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

It has two sets of proposed changes:

• Nutrition and Supplement Facts Labels
• Serving Sizes

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:

• All necessary information in one place.
• A short guide and checklist
• Nutrition and Supplement Facts Label: Docket FDA-2012-N-1210  Comment here now
• Serving Sizes: Docket FDA-2004-N-0258  Comment here now

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?

3. The economic question.  Fish are expensive.
4. 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.

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. 

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

• Register Online 
• Federal Register Notice
• Fact Sheet on the Proposed Rules

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.

• For the Nutrition Facts Label Proposed Rule, see Docket No. FDA-2012-N-1210.
• For the Serving Size Proposed Rule, see Docket No. FDA-2004-N-0258.

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

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.

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:

• ConAgra Foods
• Nestle (no relation)
• The Schwan Food Company,
• Archer Daniels Midland
• Grocery Manufacturers Association (GMA).  Note: its comment is 104 pages.
• Food Marketing Institute

Writing in favor of the revocation are:

• Center for Science in the Public Interest
• Academy of Nutrition and Dietetics

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.

Yesterday, Emily Main of Rodale Press sent me this question:

Have you ever heard of this new “sweetness enhancer” that just got approved by the FDA? It’s called Sweetmyx and is made by a company called Senomyx, and is apparently licensed by Pepsi for exclusive use.  All I can really find out about it is that it enhances the sweet flavor of other sugars, so soda companies can use less sugar in their regular products…Do you have any insight about it?

Nope.  Never heard of it..  All I could find out was that Pepsi had an exclusive deal to use it, according to a Bloomberg report.

Sweetmyx, a new ingredient by Senomyx Inc. (SNMX), received approval for foods and beverages, clearing the way for PepsiCo Inc. (PEP) to use it to make lower-sugar beverages taste sweeter.

The Flavor and Extract Manufacturers Association’s expert panel has determined that Sweetmyx is generally recognized as safe as an ingredient, San Diego-based Senomyx said today in a statement. PepsiCo has the exclusive right to use the product, a so-called flavor modifier, in many nonalcoholic drinks under a 2010 agreement.

While I was trying to discover what Sweetmyx is, exactly, this notice came in from the FDA: 

On March 11, 2014, Senomyx, Inc. issued a public statement suggesting that its food ingredient Sweetmyx (also known as S617) was generally recognized as safe (GRAS). The statement appeared to suggest that the U.S. Food and Drug Administration (FDA) had made the GRAS determination. In fact, the agency had not made this determination nor had it been notified by Senomyx regarding a GRAS determination for this food ingredient. The company’s statement has been corrected and now notes that a third party organization made the determination.

A company can make an independent GRAS determination without notifying the FDA. However, the agency does have a voluntary GRAS notification program whereby a company can inform the FDA of the company’s determination. The FDA maintains an inventory of such GRAS Notices on its website, allowing the public to confirm whether FDA has filed and responded to a GRAS notice.

When making a GRAS self-determination, companies should not state or imply that the FDA has made a GRAS determination on their food ingredients.

For more information on the GRAS notification process, please see: Generally Recognized as Safe (GRAS).

Recall from one of my previous posts the shocking gap in FDA regulatory authority over GRAS determinations.

• Manufacturers get to decide whether food additives are safe or not.
• Manufacturers get to decide whether to bother to tell the FDA the additives are in the food supply, and even if they do.
• Manufacturers get to decide who sits on the panels that review the evidence for safety.
  

In the case of Sweetmyx, the company’s consultant says it’s safe so why bother to see if the FDA agrees.

My questions:

• Pepsi: don’t you want FDA approval before putting this stuff in your drinks?
• Chemists: what is Sweetmyx anyway?
• FDA: don’t you think you ought to take a look at this thing?
• Congress: how about insisting that the FDA establish a better system for dealing with food additives

Hey, I can dream.

Additions, March 14:

A reader reminds me that the Center for Food Safety filed a lawsuit to get the FDA to do a better job on GRAS determinations (more information is here).

Another reader points out that Coca-Cola also was flirting with Senomyx a few years ago but evidently gave up the idea.

And another notes that Senomyx’s financial report makes it clear that the company knows it has regulatory issues: “Senomyx may be asked to complete additional studies to evaluate and/or monitor the safety of new flavor ingredients in order to maintain applicable regulatory approvals and/or obtain regulatory approvals outside of the United States.”

Over the weekend, Politico announced that the Grocery Manufacturers Association (GMA) and Food Marketing Institute (FMI) were finally going to launch their long-threatened $50 million campaign to promote voluntary “Facts Up Front” labels on food packages.

In case you never noticed these labels—and I doubt most people do—here is an example:

GMA and FGI conducted their own survey.  This—no surprise—found that people love Facts Up Front labels, but I find that hard to believe.  Neither do others, according to Politico reporters.

For what $50 million will buy, see yesterday’s Washington Post, page A5 (thanks Politico).

Recall the history

Facts Up Front (formerly known as Nutrition Keys), was originally launched as an end run around what the FDA was then trying to do with front-of-package labeling initiatives.  This happened early in 2011.

The GMA/FMI ploy brought the FDA’s initiatives to a halt—despite the agency’s investment in two Institute of Medicine (IOM) studies to establish a research basis for front-of-package labels.

These, in turn, followed on the heels of the food industry’s ill-fated Smart Choices—an attempt to promote highly processed foods as healthy.

GMA/FMI’s goal was to head off any possibility that the FDA would mandate red, yellow, and green traffic light signals.

Red signals might discourage consumers from buying products made by the companies GMA and FMI represent.

The food industry had cause to worry.  The IOM was considering—and eventually published—a front-of-package scheme similar to traffic lights.  It used checks or stars to evaluate the content of calories, saturated and trans fat, sodium, and sugars, all nutrients to watch out for.

GMA/FMI got its much more complicated—and, therefore, harder to understand—Nutrition Keys out first.  This preempted the IOM recommendations.

The FDA gave up.  The two IOM reports went into a drawer and the FDA has done nothing with them.

Why is GMA/FMI doing this now?

Surely, it is no coincidence that GMA/FMI is rolling out this campaign on the heels of Let’s Move!’s triumphant release of the FDA’s new food labeling proposals.

They must be worried that the FDA will unearth the two IOM reports, adopt the IOM recommendations, and start rulemaking for front-of-package labeling.

One sign of the food industry’s strategy comes from Bruce Silverglade, who for years was head counsel for the Center for Science in the Public Interest (CSPI), but has now revolved to a Washington, DC law firm that represents food companies.  He told Politico:

The general view in the industry is that nutrition information has really moved to the front of the pack. What FDA is doing is essentially proposing a new model of an old dinosaur.

As Michele Simon tweeted: “that comment…is rich coming from ex-@cspi lawyer who fought for label.”

What’s wrong with Facts Up Front? 

Plenty.

The IOM recommended that front-of-package labels be:

• Simple: easy to understand
• Interpretive: putting judgments in context
• Scaled: indicating good, better, and best

Facts Up Front does none of the above.

Facts Up Front is a tool for selling, not buying.

Its purpose is to make highly processed foods look healthier, whether or not they really are.

Whether slightly better-for-you processed foods will help anyone make better food choices and be healthier remain open questions.

What should happen now?

With Let’s Move! really moving, this seems like a great time to urge the FDA to pull out those IOM reports and get busy on a front-of-package labeling method that will really help the public make healthier dietary choices.