by Marion Nestle

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Apr 20 2016

Federal Appropriations and the FDA

Yesterday, the House Appropriations Committee passed the 2017 Agriculture-FDA spending bill.

As Politico explains (behind a paywall, unfortunately)

The bill would boost funding for rural development to $2.9 billion and allocate an additional $33 million over fiscal 2016 levels for the FDA to carry out the requirements of the Food Safety Modernization Act.

This isn’t nearly enough to permit FDA to carry out its functions.

The committee also passed amendments to:

  • Block the USDA from carrying out rules to protect chicken farmers with contracts with processing companies (they own the birds).
  • Exempt e-cigarettes from FDA regulations that restrict e-cigarettes advertising.

Can someone please explain to me why agricultural appropriations committees have jurisdiction over FDA and FDA spending is linked to agriculture spending?  OK, this is an historical anomaly; the FDA used to be part of USDA, but that was nearly a century ago.

Today’s FDA is part of the public health service, along with the CDC.

Shouldn’t health committees decide how much funding should go to FDA’s mandate to protect public health?

Just asking.

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Apr 19 2016

A rare industry-funded study with unhappy results for the Honey Board funder

The USDA has just done a write up on a study it funded in collaboration with the National Honey Board:  Consumption of Honey, Sucrose, and High-Fructose Corn Syrup Produces Similar Metabolic Effects in Glucose-Tolerant and -Intolerant Individuals.

This was one of the 12 industry-negative studies I posted to my collection of 168 industry-funded studies from March 2015 to March 2016.

 

The USDA article explains:

Controversy exists over whether all sweeteners produce the same metabolic effects in consumers despite the sweeteners’ chemical similarities. A study conducted by U.S. Department of Agriculture (USDA) researchers indicates that consuming lower amounts of added sugars is a more effective approach to health than finding a sugar that is more neutral in terms of its health effects…Volunteers [consuming honey, white cane sugar, or HFCS] did not show any differences in blood sugar levels based on the dietary sugar source. In addition, blood levels of triglyceride, an indicator of blood fat concentrations (a marker for heart disease risk), increased in response to all three sugars tested.

White cane sugar is 50% glucose and 50% fructose, linked together (but quickly separated in the body).  Honey and High Fructose Corn Syrup are glucose and fructose, already separated, but with slightly higher percentages of fructose.  Biochemically, they are not all that different.

So the results of this study, disappointing as they may have been to the Honey Board, were predictable on the basis of basic sugar biochemistry.

 

Mar 22 2016

GMO labeling: it’s happening!

When the Senate last week failed to pass a bill that would block individual states from passing laws requiring GMO labeling, it meant that Vermont’s labeling law would go into effect July 1.  Vermont passed its bill in 2014.

 

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Too bad for the Grocery Manufacturers Association and its food and biotech company members who spent hundreds of millions of dollars fighting labeling requirements.

Food companies now have a big problem.  If they want to sell products in Vermont, they must comply with GMO labeling.  Also, if other states pass slightly different laws, they will have to do labels state by state—a compliance nightmare.

Hence their attempt to get Congress to preempt Vermont’s law.  That ploy failed.

The result: one huge food company after another says it will voluntarily institute GMO labeling to comply with Vermont’s requirements.

As quoted by Reuters, General Mills says:

We can’t label our products for only one state without significantly driving up costs for our consumers, and we simply won’t do that,” Jeff Harmening, head of General Mills’ US retail operations said in a post on the company’s blog. “The result: Consumers all over the country will soon begin seeing words legislated by the state of Vermont on the labels of many of their favorite General Mills food products.”

Politico Morning Agriculture explains:

To be sure, General Mills is labeling as a practical business decision, not to change the policy discussion. The first-in-the-nation GMO labeling law is set to take effect in Vermont on July 1. As of that date, food makers face fines of $1,000 per day for every product type found on grocery store shelves in the state that’s not properly marked.

In the meantime, the Non-GMO Project, which certifies products as GMO-free, has put its seal on tens of thousands of products.

The reality: the public wants GMO foods to be labeled.

This should come as no surprise.  Public surveys since the late 1980s have come to the same conclusion.

Q: Why aren’t GMO foods labeled as such?

A.  Industry lobbying and an FDA too weak to stand up to it (see my book Safe Food: The Politics of Food Safety).

The GMO and grocery industries brought this situation on themselves by so strongly opposing labeling in 1994.  Believe me, they were warned (I witnessed all this as a member of the FDA Food Advisory Committee at the time).

Unless the industry can find another way to stop it, foods will be GMO labeled this year.

My prediction: the world will not come to an end.

Feb 10 2016

The American Society for Nutrition appoints Advisory Committee on Trust in Nutrition Science

I am a long-standing member of the American Society of Nutrition (ASN), and have been troubled for years by its cozy financial relationships with food companies (see, for example, this post from 2009 and the response from ASN).

ASN’s members are nutrition researchers.  The Society publishes the American Journal of Clinical Nutrition, the Journal of Nutrition, and Advances in Nutrition, sources of many of the industry-funded research articles I post regularly on this site.

ASN’s financial ties to food companies were the subject of an investigative report by Michele Simon last year: “Nutrition Scientists on the Take from Big Food: Has the American Society for Nutrition Lost All Credibility?

I am delighted to report that the ASN has now responded to these concerns, and in an especially constructive way.

The Society has just announced appointment of an Advisory Committee on Trust in Nutrition Science.

The Advisory Committee is charged with identifying best practices to allow effective collaborations while ensuring that ASN’s activities are transparent, advance research, and maintain scientific rigor; engendering trust among all nutrition science stakeholders…“Maintaining trust among all constituencies and stakeholders is paramount in ensuring that ASN and its membership are effective in carrying out ASN’s mission, to develop and extend the knowledge of nutrition through fundamental, multidisciplinary, and clinical research.” said ASN President Dr. Patrick Stover.

I’m even more delighted by the membership of this truly distinguished committee.  Whatever this group decides ought to carry a lot of weight.

Here’s the committee:

  • Cutberto Garza, MD, PhD, University Professor, Boston College, (Chair)
  • Vinita Bali, Chair, Board of Directors, Global Alliance for Improved Nutrition
  • Catherine Bertini, Professor of Public Administration and International Affairs, Syracuse University
  • Eric Campbell, PhD, Professor of Medicine, Harvard Medical School
  • Edward Cooney, JD, Former Executive Director, Congressional Hunger Center
  • Michael McGinnis, MD, Executive Officer, National Academy of Medicine
  • Sylvia Rowe, President, SR Strategy, LLC
  • Robert Steinbrook, MD, Professor Adjunct, Internal Medicine, Yale School of Medicine
  • Carol Tucker-Foreman, Distinguished Fellow, Consumer Federation of America Food Policy Institute
  • Catherine Woteki, PhD, Under Secretary for Research, Education and Economics, US Department of Agriculture
  • Patrick Stover, PhD, President, American Society for Nutrition (ex-officio member)
  • John Courtney, PhD, Executive Officer, American Society for Nutrition (ex-officio member)

The group is expected to complete its work within a year.  I eagerly await its report.

Jan 27 2016

Two industry-funded studies with results that must have disappointed sponsors. The score: 105/11

Sharp-eyed readers have sent in two studies sponsored by food companies with results that will be difficult to use for marketing.  This brings the score since mid-March to 105 sponsored studies useful in marketing to 11 that are not.

Effects of Pomegranate Extract Supplementation on Cardiovascular Risk Factors and Physical Function in Hemodialysis Patients. Wu Pei-Tzu, Fitschen Peter J., Kistler Brandon M., Jeong Jin Hee, Chung Hae Ryong, Aviram Michael, Phillips Shane A., Fernhall Bo, and Wilund Kenneth R.. Journal of Medicinal Food. September 2015, 18(9): 941-949. doi:10.1089/jmf.2014.0103.

  • Conclusions: Systolic blood pressure and diastolic blood pressure were reduced by 24±13.7 and 10±5.3 mmHg, respectively, in POM (P<.05). However, the BP differences in POM were no longer significant after controlling for baseline BP…However, pomegranate supplementation had no effect on other markers of cardiovascular disease risk, inflammation and oxidative stress, or measures of physical function and muscle strength. While pomegranate extract supplementation may reduce BP and increase the antioxidant activity in HD patients, it does not improve other markers of cardiovascular risk, physical function, or muscle strength.
  • Funding: This work was supported by the POM Wonderful, LLC.

The association between dietary saturated fatty acids and ischemic heart disease depends on the type and source of fatty acid in the European Prospective Investigation into Cancer and Nutrition–Netherlands cohort.  Jaike Praagman, Joline WJ Beulens, Marjan Alssema, Peter L Zock, Anne J Wanders, Ivonne Sluijs, and Yvonne T van der Schouw.  Am J Clin Nutr. First published ahead of print January 20, 2016 as doi: 10.3945/ajcn.115.122671

  • Conclusions: In this Dutch population, higher SFA intake was not associated with higher IHD risks. The lower IHD risk observed did not depend on the substituting macronutrient…Residual confounding by cholesterol-lowering therapy and trans fat or limited variation in SFA and PUFA intake may explain our findings.
  • Authors’ disclosures: JP is financially supported by a restricted research grant from Unilever Research and Development, Vlaardingen, Netherlands. MA, AJW, and PLZ are employees of Unilever Research and Development. None of the other authors reported a conflict of interest related to this study.
  • Comment: Unilever sells low-saturated fat/high-polyunsaturated fat margarines (e.g., Flora, Becel) for reducing coronary risk.  If higher saturated fat intake does not increase heart disease risk (perhaps because the study subjects were on statins), these products are unnecessary.
Dec 16 2015

House Appropriations Bill Affects 2015 Dietary Guidelines

The bill just passed by the House contains this language:

SEC. 734. None of the funds made available by this or any other Act may be used to release or implement the final version of the eighth edition of the Dietary Guidelines for Americans, revised pursuant to section 301 of the National Nutrition Monitoring and Related Research Act of 1990 (7 U.S.C. 5341), unless the Secretary of Agriculture and the Secretary of Health and Human Services ensure that each revision to any nutritional or dietary information or guideline contained in the 2010 edition of the Dietary Guidelines for Americans and each new nutritional or dietary information or guideline to be included in the eighth edition of the Dietary Guidelines for Americans.

(1) is based on significant scientific agreement; and

(2) is limited in scope to nutritional and dietary information.

SEC. 735.

(a) Not later than 30 days after the date of the enactment of this Act, the Secretary of Agriculture shall engage the National Academy of Medicine to conduct a comprehensive study of the entire process used to establish the Advisory Committee for the Dietary Guidelines for Americans and the subsequent development of the Dietary Guidelines for Americans, most recently revised pursuant to section 301 of the National Nutrition Monitoring and Related Research Act of 1990 (7 U.S.C. 5341). The panel of the National Academy of Medicine selected to conduct the study shall include a balanced representation of individuals with broad experiences and viewpoints regarding nutritional and dietary information.

(b) The study required by subsection (a) shall include the following:

(1) An analysis of each of the following:

(A) How the Dietary Guidelines for Americans can better prevent chronic disease, ensure nutritional sufficiency for all Americans, and accommodate a range of individual factors, including age, gender, and metabolic health.

(B) How the advisory committee selection process can be improved to provide more transparency, eliminate bias, and include committee members with a range of viewpoints.

(C) How the Nutrition Evidence Library is compiled and utilized, including whether Nutrition Evidence Library reviews and other systematic reviews and data analysis are conducted according to rigorous and objective scientific standards.

(D) How systematic reviews are conducted on longstanding Dietary Guidelines for Americans recommendations, including whether scientific studies are included from scientists with a range of viewpoints.

(2) Recommendations to improve the process used to establish the Dietary Guidelines for Americans and to ensure the Dietary Guidelines for Americans reflect balanced sound science.

(c) There is hereby appropriated $1,000,000 to conduct the study required by subsection (a).

Comment:  I continue to be astonished that the House of Representatives would take such an intense interest in the science of nutrition when it is so uninterested in the science of climate change.  And I am puzzled as to why the House thinks that nutrition scientists appointed by the Academy of Medicine (formerly Institute of Medicine) would have views any different from those of the current Dietary Guidelines Advisory Committee.

Will the USDA and HHS release the 2015 Dietary Guidelines before the Senate passes its version of the Appropriations bill?

I’m in Geneva this week and am hoping they wait until I get back.

Dec 8 2015

Three rare industry-funded studies with disappointing results. The score: 85:9.

Here are three rare studies sponsored by food companies with results that must have disappointed their funders.  Since mid-March when I started this collection, these bring the score to 85:9 (studies with results favorable to the sponsor’s interests vs. those against).

Acute Cocoa Supplementation Increases Postprandial HDL Cholesterol and Insulin in Obese Adults with Type 2 Diabetes after Consumption of a High-Fat BreakfastArpita Basu, Nancy M Betts, Misti J Leyva, Dongxu Fu, Christopher E Aston, and Timothy J Lyons.  J. Nutr. 2015; 145:2325-2332 doi:10.3945/jn.115.215772

  • Conclusion: Acute cocoa supplementation showed no clear overall benefit in T2D [type 2 diabetes] patients after a high-fat fast-food–style meal challenge. Although HDL cholesterol and insulin remained higher throughout the 6-h postprandial period, an overall decrease in large artery elasticity was found after cocoa consumption.
  • Funding: Supported by NIH Centers of Biomedical Research Excellence Program of the National Center for Research Resources at University of Oklahoma Health Sciences Center…a grant from The Hershey Company (to AB), and the Dean’s Research Incentive program in the College of Human Sciences at Oklahoma State University.

Associations between flavan-3-ol intake and CVD risk in the Norfolk cohort of the European Prospective Investigation into Cancer (EPIC-Norfolk).  Vogiatzoglou A1Mulligan AA2Bhaniani A2Lentjes MA2McTaggart A2Luben RN2Heiss C3Kelm M3Merx MW3Spencer JP3Schroeter H4Khaw KT5,Kuhnle GG6.  ).  Free Radic Biol Med. 2015 Jul;84:1-10. doi: 10.1016/j.freeradbiomed.2015.03.005. Epub 2015 Mar 17.

  • Conclusion:  There were no consistent associations between flavan-3-ol monomer intake and baseline systolic and diastolic blood pressure (BP)…Flavan-3-ol intake in EPIC-Norfolk is not sufficient to achieve a statistically significant reduction in CVD risk.
  • Funding: The present study was supported by the EU (Grant 226588, “Flaviola”) and an unrestricted grant from Mars, Inc. Mars, Inc. had no role in the design and analysis of the study or in the writing of this article. EPIC-Norfolk is supported by Cancer Research UK (SP2024-0201 and SP2024-0204) and the Medical Research Council (G9502233). H.S. is employed by MARS, Inc., a member of the FLAVIOLA research consortium and a company engaged in flavanol research and flavanol-related commercial activities. None of the other authors has a conflict of interest to declare.
  • Comment: This and the previous study are part of an effort to make chocolate seem like a health food.  Alas, these didn’t work.

No Change in 24-Hour Hydration Status Following a Moderate Increase in Fluid Consumption.  Matthew A. Tucker MA, J. D. Adams MS, Lemuel A. Brown MS, Christian B. Ridings MS, Jenna M. Burchfield MS, Forrest B. Robinson BS, Jamie L. McDermott MS, RD, LDN, Brett A. Schreiber MS, Nicole E. Moyen MS, Tyrone A. Washington PhD, Andrea C. Bermudez BS, Meredith P. Bennett BS, Maxime E. Buyckx MD & Matthew S. Ganio PhD.  Journal of the American College of Nutrition, DOI: 10.1080/07315724.2015.1046196.

  • Conclusions: Regardless of fluid volume or beverage type consumed, measures of 24-hour hydration status did not differ, suggesting that standard measures of hydration status are not sensitive enough to detect a 22% increase in beverage consumption.
  • Funding: This study was supported by a grant from The Coca-Cola Company. M.E.B., an employee of The Coca-Cola Company, contributed to study design and writing the article.
  • Comment: Coca-Cola has long advertised its products as promoting hydration.  In most people, thirst and normal food intake take care of hydration.  This study confirms that if you drink more than you need, you pee out the excess.
Nov 20 2015

FDA approves genetically modified salmon, and it won’t be labeled

The FDA has just approved AquAdvantage’s genetically engineered (GMO) Atlantic salmon.  The salmon will not have to be labeled as GMO.

The FDA has spent at least four years coming to this decision.  In previous posts, I’ve discussed.

What more to say?  Only that federal agencies are tone deaf about the GMO issue.

The FDA thinks that just because it judges the salmon safe to it, that automatically makes it acceptable to the public.

But as anyone who knows anything about risk communication can tell you, even if the salmon is safe to eat, the public may not want it for a host of other reasons.

The decision not to label the salmon, is also tone deaf.  The FDA bases its decision on its decision that genetic modification is not material, meaning that the GMO fish has a similar nutrient composition to wild or other farm-raised salmon.

But the FDA requires labeling of plenty of other non-material processes: made from concentrate, previously frozen, and irradiated, for example.

As far as I can tell, the FDA has learned nothing about risk communication in the 20 years since it approved GMO foods for production and consumption.  The protests are already underway, some from members of Congress.

Politico Pro Agriculture quotes Senator Lisa Murkowski (Dem-AK):

“We have made no bones about the fact that this is wrong, not only for Alaska and our wild salmon stocks…but around the country,” she said, adding: “At a bare minimum people around this country need to know what they are serving their families when it comes to seafood.”

Murkowski said the draft labeling guidance released today fell short of what consumers need and plans to “continue the fight” against the fish.

This will be interesting to watch.

The FDA documents

News