr. Robert Califf, FDA Commissioner for Food and Drugs. The evaluation and report, which addressed culture, structure/leadership, resources, and authorities, were facilitated by the Reagan-Udall Foundation at Dr. Califf’s request.

The panel, chaired by former Commissioner of Food and Drugs Dr. Jane Henney, highlighted several concerning findings in their report, including lack of communication, lack of a clear vision and mission, lack of a clear, overarching leader, and siloed workers within the FDA’s Human Foods program. Its recommendations to improve both food safety and nutrition in the U.S. included creating a new Federal Food Administration under HHS that would operate parallel to, rather than under the auspices of, the FDA.

Notably, the panel found that the FDA Human Foods program was ill defined with multiple agencies, including CFSAN, OFPR and OVA, working independently of each other, often with separate leadership and little sharing of information.

“The current structure of the FDA Human Foods Program reinforces duplicative or competing roles and responsibilities, siloed work, and inadequate internal and external engagement. This reality impedes the Human Foods Program move toward a prevention paradigm. While a change in structure cannot address all the challenges identified through this Human Foods Program review, changing the current organizational configuration will assist the Agency in advancing its mission,” the panel wrote.

In addition to Dr. Henney, the panel included Francisco Diez-Gonzalez, PhD, James Jones, Barbara Kowalcyk, PhD, Shiriki Kumanyika, PhD, MS, MPH, and John Taylor, JD. The team of researchers, former regulators, and process improvement specialists used a three-phase evaluation protocol consisting of information gathering, information synthesis and analysis, and report generation. The panel heard from more than 350 stakeholders through a two-day in-person stakeholder meeting, an online stakeholder public portal, and a series of interviews.

“We were honored to take on this challenge and worked diligently to propose changes to strengthen the operation of FDA’s Human Foods Program,” said Dr. Henney. “The report provides constructive recommendations that will take time to work through and implement, but we are confident the effort will benefit the health and safety of the American public.”

Read the full report here.

FDA

Why One Former FDA Food Commish Thinks the Food Program Needs Its Own Agency

By Food Safety Tech Staff
No Comments
FDA

In an Op-Ed published by Politico today, former FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor is calling on FDA’s Food Program to be separated from the current hierarchy—with the establishment of a new agency that has its own head and reports directly to the HHS secretary.

“Under FDA’s current structure, no one is really in charge and realistically accountable for the food program’s strategic direction, sound resource management and overall success; and this state of play has real consequences for consumers. It puts at risk the public’s health and consumer confidence in the nation’s food supply,” Taylor wrote in “It’s Time to Fix FDA by Breaking It Up”. He emphasizes that food has not been given a high enough priority at the agency, despite the passage and implementation of FSMA, and the past two administrations did not help either. “Neither the Obama nor Trump administration empowered the deputy commissioner for food to oversee the program’s largest organizational unit, which is responsible for food inspection and import activities and manages nearly 70% of all the dollars Congress gives the food program,” he stated. “The success of food safety modernization won’t succeed without the policymaking and inspection units working as an integrated whole. Because they are all managed separately and report directly to commissioners whose attention is elsewhere, this is virtually impossible in today’s FDA.”

Allowing the Food Program to stand on its own, reporting directly to HHS, would create an agency that is empowered not only with more resources but also with having more accountability.

FDA

President Trump to Nominate Stephen Hahn as Next FDA Commissioner

By Food Safety Tech Staff
No Comments
FDA

Today The White House issued a statement in which President Trump announced his plan to nominate Stephen Hahn, M.D. to the position of FDA commissioner. Hahn is a radiation and medical oncologist, and currently serves as the chief medical executive at The University of Texas MD Anderson Cancer Center in Houston.

According to The Washington Post, current Acting FDA Commissioner Ned Sharpless will return to his position as director of the National Cancer Institute while HHS official Brett Giroir will step in at FDA until Hahn is confirmed.
The Post reports that Sharpless’ term ends Friday, and it could only be extended if the White House named a successor—however, the White House cannot do so because paperwork has not been completed.