Currently browsing posts about: FDA

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.

I was interested to see this report in the BMJ (formerly British Medical Journal): Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs. BMJ 2024;386:q1418. doi: 10.1136/bmj.q1418.

The “Revolving Door,” of course, is the term used to describe how officials of federal regulatory agencies leave to take jobs with the industry they formerly regulated, and vice versa.  I’ve written about this previously. Others have written about the FDA’s “revolvement” with the drug industry.

You can easily imagine why a food company would want to hire a former FDA official.  That person will know how to deal with annoying regulatory issues, and will no doubt still have friends and former colleagues in the agency who can help smooth the way.aa

So what does the BMJ add to this?  Plenty, unfortunately.  Evidence from e-mails obtained through FOIA (freedom-of-information) requests.

Internal emails show that the US Food and Drug Administration informs employees leaving for industry jobs that, despite restrictions on post-employment lobbying, they are still permitted to influence the agency…The legal ability to work “behind the scenes” is enshrined in federal regulations2 and highlights a “critical, critical loophole” in US revolving door policy, says a leading consumer advocate.

Craig Holman, a government affairs lobbyist for the organisation Public Citizen, told The BMJ that the rules forbid various forms of direct lobbying contact but permit lobbying activity that is indirect. “So, people will leave government service and can immediately start doing influence peddling and lobbying,” Holman explained. “They can even run a lobbying campaign, as long as they don’t actually pick up the telephone and make the contact with their former officials—and that’s exactly the advice that’s being given here.”

The BMJ notes:

Since 2000 every FDA commissioner, the agency’s highest position, has gone on to work for industry. These include Robert Califf, the agency’s current chief, who re-established ties with industry in between his two stints at the agency’s helm.

One argument here is that the human resources folks are just explaining existing ethical requirements.

But a legitimate worry is corporate “capture.”  When federal regulatory agencies are “captured,” they neglect public interest in favor of corporate interest.

This has been a concern about the FDA for a long time.  The FDA needs to do all it can to restore public trust in its integrity.

The FDA has issued its boringly titled Southwest Agricultural Region Environmental Microbiology Study (2019 – 2024).

The report seems designed to be boring.  Its subject, however, is anything but.

Let me do some translating (in Italics).

• “The study was designed to improve understanding of the environmental factors that may impact the presence of foodborne pathogens in the Southwest agricultural region.”  [Leafy greens contaminated with pathogenic bacteria make lots of people really sick, undoubtedly because they come in contact with CAFOs, confined animal feeding operations].
• “Samples were collected from irrigation waters, soil, sediments, air/dust, animal fecal material, wildlife scat, and other sources across approximately a 54 mile (7,000 acres) area of the southwest growing region.” [It’s about time the FDA did this].
• “Special attention was given to the geography of the study region and the types and locations of agricultural and other adjacent and nearby land use activities relative to produce production areas.  For example, there is a Concentrated Animal Feeding Operation (CAFO) with more than 80,000 head of cattle and an associated compost operation in proximity to some of the produce production areas studied. [Oh.  What a surprise].

The investigation’s findings

• “STEC [Shiga toxin-producing E. coli] can survive in the air and that dust can act as a transfer mechanism for both pathogens and indicator organisms (e.g. generic E. coli) from adjacent and nearby land to water, soil, and plant tissue “[toxic bacteria spread from CAFOs by air and dust].
• “The research team repeatedly observed that generic E. coli concentrations and STEC prevalence and isolation frequency increased as irrigation canal water flowed past an adjacent livestock and compost operation” [toxic bacteria spread from CAFOs by water].
• “…birds and other wildlife do not appear to be significant sources of STEC or E. coli O157:H7 ” [blaming wild birds for contaminating leafy greens is not going to work].
• “STEC strains detected in water, sediment, and plant tissue harvested from our research plots genetically matched strains isolated in air samples providing evidence that bacteria in air can transfer to other locations and surfaces.”  [Toxic bacteria get around easily].

The conclusions

Having proven that CAFOs contaminate air, soil, and water with toxic bacteria, the report concludes:

The preliminary results of this study stress the interconnectedness between people, animals and the environment and serve as an important model for how to foster productive dialogue among diverse stakeholders to improve food safety.

Comment

Foster dialogue?  They have to be kidding.  CAFOs need to be held responsible for the waste produced by their animals.  Human wastes are not allowed to be released untreated into the environment; neither should animal wastes.

Here is food safety lawyer Bill Marler’s comment.

The Department of Health and Human Service’s Inspector General has reported on its investigation of the FDA’s mis-handling of infant formula shortages a couple of years ago: The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply.

I see this as a direct result of Helena Bottemiller Evich’s reporting in Politico—the power of the press, indeed (she now writes Food Fix, to which I subscribe, and where she discusses this report).

In an earlier report, she detailed the history of FDA’s inspections of the Abbott laboratory and the agency’s surprising delay in getting Abbott to do a “voluntary” recall.

She, justifiably, takes some credit. 

Food safety lawyer Bill Marler also had questions about the quality of production and FDA’s surprising lack of action.

What this is about

Infants who are not breastfed are completely dependent on infant formula. In 2022, contaminated powdered formula from Abbott Labs was associatied with the illness or deaths of several infants,  Despite earlier complaints from whistleblowers about poor sanitation at Abbott plants, the FDA was slow to advise not using this formula.

At the time of the FDA advisory, one infant was ill with Salmonella Newport, and four were ill with Cronobacter sakazakii ); of these, two died—a shocking tragedy.

What the report says

The Inspector General summarizes the findings:

• FDA had inadequate policies and procedures to identify risks to infant formula and respond effectively
• FDA took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. I
• FDA did not escalate an October 2021 whistleblower complaint to senior leadership
• FDA did one inspection 102 days after a whistleblower complaint was received.
• FDA did not initiate an infant formula recall under its FDA-required recall authority.

Why didn’t the FDA act?

One reason was probably because “FDA could not confirm that the Abbott facility’s products caused the infant illnesses or deaths because clinical isolates for the infants were not available or whole genome sequencing was not a match to the Abbott facility Cronobacter investigation findings.”

Another is likely to be inadequate staffing, but a third, I’m guessing, has to do with the culture of the FDA, which increasingly appears captured by the industries it is supposed to be regulating.  The infant formula industry is highly concentrated and Abbott made something like 40% of it—even more reason to make sure the company was taking scrupulous care about safety.

The report instructs the FDA to do better.  Let’s hope.

Last week, the FDA essentially took tara flour out of the food supply.

Today, the U.S. Food and Drug Administration (FDA) posted on its website its determination that tara flour in human food does not meet the Generally Recognized As Safe (or GRAS) standard and is an unapproved food additive. The FDA’s assessment of the ingredient is detailed in a memo added to the agency’s public inventory.

The FDA explained what this is about.

In 2022, Daily Harvest used tara flour in a leek and lentil crumble product which was associated with roughly 400 adverse event reports. The firm took prompt action to voluntarily recall the product and conduct their own root cause analysis, during which they identified tara flour as a possible contributor to the illnesses. To date, the FDA has found no evidence that tara flour caused the outbreak; however, it did prompt the agency to evaluate the regulatory status of this food ingredient.

Daily Harvest makes frozen vegan meals for home delivery.  One of these meals contained tara flour.  Of 26,000 such meals sent out, 400 caused eaters to become desperately sick, some needing hospitalization, some needing surgery (I’ve met some of them).

In my posts, I speculated about why tara flour could cause such severe reactions.

Bill Marler, the food safety lawyer representing a great many of the victims, pushed the FDA to get tara flour out of the food supply before anyone else got sick.  His December 2023 letter reviews what is known about this situation to date.  The FDA paid attention!

Now, two years later, the FDA is doing what it can to prevent tara flour from getting into the food supply.  Good.

Here’s what I’ve had to say about this:

• The Daily Harvest mystery—a cause at last?
• The Daily Harvest recall mystery: update
• Tara flour: a quick review of the research
• What’s up with the Daily Harvest recall?

Here’s what Food Safety News has to say.  It notes more cases than are reported by the FDA, many of them represented by food-safety attorney Bill Marler.

Daily Harvest seems to have survived this tragedy, is still in business, and right on top of currents trends.  Its latest:

Daily Harvest’s January Jumpstart program features GLP-1-focused meal plans:  Daily Harvest’s debut of its GLP-1 Companion Food Collection as part of its quick-to-prep January Jumpstart plan includes “meals made with only real foods that are calorie-conscious while delivering ample vitamins and minerals,” Carolina Schneider, MS, RD, Daily Harvest’s nutrition advisor, told FoodNavigator-USA…. Read more