by Marion Nestle

Currently browsing posts about: Labels

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

Jul 17 2014

FDA’s proposed food label changes: comments on Added Sugars

The FDA is taking comments on its proposals to revamp the food label until August 1, 2014.

It has two sets of proposed changes:

Here is the first of my comments on several food label items.  Feel free to copy, edit, or file your own (see directions below).

July 16, 2014

TO:  FDA

FROM:  Marion Nestle, Professor, New York University

RE:  Nutrition Facts panel: ADDED SUGARS

1.  Retain the line for Sugars but call it Total Sugars

2.  Add a line for Added Sugars

Rationale:

  • Excessive intake of dietary sugars is well established to raise the risk of obesity and type-2 diabetes.[i]
  • Americans on average twice as much as is generally recommended.[ii]
  • The amount typically consumed comes close to the upper limit recommended by the Institute of Medicine on the basis of increased risk of nutrient deficiencies.[iii]
  • Sugars intrinsic to foods are accompanied by nutrients; added sugars are not.
  • Although there is no biochemical difference between intrinsic and added sugars, food and beverage companies know exactly how much sugar they add as part of the recipes for their products.
  • Listing the amount of added sugars on food labels would inform consumers about how much sugars are added to the foods they buy.
  • Randomized, controlled clinical trials to test the hypothesis that added sugars increase disease risk would violate ethical standards and, therefore, are impossible to conduct.

3.  Establish a Daily Reference Value for Added Sugars of 10% of total calories

Rationale:

  • Since the 1977 Dietary Goals, health officials have consistently recommended an upper limit of 10 percent of calories from added sugars.[iv]
  • The 1992 USDA Food Guide Pyramid suggested an upper limit of 6, 12, and 18 teaspoons of sugars, respectively, for daily diets of 1,600, 2,200, and 2,800 calories, respectively.  This works out to 7, 10, and 13 percent of calorie intake, respectively, for an average of 10 percent.[v]
  • By 1992, health officials in several European countries had recommended much the same.[vi]
  • The Institute of Medicine’s 2002 upper safety limit of 25% of calories was based on risk for nutrient deficiencies, not obesity and chronic disease.[vii]
  • In 2009, the American Heart Association recommended that women consume no more than 100 calories per day from added sugars (25 grams), and men no more than 150 calories per day (38 grams).  These come to 5 percent and 7.5 percent, respectively, of a 2000-calorie daily diet.[viii]
  • The 2010 Dietary Guidelines for Americans state that no more than 5 to 15 percent of calories should come from a combination of solid fats and added sugars.  This implies that added sugars should be less than 10% of calories.[ix]
  • Dr. Robert Lustig says that a “dose” of added sugars up to 50 grams a day poses little risk for metabolic or chronic disease.  This amounts to 200 sugar calories and 10% of a 2,000-calorie daily diet (he says twice that much, the amount commonly consumed by Americans, is toxic.[x]
  • The World Health Organization in 2014 said that added sugars should make up less than 10 percent of total calories per day, and less than 5 percent would be even better,[xi] based on two research reviews, one on sugars and obesity[xii]  and one on sugars and tooth decay.[xiii]
  • Added sugars as 10% of calories represents about half the amounts currently consumed and comes close to consensus.

References

[i] Te Morenga L, Mallard S, Mann J. Dietary sugars and body weight: systematic review and meta-analyses of randomised controlled trials and cohttp://steinhardt.nyu.edu/nutrition/hort studies. BMJ 2012;345:e7492.  doi: 10.1136/bmj.e7492.

[ii] USDA.  Loss-adjusted food availability documentation.  March 11, 2014.  http://www.ers.usda.gov/data-products/food-availability-(per-capita)-data-system/loss-adjusted-food-availability-documentation.aspx#.UzlzcfldU6w.   USDA.  Food availability documentation: added sugar and sweeteners.  http://www.ers.usda.gov/data-products/food-availability-(per-capita)-data-system/food-availability-documentation.aspx#sugar.   The tables used to construct figure 3D are at: Refined Sugar, Corn Syrup, Other Sweeteners.

[iii] Institute of Medicine (IOM) of the National Academies. “Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 6: Dietary Carbohydrates: Sugars and Starches”, Washington, DC: National Academies Press; 2002.

[iv] U.S. Senate Committee on Nutrition and Human Needs.  Dietary Goals for the United States, December 1977.

[v] USDA.  Food Guide Pyramid, 1992.

[vi] Cannon G:  Food and Health: The Experts Agree.  London:  Consumers’ Association, 1992.

[vii] USDA.  Is intake of added sugars associated with diet quality?  Nutrition Insights, Insight 21, October 2000.

[viii] Johnson RK, Appel LJ, Brands M, et al.  Dietary sugars intake and cardiovascular health: a scientific statement from the American Heart Association.  Circulation. 2009;120(11):1011-1120.  doi: 10.1161/CirculationAHA.109.192627.

[ix] USDA and USDHHS.  Dietary guidelines for Americans, 2010.  http://www.cnpp.usda.gov/dgas2010-policydocument.htm.

[x] Lustig RH.  Fat Chance: Beating the Odds Against Sugar, Processed Food, Obesity, and Disease.  Hudson Street Press, 2012.

[xi] WHO.  Draft guideline: Sugars intake for adults and children, March 2014. http://www.who.int/nutrition/sugars_public_consultation/en/.

[xii] Te Morenga L, Mallard S, Mann J. Dietary sugars and body weight: systematic review and meta-analyses of randomised controlled trials and cohort studies. BMJ 2012;345:e7492 doi: 10.1136/bmj.e7492.

[xiii] Moynihan PJ, Kelly SAM.  Effect on Caries of Restricting Sugars Intake. Systematic Review to Inform WHO Guidelines.  JDR 2014;93:8-18.  doi:10.1177/0022034513508954.

 

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

Jun 19 2014

Corn Refiners to test the new food label

ProPolitico writes that the Corn Refiners Association (CRA) and five other industry groups have written the FDA that they intend to fund their own research on the FDA’s proposed changes to the Nutrition Facts label.

The FDA already has a research project underway.

Why would the CRA—the trade association for the makers of high fructose corn syrup—want to bother with an expensive and complicated research project like this?

In an interview, John Bode, CRA president and CEO, told Politico:

The FDA has estimated that changes to the label could cost the industry $2.3 billion, but ‘we suspect that is a very conservative number.

OK.  So one purpose of the research will be to prove that the new food label will cost industry a lot more money than the FDA estimates.

Let me take a guess here and surmise that another purpose will be to prove that listing “added sugars” on food labels “misleads” the public.

This will be industry-funded research.  No matter how well it appears to be done, it is highly likely to produce the answers the CRA wants.

Otherwise, why do it?

If you are a betting person, this one looks like a sure thing.

FDA: finish up those studies and get the results out!

Addition, June 20:  Legal analysts, one a former attorney for CSPI who now works for a law firm representing industry clients, advise against putting “added sugars” on the label.  

 

May 30 2014

FDA to hold hearing, take comments on new food label: deadline August 1

The FDA is holding a public meeting on June 26 to solicit comments on its proposed rules for Nutrition and Supplement Facts Labels.

The meeting’s purpose is to

  • Inform the public of the provisions of the proposed rules and the rulemaking process (including how to submit comments, data, and other information to both dockets)
  • Respond to questions about the proposed rules
  • Provide an opportunity for interested persons to make oral presentations.

Instructions and information

Deadlines for the hearing

  • June 12, 2014: Closing date for request to make Oral Comment
  • June 12, 2014: Closing date to request special accommodation due to a Disability
  • June 20, 2014: Closing date for Registration

The deadline for comments on the proposals has been extended to August 1: Submit either electronic or written comments to FDA’s Division of Dockets Management.

Here’s your chance to weigh in on the proposed label changes.  Don’t miss it!

May 23 2014

GMO labels cost families $800/year: Guess who paid for the study?

Yesterday, Food Navigator reported that Cornell economists calculated that GMO labels would cost the average family of four a whopping $800 per year.

This seemed so improbable that I immediately wondered:  Who paid for it?

I clicked on the link to the study: Bingo!

The work on this report was supported financially by the Council for Biotechnology Information.

You won’t find the list of companies and groups that support the Council on its website, but Source Watch fills the gap.

I am increasingly alarmed by the increasing extent of industry research sponsorship—it’s become a huge issue in  studies of nutrition, diet, and health.

The influence of funding source on research outcomes is so predictable—many studies have now shown that industry-funded studies almost invariably produce results that favor the sponsor—that I’m batting nearly 100% on conflict-of-interest  checks, of which this GMO study is a particularly blatant example.

It’s not that industry pays investigators to find the desired answers to questions.  It’s more complicated than that.  It has to do with the way investigators ask and try to answer the research questions.  The industry favored biases get built into the study’s assumptions and controls, often (I think) unconsciously.

This study, for example, is based on an elaborate set of assumptions leading to the $800 per family estimate.  Other assumptions might give different results.   The authors do not discuss the limitations of their estimates, nor are they required to in this type of report.

But I’m willing to hazard a guess that independently funded studies would come to considerably lower estimates.

Moral: if a study produces surprising results that favor an industry position, look hard to see who sponsored it.

Addition, May 24:

A reader sent in further information about the Council for Biotechnology Information:

Council for Biotechnology Information

1201 Maryland Avenue, SW., Suite 900, Washington, DC 20024 USA

Phone: 202-962-9200 web site: http://gmoanswers.com

(CBI: http://www.sourcewatch.org/index.php?title=Council_for_Biotechnology_Information.

http://www.powerbase.info/index.php/Council_for_Biotechnology_Information.

Experts: http://gmoanswers.com/experts. Founding members and supporting partners:

http://gmoanswers.com/about. There are also offices in Saskatoon (SK, Canada)

(http://whybiotech.ca)  and Mexico City (AgroBio Mexico: http://agrobiomexico.org.mx.)

Apr 23 2014

POM v. Coca-Cola at the Supreme Court: The Mind Boggles

You might think that the Supreme Court of the United States would have more important things to do than to weigh in on which of two beverage companies puts less misleading labels on its products, but apparently not.

The highest court in the land takes POM Wonderful’s accusation against Coca-Cola seriously.  Coke’s Minute Maid juice, POM says, is advertised in ways that mislead the public.

POM should know.   It’s been under fire from the Federal Trade Commission for equally absurd label claims.

Here’s the Coca-Cola product at issue.

And here’s what the label says, in case you can’t read it (with emphasis added):

Enhanced Juice/Minute Maid/100% Fruit Juice Blend

Omega-3/DHA/HELP NOURISH YOUR BRAIN

5 Nutrients to Support Brain and Body

Pomegranate  Blueberry Flavored Blend of 5 Juices

From concentrate with added ingredients and other natural flavors

Never mind the nutritional quality or the ridiculous structure/function claims on this particular product (here’s Fooducate’s analysis from 2009—it has 29 grams of sugars, among other things).

POM doesn’t want Coke getting away with selling cheap grape and apple juices as pomengranate juice and undercutting their prices.  Coke’s drink is 99% apple and grape juice; it contains less than 1% pomegranate or blueberry juice.  You would never know that from looking at the label.

Why is the court interested?  The Minute Maid label is legal by FDA standards.  Therefore, can the label be considered misleading?

Coca-Cola won in the lower court, but the Supreme Court seems sympathetic to POM (here’s the transcript of the hearing).

The New York Times account has the best quotes:

Kathleen M. Sullivan, a lawyer for Coca-Cola, said consumers were not misled.

“We don’t think that consumers are quite as unintelligent as Pom must think they are,” she said. “They know when something is a flavored blend of five juices and the nonpredominant juices are just a flavor.”

Justice Kennedy frowned. “Don’t make me feel bad,” he said, “because I thought that this was pomegranate juice.”

It also quotes from Justice Alito:

You don’t think there are a lot of people who buy pomegranate juice because they think it has health benefits, and they would be very surprised to find when they bring home this bottle that’s got a big picture of a pomegranate on it, and it says ‘pomegranate’ on it, that it is — what is it — less than one half of 1 percent pomegranate juice?”

Where is the FDA on all this?  Blame its inaction on the Dietary Supplement Health and Education Act of 1994, which allowed ridiculous health claims on food labels and forced the FDA to keep hands off.

This outcome of this case, silly as it is, will be fun to watch.

Mar 18 2014

And on the GMO labeling front…

The food industry is so worried about the prospect of GMO labeling that companies have banded together to try an end run.  According to Politico

The coalition is calling for legislation that would require mandatory premarket approval of GMO food ingredients by FDA and grant authority to the agency to label products that raise safety concerns, set up a voluntary program for food companies to label foods that are GMO free, include GMO ingredients in a definition of “natural” foods and preempt state labeling laws.

Voluntary, of course, means that companies can voluntarily not label and maintain the status quo.

Considering GMO foods as “natural” is unlikely to go over well with anyone who already thinks that calling high fructose corn syrup “natural” is a stretch.

As for preempting state labeling laws, here’s what the industry is up against—a plethora of proposals—here summarized by  Politico Morning Agriculture:

- Rhode Island: H 7042, would require food and seed that contains more than .09 percent GMO ingredients to be labeled. The bill further defines “natural” to mean GMO-free.  

- Missouri: SB533 seeks to require the labeling of all genetically modified meat and fish raised and sold in the state.

- Vermont:  MA has already reported on the introduction last week in Vermont’s Senate of H. 112, a House-passed bill that would require GMO food labeling.  State Sen. Eldred French (D) has introduced S. 289, which would make manufacturers and growers of GMO crops liable for trespassing and damages should their seed drift into other fields:

- Washington: While voters in the Evergreen State knocked down a GMO labeling ballot initiative last fall, lawmakers are pushing for a narrower labeling effort that focuses on specifically protecting the state’s salmon fisheries in the event that FDA approves the genetically engineered AquaAdvantage Salmon. State Rep. Cary Condotta (R) has introduced HB 2143, which would require the labeling of GMO salmon:

- Alaska: State Rep. Geran Tarr (D) has introduced HB 215, which would require the labeling of foods with GMO ingredients with exceptions for animal feed, alcohol and foods processed with GE enzymes. The bill also would create an exemption from labeling forgenetically modified fish or genetically modified fish products”:

- Florida: SB 558 would require that by Jan. 1, 2016, GMO food items for sale in the state be labeled in text printed underneath the product’s ingredient list. The bill contains exceptions for animal feed, alcohol and processed food that a GMO ingredient does not account for “more than one-half of 1 percent of the total weight.”

- West Virginia: Mountain State lawmakers are set to consider three GMO bills — a labeling measure, a seed and crop disclosure initiative, and a liability measure for contamination crops at another agricultural operation.

- 2013 labeling bill carryovers: A labeling bill in Hawaii’s House of Representatives, HB 174, which was introduced last January, could see some action this year as efforts by many of the islands each tackle the cultivation of GMOs could spur action by the state house on the issue. Also, a labeling bill in Illinois, SB 1666, has picked up 12 cosponsors, many of them signing on just this fall.

The Biotechnology Industry Organization (BIO) seems to think that GMO labeling initiatives are winning.  It is now calling for “open dialogue.”  

And if the mandatory ballot labeling activity in more than 30 states in 2013 is any indication, the anti-GMO message is getting through. There are three components common to all these legislative efforts and ballot initiatives: they are framed as consumers’ “right to know;” they exempted alcohol, dairy, meat and restaurant food; and they would allow lawsuits based on asserted non-compliance.

I still don’t get it.  What are the food and biotechnology industries so afraid of?

They think GMOs solve major world food problems.  If so, what’s to hide? 

Feb 28 2014

The food label proposals: some follow-up items

Release of the FDA’s proposals for revisions of the Nutrition Facts label got, to say the least, lots of attention.

A few items need some follow up.

The politics

The best discussion of the First Lady’s involvement in the new food label comes from Helena Bottemiller Evich at Politico:

The reaction of the Grocery Manufacturers Association (GMA)

How’s this for a brilliant response?

We welcome First Lady Michelle Obama’s announcement of the proposed updates to the Nutrition Facts panel and thank her for her leadership on this and broader health issues.  The nation could not ask for a more thoughtful, effective or passionate advocate than Michelle Obama.

For 20 years, the Nutrition Facts panel has been an invaluable tool to help consumers build more healthful diets for themselves and their families, and the time is right for an update.

Diets, eating patterns and consumer preferences have changed dramatically since the Nutrition Facts were first introduced.  Just as food and beverage manufacturers have responded by creating more than 20,000 healthier product choices since 2002, and by providing tools like Facts Up Front front-of-pack labels, the FDA is responding with a thoughtful review of the Nutrition Facts panel.

We look forward to working with the FDA and other stakeholders as these proposed updates to the Nutrition Facts label make their way through the rule making process.

It is critical that any changes are based on the most current and reliable science.  Equally as important is ensuring that any changes ultimately serve to inform, and not confuse, consumers.

How you can file comments

A frustrated reader complains that he can’t find information on the FDA’s website about how to file comments.     That’s because the proposals haven’t been published yet.

They are scheduled for publication in the Federal Register on March 3.  Look for instructions then.  After that, the FDA will collect comments for 90 days.

Two sets of proposed rules will be open for comment:

Start drafting comments now!

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