Currently browsing posts about: FDA

It’s not easy to figure out what’s happening on the food front in DC these days, but a lot of it does not sound good.  Here are a bunch from last week.

I.  Food Bank Support. USDA stops $500 million worth of shipments of food to food banks.

Food banks across the country are scrambling to make up a $500 million budget shortfall after the Trump administration froze funds for hundreds of shipments of produce, poultry and other items that states had planned to distribute to needy residents.

The Biden administration had slated the aid for distribution to food banks during the 2025 fiscal year through the Emergency Food Assistance Program, which is run by the Agriculture Department and backed by a federal fund known as the Commodity Credit Corporation. But in recent weeks, many food banks learned that the shipments they had expected to receive this spring had been suspended.

II.  Line speeds in meat processing plants.  USDA announces “streamlined” meat processing.  This is USDA-speak for increasing line speeds in processing plants, something terrifying to anyone who cares about worker safety and food safety.  As Food Safety News puts it, this is unsafe at any speed—again.

Once more, policymakers are making the same catastrophic mistake. Once more, industries are downplaying risk while lives hang in the balance. Once more, we are choosing efficiency over responsibility…It’s a reckless increase in processing speeds that threatens to overwhelm the very safeguards meant to protect both workers and consumers.

III.  Food safety rules.  FDA puts food safety rule on hold

In an announcement on March 20, the Food and Drug Administration said it intends to publish a proposed rule “at a later time.” The rule has already been published and approved and was set to go into effect Jan. 1, 2026. The rule was mandated by the Food Safety Modernization Act, which Congress approved in 2010.

The food industry has been pushing back against the rule since before it was written, citing expenses. Industry groups applauded the FDA’s postponement of enforcement of the rule.

IV.  Seed Banks.  DOGE is trying to fire staff of the USDA’s National Plant Germplasm System, which stores 62,000 seed samples.

Comment

I’m not seeing much about Making America Healthy Again, beyond encouraging the elimination of artificial colors and trying to do something about the GRAS loophole, which lets companies essentially self-determine whether additives are safe.  Those are both worth doing, and have been a long time coming.  I still want to see this administration take strong action on:

• Ultra-processed food
• Food Safety
• School meals
• Support for small and medium farms

The cancelling of funding for the Diabetes Prevention Program, a 30-year longitudinal study, seems at odds with MAHA.  I hope the funding gets restored quicky.

Food Fix broke the news: Jim Jones, FDA Deputy Commissioner for Human Foods , resigned saying that the firings of the staff he had recruited over the last year made his job impossible.

The New York Times quotes Jones. 

They’ve created a real pickle for themselves,” by cutting staff members working on a key priority, Mr. Jones said. “You just can’t do an assessment [of food additives] for free and you can’t ban chemicals by fiat.

But wait!  Maybe you can.

The FDA is an agency of the Department of Health and Human Services (HHS).  And that brings me to its new secretary’s astonishing opening statement on his first day on the job.

I’m totally for making chronic disease a national priority for intervention, for getting conflicts of interest out of the FDA, and for focusing on child health.  And for Making America Healthy Again (MAHA).

I am eager to see what he does.

The FDA has long been plagued by cumbersome procedures (many of which do protect the public), conflicts of interest (especially the “revolving door” between the agency and industry), and apparent capture by the industries it is supposed to regulate.

Can RFK Jr address those problems in a way that promotes the public interest?  We shall see.

In the meantime, Jim Jones is being replaced by Kyle Diamantas, a lawyer from the large firm, Jones Day.

Not much is known about Mr. Diamantas, beyond his hunting turkeys with President Trump.

Food Fix quotes Vani Hari, the Food Babe as saying Diamantas “has a lot of Big Food contacts…I think that actually serves him. It puts him in an interesting position because he understands the stakeholders at play….I think that puts him in a good position to figure this out…He gets this issue.”

The nominee to be the new FDA Commissioner,  Martin Makary, has not yet been confirmed.

So much remains uncertain.  I am following all this with great interest.

Update on the chaos

The FDA has now rehired some of the people who were fired (particularly those supported by user fees).  Presumably, Jim Jones remains out.

As practically its last act under the Biden Administration, the FDA  Revoked Authorization for the Use of Red No. 3 in Food and Ingested Drugs.

The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.

The Delaney Clause says the FDA cannot consider any substance that causes cancer in animals to be GRAS (generally recognized as safe).

Red 3 was associated with cancer in laboratory animals 30 years ago but the FDA considered the issue low priority and nobody complained until the Center for Science in the Public Interest filed its petition.  Then the FDA had to act.

For food safety advocates, this has been a long time coming.

The FDA’s action fits well with the Make America Health Again (MAHA) agenda.

Vani Hari (the Food Babe) says:

thefoodbabe (@Vani Hari) posted: It’s truly amazing what can happen when we put our differences aside & work together, it took a lot of loud American voices to get the FDA to ban red #3. Big thanks to @CSPI @ewg @SenRonJohnson @SenSanders @TTuberville @realannapaulina @CFSTrueFood @CoryBooker @RobertKennedyJr

She points out that this is only the first salvo in getting artificial food colors out of the food supply, especially breakfast cereals.

thefoodbabe (@Vani Hari) posted: .@KelloggsUS refusal to sit down with us will be biggest PR mistake in the Food Industry.

Food dyes may not be the most important food concern but they are unnecessary cosmetics and ought to be low hanging fruit for action.  Getting rid of them is long overdue.

Comment

RFK, Jr promised to get the artificial food dyes out of cereals as soon as he could be appointed HHS Secretary.  Will he do that immediately, or will this need to wait for the MAHA Commission action report in 6 months?  We shall see.

Press accounts

• The Washington Post – FDA bans controversial red dye found in candy, drinks and snacks
• cnnbrk (@CNN Breaking News) posted: FDA bans red dye No. 3 from food and ingested drugs in the US, more than 30 years after scientists discovered links to cancer in animals
• New York Times: F.D.A. Bans Red Dye 3 in Foods, Linking It to Cancer in Rats

The Government Accountability Office (GAO) has issued: Food Safety: Status of Foodborne Illness in the U.S.

This one sounds much like GAO reports I’ve been reading since the early 1990s.

We have long reported that the fragmented nature of the federal food safety oversight system causes inconsistent oversight, ineffective coordination, and inefficient use of resources. Since 2007, we have identified federal oversight of food safety as a high-risk issue and made several recommendations and matters for congressional consideration. In 2017, we called for the Executive Office of the President to develop and implement a national strategy for overseeing food safety. As of January 2025, there were no plans to create a national strategy, according to officials from the Office of Management and Budget.

What’s impressive about this report is its comprehensiveness.  If you want to understand why food safety in the U.S. remains a problem, this is the place to start.

Among other things, it’s got great graphics, like this one.

It makes several points, none for the first time.

Oversight of food safety is a mess; it needs consolidation.

At least 30 federal laws govern the safety and quality of the U.S. food supply, both domestic and imported. Collectively, 15 federal agencies administer these laws, including CDC, USDA’s Food Safety and Inspection Service (FSIS), and HHS’s Food and Drug Administration (FDA). The federal food safety oversight system is supplemented by states, localities, Tribes, and territories, which may have their own laws and agencies to address the safety and quality of food.

The division of oversight responsibility between USDA (meat and poultry) and FDA (everything else) makes no sense.  It needs fixing.

Foodborne pathogens can be transmitted through multiple types of food and, therefore, can affect both FDA- and FSIS-regulated foods. For example, in 2024, two Salmonella outbreaks—one attributed to cucumbers, an FDA-regulated food, and one attributed to charcuterie meats, an FSIS-regulated food—collectively caused 650 confirmed illnesses and about 180 hospitalizations.

We keep trying and wish everyone would listen to us.

We previously reported on the need for a national strategy to guide federal efforts to address ongoing fragmentation and improve the federal food safety oversight system. This strategy could address our other previous matters for congressional consideration about a government-wide performance plan and sustained leadership for federal food safety. We maintain that such a strategy could create an opportunity to further strengthen federal oversight of the nation’s food supply and reduce the economic and public health effects of foodborne illness.

Food Safety News reports that the FDA says

the biggest stumbling block to conducting inspections of food facilities is understaffing…The annual target for FDA inspections is 19,200, according to the report. The most annual inspections of foreign food facilities occurred in 2019, with 1,727 inspections, or 9 percent of the annual target… in July 2024, FDA had a total of 432 investigators — 90 percent of the full-time equivalent ceiling — for conducting both domestic and foreign inspections, according to FDA officials.

Comment

The instructions to the MAHA Commission (see yesterday’s post) say nothing about food safety beyond its being a matter requiring fresh thinking. Food safety does not appear to be a MAHA priority, especially in light of the threatened mass firings of FDA staff.  Reducing the number of FDA inspectors is unlikely to help at this point.  I hope the Commission adds safe food to its agenda.  The GAO has called for a single food safety agency for decades.  This might be just the time to take that on.  Fresh thinking indeed!

With much fanfare, the FDA released its proposed rule for a new front-of-package summary of the Nutrition Facts panel.  I’ve written about the history of this previously.

Of all the options tested (Food Fix had the best summary), the FDA picked this one—not my first choice.

Why not?  I don’t think it’s much of an improvement over this one, produced by industry to head off something that might be more useful.  This one is easy to ignore and pretty much everyone does.  The FDA’s is a bit better, but not nearly enough.

I was hoping the FDA would at least use traffic light colors.  Even more, I wish the FDA had used “High in” warning labels used in Latin America.

These have been shown to be highly effective in discouraging purchases of food products high in sugar, saturated fat, sodium, and calories—the point of this exercise, after all (and why the food industry so opposes it).

Will this label do as well?  We will have to wait and find out.

In the meantime, this is your chance to comment.  Please do.

To Submit Comments

Comments on the proposed rule can be submitted electronically on http://www.regulations.gov by May 16, 2025.

Written comments can be submitted to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with the docket number FDA-2024-N-2910 and with the title “Food Labeling: Front-of-Package Nutrition Information.”

Here’s what the FDA says about Use of the Term Healthy on Food Labeling.

To meet the updated criteria for the claim, a food product needs to

1. contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and
2. meet specific limits for added sugars, saturated fat and sodium.

To qualify, a breakfast cereal, bread, or any other grain food would need to have 3/4 ounce of whole grains, and have less than 10% of the Daily Value for added sugars (5 grams per serving), less than 10% for sodium (230 mg per serving), and less that 1 gram of saturated fat (5% DV).

On this basis, kids cereals won’t qualify.

Oh.  And the FDA is still working on the symbol.

Resources

• Use of the Term Healthy on Food Labeling | FDA
• FDA Finalizes Updated “Healthy” Nutrient Content Claim | FDA
• Constituent update
• FDA’s Updated “Healthy” Claim Definition: Fact Sheet
• Federal Register: https://public-inspection.federalregister.gov/2024-29957.pdf
• New York Times: What Are ‘Healthy’ Foods? The F.D.A. Updates the Labeling Terms
• The Hill: FDA updates definition of ‘healthy’ on food labels for first time in 30 years

I have to say, it’s thrilling to see chronic disease prevention at last getting the attention it totally deserves.  Last week, Senator Bernie Sanders’ Health, Education, Labor & Pensions committee held a hearing: What Is the FDA Doing to Reduce the Diabetes and Obesity Epidemics in America and Take on the Greed of the Food and Beverage Industry?

Sanders was eloquent about the need to prevent obesity and its healtth consequences, particularly among children.

Food Fix has an excellent summary: Concern about chronic disease crisis takes a bipartisan turn

During the two-hour hearing, FDA was roundly criticized for not taking a more active role in combating diet-related diseases and cracking down on the food industry. (Nevermind that Congress has not been on FDA about these issues and has actually thwarted the agency’s work on nutrition over the years at the behest of industry, but I digress!)

If you were listening to this hearing, you really couldn’t tell which lawmaker was Republican or Democrat based on their comments alone. And as far as I could tell, no lawmaker came to the defense of the industry. Instead, there was broad, bipartisan agreement that the status quo isn’t acceptable.

….The sharpest exchange of the hearing this week came from Sen. Sanders. He pressed FDA Commissioner Robert Califf on what progress FDA has made to warn Americans about the harms of processed foods. Sanders noted that it was 14 years ago that FDA began looking into front-of-pack labeling, and a proposal has still not been released. Meanwhile, many other countries have gone ahead with such labels and/or gone further, implementing bold front-of-pack warning labels.

Califf, who I find thoughtful and impressively honest, was pushed hard by Sanders.  He explained the congressional restrictions on what FDA can do (money, laws).  Obviously, these can be changed.

Mostly, I found the emphasis on stopping marketing of junk food to kids particularly heartening.

In 2006, the Institute of Medicine published a terrific report on Food Marketing to Children and Youth: Threat or Opportunity?

One of its recommendations:

Recommendation 8: Government at all levels should marshal the full range of public policy levers to foster the development and promotion of healthful diets for children and youth.

It went on to say:

If voluntary efforts related to advertising during children’s television programming are unsuccessful in shifting the emphasis away from high-calorie and low-nutrient foods and beverages to the advertising of healthful foods and beverages, Congress should enact legislation mandating the shift on both broadcast and cable television.

Well, yes.  It’s been nearly 20 years since that report.  Surely, the time has come.

The FDA has announced its 2025  Priority Deliverables for the Human Food Program.

These cover the microbial and chemical safety of foods, but I am especially interested in what the FDA is and is not doing about nutrition and chronic disease prevention—something mentioned by FDA Commissioner Robert Califf as a priority for American public health.

Based on FDA’s Nutrition Initiatives, the deliverables begin with:

FDA’s Role in Empowering Consumers to Build Nutritious Diets that Support Health and Wellness

Using a risk management approach, we focus our efforts in FY 2025 on labeling and other initiatives to help consumers make more informed choices about the food they eat, and, for those who rely on certain critical foods, such as infant formula, as their sole source of nutrition, we work to make sure those products are safe, properly labeled, and nutritionally sound.

As for the Human Food Program’s priority policy initiatives:

• Update FDA’s Nutrient Content Claim “Healthy”
• Propose Front-of-Package Nutrition Labeling:
• Support Reductions in Sodium in the Food Supply
• Increase the Resiliency of the U.S Infant Formula Market

The deliverables do mention diet-related chronic disease in the contexts of sodium and research.

• We will also collaborate with our federal partners and engage with key stakeholders to enhance sodium-related data sharing and learnings, as part of these efforts to help reduce diet-related chronic diseases and deaths associated with high sodium intake, such as hypertension and stroke.
• We will continue to collaborate with other federal agencies on developing and advancing a nutrition research agenda, including accelerating high-quality research to better understand the mechanisms between ultra-processed foods and poor health outcomes.

Despite Commissioner Califf’s statements, it looks like the Human Food Program is not particularly interested in chronic disease prevention or policy approaches to improving the environment of food choice.

Instead, its policies put the burden of responsibility on you as an individual to make healthier choices—not to find ways to counter the food industry’s marketing imperatives.

The FDA’s Human Food Program is all about empowering consumers.  Good luck with that.

Yes, the FDA is grossly underfunded and handicapped in what it can do, and yes, addressing environmental determinants of chronic disease would encounter opposition from vested interests.

But the FDA is an agency of the Public Health Service.  It needs to do better.

The Human Food Program should be taking the lead in addressing Commissioner Califf’s stated concerns

• The big issue is chronic disease, on which we are “doing terribly.”
• We have to deal with the marketing of ultra-processed foods designed to make you hungry for more.

These issues are consistent with the new administration’s Make America Healthy Again campaign.  Let’s hope that works.