Search results: reagan udall

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

• Appointing a committee to oversee the evaluation
• Opening a stakeholder portal where you can file anonymous comments
• Holding hearings: Agenda

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

• First day
• Second day

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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In the Atlantic (to which I subscribe), Eric Schlosser writes: Do We Really Want a Food Cartel? 

Mergers and acquisitions have created food oligopolies that are inefficient, barely regulated, unfair, and even dangerous.

He begins with the Federal Trade Commission’s report on what happened to the US food supply during the COVID-19 pandemic: Feeding America in a Time of Crisis: FTC Staff Report on The United States Grocery Supply Chain and the COVID-19 Pandemic.  This report focuses on the hazards of corporate consolidation for workers and consumers.

We see the effects in the grocery store.  Prices are up and executive compensation even more so.

As Schlosser puts it,

When four companies gain a combined market share that is greater than 40 percent, an oligopoly has formed. The prices offered to suppliers, the prices charged to consumers, and the wages paid to workers are no longer determined mainly by market forces. Further, the power these corporations exert within their industries and the economy as a whole leads to a well-documented dynamic: Effective government regulation becomes difficult, whether because state and federal agencies are “captive” or because they are outmatched in terms of resources and personnel.

This brings us back to my post this week about the FDA.  Schlosser describes the agency as “Poorly managed and notoriously reluctant to confront major food companies,” as shown by its inability to get on top of infant formula shortages.

Read his piece and see if he makes the case for his conclusion:

the fight against oligopolies and monopolies won’t be easy. A small number of corporations have tremendous political influence, expensive attorneys, and great skill at rigging markets in ways the public just can’t see.

We all need to pay close attention.

The FDA issued its most recent report on antibiotics late last year: 2022 Summary Report On Antimicrobials Sold or Distributed for Use in Food-Producing Animals, along with Antimicrobial Sales and Distribution Data 2013-2022.

It did this in response to public concerns about antibiotic use in food animals: if antibiotics are used at subtherapeutic doses, they might induce microbial resistance to drugs used to treat diseases in humans.

This is not a theoretical concern.  It’s a real problem.

It’s also a problem because the vast majority of antibiotics were used as growth promoters or to prevent infections in animals crowded together—not to treat disease.

In 2014 or so, the FDA ruled that medically important antibiotics could no longer be used as growth promoters in farm animals.  That rule went into effect in 2017.

The FDA’s good news: the amounts of antibiotics used in farm animals has declined since then.

Are medically important antibiotics still used for non-therapeutic purposes?

The report says that since 2017, zero antibiotics are administered for growth promotion.

If you wonder whether this is really true (as I do), consider that $11.2 million kilograms of antibiotics were used in food animals in 2022.  This is a decrease from the 15.6 million kg used in 2015, but still a lot.

Of these drugs, 63% are administered in feed, and 31% in water.

All antibiotics still used as growth promoters are supposed to be drugs not used in human medicine.

I’m not the only skeptic on this one.  See:

I.  The Bureau of Investigative Journalism’s Antibiotics in agriculture: The blurred line between growth promotion and disease prevention.

In an investigation published today, the Bureau revealed how US farm animals are still being dosed with antibiotics vital to human health, despite efforts to curtail such usage and combat the spread of deadly superbugs. We also found that a regulatory loophole means that using antibiotics to make animals fatter – a process known as growth promotion – is technically still possible, despite this practice being banned in January 2017.

II.  Nature: Antibiotic use in farming set to soar despite drug-resistance fears. Analysis finds antimicrobial drug use in agriculture is much higher than reported.

III.  Vox: Big Meat just can’t quit antibiotics: Meat production is making lifesaving drugs less effective. Where’s the FDA?

According to an analysis published in September by the Natural Resources Defense Council and One Health Trust, medically important antibiotics are increasingly going to livestock instead of humans. In 2017, the meat industry purchased 62 percent of the US supply. By 2020, it rose to 69 percent.

Does the FDA check?  It has guidance for industry on The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, but this guidance is non-binding.

Obviously, the FDA needs to do more.  Its officials told Vox:

Once again I am indebted to Bill Marler for keeping me informed about items related to food safety: Publisher’s Platform: The House Appropriations Committee Directs the FDA to Restructure – will it be Ignored? 

He points to this item on page 79 of the House Agriculture Appropriations bill.

I’ve written about problems with the FDA’s oversight of food and food safety previously (see this for example).

Food has always been a stepchild at the FDA, getting much less attention than drugs or medical devices.  When I was on the FDA’s Food Advisory Committee in the early 1990s, the FDA seemed to be trying to do better but that committee did not last long.  In any case, we were not advising the FDA on what it was proposing to do; we were giving the FDA a notion of the response to decisions it had already made.

What’s needed now is to unite the three units of FDA that deal with food: the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine’s food oversight programs, and the office that overseed food regulations.

And bring back the Foods Advisory Committee and listen to its advice.

The FDA commissioned a report on what it should do (see Reagan-Udall Foundation report and my comments on it).

What will happen now?  As Bill Marler puts it, “Grab the popcorn.”

Here’s what the FDA says it’s doing (thanks to Jerry Hagstrom’s Hagstrom Report for the links)

• FDA — Proposed Human Foods Program Organization Chart 
• Updates to FDA Proposal to Unify Human Foods Program / Create New ORA Model
• Proposed Office of Regulatory Affairs Organization Chart

This does some of what’s needed but the organization charts still look complicated, and the more complicated an organization chart, the least likely it is to work.

Will this work?  Bill Marler says it might.  Grab the popcorn indeed.

Last week, the FDA announced its proposed Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities.   You can also watch this announcement on video.

This action comes in the wake of:

• The infant formula crisis [Contaminated formula made babies sick. The FDA was warned about food safety concerns at an Abbott plant but took no action.  Abbott recalled formulas,shut down the plant.  This led to empty shelves.  Abbott is now under criminal investigation].
• The FDA’s evaluation of its performance during the crisis [this didn’t say much about accountability]
• The evaluation of the FDA by the Reagan-Udall Foundation [it called for major structural changes]
• The resignation of Frank Yiannas, deputy FDA commissioner [which made clear needed changes were not going to happen]
• Bipartisan pressure from members of Congress to enact major reforms
• Pressure from Senators DeLauro and Durbin to enact reforms
• The Washington Post editorial calling for breaking up the FDA
• Pressure from food safety lawyer Bill Marler to put food back into the FDA and to make fundamental changes

The FDA proposal comes with a vision of how the redesign would work.

The complaints and pressures argued for appointing a senior FDA official in charge of all FDA food programs and units.  Instead, the FDA proposes to create a Human Foods Program encompassing some, but not all, FDA food units.

Most prominently missing is the Center for Veterinary Medicine which deals with food for farm animals and pets.  These, however, fully participate in the food system for humans; they eat most of US corn production and loads of byproducts of human food production.  The systems for humans and animals are inextricably linked.

The organizational chart will look like this.  It splits the food units and connects them with dotted lines.  Good luck with that.  That was precisely the problem with the previous organization.

This looks better than the previous organization chart but falls far short of the authority needed to solve the nation’s food safety problem.

What’s needed?

• Unification of food safety under a central authority that unites the functions of USDA and FDA (the Government Accountability Organization has been calling for that for decades).
• Short of that, high-level FDA authority over the entire food supply under its jurisdiction.
• And much more FDA attention to its public health as well as its safety functions.  It should be taking the lead on actions to prevent diet-influenced chronic diseases.

Hey, I can dream.

In the meantime, let’s see how the FDA’s new structure goes and who it hires into that key position in charge of human foods.

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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

• Jerold Mande in the Washington Post: Food is making us sick. The FDA can do something about it.  
• Bill Marler asks: Hey FDA, its been over a month, are you going to do anything with the Reagan-Udall Foundation reccomendations?  Note: I discussed the Reagan-Udall report here.

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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.