by Marion Nestle

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Aug 20 2024

The FDA’s Revolving Door: an ongoing concern

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.

Aug 19 2024

Industry-funded study of the week: supplemented infant formula

I saw this announcement in Food Navigator: Study: Nutrient dense formula could improve cognition and behaviour in infants.

My immediate question: Who paid for this?

I went right to it.

The study: Schneider N, Hartweg M, O’Regan J, Beauchemin J, Redman L, Hsia DS, Steiner P, Carmichael O, D’Sa V, Deoni S. Impact of a Nutrient Formulation on Longitudinal Myelination, Cognition, and Behavior from Birth to 2 Years: A Randomized Clinical Trial. Nutrients. 2023; 15(20):4439. https://doi.org/10.3390/nu15204439

Conclusions: The results suggest that brain development may be modifiable with brain- and age-relevant nutritional approaches in healthy infants and young children, which may be foundational for later learning outcomes.

Funding: This study received funding from the Société des Produits Nestlé S.A.

Conflicts of Interest: This study received funding from the Société des Produits Nestlé S.A. The funder had the following involvement with the study: study design, study monitoring and oversight, data collection and analysis, decision to publish, and preparation of the manuscript.

Comment: Some of the authors of this study are employed by Nestlé (no relation).  Their disclosure statement is unusually candid: the funder was totally involved in every aspect of the research.  It’s refreshing to see that dislosed.  But the underlying issue still holds: industry-funded reseach all too often produces results favorable to the commercial interests of the funder.

The concern here is that promoting infant formula as better than breast milk is a marketing strategy, as described in reports from the World Health Organization.  And see my previous post on this.

Aug 16 2024

Weekend reading: refrigeration!

This book was sent to me by its publisher (Penguin) and was it ever fun to read.  Twilley’s subtitle says it all.  She connects it to everything.

I particularly enjoyed two things in this book: its broad scope, from home ice boxes to economic development in Rwanda, and her personal experiences visiting icy cold packing plants, storage facilities, trucks, and seed vaults on the Faroe Islands.

Here is Twilley on bananas, of all things:

Contrary to popular belief, bananas are the ultimate refrigerated fruit.  In order to be a global commodity rather than an exotic luxury, the banana depends on a seamless network of thermal control.  This comes as something of a shock to most people.  Indeed, it seems to directly contrdict the advice issued by one of America’s most memorable brand mascots, Miss Chiquita….this sultry lady banana warned viewers, “Bananas like the climate of the very, very tropical equator / So you sould never put bananas in the refrigerator.”   In reality, before the advent of refrigeraion, bananas were a rare and expensive treat outside their tropical homelands.

Bananas, she tells us, are picked green and refrigerated, sometimes for weeks “between their places of harvest and their ultimate country of consumption.”

Refrigeration, she points out, changed the American diet, especially with respect to meat.

The ripple effect of this transformation shapes the geography and economics of American meat to this day.  Urban stockyard workers had been unionized since the 1930s; employees of the new rural processing plants were not: they were and are paid much less.  With the savings on labor and food costs, the new meat-packers could cut beef prices while still making more money, and Americans responded by eating ever more meat.

The book focuses on the Big Picture:

In short, our food system is frostbitten: it has been injured by its exposure to cold.  Part of the reason for that is that refrigeration was implemented, for the most part, in order to optimize markets rather than human and environmental health.

I thought this was a great read, totally deserving of its front page review in the New York Times.

But I wish she had cited Hi’ilei Julia Kawehipuaakahaopulani Hobart’s Cooling the Tropics: Ice, Indigeneity, and Hawaiian Refreshment (Duke University Press, 2022)   Hi’ilei’s terrific book covers some of the same themes with respect to Hawai’i.  She got her doctorate in my NYU department and is now teaching at Yale.  We are proud of her!

And one tiny quibble.  Twilley makes the point that refrigeration technology is so solid that refrigerators last for decades.  Well, they used to.  Today, not so much.  Those big expensive machines are not expected to last more than a few years, not because of the refrigeration mechanisms but because of the electronics.  These burn out but by the time they do, the companies are no longer making replacements–as expensive and wasteful example of planned obsolescence as anyone can imagine.  I was sorry she didn’t mention this.

Aug 15 2024

What’s up with: Snacks

I’ve been collecting articles on snacks.

Some things to know about snacks:

  • They are hugely profitable
  • They have largely replaced meals among some population groups
  • They are mostly ultra-processed
  • The more snacks you eat, the more calories you are likely to take in

With that said, here are some recent items:

And last but not least…

Aug 14 2024

AI’s dietary advice about diabetes

NutraIngredients-Europe is interested in AI.  Here’s another item:

ChatGPT’s nutrition advice is limited for NCD patients: Study: ChatGPT is “unable to replace a healthcare professional’s consultation”, new research has concluded, following an assessment of the chatbot’s ability to handle prompts for nutrition advice for patients with multiple noncommunicable diseases (NCDs).

I went right to the study:

Ponzo V, Goitre I, Favaro E, Merlo FD, Mancino MV, Riso S, Bo S. Is ChatGPT an Effective Tool for Providing Dietary Advice? Nutrients. 2024; 16(4):469. https://doi.org/10.3390/nu16040469.

The conclusion: “although ChatGPT exhibited a reasonable accuracy in providing general dietary advice for NCDs, its efficacy decreased in complex situations necessitating customized strategies; therefore, the chatbot is currently unable to replace a healthcare professional’s consultation.”

Here’s an exeerpt from an example:

Prompt: I have type 2 diabetes mellitus, obesity, and chronic kidney disease. Can you give me nutritional advice?

ChatGPT answer:
I’m not a doctor, but I can offer some general advice that you may find helpful. It’s important to consult with a healthcare professional or a registered dietitian who can provide personalized advice based on your specific health conditions and needs.

That being said, managing type 2 diabetes, obesity, and chronic kidney disease often requires a combination of healthy eating habits, regular physical activity, and sometimes medication.

[It then goes on an on about controlling portion sizes, limiting sugars, choosing lean proteins and healthy fats, etc, and ends with]

Consult a Registered Dietitian: A registered dietitian can create a personalized meal plan tailored to your specific needs, taking into account your type 2 diabetes, obesity, and chronic kidney disease.

Comment

AI is only as good as its programming.  This is boilerplate.  I don’t know about you but I don’t like talking to machines and robots (dealing with Verizon, anyone?).

Part of the demonstrable effectiveness of health care professionals is the human interaction; someone cares enough about you to offer personalized advice.

Is this kind of thing better than nothing?  I remain to be convinced.

Aug 13 2024

What I’m reading: Mexico’s nutrition law

I was interested to see this article in The Lancet: Mexico’s bold new law on adequate and sustainable nutrition.  

Mexico’s new General Law on Adequate and Sustainable Nutrition (Ley general de Alimentación Adecuada y Sostenible) is a substantial step towards transforming food systems to address NCDs and promote environmental sustainability… It enshrines the human right to food…It prioritises health, environmental stewardship, water access, children’s health, enhanced food supply and distribution, the promotion of nutritious food, reduced food loss and waste, food provision in crisis situations, and social participation in food strategies…>It includes specific goals such as the prevention of diet-related non-communicable diseases (NCDs) and the mitigation of global warming….

…The law must be protected from undue commercial determinants. Powerful individuals and organisations in the food industry can both benefit and harm human health and the environment.  Although the law promotes multistakeholder engagement, it also includes safeguards against undue influence.
This sounds great, but what does the law actually say?  Fortunately, the USDA Foreign Agricultural Service did a translated summary: Mexico Enacts the General Law on Appropriate and Sustainable Food.
Some excerpts:

Article 4 describes that the right to food includes biocultural wealth, emphasizing gastronomic diversity and agrobiodiversity, as well as the link between food and culture.

Article 5 obligates the state to fulfill the terms provided in the law with international treaties on human rights to which Mexico is a party.

Article 16 describes that students enrolled in elementary schools have the right to receive adequate food in school establishments, free of charge or at affordable prices for their families, according to their conditions of vulnerability and considering the economic situation of the geographical area in which they are located.

Article 21 involves mandatory warning label requirements for products that contain GE ingredients.

Article 22 mandates that food producers and distributors provide information requested by any individual regarding the inputs or processes used to generate their products or services.

Article 24 describes that the Secretariat of Health (SALUD) will suggest the content of food staple baskets in the states to include cultural relevance.

Article 25 describes that SALUD will determine regional food staple baskets with a priority on food that is produced locally or regionally, according to season, derived from sustainable production, and that are part of the diets in a specific region by culture and tradition.

Article 28 gives preference to state purchases of food from local or regional producers of small and medium scale, including farmers in home or backyard gardens.

Article 36…will establish a list of harmful substances based on the current regulatory and legal framework taking into consideration the principles of precaution, prevention, and sustainability. The use of substances deemed harmful to health and the environment in the production, transportation, storage, or packaging of food of any kind is prohibited.

Article 37 describes that the government, within the scope of its power, will incorporate at least 30 percent of purchases of food and primary supplies directly from small and medium-scale producers within budgetary limits.

Article 44 states that the guiding principles of the national food policies, programs, and actions which guide food production much include assurance of self-sufficiency, biodiversity, and agrobiodiversity in production.

Article 50 describes that the State and the state agencies shall jointly decide on the location of these warehouses, considering the necessary criteria for the security of the reserves and the efficient transport of food to the population affected.

Articles 56 through 63 describe the powers of SINSAMAC, an agency that will develop national food policy.

If Mexico can pass legislation like this, shouldn’t we do this too?

Aug 12 2024

Industry-funded studies of the week: Eggs

Last year, the Egg Nutrition Center offered free continuing education credits for dietitians.

This year, I received an e-mailed press release: EMBARGOED FOR RELEASE: 8:00 a.m. ET, Thursday, March 28, 2024

Fortified Eggs Did Not Raise Cholesterol in Modest-Sized Cardiology Study

Further study needed to investigate secondary findings.

…A study presented at the American College of Cardiology’s Annual Scientific Session and led by researchers at Duke, offers new evidence on fortified eggs, which are eggs enriched with various vitamins or nutrients. In a modest-sized randomized trial, researchers found that fortified eggs did not have a negative impact on bad cholesterol (LDL cholesterol) or good cholesterol (HDL cholesterol) over the course of the four-month study.

The study was sponsored by Eggland’s Best, a company that makes and sells fortified eggs. It also provided the eggs used in the research.

The egg industry funds research in collaboraion with the USDA.

Example: Mott MM, Zhou X, Bradlee ML, Singer MR, Yiannakou I, Moore LL. Egg Intake Is Associated with Lower Risks of Impaired Fasting Glucose and High Blood Pressure in Framingham Offspring Study Adults. Nutrients. 2023 Jan 18;15(3):507. doi: 10.3390/nu15030507.

Conclusion: This study found that regular egg consumption as part of a healthy diet had long-term beneficial effects on blood pressure and glucose metabolism and lowered the long-term risks of high blood pressure and diabetes.

Funding: These data were originally collected with funding from the National Heart, Lung, and Blood Institute (Framingham Study contract N01-HC-25195 and HHSN268201500001I). These analyses were also supported by a small grant from the American Egg Board’s Egg Nutrition Center of the U.S.Department of Agriculture.

Comment: Regardless of recommedations about dietary cholesterol, the advice has always been that one egg a day is OK.  That’s 365 a year.  According to the USDA’s per capata availability data, the average is only 275 (in 2021).  The egg industry wants you to eat more eggs and is working hard to get you to do that.

Aug 9 2024

Weekend Reading: Food Economics (also a gift!)

This brand new book—all 498 pages of it—is open access.

As the publisher explains,

  • This book is open access, which means that you have free and unlimited access
  • Analyzes the connections between agriculture and resource use, commodity trade, food businesses, and retail markets
  • Provides diagrams and data visualizations to explain, predict, and assess changes in the food system
  • Features rich visualizations and primary source information for updated charts from US and international sources

The authors have gone to a lot of trouble to make basic economic concepts clear.  For example,

We use the term monopoly to describe a market with just one seller and the less common term monopsony when there is just one buyer. The two are symmetrical, so both kinds of market power are sometimes called monopoly power. But distinguishing between monopoly and monopsony is useful because food businesses can potentially exercise both at the same time. For example, a large dairy processor and distributor might become a monopsonist in buying raw milk from farmers and a monopolist in selling dairy products to consumers. Their potential market power is ‘two-sided’, similar to online platforms for food delivery that could potentially become the only intermediary between restaurants and customers.

They also have lots of ifnteresting points to make.

The persistence of family farming is among the most surprising facts about the economics of food. In the U.S. and elsewhere most farms do not sell directly to consumers but operate behind the scenes, selling their produce in bulk to specialists for transport and distribution, often for use as ingredients in packaged and processed foods. Unlike farms, the food companies with whom consumers usually interact are typically owned by investors and run by hired managers. They buy ingredients from various sources, often combining produce from many different farms. Consumers everywhere in the world often seek out opportunities to buy directly from individual farmers, but that is special in part because it is relatively rare.

Take advantage of this offer!