by Marion Nestle

Search results: dietary guidelines

Nov 21 2018

New recommendations for type 2 diabetes in kids

Dr. Robert Lustig notes that the American Diabetes Association (ADA) has just released its newest guidelines for management of type 2 diabetes in children.

He has plenty to say about this organization, its ties to the pharmaceutical industry, and its lack of focus on effective dietary approaches to prevention and treatment—at a time when “insulin prices have soared into the stratosphere.”

The ADA, he says,

is a “bought” organization. Bought by Big Pharma. It’s only about the money. It’s not about lives or health or society. This is extortion. Big Food is Al Capone. And the ADA is Frank Nitti, his henchman.

The ADA recommendations do talk about physical activity and diet, but judge the evidence for them as not particularly strong (grades B and C).

These are standard recommendations, but difficult to follow consistently, not least because they are not nearly forceful or specific enough.

Dr. Lustig would like much greater emphasis on restricting sugars.  That’s a good place to begin.

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Apr 3 2017

The U.K.’s efforts to reduce sugar intake

The British government is serious about reducing sugars, especially in the diets of children.  Its agency, Public Health England (PHE), has been hard at work for several years.

In 2014, it issued a report announcing plans for initiatives to reduce overall sugar intake: Sugar Reduction: Responding to the Challenge.

In 2015, its report provided evidence for why eating less sugar is necesssary: Sugar Reduction: The Evidence for Action.

The Scientific Advisory Committee on Nutrition (SACN) has concluded that the recommended average population maximum intake of sugar should be halved: it should not exceed 5% of total dietary energy. SACN also recommended that consumption of sugar sweetened drinks should be minimized by both adults and children. By meeting these recommendations within 10 years we would not only improve an individual’s quality of life but could save the NHS, based on a conservative assessment, around £500 m every year.

In 2016, a different agency of the UK government issued a plan for action to reduce childhood obesity. Among other recommendations, the plan called for taxes on soft drinks, but it also challenged the food and beverage industries to reduce sugars in products aimed at children by at least 20% by 2020, including a 5% reduction in the first year.  It said companies could do this by reducing sugar levels in products, reducing portion size, or shifting purchases to lower sugar alternatives.

In 2017, Public Health England set targets: Sugar Reduction: Achieving the 20%.

The role for Public Health England (PHE) is to advise government on setting the sugar reduction guidelines per 100 g of product and the calorie or portion size guidelines for specific single serving products. PHE is committed to publishing the category-specific guidelines for the nine initial categories of food in March 2017 and this report fulfills that commitment.

The guidelines are quite precise:

The good news: everyone has to do this so it will be an across-the-board reduction.

The not-so-good news: the reports say not one word about enforcement.

Public Health England plans follow-up reports.  Stay tuned.

Jun 2 2016

Open for comment: the FDA’s new guidance for voluntary salt reduction

Yesterday, the FDA opened for public comment its long-awaited guidance for industry about reducing salt in processed food products.  The guidance affects about 150 products.  It gives baseline data for those products and sets targets for salt reduction.

Please note that I am using the word salt, not sodium.  The targets are for sodium reduction.  Most dietary sodium comes from salt added to processed foods and pre-prepared foods.  Salt is 40% sodium.  The target dietary intake of 2300 mg sodium comes to just under 6 grams of salt a day, which is not particularly low.  It is, however, lower than current intake levels.

In a blog post, FDA official Susan Mayne said the link between sodium intake and blood pressure is “strong and well documented,” but

In fact, it’s very difficult in the current marketplace NOT to consume too much sodium. The average intake today is over 3,400 milligrams—significantly more than the 2,300 milligram limit recommended by federal guidelines. And it’s not just adults who are eating too much sodium: Children and teens consume more than is recommended.

Vox, for example, provides a terrific chart on the amounts of sodium in foods.  It starts with this:

Susan Mayne goes on to explain that

the FDA assessed the sodium content of thousands of products in the marketplace and engaged with experts in industry, academia, and government to get the best available scientific and technical input. We know that sodium has important functions in many foods, such as taste, texture, and microbial safety… Our approach encourages gradually reducing sodium in the majority of foods that contain it…Moreover, our draft targets apply to processed and prepared foods that are eaten both at home and outside the home.

Despite the voluntary nature of the guidance and the lengthy timeline (up to ten years) for implementation, the makers of processed foods are sure to object.  At their urging, the House committee on appropriations, in draft report language, urged the FDA to postpone guidance on salt until the CDC and Institute of Medicine update the Dietary Reference Intake standards for sodium intake.

The Salt Institute, the trade association for the salt industry, issued a press release charging malpractice:

The issuance today of new “voluntary” sodium reduction mandates by the FDA is tantamount to malpractice and inexcusable in the face of years of scientific evidence showing that population-wide sodium reduction strategies are unnecessary and could be harmful. This effort will limit the food choices of Americans, not increase them as the FDA claims. It will make our food less safe and endanger public health.

In JAMA, CDC Director Thomas Frieden rebuts the scientific arguments point by point and, in my view, demolishes them.  He explains how important this initiative is to public health:

Thirty-nine countries have established sodium targets for foods and meals, with 36 of those adopting voluntary approaches. Setting targets helps create a level playing field for the food industry, supporting reductions already begun by companies such as Walmart, Darden, Unilever, PespsiCo, General Mills, Mars, Nestlé, and others. The United Kingdom set voluntary sodium reduction targets in 2003; from 2003 to 2011 sodium intake decreased 15%. During this same period, average blood pressure decreased, and, following no change in prior years, deaths from ischemic heart disease and stroke decreased by approximately 40% [the reference for this last statement is BMJ Open. 2014;4(4):e004549].

Most people would be healthier cutting down on salt intake.  Food company executives know this.  Politico Morning Agriculture points out that some Big Food companies have joined the public health community in supporting the FDA’s proposal.

The band of strange bedfellows – the American Heart Association, Mars, Academy of Nutrition and Dietetics, Nestlé, PepsiCo, American Public Health Association, Unilever and the Center for Science in the Public Interest – all signed on to a letter last month to Senate Appropriations ag subcommittee Chairman Jerry Moran and ranking member Jeff Merkley to support the FDA on sodium. Find that here.

From a public health perspective, the FDA initiative is a step in the right direction but could go further.  It should have required mandatory salt reduction.  Judging from the Salt Institute’s reaction, this is still a big step.  The New York Times quotes Michael Jacobson:

“The F.D.A. found a sweet spot between doing nothing and regulating…This will at least give the public benchmarks against which we can gauge sodium content of foods.”

FDA resources:  

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Mar 14 2016

Gaming Australia’s Health Star labeling system

Australia has government-sponsored front-of-package nutrient labeling—the Health Star system—that looks a lot like the U.S. grocery industry’s Facts Up Front, but is even more favorable to manufacturers of processed foods.

As I explained a few years ago, Facts Up Front was a successful scheme by the Grocery Manufacturers and Food Marketing Associations to head off the FDA’s attempts to put traffic-light signals on the front of processed food products (here’s more of the back story).

Like the U.S. system, the Australian system is voluntary.  Unlike it, Health Stars are prominent and convey the impression that the more starts, the better.

A year into the program, Australian newspapers are writing about how companies are “gaming” the system:

SOURCE: CHOICE

Deakin University professor of public health nutrition Mark Lawrence said the health star rating system was being exploited as a marketing tool by junk food manufacturers to make consumers think their food was healthy. He said the scheme for packaged food undermined the public health message that people should eat fresh, unprocessed food.

This article quotes a statement by Kellogg that sales of Nutrigrain cereal went up after the company reformulated the product to raise its rating from 2 to 4 stars.

But isn’t reformulation a good thing?  It could be but just because a processed food is “better-for-you,” does not necessarily make it a good choice.

Professor Mark Lawrence of Deakin and Christina Pollard of Curtin University write:

Its main design limitation is that it simplistically frames the cause of, and solution to, dietary imbalances in terms of nutrients. This is fundamentally at odds with the latest nutrition advice, which uses a food-based approach…So what the health star rating system ends up doing is encouraging marketing of unhealthy or discretionary foods, as healthy options.

Overall, they point out:

Part of the problem is that the campaign’s main message – “the more stars the better” – is misleading…The actual health message is to eat more of these [recommended healthy] foods; it’s not that we should try to eat food with more stars.

Good advice.

Mar 8 2016

Another five industry-funded studies with sponsor-favorable results. The score: 145/12

Thanks to a reader for sending these items from a journal that I don’t usually come across.  These bring the casually collected total since last March to 145 studies favorable to the sponsor versus 12 that are not.

Consuming the daily recommended amounts of dairy products would reduce the prevalence of inadequate micronutrient intakes in the United States: diet modeling study based on NHANES 2007–2010Erin E Quann, Victor L Fulgoni III and Nancy Auestad. Nutrition Journal 2015; 14:90 DOI: 10.1186/s12937-015-0057-5

  • Conclusion: Increasing dairy food consumption to recommended amounts is one practical dietary change that could significantly improve the population’s adequacy for certain vitamins and minerals that are currently under-consumed, as well as have a positive impact on health.
  • Funding: The study and the writing of the manuscript were supported by Dairy Management Inc.

Association of lunch meat consumption with nutrient intake, diet quality and health risk factors in U.S. children and adults: NHANES 2007–201Sanjiv Agarwal, Victor L. Fulgoni III and Eric P. Berg. Nutrition Journal. 2015;14:128.  DOI: 10.1186/s12937-015-011f8-9

  • Conclusions: The results of this study may provide insight into how to better utilize lunch meats in the diets of U.S. children and adults.
  • Funding: The present study was funded by North American Meat Institute.

A review and meta-analysis of prospective studies of red and processed meat, meat cooking methods, heme iron, heterocyclic amines and prostate cancerLauren C. Bylsma and Dominik D. Alexander.  Nutrition Journal. 2015;14:125. DOI: 10.1186/s12937-015-0111-3

  • Conclusion: Dose-response analyses did not reveal significant patterns of associations between red or processed meat and prostate cancer….although we observed a weak positive summary estimate for processed meats.
  • Funding: This work was supported in part by the National Cattlemen’s Beef Association (NCBA), a contractor to the Beef Checkoff. NCBA did not contribute to the writing, analysis, interpretation of the research findings, or the decision to publish…LCB and DDA are employees of EpidStat Institute. EpidStat received partial funding from the National Cattlemen’s Beef Association (NCBA), a contractor to the Beef Checkoff, for work related to this manuscript. The conceptualization, writing, analysis, and interpretation of research findings was performed independently.

Are restrictive guidelines for added sugars science based?  Jennifer Erickson and Joanne Slavin.  Nutrition Journal. 2015;14:124.  DOI: 10.1186/s12937-015-0114-0

  • Conclusion: However, there is currently no evidence stating that added sugar is more harmful than excess calories from any other food source. The addition of restrictive added sugar recommendations may not be the most effective intervention in the treatment and prevention of obesity and other health concerns.
  • Disclosure: Jennifer Erickson, is a PhD student in Nutrition at the University of Minnesota working with Dr. Joanne Slavin. Joanne Slavin is a professor in the Department of Food Science and Nutrition, University of Minnesota.  In the past 5 years, she has given 150 scientific presentations in 13 countries. Many of these meetings received sponsorship from companies and associations with an interest in carbohydrates and nutritive sweeteners…Her research funding for the past 5 years has included grants from General Mills, Inc., Tate and Lyle, Nestle Health Sciences, Kellogg Company, USA Rice, USA Pears, Minnesota Beef Council, Minnesota Cultivated Wild Rice Council, Barilla Company, USDA, American Egg Board, American Pulse Association, MNDrive Global Food Ventures, International Life Science Institute (ILSI), and the Mushroom Council. She serves on the scientific advisory board for Tate and Lyle, Kerry Ingredients, Atkins Nutritionals, Midwest Dairy Association and the Alliance for Potato Research and Education (APRE). She holds a 1/3 interest in the Slavin Sisters Farm LLC, a 119 acre farm in Walworth, WI.

Cow’s milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCTM. V. Pontes, T. C. M. Ribeiro, H. Ribeiro, A. P. de Mattos, I. R. Almeida, V. M. Leal, G. N. Cabral, S. Stolz, W. Zhuang and D. M. F. Scalabrin.  Nutrition Journal. 2016;15:19.  DOI: 10.1186/s12937-016-0138-0

  • Conclusion: A cow’s milk-based beverage containing DHA, PDX/GOS, and yeast β-glucan, and supplemented with micronutrients, including zinc, vitamin A and iron, when consumed 3 times/day for 28 weeks by healthy 1- to 4-year-old children was associated with fewer episodes of allergic manifestations in the skin and the respiratory tract.
  • Funding: This study was funded by Mead Johnson Nutrition…The study products were provided by Mead Johnson Nutrition. Dr. Scalabrin, S. Stolz, and W. Zhuang work in Clinical Research, Department of Medical Affairs at Mead Johnson Nutrition. All of the remaining authors have no financial relationships to disclose.

Whole grain consumption trends and associations with body weight measures in the United States: results from the cross sectional National Health and Nutrition Examination Survey 2001–2012.  Ann M. Albertson, Marla Reicks, Nandan Joshi and Carolyn K. Gugger.  Nutrition Journal 2016;15:8.  DOI: 10.1186/s12937-016-0126-4

  • Conclusions: The data from the current study suggest that greater whole grain consumption is associated with better intakes of nutrients and healthier body weight in children and adults. Continued efforts to promote increased intake of whole grain foods are warranted.
  • Competing interests:  Marla Reicks received an unrestricted gift from the General Mills Bell Institute of Health and Nutrition during the manuscript preparation to support research at the University of Minnesota.  Carolyn Gugger and Nandan Joshi are current employees and stockholders of General Mills, Inc.  Ann Albertson was an employee of General Mills, Inc during the conception, analysis and initial preparation of the manuscript. She is currently retired from General Mills.
  • Non-financial competing interests: General Mills, Inc is a global consumer foods company that manufactures and sells products across a broad variety of food categories, including grain-based foods. General Mills product portfolio includes ready-to-eat cereals, cereal bars, baked goods, flour, and salty snacks that may contain whole grain.
Apr 1 2015

Interview with Columbia University Public Health Students

For tonight’s Grand Rounds at Columbia University, I did an interview with FPOP (Food Policy and Obesity Prevention).

Food Policy Expert Marion Nestle on the Heinz-Kraft Deal, GMOs, and the Secret Ingredients to Healthy School Lunches

March 31, 2014—Years before the Reagan Administration decreed that ketchup was a vegetable, Marion Nestle saw the connections between the dinner table and politics. Nestle, the nation’s leading advocate for good nutrition, will address the Mailman School in a Grand Rounds talk tomorrow and kick-off Public Health Fights Obesity, a month-long series of lectures and special events, including an April 16 symposium on preventing childhood obesity.

Nestle, a professor and founder of the department of Nutrition, Food Studies, and Public Health at New York University, is the author of acclaimed books, includingFood Politics: How the Food Industry Influences Nutrition and Health, and most recently, Why Calories Count: From Science to Politics.

In anticipation of her Grand Rounds talk, the student group Food Policy and Obesity Prevention interviewed Nestle about everything from attempts to regulate Big Soda, GMO labeling, to school lunches done right.

The federal Dietary Guideline Advisory Committee recently published recommendations that for the first time considered issues of food sustainability. There has been a lot of controversy.    

The guidelines have always been controversial, but never anything like this. I think this is an example of how worried the food industry is about the pushback about diet and health in America. Sustainability is the “S word” in Washington. The guidelines committee is trying to do is what I’ve been advocating for a very long time, which is to bring agricultural policy in line with health policy. Right now the policies are completely divorced.

At the same time you have Heinz and Kraft joining forces.  

The food industry is in a defensive position because food and health advocates have been enormously successful in changing the market and changing people’s views. The fastest growing segment of the food industry is organics. The makers of processed foods are in retreat.  Warren Buffett must think there’s plenty of money to be made in selling junk foods.  I hope he’s wrong.

Is Big Food increasingly eyeing opportunities overseas?

If you can’t sell it here, you sell it there. The best example of this is the soda industry, which is the subject of my next book. There has been a 10- to 15-year decline in sales of carbonated sweetened beverages in the United States. It’s one of the great successes of health advocacy. To compensate, Coke and Pepsi are increasingly focusing their efforts overseas. Expect obesity and its consequences to follow.

Speaking of global commerce, should we be concerned about trade agreements like the Transpacific Partnership?

Food and Water Watch called it “NAFTA on steroids.” It’s very hard to know what’s going on because the negotiations are being done in secret. People are worried that a lot of the protections we have against bad things in food will be taken away on the basis of violations of trade agreements.


Poster supporting a soda tax in Berkeley

Closer to home, here in New York we’ve heard a lot about attempts to legislate on soda with failed attempt to limit portion sizes. Other areas have had more luck—

Not luck—skill! The only place in the United States where a soda tax has been successful is Berkeley. They did everything about advocacy right. Instead of framing it as a health argument, they framed it as an argument against corporate power: Berkeley versus Big Soda. And there was an enormous grassroots effort to engage the entire community. Community organizing is classic public health. Nobody does it very often. But when it’s done, it works!

Another issue people have been talking about is GMO labeling. 

I was on the FDA food advisory committee in 1994 when they were in the process of approving GMOs. Those of us who were consumer representatives told the FDA that it had to require labeling. I’m surprised it’s taken this long for there to be a major national uproar. From the beginning, the question was: if they don’t want labels, what are companies like Monsanto trying to hide?

Speaking of Monsanto, there was news this week that a chemical in their Round Up herbicide is a likely a carcinogen.

RoundUp also induces weed resistance, which has become an enormous problem for the industry. And most of it is used on GMOs. It’s a plant poison! Why would anyone think it would be good for health?

Are GMOs always bad?

The papaya that’s engineered to resist ring spot seems like a reasonable use of biotechnology to me. It saved the Hawaiian papaya industry. That’s the only example I can think of that’s beneficial. Most of the technology has been applied to commodity crops.

What about food insecurity? Can GMOs help?

If you want to help food-insecure nations, you need to empower them to do their own agriculture. That agriculture needs to be sustainable. GMO crops are not sustainable.  They require seeds, fertilizer, and pesticides, every year.


President Obama signs the Healthy Hunger-Free Kids Act in 2010

According to a new Rudd Center study, more kids are eating fruit at school. At the same time, there’s a lot of pushback against healthy foods at school.

In 2010, Congress passed the Healthy Hunger-Free Kids Act. That was bipartisan. Today, bipartisan seems out of the question. The Republicans want to roll the Act back. There’s no question it’s working in most schools that have people committed to it. There are huge advances being made in school food that carry over to food outside school. Kids come home and they want different foods because they see that eating healthy foods is valued.

How much is this change tied to school leaders compared to funding?

More funding would help. But some of the poorest schools have cafeterias where you walk in and the food smells good. They’re making it happen by cooking onsite with USDA commodity foods, which are unprocessed and cheap. Someone who knows how to cook can turn USDA surpluses into good meals. But not every school does that. I’ve been in schools where the food was terrible, the kids weren’t eating it, and the plate-waste was astronomical.  If the food service workers know the names of the kids, it’s a good sign the food will be good too.

For students interested in food and health, what sectors offer the most opportunity? Government? Nonprofit?

It depends on what you like. We need good people in government. It’s really important to have public health professionals work from within to make agencies like the FDA and Department of Agriculture do useful work. Everybody loves NGOs. It doesn’t matter which. Just do it!

Attend Marion Nestle’s Grand Rounds talk on April 1, 4:00-5:30 p.m., at Alumni Auditorium, 650 West 168th Street, or watch it on LiveStream.

Jan 28 2015

WHO versus noncommunicable (chronic) disease: where’s the sugar target?

The World Health Organization (WHO) released two reports within the last week aimed at preventing noncommunicable diseases.  Although the second is all about reducing sugar intake, the first report is about everything but.

1.  The Global Status Report on Noncommunicable Diseases, 2014.* 

The WHO press release points out that the report calls for:

more action to be taken to curb the epidemic, particularly in low- and middle-income countries, where deaths due to NCDs are overtaking those from infectious diseases. Almost three quarters of all NCD deaths (28 million), and 82% of the 16 million premature deaths, occur in low- and middle-income countries.

How?  By working to achieve 9 targets:

  • Target 1: A 25% relative reduction in risk of premature mortality from CVDs, cancer, diabetes, chronic respiratory diseases.
  • Target 2: At least 10% relative reduction in the harmful use of alcohol, as appropriate, within the national context.
  • Target 3: A 10% relative reduction in prevalence of insufficient physical activity.
  • Target 4: A 30% relative reduction in mean population intake of salt/sodium.
  • Target 5: A 30% relative reduction in prevalence of current tobacco use in persons aged 15+ years.
  • Target 6: A 25% relative reduction in the prevalence of raised blood pressure or contain the prevalence of raised blood pressure, according to national circumstances.
  • Target 7: Halt the rise in diabetes and obesity.
  • Target 8: At least 50% of eligible people receive drug therapy and counselling (including glycaemic control) to prevent heart attacks and strokes.
  • Target 9: An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major NCDs in both public and private facilities.

Don’t dietary sugars have something to do with diabetes and obesity?  How come no specific target?  This is especially odd in light of the second report.

2. Guideline: Sugars Intake for Adults and Children [see updated, revised publication released March 2015]

The WHO makes three recommendations about intake of added (“free”) sugars:

  • A reduced intake of free sugars throughout the lifecourse (strong recommendation).
  • Reducing the intake of free sugars to less than 10% of total energy intake (strong recommendation).
  • A further reduction of the intake of free sugars to below 5% of total energy intake (conditional recommendation)

Why no target for sugar reduction to 10% of energy  in the first report?

The omission is glaring.  Could politics be involved?  It’s hard to think of any other explanation.

WHO needs to speak with one voice on NCD targets, guidelines, and recommendations.

* Along with the NCD target report, WHO also released:

**Thanks to Dr. Karen Sokal-Gutierrez for alerting me to the lack of a sugar target.

Jul 24 2014

FDA’s food label proposals: comments on Vitamin D

The FDA is taking comments on label proposals until August 1 (see info at end of post).  Here’s mine on voluntary vitamin D labeling.

July 17, 2014

TO:  FDA

FROM:  Marion Nestle, Professor, New York University

RE:  Proposed revision to Nutrition Facts Panel: VITAMIN D

This is to argue against permitting food companies to voluntarily label added “Vitamin” D on the Nutrition Facts panel.  Doing so will not promote—and may possibly harm–public health.

Rationale

  • “Vitamin” D is not a vitamin; it is a hormone synthesized by the action of sunlight on skin.  For this reason alone, it does not belong on the food label.
  • Vitamin D fortification must be understood as a form of hormone replacement therapy.   As such, it raises questions about efficacy, dose, and side effects that should be asked about all such therapies.
  • Fortification and supplementation provide hormone Vitamin D by the oral route.  This is not physiological.  Active vitamin D is synthesized in the body through a series of reactions that begin with the action of sunlight on skin.  Sunlight on skin produces ample Vitamin D, is regulated to promote synthesis as needed and avoid toxicity, and may lead to synthesis of other useful biological components; the unphysiologic oral route does not produce the same benefits.[i]
  • As a hormone, Vitamin D is found naturally in very few foods (e.g., fish); in them, it is present in small amounts.  It is present in most foods as a result of fortification.
  • Permitting Vitamin D to be listed on food labels will encourage fortification, undoubtedly of foods that would not otherwise necessarily be recommended.  To cite just one example: Yum Bunny Caramel Milk Spread fortified with vitamin D at 10% of the DV.  This product is half sugars by weight, marketed as “a good source of calcium and vitamin D,” and clearly aimed at children. See: http://www.yumbunny.com/about-us.   Whether such products should be considered “good sources” also deserves scrutiny.
  • The U.S. Preventive Services Task Force concludes that evidence is insufficient to determine how Vitamin D supplementation (and, therefore, fortification) affects fracture incidence.[ii],[iii],[iv] 
  • Data from the Women’s Health Initiative also are consistent with largely inconclusive findings about hormone Vitamin D supplements and bone health.[v]
  • The Institute of Medicine (IOM) does not consider deficiency of Vitamin D to be a serious problem in the United States, except among certain population groups.  Instead, because of widespread fortification and supplementation, it is concerned about the possibility of adverse consequences from overconsumption through supplementation or fortification.[vi]
  • Many scientific debates about hormone Vitamin D are as yet unresolved.[vii],[viii]  
  • The lack of compelling research has permitted Vitamin D to become “trendy.”  It is advertised on boxes of fortified cereals, has its own pro-supplement advocacy group, and generates millions in annual supplement sales.[ix]

In the absence of stronger evidence for benefit from fortification, and some evidence for possible adverse consequences, the FDA should not contribute to further commercialization of this misnamed hormone by permitting it to be listed on food labels.

References

[i] Wacker M, Holick MF.  Sunlight and Vitamin D: A global perspective for health. Dermato-Endocrinology 2013;5(1):51–108.

[ii] Cranney A, Horsley T, O’Donnell S, Weiler H, Puil L, Ooi D, et al.  Effectiveness and safety of vitamin D in relation to bone health. Evidence Report/Technology Assessment No. 158. Rockville, MD: Agency for Healthcare Research and Quality. 2007.  http://www.ncbi.nlm.nih.gov/books/NBK38410. Accessed February 5, 2013.

[iii] Chung M, Balk EM, Brendel M, Ip S, Lau J, Lee J, et al  Vitamin D and calcium: a systematic review of health outcomes. Evidence Report/Technology Assessment No. 183. Rockville, MD: Agency for Healthcare Research and Quality. 2009.  http://www.ncbi.nlm.nih.gov/books/NBK32603/. Accessed February 5, 2013.

[iv] Chung M, Lee J, Terasawa T, Lau J, Trikalinos T. Vitamin D with or without calcium supplementation for prevention of cancer and fractures: an updated meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155(12):827-38.

[v] Prentice RL, Pettinger MB, Jackson RD, Wactawski-Wende J, LaCroix AZ, Anderson GL, et al.  Health risks and benefits from calcium and vitamin D supplementation: Women’s Health Initiative clinical trial and cohort study.  Osteoporosis Int.  2013;24(2):567-580.

[vi] Institute of Medicine.  Dietary Reference Intakes: Calcium, Vitamin D.  Washington, DC: National Academies Press, 2011.

[vii] Rosen, Clifford J,  Abrams, Steven A,  Aloia John F. et al.  IOM Committee members respond to endocrine society vitamin D guideline. J Clin Endocrinol Metab. 2012;97:1146-1152.

[viii] Holick, Michael F,  Brinkley Neil C, Heike, A et al  Guidelines for preventing and treating vitamin D deficiency and insufficiency revisited.  J Clin Endocrinol Metab. 2012;97:1153-1158.

[ix] Much growth in vitamin sales driven by vitamin D.  Nutr Business J. 2009;14(6/7):5.

Here’s how to file comments:

The proposed revisions are to:

The FDA makes it very easy to file comments. It provides:

File comments here