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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

The headline caught my eye: FDA Publishes Landmark Final Rule to Enhance the Safety of Agricultural Water

Today, the U.S. Food and Drug Administration (FDA) published a final rule on agricultural water that represents an important step toward enhancing the safety of produce.

This addresses a big problem: contamination of agricultural land growing produce by bacteria in animal waste running off from CAFOs(onfined animal feeding operations), and dairy farms.

As I read it, the new rule requires:

• Annual evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on water from adjacent and nearby land, and other relevant factors.
• Testing pre-harvest agricultural water.
• Implementation of mitigation measures needed, especially those “associated with adjacent and nearby land uses.”

In the usual way the FDA does these things, farms have roughly one or two years after the final rule is published to comply.

The agency says it “is committed to taking an “educate before and while we regulate” approach to supporting compliance.”

I’m not sure what this means, but this rule can’t be implemented soon enough.

Next: USDA has to do the same thing for water on CAFOs and dairy farms.

Resources

• FSMA Final Rule on Pre-Harvest Agricultural Water
• Factsheet on the Final Rule
• FSMA Final Rule on Produce Safety
• Questions & Answers
• Harvest and post-harvest agricultural water activities.

In the Atlantic (to which I subscribe), Eric Schlosser writes: Do We Really Want a Food Cartel? 

Mergers and acquisitions have created food oligopolies that are inefficient, barely regulated, unfair, and even dangerous.

He begins with the Federal Trade Commission’s report on what happened to the US food supply during the COVID-19 pandemic: Feeding America in a Time of Crisis: FTC Staff Report on The United States Grocery Supply Chain and the COVID-19 Pandemic.  This report focuses on the hazards of corporate consolidation for workers and consumers.

We see the effects in the grocery store.  Prices are up and executive compensation even more so.

As Schlosser puts it,

When four companies gain a combined market share that is greater than 40 percent, an oligopoly has formed. The prices offered to suppliers, the prices charged to consumers, and the wages paid to workers are no longer determined mainly by market forces. Further, the power these corporations exert within their industries and the economy as a whole leads to a well-documented dynamic: Effective government regulation becomes difficult, whether because state and federal agencies are “captive” or because they are outmatched in terms of resources and personnel.

This brings us back to my post this week about the FDA.  Schlosser describes the agency as “Poorly managed and notoriously reluctant to confront major food companies,” as shown by its inability to get on top of infant formula shortages.

Read his piece and see if he makes the case for his conclusion:

the fight against oligopolies and monopolies won’t be easy. A small number of corporations have tremendous political influence, expensive attorneys, and great skill at rigging markets in ways the public just can’t see.

We all need to pay close attention.

The keynote address at the Consumer Federation of America’s annual food policy conference was given by the FDA’s new Deputy Commissioner for Human Foods, James “Jim” Jones.

He talked about his priorities and what he’s hoping the FDA will do.  Fine.

But in the Q and A, he was pushed repeatedly by Mike Jacobson (former head of CSPI) to say what the FDA would be doing to pressure the food industry to reduce salt in the food supply, something the FDA has promised to do for years with little progress.

In response, Jones said: “…I wouldn’t say pressure.  Pressure is not our statutory authority…isn’t to pressure….it is to help manage the food supply in a way that makes it healthier for Americans.”

Oh dear.

Pressuring the food industry most certainly is in the FDA’s authority.  I can think of lots of things the FDA has done that directly oppose food industry interests despite plenty of industry pushback: food labels in general and trans fat and sugar labeling in particular, restrictions on health claims, food safety regulations, and anything else the agency has done to force food companies to behave in the interest of public health.

Food companies will act in the public interest, only when they have to.  Jones’ statement, if that’s what he meant, is an alarming indication of agency capture.

The FDA is a regulatory agency and part of the Public Health Service.  It’s not supposed to win popularity contests.  It’s not supposed to be an arm of the food industry.

It’s supposed to take whatever tough steps are needed to keep the food supply safe and healthy so as to improve the overall health of Americans.

Yes, the FDA should be pressuring food companies about salt (and sugar, for that matter), and as strongly as possible.

Maybe I am misunderstanding what he said.  I hope so.

Here’s the video of the session.  Jacobson’s questions begin at 19:30.  Watch and decide for yourself.

The FDA Announces Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes.

FDA intends to consider exercising its enforcement discretion for the following qualified health claims:

“Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. FDA has concluded that there is limited information supporting this claim.”

“Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”

FDA intends to consider exercising enforcement discretion for the above qualified health claims for when all other factors for enforcement discretion identified in Section IV of this letter are met.

All I can do is laugh.  As I told CNN,

Qualified Health Claims are ridiculous on their face.

Why would any sensible person think that all you have to do to prevent type 2 diabetes is eat 2 cups of yogurt a week?…All we can hope is that the yogurt is at least unsweetened, but since it’s really hard to find unsweetened yogurt [in small cups], this is telling people who want to avoid type 2 diabetes that sweetened yogurts are good for them…According to the FDA’s review of the studies, the amount of sugar in the yogurt made no difference to the results…Therefore, according to the FDA, sugar is a non-issue.”

The reason for my amusement?  Limited evidence.  Translation: if you want to believe this, go ahead, but it’s not on the basis of compelling evidence.

Take a look at the Danone petition.  The company asked for—and got—the qualified claim on the basis of observational evidence along with consumption data indicating that Americans currently do not eat much yogurt.

Given this low consumption, such a QHC is important to encourage food companies to increase yogurt in the food supply and inform consumers of current evidence in order to help them make informed choices.

It’s not that the FDA is ignoring the sugar issue despite its allowing the claim no matter how much sugar the yogurt contains.  In its letter of acceptance of Danone’s petition, the FDA said,

we are concerned that the use of a qualified health claim on yogurts that contain a significant amount of added sugars could contribute empty calories to the diet. The Dietary Guidelines for Americans, 2020-2025 recommend limiting added sugars to less than 10 percent of total calories and note that added sugars account on average for almost 270 calories, or more than 13 percent of total calories per day in the U.S. population.

…Consequently, while there is currently no disqualifying level for added sugars, given that Americans are exceeding recommended limits on added sugars, and some yogurts on the market are high in added sugars, FDA encourages careful consideration of whether to use the claim on products that could contribute significant amounts of added sugars to the diet.

Is this a warning to Danone to avoid using the claim on sugary yogurts?  We shall have to wait and see.

In the meantime, Danone is delighted: Danone North America Announces the FDA’s Decision on Their Petition for the First-Ever Qualified Health Claim for Yogurt, Linking This Dairy Aisle Staple to a Reduced Risk of Type 2 Diabetes

In response to efforts led by Danone North America, the new claim states that “eating yogurt regularly, at least 2 cups (3 servings) per week” may reduce the risk of developing type 2 diabetes, a condition 1.4 million Americans are diagnosed with every year.

Qualified Health Claims are about selling food products, not science.