by Marion Nestle

Currently browsing posts about: FDA

Aug 1 2023

Letter to FDA on front-of-package labels

I signed a letter organized by the Center for Science in the Public Interest calling on the FDA to do more to research front-of-package labels.

This is in response to the FDA’s announcement of what it plans to test in developing a front-of-package labeling scheme.

We asked the FDA for specific additions to the research proposals, among them this one:

  • Consider testing additional High In scheme designs with attention-grabbing features like these:

We noted that the FDA states three goals for the research:

  1. Participants’ ability to correctly interpret the nutritional profile of the product
  2. The speed at which participants make their decisions
  3. Whether or not participants search for more information to answer the question (i.e., whether they click a link to view the Nutrition Facts label)

We argued that

Of the three outcomes, we believe that participants’ ability to correctly interpret the nutritional profile of the product is the most important [because it is the only one that is independently and objectively desirable. In contrast, the desirability of faster decision-making is dependent on whether the decision is correct, and it is unclear what would be the more desirable outcome with respect to searching for the Nutrition Facts label. Searching for the Nutrition Facts label could be positive (if the labeling scheme spurs consumers to learn more about the product’s nutrition information and ingredients) or negative (if the labeling scheme is not noticeable or confusing and thus participants need to seek more information).

Front-of-package labeling has been in the works for a long time.  It’s great the FDA is getting to it.

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Jul 5 2023

Comment now on FDA’s front-of-package label proposals

The FDA is asking for public feedback on an updated research study to decide which front-of-package labeling design will work best to help the public choose healthy fpackaged foods.

To submit comments, go here.  They are due by July 17.

I’ve written about this issue previously.

The FDA tried to do this a decade ago.  But the Grocery Manufacturers Association (now Consumer Brands Association) did an end run and volunteered to use Facts Up Front/Guideline Daily Amounts, which nobody understands or pays attention to.  The FDA caved in and let that happen.

Now countries all over the world are putting warning labels on foods high in calories, fat, salt, and sugar, most of them ultra-processed.

The FDA says it will  test 8 front-of-package label designs to see which work best in conveying healthfulness. The study materials are here and here.

Earlier, if those links don’t work, it proposed to test all of these designs.

I don’t think any of the choices is as compelling as Chile’s warning labels, which can be understood easily by children and people who cannot read.

Among the FDA’s choices, here’s my preference (it’s most like the labels from Canada and Brazil).

This still requires people to figure out what it means if the colors differ, as they do here, but surely everyone will understand that the more red boxes, the worse.

One other complaint: Since this effort started, the concept of ultra-processed has become much more prominent and is backed up by a tremendous amount of research.

Avoiding ultra-processed foods is the key message needed now.

The FDA’s proposals will take care of most ultra-processed foods, but miss the point.  Whatever the FDA chooses will be out of date no matter when it appears.

Never mind.  This is a step in the right direction.  Food industry opposition to any of it is strong.

It’s important to tell the FDA to get busy on this, and to strengthen the warning.

Write the FDA NOW!

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Jun 28 2023

Unify the FDA’s food programs—says Congressional Ag Appropriations

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)

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.

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May 4 2023

More pro-GMO info from the FDA

I’m working on a new edition of What to Eat and am spending a lot of time in grocery stores seeing what’s new and different since 2006—vastly more than I thought when I signed up to do this project, which is why it is taking a long time to do.

One change is in the number of products displaying Non-GMO labels.  The Non-GMO Project says it has certified 60,000 products, and I believe it.

On the other hand, don’t expect to see labels on foods that are genetically modified even though they are required.  With much searching, I found a few on shipping boxes but not on grocery shelf labels.

So I’m interested to see what the FDA is saying about genetically modified foods.

It sent out a press release recently.

Today, the U.S. Food and Drug Administration (FDA) released new “Feed Your Mind” educational materials to provide science-based information on genetically modified organisms (GMOs). “Feed Your Mind” is an education initiative launched in 2020 to help increase consumer understanding of GMOs and was developed in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency.

The new materials for consumers include:

…Funding for the “Feed Your Mind” initiative was provided by Congress in the Consolidated Appropriations Act of 2017 to conduct “consumer outreach and education regarding agricultural biotechnology and biotechnology derived food products and animal feed, including through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian impacts of such biotechnology, food products, and feed.” More funds were provided through 2018 and 2019 Appropriations bills.

For More Information

The last time I wrote about the FDA’s GMO initiatives, I titled the post “The FDA’s new pro GMO propaganda.”  I pointed out that the FDA’s materials stick with limited issues, and say nothing about:

  • Corporate control of commodity agriculture
  • Glyphosate, the herbicide used with GMOs and considered carcinogenic by international health agencies and US courts
  • How pesticides used on GMO crops contaminate organic production
  • The ways GMO companies harrass independent farmers by enforcing intellectual property rights
  • How the Farm Bill subsidizes GMO corn and soybeans, causing them to be overproduced and corn to be used for ethanol
  • The lack of labeling of the few GMO foods on the market.

No wonder sales of organic foods are booming and so many people look for Non-GMO labels on food products.

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Apr 7 2023

Weekend reading: The FDA on food label dietary guidance statements

Press release: FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels

The draft guidance provides the agency’s thinking about the use of such statements, including recommendations that products contain a meaningful amount of the food, or category of foods, that is the subject of the statement, and that they also not exceed certain amounts of saturated fat, sodium and added sugars.

Translation: The idea here is to make sure that packages making health claims can back them up, or disclose relevant information.  This will automatically eliminate health claims from lots of products (see post on “healthy”).

The FDA is proposing something like this.

 

Here are the relevant documents:

This is all open for public comment now.  Here’s where to submit comments.

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Apr 4 2023

The FDA’s ongoing infant formula drama: an update

The FDA is under siege these days.  Two reasons why.

  • Its failure to follow the advice of experts on how to reorganize the agency to give greater prominence and authority to food as opposed to drugs.
  • Its failure to get on top of the safety and supply problems with infant formula.

As usual, Bill Marler gets right to the point.

Two top  food officials at the FDA have retired recently.

Food and Drug Administration Director of the Center for Food Safety and Applied Nutrition (CFSAN) Susan Mayne announced that she will retire on May 31, 2023. Dr. Mayne has served as Director of CFSAN since January 2015. Another retirement among FDA leadership occurred earlier this year when FDA Deputy Commissioner of Food Policy and Response Frank Yiannas retired on February 24, 2023.

Frank Yiannis, formerly deputy commissioner for food policy at the FDA, testified to Congress:

Yiannas said that the FDA’s structure and culture exacerbated delays and that the agency had no data system in place to monitor key food supply chains. While Abbott is responsible for the safety and testing of its own powdered formula, he said, the sickened children and months-long shortage “was all a preventable tragedy” had FDA acted more urgently.

To deal with the uproar about infant formula, the FDA has just released:

But this will not be enough.

Helena Bottemiller Evich’s most recent Politico report is titled “‘Lessons have not been learned’: FDA knew of positive test months before latest infant formula recall.”

And another recall of infant formula occurred more recently.

All of this increases the urgency of the calls on FDA to pay more attention to food issues.

Congress:  Act now!

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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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