Food Politics

by Marion Nestle
Jun 25 2019

FDA approves qualified health claim for omega-3s

I love the FDA’s qualified health claims for food products because they are so patently ridiculous.

These are health claims so poorly supported by science that the FDA insists on a disclaimer.

What’s their point?  Companies can use them for marketing and put the disclaimer in tiny print.

The latest is the FDA’s response to a petition from the Global Organization for EPA and DHA Omega-3s, which asked the FDA to approve these health claims:

  • EPA and DHA help lower blood pressure in the general population.
  • EPA and DHA reduce BP, a risk factor for CHD (coronary heart disease).
  • EPA and DHA reduce the risk of CHD.
  • Research shows that EPA and DHA may be beneficial for moderating BP, a risk factor for CHD.
  • Convincing scientific evidence indicates that EPA and DHA help lower blood pressure in the general population, with comparable reductions to those achieved with other diet and lifestyle interventions.

Not a chance.

The FDA did its own review of the literature and quite sensibly concluded that evidence supporting such claims is too weak to take seriously.

Instead, the FDA said that

In light of the above considerations, FDA intends to consider the exercise of its enforcement discretion for the following qualified health claims [with my emphasis in red]:

  • Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by reducing the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.

In order to use these claims, the products would have to contain at least 0.8 g EPA and DHA (combined total).

Absurd as all this may seem, the approval of qualified claims is considered a win for the omega 3 industry.

Why does the FDA allow such claims?  Because Congress said it had to permit claims even if evidence was insufficient to back them up [but see below].

Sigh.

Correction: A Twitter correspondent, Ilene Heller (@foodcop819), reminds me that the courts, not Congress, forced the FDA to allow qualified health claims on First Amendment grounds.  In 1990, Congress forced the FDA to allow health claims in general as part of the nutrition labeling act.  In 1994, Congress passed the dietary supplement act that essentially deregulated these products and allowed “structure/function” claims for them.  Food companies wanted to use them too.  Whenever the FDA objected that science didn’t support the claims, supplement companies took the FDA to court.  In 2003, the FDA gave up: We have lost 8 of 10 First Amendment decisions, and doing business the way we were doing it was unsustainable” (New York Times, July 6, 2003).  The so-called qualified health claims are the absurd result.

Jun 24 2019

Industry-funded study of the week: Nestlé’s latest

Estimation of Total Usual Dietary Intakes of Pregnant Women in the United States.  Regan L. Bailey, Susan G. Pac, Victor L. Fulgoni III, et al.  JAMA Network Open. 2019;2(6):e195967. doi:10.1001/jamanetworkopen.2019.5967 June 21, 2019

Question  How do the usual dietary intakes of pregnant US women compare with the National Academies of Science, Engineering, and Medicine Dietary Reference Intakes for nutritional adequacy and excess?

Conclusions and Relevance.  This study suggests that a significant number of pregnant women are not meeting recommendations for vitamins D, C, A, B6, K, and E, as well as folate, choline, iron, calcium, potassium, magnesium, and zinc even with the use of dietary supplements.

Conflict of Interest Disclosures: Dr Bailey reported serving as a consultant to Nutrition Impact LLC, Nestle/Gerber, RTI International, and the National Institutes of Health Office of Dietary Supplements. Dr Fulgoni, as Senior Vice President of Nutrition Impact LLC, reported performing consulting and database analyses for various food and beverage companies and related entities. Ms Pac and Dr Reidy reported being employees of Nestle Nutrition. No other disclosures were reported.

Funding/Support: This research was funded by Nestle Nutrition. Nestle Nutrition and Nutrition Impact had a financial agreement for completion of the statistical analysis. Drs Bailey and Catalano received an honorarium for the time contributed to manuscript development.

Role of the Funder/Sponsor: Nestle Nutrition had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Comment: It’s Nestlé, not Nestle, the company, not me.  Nestlé is the largest food and beverage company in the world, selling $94 billion worth of products in 2018.  This study is part of the company’s plan to focus on personalized nutrition—functional food products targeted to the personal nutritional needs of individuals.

We continue to invest in long-term innovation projects with the potential for high returns. Examples include infant and maternal nutrition, healthy aging, personalized nutrition, and understanding the microbiome.

It is in Nestlé’s corporate interests to demonstrate that pregnant women are deficient in essential nutrients as a basis for creating nutrient-supplemented products targeted to this group.  Are U.S. pregnant women really deficient in 13 nutrients as reported here?  This study’s conclusions are based on comparison of self-reported dietary intake to average daily nutrient intakes.  They are not based on laboratory or observed measurements of clinical signs of deficiency. To me, this looks like a typical industry-funded study with results favorable to the sponsor’s marketing interests, as I discuss in my book, Unsavory Truth.

Jun 21 2019

Weekend reading: plant-based and cell-cultured meat alternatives

I can hardly keep up with what’s happening with plant-based and cultured-meat products.  Here’s my latest collection from various newsletters and other sources.  Take a look at the ones that interest you.  This is a quick way to get a broad picture of where this industry is headed and how these products are viewed.

Bottom line: meat alternatives are big business.

Jun 20 2019

Kombucha: A collection of industry articles

FoodNavigator-USA.com, an industry newsletter, has a collection of articles about Kombucha, a drink that Wikipedia defines as:

A fermented, slightly alcoholic, lightly effervescentsweetened black or green tea drink commonly intended as a functional beverage for its supposed health benefits. Sometimes the beverage is called kombucha tea to distinguish it from the culture of bacteria and yeast.  Juice, spices, or other flavorings are often added to enhance the taste of the beverage. The exact origins of kombucha are not known…Kombucha is produced by fermenting sugared tea using a symbiotic culture of bacteria and yeast (SCOBY) commonly called a “mother” or “mushroom”…The living bacteria are said to be probiotic, one of the reasons for the drink’s popularity.

Slightly alcoholic?  No wonder it is so popular.

It’s obviously a major seller.  Here is the dedicated Kombucha display at the Wegmans upstate in Ithaca, New York.

The makers of kombucha want to sell more of it.  Here’s what they think the market issues are these days:

And here’s a later addition:

Jun 19 2019

PepsiCo’s $4 billion investment in Mexico

I was interested to see what BakeryandSnacks.com had to say about PepsiCo’s investment in Mexico.

This company, which makes ultra-processed drinks and snacks, plans to invest $4 billion in Mexico over the next two years.

The $4 billion will be spent on “four strategic areas:”

  • Improved supply chains for potatoes, corn, and sugar, purchased from small, medium and large producers ($1 billion).
  • Improved nutrient profile of PepsiCo products (the total is unspecified but $13 million will go to reducing saturated fats).
  • Reduced CO2 emissions and increased renewable energy (amount unspecified).
  • Strengthened development programs focused on water, recycling, nutrition and the empowerment of women (> $7 million).

This is on top of the $5 billion Pepsi invested in Mexico in 2014 for “product innovation, brand consolidation, infrastructure, sourcing, and community outreach.”

Pepsi has a big operation in Mexico.  It claims the new investment will add 3000 jobs to the 80,000 it already employs there.

What is this about?  In 2017, Mexico’s $3.6 billion in sales represented nearly 6% of PepsiCo’s total global net revenues of $63.5 billion.

I’ll bet Pepsi sees plenty of room for growth.  I do too, but also in the prevalence of obesity and related chronic disease.

Jun 18 2019

The tragic destruction of the Economic Research Service, continued

I care about what’s happening to the ERS because I depend on the research it produces and have relied on its authoritative studies for decades.  I trust ERS researchers to be honest, independent, and wonderfully available to provide expert interpretation of USDA data.  It breaks my heart to see the destruction of an agency I considered to be a national treasure.  I thought it would be protected by being under the radar.  Apparently not.

Staff losses and politicization means that the ERS is highly unlikely to continue doing that same kind of independent, critical research.  This is an enormous loss.

The USDA sent out a press release announcing that the ERS offices would be moved to Kansas City.

USDA says it is doing this for these reasons:

The considerable taxpayer savings will allow us to be more efficient and improve our ability to retain more employees in the long run. We will be placing important USDA resources closer to many stakeholders, most of whom live and work far from Washington, D.C. In addition, we are increasing the probability of attracting highly-qualified staff with training and interests in agriculture, many of whom come from land-grant universities.

Do we believe this?  No, we do not.

As Politico reports,

The proposal has already sparked a brain-drain of veteran economists from ERS, and some lawmakers and ERS staff allege relocation is a back-door attempt to shrink the agency and clamp down on research that doesn’t align with the Trump administration’s priorities.

Politico notes that “USDA paid the consulting firm Ernst & Young $340,000 to run the site selection process.”

In the meantime, ERS employees voted to unionize.  OK, better late than never.

Jerry Hagstrom of The Hagstrom Report  attended USDA Secretary Sonny Purdue’s announcement of the location of the move to ERS employees.  Union members expressed their displeasure openly (they have nothing to lose at this point).

This was a small agency doing quality work.  Its destruction is an American tragedy.

Thanks to the Hagstrom report for providing links to relevant documents:

USDA Research, Education, and Economics — ERS Directed Reassignment Letter (sample)
— Notice of Voluntary Separation Incentive Payment Authority
— Offer of Directed Reassignment: Acceptance/Declination Form
— Application for Voluntary Separation Incentive Program Buyout
— Frequently Asked Questions: Voluntary Separation Incentive Payments (VSIP)
— Sample Buyout Computation Worksheets
— Tax Questions on Buyouts (VSIP)

KC Area Development Council — USDA + KC: Relocation
— KC Now (video)

The ERS union’s letter to USDA for help with the move

 

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Jun 17 2019

Industry-funded study of the week: this time, Pistachios

Pistachio consumption modulates DNA oxidation and genes related to telomere maintenance: a crossover randomized clinical trial.
Silvia Canudas, Pablo Hernández-Alonso, Serena Galié, Jananee Muralidharan, Lydia Morell-Azanza, Guillermo Zalba, Jesús García-Gavilán,1Amelia Martí, Jordi Salas-Salvadó, and Mònica Bulló.  Am J Clin Nutr 2019;0:1–8.

Conclusions: “Chronic pistachio consumption reduces oxidative damage to DNA and increases the gene expression of some telomere-associated genes. Lessening oxidative damage to DNA and telomerase expression through diet may represent an intriguing way to promote healthspan in humans, reversing certain deleterious metabolic consequences of prediabetes.”

Funding: “The Western Pistachio Association( USA) and Paramount Farms [which grows pistachios and is owned by POM Wonderful] supported the trial… None of the funding sources played a role in the design, collection, analysis, or interpretation of the data, or in the decision to submit the manuscript for publication.”

Comment: I love pistachios.  Like other seeds and nuts, pistachios provide healthy fats and other nutrient along with their calories.  POM Wonderful is notorious for spending fortunes on research to prove the health benefits of the nuts and fruits it produces.  These are, of course, high on the recommended-for-health list.  Therefore, as I discuss in Unsavory Truth, such studies are about marketing, not science.

Jun 14 2019

Weekend reading: Canned

Anna Zeide.  Canned: The Rise and Fall of Consumer Confidence in the American Food Industry.  University of California Press, 2018.

Image result for Canned: The Rise and Fall of Consumer Confidence in the American Food Industry

This book uses the history of canned foods—beginning with condensed milk, peas, olives, tomatoes, and tuna, and ending up with BPA (bisphenol A, an endocrine disrupter)—to examine Americans’ changing relationship with industrially produced foods.

Canned foods have had their ups and downs in this country.  As Zeide explains, canning

means that people who have insecure housing without steady access to refrigeration, or who simply to not have the time or materials to prep fresh ingredients, can still eat relatively healthful meals.  Canned fruits, vegetables, and fish would be welcome additions to the food deserts of many low-income areas, which otherwise provide highly processed, sugary, and fatty foods with little nutritional quality.  Relatedly, the rejection of canned food—especially among members of a younger generation who hail from middle-and upper-class backgrounds—has implicit class biases.  Cans were once a symbol of modernity in the United States but now are seen as poverty food.  If we are to expect a fresher, perhaps healthier, way of eating to spread to all people, we must create economic and regulatory systems that make that possible (p. 192).

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