by Marion Nestle

Currently browsing posts about: FDA

Jul 28 2014

On deadline: comments on FDA’s food label proposals

The FDA is taking comments on its proposals to revamp the food label through August 1, 2014 (instructions are at bottom of post).

I’ve already filed comments on Added Sugars and on whether Vitamin D should be added to food labels.

And I just filed further comments on the FDA’s proposals for the Nutrition and Supplement Facts Labels.  If you would like to read what I said, click here.

I’ve also filed comments on the FDA’s Serving Size proposals.

These proposals are highly technical and tough to slog through, so I tried to deal with the big picture.

July 27, 2014

TO:                  FDA

FROM:           Marion Nestle, Professor of Nutrition, Food Studies and Public Health, New York University

RE:                  Comments: Serving size proposals, Docket No. FDA-2004-N-0258

In addressing the question of how to change serving size designations on food labels, FDA is faced with an impossible dilemma .  Serving sizes, which are supposed to be based on amounts typically consumed from packaged products, are invariably perceived as recommendations for dietary intake.

To comment on each of the bold-face, italicized points:

  • Typically consumed:  This information derives from dietary intake surveys which invariably underestimate actual intake, often by 30% to 40%.
  • Packaged foods: Food labels only appear on packaged foods.  RACC amounts on packaged foods are often much lower than amounts served in restaurants or fast-food places (pizza is an obvious example).  It is unclear whether amounts reported as consumed are from packages (with Nutrition Facts labels) or are from restaurants or fast-food places where portion sizes can be much higher than those for foods in packages.
  • Recommendation:  Substantial anecdotal information suggests that people view labeled serving sizes as what they should be eating.  They view the serving sizes as meaningless compared to the portion sizes of foods they are accustomed to eating.

What is well established is that overall calorie intake has increased since RACCs were established in 1993 and marketplace portion sizes have also increased.

Therefore, any increase in RACC runs the risk of being interpreted as a validation of current portion sizes and as a recommendation to eat more.

On the other hand, larger portions have more calories.  These must appear on the label.

To address this dilemma, FDA should:

  • Make dual-column labeling mandatory for all food and beverage packages likely to be consumed in one sitting.
  • Require total calories in the package to be displayed on the front of the package.
  • Include a footnote explaining that the serving size is not meant as a recommendation

INSTRUCTIONS FOR FILING COMMENTS

The FDA provides:

File comments here

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 30 2014

The FDA’s fish advisory for pregnant women: some additional thoughts

When the FDA advisory came out a week or so ago, I started getting questions about whether it meant that women must eat fish during pregnancy and, if so, how much.

As I said in my previous post on the topic, if you like fish, of course eat it, otherwise I can’t think of any compelling reason why anyone has to eat fish.

I view the data on the dilemma caused by omega-3 fatty acids in fish (good) versus the content of methylmercury (bad) as still rather uncertain.  Dr. Malden Nesheim and I discussed this point in an editorial we wrote for the American Journal of Clinical Nutrition [reference 1 below].

Here’s what the FDA advisory says:

Eat 8 to 12 ounces of a variety of fish each week from choices that are lower in mercury. The nutritional value of fish is important during growth and development before birth, in early infancy for breastfed infants, and in childhood… Fish contains important nutrients for developing fetuses, infants who are breastfed, and young children. Fish provides health benefits for the general public. Many people do not currently eat the recommended amount of fish.

This is a prescriptive statement telling pregnant women that they should eat fish.

I would argue that the data on which FDA based this prescription are limited, especially because the results of its scientific assessment are based mostly on theoretical models rather than empirical studies.

Here’s what makes me think some skepticism is warranted:

  1. The effects of even low-level methylmercury exposure may be greater than discussed in the assessment [see reference 2], as the latest analysis from the Environmental Working Group explains.
  2. The increase in young children’s IQ associated with fish-eating during pregnancy is low—-0.7 to a maximum of 3 IQ points.

As the FDA’s assessment report says:

On a population basis, average neurodevelopment in this country is estimated to benefit by nearly 0.7 of an IQ point (95% C.I. of 0.39 – 1.37 IQ points) from maternal consumption of commercial fish. For comparison purposes, the average population-level benefit for early age verbal development is equivalent in size to 1.02 of an IQ point (95% C.I. of 0.44 – 2.01 IQ size equivalence). For a sensitive endpoint as estimated by tests of later age verbal development, the average population-level benefit from fish consumption is estimated to be 1.41 verbal IQ points (0.91, 2.00). The assessment also estimates that a mean maximum improvement of about three IQ points is possible from fish consumption, depending on the types and amounts of fish consumed.

How significant is this?  And does the small benefit in childhood persist into adolescence or adulthood?

  1. The economic question.  Fish are expensive.
  2. The ecological questions.  Advice to increase fish consumption comes up against environmental realities—-overfishing, fish farming—-that make the recommendation impossibly unsustainable [reference 3].
  • The levels of long-chain omega-3s in farmed fish depend on feeding them wild fish, an ecological problem on its own.
  • Guidance about fish can’t be just nutritional; it has to take the economic and ecological impact of fish choices into consideration [reference 4].
  • Current per capita fish consumption is about half the FDA recommended level, and half of that is shrimp.  Fortunately, shrimp don’t have much mercury (although the ones from Asia may have other contaminants), but they also don’t have much omega-3).

All of this suggests grounds for skepticism.  I think a better recommendation would leave more wiggle room to account for uncertainties.  Here’s how I would edit the FDA’s statement:

Pregnant women may eat up to 8 to 12 ounces of a variety of fish each week from choices that are lower in mercury.  Fish are useful sources of nutrients that may have value for growth and development before birth, in early infancy for breastfed infants, and in childhood, and may provide health benefits for the general public.  Other food sources also provide such benefits.

References

[1] Nesheim MC, Nestle M. Advice for fish consumption: challenging dilemmas. American Journal of Clinical Nutrition. 2014;99:973-974.

[2] Karagas MR, Choi AL, Oken E, Horvat M, Schoeny R, Kamai E, Cowell W, Grandjean P, Korrick S. Evidence on the human health effects of low-level methymercury  exposure. Environ Health Perspect. 2012; 120:799-806.

[3] Jenkins D, Sievenpiper JL, Pauli D, Sumaila UR, Kendall CWC  Are dietary recommendations for use of fish oils sustainable? Canadian Medical Association Journal 2009;180: 633-637.

[4] Oken E, Choi AL Karagas MR, Marien K, Rheinberger CM, Schoeny R, Sunderland E, Korrick S  Which fish should I eat? Perspectives influencing fish consumption choices. Environmental Health Perspectives 2012;120:790-798.

Jun 13 2014

The FDA, cheese boards, and public policy

Is the FDA at war with small, artisanal cheese makers?

I hope not.

But the FDA seems especially clumsy in its dealings with artisanal cheese makers over food safety issues.

The FDA has some legitimate concerns.  Milk is anything but sterile.  Salting and aging cheese kills pathogens but not always completely, and there is always a possibility of recontamination of the rind.

Like all food producers, cheese makers— no matter what their size—ought to be following standard food safety procedures.  Most do.

Even so, contamination happens.  That’s why testing is such a good idea.   It can stop contaminated cheese from making customers sick.

Last week, an FDA official, Monica Metz,  set off a firestorm with a letter to the New York State Department of Agriculture and Markets,

The use of wooden shelves, rough or otherwise, for cheese ripening does not conform to cGMP requirements, which require that “all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained.” 21 CFR 110.40(a). Wooden shelves or boards cannot be adequately cleaned and sanitized.  The porous structure of wood enables it to absorb and retain bacteria, therefore bacteria generally colonize not only the surface but also the inside layers of wood. The shelves or boards used for aging make direct contact with finished products; hence they could be a potential source of pathogenic microorganisms in the finished products.

The American Cheese Society immediately issued a rebuttal:

For centuries, cheesemakers have been creating delicious, nutritious, unique cheeses aged on wood.

Today’s cheesemakers—large and small, domestic and international—continue to use this material for production due to its inherent safety, unique contribution to the aging and flavor-development process, and track record of safety as part of overall plant hygiene and good manufacturing practices. No foodborne illness outbreak has been found to be caused by the use of wood as an aging surface.

The FDA responded with a clarification

Recently, you may have heard some concerns suggesting the FDA has taken steps to end the long-standing practice in the cheesemaking industry of using wooden boards to age cheese. To be clear, we have not and are not prohibiting or banning the long-standing practice of using wood shelving in artisanal cheese. Nor does the FDA Food Safety Modernization Act (FSMA) require any such action. Reports to the contrary are not accurate.

Whew.  Hang onto those boards, but do keep them clean.

As for the FDA: it needs to go further and do a whole lot more to reassure artisanal cheese makers who are convinced that the agency is out to get them and put them out of business. 

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 22 2014

A roundup on pet food items

I haven’t said anything about pet food in a while, but plenty is happening with it since my pet food books came out—Pet Food Politics (2008) and Feed Your Pet Right (2010).

A few items I’ve collected over the past month or so.

  • FDA regulations: The FDA finally issued its proposed rule for processing standards for all facilities engaged in manufacturing, processing, packing or holding animal feed and pet food.  These include  Good Manufacturing Processes (GMPs) and risk-based preventive controls (formerly known as HACCP), among other provisions.
  • Safety tips: Food Safety News lists ten ways to make pet food safer—pay attention and follow food safety procedures diligently, for one thing.
  • Double standard: Bill Marler complains that the FDA is constantly announcing recalls of Salmonella-contaminated pet foods, even though few of them result in cases of Salmonella in pets or humans, whereas foods for humans take forever to get recalled even when they cause illness.
  • Pet food recalls: The FDA certainly lists plenty of pet food recalls, and even has a web page for them.
  • FDA oversight: The FDA is on the job and testing.  Bravo issued recalls because of potential Listeria contamination.  It did so because the FDA says an independent lab detected the bacteria in a sample.
  • Marketing wars: Pet Food Industry, the excellent publication for manufacturers, has a juicy story about the marketing claims war between Nestlé (no relation) Purina PetCare and Blue Buffalo.  Each has sued the other.  Blue Buffalo has already been called on its advertising claims, perhaps in response to a complaint from  Hill’s Pet Nutrition.
  • The ongoing mystery: Pet jerky treats, mostly imported from China, linked to at least 3 human illnesses and more than 1,000 dog deaths and 4,800 dog illnesses, mostly from gastrointestinal problems, liver and kidney disease, and neurological and skin conditions.  The FDA says it still can’t figure out the cause, despite 7 years of trying. symptoms in their pets,” said FDA.

If we can’t get pet food right, there’s not much hope for human food either.

Mar 25 2014

Food companies want to hang onto trans fats

Good try FDA.

ProPolitico Morning Agriculture has a story today that surprises me.  Food companies are opposing the FDA’s proposal to revoke the GRAS status of trans fats (see previous post).

Why am I surprised?  I thought we were done with this one.  I didn’t think it was all that difficult to find substitutes for partially hydrogenated oils.  When trans fats went on food labels, most companies didn’t take long to go trans-fat free.

Now food companies are complaining that the FDA has gone too far, needs to allow companies to keep small amounts in foods, and doesn’t really have the authority to revoke GRAS status.

Among the 1600 comments received by the FDA are these:

Writing in favor of the revocation are:

As a reminder of what this is about, here’s a taste of what I said about trans fats in What to Eat:

Trans fats are not normal.   Hydrogenation causes some of the hydrogens in unsaturated and polyunsaturated fatty acids to flip abnormally from the same side of the carbon chain (in Latin, “cis”) to the opposite side (“trans”).   The normal cis unsaturated fatty acids are flexible, which is why they are liquid; they bend and flow around each other.   But the change to trans causes unsaturated fatty acids to stiffen.  They behave a lot like saturated fatty acids in the body, where they can raise cholesterol levels and increase the risk of heart disease.

Mind you, this is not new information.   My trans fat file has papers on heart disease risk dating back to the mid-1970s.   In 1975, for example, British scientists suggested that one reason poor people in England had higher rates of heart disease was that they so often ate fish-and-chips fried in partially hydrogenated oils.   Since then, researchers have consistently found trans fats to be just as bad–or worse–than saturated fats from the standpoint of heart disease risk.

The recent meta-analysis says much the same thing.

Let’s get rid of trans fats once and for all and be done with them.  I hope the FDA holds firm on this one.

Page 1 of 2912345...Last »