by Marion Nestle

Search results: reagan udall

Oct 12 2022

The FDA under siege

My book talk today:  Online with NYU’s Fales Library in conversation with Clark Wolf.  5:00-6:00 p.m.  Registration is HERE.

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The FDA has come under heavy criticism this year for its failure to handle the infant formula crisis adequately and for its internal disorganization and lack of leadership.

To deal with this, the FDA commissioned the Reagan Udall Foundation for the FDA to do an operational evaluation of its human foods and tobacco programs.  This Foundation is “an independent 501(c)(3) organization created by Congress ‘to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.’”

As announced on July 19, 2022, the Reagan-Udall Foundation will facilitate, via two Independent Expert Panels, operational evaluations of FDA’s human foods and tobacco programs. Each evaluation will yield a report with operational recommendations to the FDA: one for human foods and the other for tobacco. Each evaluation, and therefore report delivery, is on its own 60-business-day timeline. Both reports will be delivered to the FDA Commissioner and made available to the public.

The Foundation began its work by

The two-day hearings were held right after the White House Conference on Hunger.  Videos are posted on YouTube

As far as I can tell, no reporter covered these hearings except for Helena Bottemiller Evich at Food Fix, which is what makes her newsletter an invaluable resource and essential to subscribe to (at least for me).

Her overview:

Wow, were people honest in their assessment of shortfalls at the agency.

There was a strong consensus among the nearly three-dozen experts who spoke that things are not working very well and serious changes are needed. The panel got an earful about problems with leadership structure, culture, inadequate funding and staffing, poor oversight of inspections and a lack of responsiveness to the public and Capitol Hill – as well as plenty of complaints about how painfully long it takes to get anything done.

If all of this sounds familiar, that’s because it is. I’m sure you are all tired of me referencing this, but I did an investigative piece on FDA earlier this year, based on more than 50 interviews, that found many of the same things.

Her piece goes into the details.  Subscribe and you can read them.

More complaints

  • One criticism of this entire procedure is that the Center for Veterinary Medicine (CVM) was excluded from the review.  This is a serious oversight, as noted by a letter from several groups to the FDA.
  • Senator Richard Burr says in a letter to the FDA that he won’t support funding until the agency cleans up its ac

We only have one food supply: it serves people and animals inextricably (an issue discussed in my books Feed Your Pet Right and Pet Food Politics).

In the meantime I want to know:  Why aren’t more journalists covering this issue?

The FDA is responsible for regulating the safety and health of 80% of the foods we eat.  If we want foods to be safe and healthy, we need a strong, vigilant FDA willing to stand up to lobbying and industry pressure.

This needs press attention.

The Reagan Udall Foundation has to issue reports within the next couple of months.  Let’s see how well those reports reflect what was said at the hearings.

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Jan 17 2023

Washington Post calls for breaking up the FDA to get more focus on food

Last week, the Washington Post editorial board gave its Opinion For the nation’s health, break up the Food and Drug Administration.

The Food and Drug Administration last year failed repeatedly to keep the nation’s babies safe from tainted formula. The baby formula fiasco was the latest in a long line of food crises that the agency was slow to catch and handle. But the deaths of babies and the desperation of parents trying to find enough food for their newborns shocked Congress, the public and the world into realizing just how broken the U.S. food-monitoring system had become.

The editorial cited:

  • Helena Bottemiller Evich’s investigation in Politico, which found the FDA’s food-safety operations to be so slow as to be “practically in its own league.”
  • A 2017 inspector general report finding the food recall system to be “dangerously sluggish.
  • Reports from the Government Accountability Office which have “repeatedly called out ‘high risk’ problems, including an urgent need for a national food-safety strategy and ‘high-level sustained leadership.'”

Bottemiller Evich is now doing her own invaluable newsletter, Food Fix (subscribe here, and  follow Food Fix on Twitter and LinkedIn).

In it, she says, “The FDA is not working if…”

  • it takes a years-long struggle to set even interim, voluntary limits for heavy metals and other neurotoxins in baby food.
  • its public health mission is to improve nutrition, but diet-related diseases continue to worsen unabated, driving massive human and health care costs.
  • it takes more than a decade to address agricultural water safety…sparking deadly outbreaks year after year.
  • it routinely fails to get to the bottom of serious food poisoning incidents – like last summer, when hundreds of people were sickened and more than 130 were hospitalized after eating Daily Harvest frozen crumbles.
  • it is conducting fewer and fewer food safety inspections, even as Congress has given the agency more resources over the years to do more inspections.

The FDA says it is taking all this seriously and will come up with a plan to address these failings.  I can’t wait to see it.

Other comments

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For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

Dec 8 2022

Reforming the FDA: a food industry view

Food Safety News hosted an opinion piece by Sarah Gallo, vice president of product policy for the Consumer Brands Association (formerly the Grocery Manufacturers of America, an industry organization I’ve written about frequently, most recently about its name change).

Ms. Gallo joins consumer food advocates in arguing that the FDA needs reform (see Helena Bottemiller Evich’s account here).

The FDA is released its internal review yesterday (see my post), with insiders doing the reviewing (see Helena Bottemiller Evich’s account here).

Here’s what the food industry says it wants (my selection from Ms. Gallo’s list):

  • Quicker reviews of new foods and ingredients.
  • Tailored inspections.
  • Updated recall processes.
  • Flexible food labeling.
  • Improved industry collaboration.
  • “A transparent regulatory agenda for chemicals in packaging.”
  • Better IT systems.

It’s hard to argue with some of these, and I won’t.

Yesterday’s report recommends some of these, not all (see my post on it).

The Coonsumer Brand Association liked the report.  Here’s why:

The FDA is a public health agency; it is part of the US Public Health Service.

I want to see it put public health first in everything it does.

If this means coming up against the food and beverage industry, so be it.  That’s its job.

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For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

 

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