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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.

I attended a meeting at Cornell last week at which FDA Commissioner Robert Califf answered questions from faculty and staff.

He started out by remarking on the poor health status of Americans, despite our spending twice as much on health as any other country.  He noted the disparities in health status, particularly singling out the declining health of rural Americans.

In answer to questions from panel members and, later, from the audience, he said (my notes and paraphrase, unless in quotes):

• We have real health problems on the ground right now.
• 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.
• On tradeoffs in trying to discourage ultra-processed foods: This isn’t like drugs with clear risk/benefit calculations.  Food research has big confidence intervals and less rigorous estimates. The FDA has lots of bosses.  The executive branch and Congress can overrule anything it does.
• One Health (the movement to treat human and animal health issues as parts of a whole) is essential to the future of humanity.
• Climate change has moved pathogens into areas where they didn’t used to be.
• Action on animal antibiotics stagnated as a result of the pandemic: “We are all sinners in this regard.”
• We need a global strategy; infectious diseases do not respect borders.
• ”There is a lot of rhetoric about food safety, but the systems do not come together as they should.
• There is too much financial influence on policy.  “Policy is everyone’s job.”
• A lot of people are making a lot of money on our food and health systems, but it’s not spent on the right things.
• On the Supreme Court’s overturn of Chevron: the FDA cannot extend its rulings beyond what Congress intended.  It will slow things down.
• “We should reserve most of our energy to do our jobs well.”
• Courage is important: we must have courage to do things differently.

Comment

I was impressed by his knowledge, thoughtfulness, and concern about public health issues, especially those around food, as well as his understanding of the current political barriers against using expertise and regulation to improve food systems and public health.

He used the occasion to encourage students to consider careers in the FDA and noted the remarkably low turnover of permanent staff.

Jerry Mande sent me a link to a report of remarks the Commisioner made in December: America has a life expectancy crisis. But it’s not a political priority (Washington Post), and also to Helena Bottemiller Evich’s report, FDA Commissioner says ultra-processed foods drive addictive behavior.

So the Commissioner is giving serious thought to these issues.  So are others: see Announcement below.

The big question: who at FDA will take the lead on all this?

The FDA has just undergone a major reorganization.

As of October 1, the Human Foods Program looks like this.

The big question: who will head the new Nutrition Center of Excellence?

My big hope: Califf will appoint someone to that position who shares his committment to reducing diet-associated chronic disease.  Fingers crossed.

Announcement

Senator Bernie Sanders (I-Vt.), announced that his Committee on Health, Education, Labor, and Pensions (HELP) will hold a hearing on the urgent need for the FDA to “adequately protect Americans – especially children – from unhealthy foods that are pushed on consumers by the food and beverage industry.”  Here is his invitation letter to Commissioner Califf and Deputy Commissioner Jim Jones, who heads the FDA’s Human Foods Program.

When: 10:00 a.m. ET, Thursday, December 5, 2024
Where: Room 562 Dirksen Senate Office Building. The hearing will also be livestreamed on the HELP Committee’s website and Sanders’ socials.

The FDA is once again asking food companies to voluntarily reduce the sodium in their products.

It says that 40% of food categories have done just that.

Prior to 2021, consumer intake was approximately 3,400 milligrams per day on average, far higher than the limit recommended by the Dietary Guidelines for Americans of 2,300 milligrams per day for those 14 years and older.

If finalized, the new set of voluntary targets would support reducing average individual sodium intake to about 2,750 milligrams per day. This reduction is approximately 20% lower than consumer intake levels prior to 2021.

it has published a report on this progress.

A quick reminder: salt is 40% sodium.  The Dietary Guidelines upper limit target of 2300 mg/day sodium means nearly 6 grams of salt per day, or 1.5 teaspoons.

As for why this matters, Sodium Reduction Is A Proven Strategy That Saves Lives—More Work Is Needed To Hold Industry Accountable.

In 2016, the Food and Drug Administration (FDA) embarked on a sodium reduction strategy, only to meet repeated political hurdles…there has been little industry engagement, minimal public reporting, and no consequences if targets are not achieved.

Salt reduction across the entire food supply is the only measure that will help people reduce sodium intake.  This issue has been around for a long time.

Voluntary reduction is nice, but does not go nearly far enough and it can always be reversed.

The FDA could and should do more.

OK, granted.  Political opposition to salt reduction is fierce—if foods aren’t salty enough, people might not buy them.

But the FDA also has a long history of protection of commercial interests, which it claims it cannot share because it is obliged to protect trade secrets.  It’s time for that to change too.