by Marion Nestle

Currently browsing posts about: FDA

Mar 21 2023

The FDA responds

My post last week on the FDA’s lack of action on ensuring the safety of infant formula elicited this response from Taryn Webb, Health Communications Specialist at CFSAN/FDA:

Hi Marion,

In your article below, “Alarming (in)action from the FDA,” you assert that “If FSMA did not require companies to notify the FDA when they found contamination, the FDA should be going to Congress to get that authority to announce its rulemaking to get that authority.” These statements could mislead readers to believe that the agency has not taken action to obtain this authority from Congress. In fact, the FDA is specifically seeking new authority to compel reporting of product positive test results for relevant pathogens (see FY 24 FDA Legislative Proposal titled, “Product Testing Requirements for Foods Marketed for Consumption by Infants and Young Children,” available at: https://www.fda.gov/about-fda/reports/budgets). Furthermore, the statement “FDA should…announce its rulemaking to get that authority,” is factually incorrect as without statutory authority, we are not in the position to undertake rulemaking to require such reporting. To reiterate what appears to be a point of confusion, the FDA cannot create authorities that we do not have through rulemaking. We did notice that you later updated your article at the very bottom to note that FDA did request such authority. However, your initial article and email distribution to readers contained incorrect information.

We are seeing a troubling pattern of articles with erroneous information that then get amplified. In the future, we would appreciate it if you contacted us before publishing articles that are solely about FDA so that we can provide you with the most up-to-date, correct information. You can reach out to our communications staff, which include myself and Jen Dooren (copied here) or by emailing CFSANTradepress@fda.hhs.gov.

As I see it, the “troubling pattern” here is FDA’s responses to advocates like me who want to support this agency’s role in making sure food companies in general—and infant formula companies in particular—do not produce unsafe food.  I want to encourage the FDA  to put public health as its first and immediate priority, as it is supposed to as an agency of the US Public Health Service.

I did not know about the FDA’s request to Congress.  The agency did not publicly announce it was asking for that authority.  I only learned about it from Helena Bottemiller Evich’s Food Fix newsletter, to which I subscribe.  I corrected my post as soon as I could.

Evich has her own issues with the FDA.  In her Food Fix letter last Friday, she said:

I updated last week’s post on FDA asking (not telling) infant formula makers to disclose contamination to clarify that the agency has determined it doesn’t have the authority to require this disclosure.  It’s perfectly normal for an agency to seek a clarification on something, as FDA did here, and I was happy to update the post – no problem. What I did take issue with, however, is FDA Commissioner Robert Califf characterizing the coverage as “misinformation” on Twitter.

…As I reported in Tuesday’s newsletter, FDA asked Congress last week for this test reporting authority in a budget document. This is notable, but it raises another critical question: Why didn’t the agency formally make this request earlier? It wasn’t in the agency’s budget request last year. It’s been more than a year since the massive Abbott Nutrition infant formula recall, and we’ve seen a handful of smaller recalls over Cronobacter concerns in recent months. And infant formula shortages and disruptions continue in many parts of the country.

If she didn’t know that FDA had asked Congress for test-reporting authority, it’s because the FDA wasn’t screaming for it as it should have been doing from the moment the infant formula crisis began.

The lives of infants are at stake.

Here what I wish the FDA had said from the beginning of the infant formula crisis and would still say:

“Marion, we are devastated by what has happened with infant formulas.  We can’t sleep for worrying about how we can protect infants from harm.  We are doing everything in our power to force formula producers to make sure their prevention controls are in place and monitored.  We never want this to happen again and won’t stop pushing them until we are sure infant formula is safe.”

I apologize for my error.  But I stand by my concerns.  FDA: If you want the troubling pattern to go away, fix the problem.

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Mar 14 2023

Alarming (in)action from the FDA

Last week I posted about Bill Marler’s “Take the F out of the FDA” campaign.

Since then, he additionally posted letters from the FDA that make it clear how poorly the agency is doing its job to protect all of us against foodborne illness.

Let’s start with the the agency’s March 8 letter to companies making infant formula.

The agency is asking—not requiring—infant formula companies to:

  • Evaluate their systems for ensuring safety
  • Comply with existing regulations
  • Follow existing rules, and
  • “Voluntarily notify the Agency any time a product sample is found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been  distributed.”

What?

The Food Safety Modernization Act (FSMA) of 2011 gave the FDA the authority to ensure safe food by requiring HACCP-like process controls at every stage of production.

Infant formula is the sole source of food for many babies.

The formula crisis of last year, where Abbott Labs produced formula contaminated with Cronobacter and Salmonella, meant that Abbott was not following the law and should have been required to clean up its act instantly.

Companies are supposed to test to make sure their process controls are working.

If FSMA did not require companies to notify the FDA when they found contamination, the FDA should be going to Congress to get that authority to announce its rulemaking to get that authority.

This is not a time for politeness.  Infants’ lives are at stake.

The FDA may argue that it cannot take action because so few companies make infant formula (illustrating why industry consolidation is not good for society).

But it must.  Marler is clear on what the FDA needs to do.

  • Put an inspector in every infant formula plant, 24/7.
  • Require product testing and report results to the CDC (to compare with illness).
  • Lobby to make Cronobacter a reportable infection (to reveal the extent of the problem).

To demonstrate the ineffectiveness of politeness, Marler also posted this 2005 letter from the FDA to lettuce growers (“we strongly encourage your industry to begin or intensify immediately efforts”)….  This was followed a year later by the Dole spinach recalls of 2006 (199 cases, 102 hospitalizations, 3 deaths) and many others, leading up to congressional action in passing FSMA.

It’s the FDA’s job to enforce FSMA.

If the FDA is too captured by industry to do that, let’s get the F out of it and into some place that is serious about doing something about food safety.

FDA Commissioner Califf ‘s tweeted response to Marler’s campaign—a thread of 14 tweets— is not reassuring.

There should be no question in anyone’s mind that the F in FDA is a top priority for me. We’ve accomplished a tremendous amount in the last 10 years to make the American food supply as safe as it’s ever been & improve the nutritional quality of foods. 
Not only does the U.S. have one of the safest food supplies in the world, we’ve also advanced our capabilities to detect pathogens. We’re now detecting more outbreaks & safety issues using modern methods like Whole Genome Sequencing that would have eluded detection in the past….
Creating a new foods agency isn’t in the FDA’s purview and would take years to put in place and distract from the important work that needs to be done today.
Right.  So do it.  Unsafe infant formula is a national scandal, unacceptable by any standard.
Addition: FoodFix reports this morning that the FDA has requested some of this authority in its legislative proposal (see page 4).as part of the Biden administration’s fiscal 2024 budget request that was unveiled Thursday (see page 4).
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Mar 8 2023

Bill Marler’s new campaign: Get the F out of the FDA

Food safety lawyer Bill Marler is calling for a new food agency on the grounds that the “FDA food reorganization plan is a “dismal failure.”

His campaign includes online advertisements, social media promotion, and survivors of foodborne illness coming to Washington DC to visit Congressional leaders and hand out “GET THE F OUT OF THE FDA” t-shirts. (Marler also will give free t-shirts to the first 100 people to request one at www.marlerblog.com—I’ve already asked for one)

Marler represents victims of food poisonings and thinks the FDA is not nearly as concerned about food safety as it needs to be because its primary focus is on drugs.

He’s also planning to run ads: “Food safety is suffering at FDA because the people at the top are doing drugs.”

He does have a sense of humor.  Marler is dead serious about cleaning up our ongoing, endless food safety problems.

Will this help?  Let’s hope.

Also

A separate food agency might be able to address what Bill Frist, Dan Glickman, and Jerold Mande are calling for: preventing unsafe food in all its manifestations, not only acute microbial, but also hyper-caloric.

 

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Feb 15 2023

More on what the FDA is doing about food and nutrition

Last week I did a post on the FDA’s reorganization.   I should have made one other point: the long-standing inadequacy of FDA funding.  For decades, Congress has assigned tasks to the FDA but provided inadequate funding to do those tasks adequately (hence 1% of imported foods are inspected).  Congress also assigns the funding for specific purposes.

Yes, FDA ought to be doing more, but it is not up to the agency to decide how to deploy its funds.

One more point: For long-standing historical reasons, FDA funding comes from congressional Agriculture committees, even though it is an agency of the Public Health Service.  That is one reason why USDA’s food safety programs are funded at so much higher a level than FDA’s.

With that said, the FDA has come out with some recent initiatives of interest.

I.  Front-of-Package labels.  The FDA is proposing to research a front-of-package symbol: “an easy-to-understand, standardized system that is 1) mandatory, 2) nutrient-specific, 3) includes calories, and is 4) interpretive with respect to the levels of added sugars, sodium, and saturated fat per serving.”

It is doing this in response to a petition from the Center for Science in the Public Interest.

The comments that have come in so far are here.

It is examining the use of front-of-pack symbols in other countries.

It also plans to conduct research on consumer understanding of multiple designs.  Here are the prototype packages on which the designs will be tested.

None of these is likely to be as effective as the ones used in other countries.

Here is one of the better options, in my opinion.

To file comments, go here.  It’s important to do this because the Consumer Brand Association (formerly the Grocery Manufacturers Association) and other industry groups are unlikely to accept any labeling scheme that might discourage you from buying a product.

II.  Qualified health claim: cocoa flavanols.  The FDA has approved a qualified health claim for cocoa flavanols and reduced risk of cardiovascular disease.

This was in response to a petition from the Swiss chocolate company, Barry Callebaut.

Here’s what the FDA will allow.  Yes, this is absurd (look at what the FDA has to go through to get to this), but companies must think statements like this will sell their products.

  • “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
  • “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols. See nutrition information for_____ and other nutrients.”

III.  GRAS panels.  The FDA has issued final guidance on best practices for panels deciding which ingredients can be Generally Recognized as Safe.

This lays out the guidelines for

  • Identifying GRAS panel members who have appropriate and balanced expertise.
  • Steps to reduce the risk of bias, or the appearance of bias, that may affect the credibility of the GRAS panel’s report, including assessing potential GRAS panel members for conflict of interest and the appearance of conflict of interest.
  • Limiting the data and information provided to a GRAS panel to publicly available information.

A lot of this is headache-inducing.  FDA rulemaking takes forever.  Can’t wait to see how all this turns out.

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Feb 7 2023

FDA organizational “reform:” clearly not fundamental, so just for show?

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 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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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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Jan 3 2023

What’s up with appropriations?

President Biden signed H.R. 2617, the Consolidated Appropriations Act, 2023.  

I’m interested in what the $1.7 trillion , 1600-page bill does for food issues.  It mentions the word “food” 786 times.  It mentions “agriculture” 213 times.  Fortunately, most of this is in Division A.  Even so, one longs for summaries. For whatever they are worth, here are a few I’ve collected.

Let me see if I can make some sense of this.

USDA highlights

  • $25.48 billion in discretionary spending (more than last year, less than what Biden asked for).
  • $3.7 billion for research ($1.74 billion for the Agricultural Reseach Service and $1.7 billion for the National Institute of Food and Agriculture
  • $1.17 billion for Animal and Plant Health Inspection Service (APHIS), more than $60 million above last year’s.
  • $1.15 billion for the Food Safety and Inspection Service, including funding to reduce user fees and to retain veterinarians.
  • Nutrition programs: $154 billion for SNAP; $6 billion for WIC; an increase of $6.6 million for commodities; an increase of $11 million for emergency food assistance.
  • International food assistance: $1.75 billion for Food for Peace grants (an increase), and $243 million for the McGovern-Dole education program (an increase).

FDA 

  • $6.56 billion for everything (but this includes a large percentage to be derived from food, drug, and tobacco user fee revenues).  These include increases for food safety and  some core functions.

The bill does some other things worth mentioning.  It includes: funds to:

  • Expand the Summer EBT program and makes it permanent as of 2024.
  • Addresses SNAP EBT skimming (stealing benefits across state lines).
  • Test for testing for per- and polyfluoroalkyl substances (PFAS—forever chemicals)
  • Make sure lobster and crab fisheries are in compliance with rules about whales.

It takes a lot of expertise to analyze all of this.  Here are two reactions.

Heritage Action: This omnibus package represents the very worst of Washington: back-room deals, $1.85 trillion dollar spending bills full of pet projects and partisan priorities, and an Establishment more interested in their own power than the wellbeing of the American people. The GOP must stand united in their opposition to this bill.

The Center on Budget and Policy Priorities: The biggest disappointment of the year-end bill by far is the failure to expand the Child Tax Credit. The American Rescue Plan’s expanded credit and other relief measures drove the child poverty rate to a record low of 5.2 percent in 2021. But with the expansion’s expiration, that record progress in reducing child poverty in 2021 has sharply reversed.

There are lots of other criticisms of this bill floating around, mainly having to do with what the Biden Administration asked for but did not get, and concerns about inadequate funding of FDA for food safety.

On this last point, let me again say that the perennially underfunded FDA gets its appropriations from agriculture committees, even though it is an agency of the public health service.  Agriculture subcommittees could not care less about FDA.  FDA needs a mandated home in Congress and much better support than it now gets.

Happy new year.

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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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