by Marion Nestle

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Mar 13 2014

No, the FDA has not approved Sweetmyx: another reason to fix the GRAS regs

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.”

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Mar 11 2014

Betting on Herbalife and hedging the bet

Skeptic of the value of dietary supplements that I am, I cannot help feeling sorry for Herbalife.

The company sells protein shakes and snacks, vitamins and dietary supplements, and energy and fitness drinks which, it says, “combined with healthy eating and exercise, can help you lead a healthy, active life.”

Yes indeed, healthy eating and exercise will do that for you every time.

But Herbalife has become the victim of a bizarre hedge fund bet and its consequences.

In what is one of the most blatant conflicts of interest besetting a food product, a hedge fund manager, William Ackman, made a billion dollar “short” bet that Herbalife’s stock would fall.

When the stock did not do so immediately, Mr. Ackman set out to destroy the company’s reputation to force its stock down.

He even got members of Congress, including Senator Edward Markey (Dem-Massachusetts) to call for an investigation of the company’s marketing practices, an action that caused a 14-point drop in the stock.

This decidedly unsavory story was the subject of a New York Times investigative report yesterday: “Staking $1 Billion That Herbalife Will Fail, Then Lobbying to Bring It Down.”

The company has grown into a global powerhouse, with a worldwide team of more than three million so-called members and distributors who operate as independent contractors through a system that rewards many of them not only based on actual sales, but also on their ability to recruit more distributors.

The sales tactic, popular with many nutritional supplement companies, has frequently been the target of criticism. In 1986, California authorities issued an order prohibiting Herbalife from making false claims about the weight-loss powers of its nutritional drinks.

Herbalife reported sales of $4 billion in 2012 and is sold in more than 90 countries by distributors who earn profits on product sales and additional commissions from a “multi-level marketing” compensation structure.

Ackman argues that this is a pyramid scheme that particularly disadvantages Hispanic distributors and customers.  Other hedge funds disagree and have placed “long” bets on Herbalife.

This is food politics at a breathtaking level of income.  The Times story is well worth a look.

Mar 10 2014

The farm bill promotes fruits and vegetables? Really?

I was surprised to read in yesterday’s New York Times that the farm bill was full of goodies for fruits, vegetables, and organics.

While traditional commodities subsidies were cut by more than 30 percent to $23 billion over 10 years, funding for fruits and vegetables and organic programs increased by more than 50 percent over the same period, to about $3 billion.

I took a quick look at the cost accounting.  Giving these program listings the benefit of the doubt:

TITLE AND PROGRAM $ MILLIONS/10 YEARS
SNAP
  Assistance for community food projects     36
  Food insecurity nutrition incentive   100
  Pilot for canned, frozen fruits, vegetables       5
Organic
  Research and extension   100
  Specialty crop research   745
  Beginning farmer development   100
  Foundation for Food and Ag Research   200
Horticulture
  Farmers market, local food promotion   150
  Organic ag and tech upgrade     10
  Organic product promotion order     61
  Plant pest and disease management   193
  Specialty crop block grants   270
Miscellaneous
  Outreach to socially disadvantaged producers     50

 

Even stretching the items like this, it’s $2 billion over ten years, not 3.   $2 billion is good; $3 would be better.

What am I missing here?

This morning, Politico Pro Agriculture summarized what states are doing to promote local food production:

Arizona: HB 2233 would create a task force to develop recommendations for how the state can improve the quality and nutrition of food sold in state facilities, including suggestions for promoting locally grown food: http://1.usa.gov/1qniAzl

Hawaii: HB 1184 seeks to set a state-wide food sustainability standard to be achieved by 2025 that would increase the availability of locally grown and produced foods to reduce the state’s reliance on imports. The standard would be set at a level double the cash farm receipts that are produced in 2015: http://1.usa.gov/1oDB9LL

HR 82 and its senate companion SCR 6 calls on the state departments of agriculture and education to develop a farm-to-school program that would provide locally grown produce to public school salad bars: http://1.usa.gov/1h4Yq6v

SB 524 similarly seeks to create an agricultural development and food security program under an existing economic development statute that would seek to increase demand for and access to locally grow foods through promotional campaigns and improving infrastructure, among other things: http://1.usa.gov/1fiiYWP

Iowa: H2426 seeks to promote small farmers through a new financial assistance program, a marketing program, a revolving grant program and a property tax exemption for farmers who sell their products to state facilities or schools. The measure also calls for state facilities, when cost effective, to purchase from local farmers: http://bit.ly/1hYHJMg

Kansas: SB 380 aims to create a local food and farm task force to develop funding and policy recommendations for supporting and expanding local food production. The task force would be required to issue a report to the legislature by the beginning of the 2016 legislative session: http://bit.ly/1fP9Lv9

New Jersey: SR 44 calls on state and local government entities to purchase locally made food and products: http://bit.ly/1dG8XX4

Michigan: HB 4487 would amend an economic development statute to include the creation and funding of programs to promote local agriculture: http://1.usa.gov/1oDBkH5

Mississippi: HB 1556 would provide a state income tax credit to grocers that amounts to 25 percent of the cost of purchasing locally grown and produced products starting in 2014: http://bit.ly/OaTaWq

Missouri: HB 2088 would create a “Farm-to-School Program” within the department of agriculture to help facilitate the use of locally grown produce in school meal programs through a website and database that would link farmers and schools. The bill, which was introduced March 5, sets up a task force that is charged with developing recommendations for the program: http://on.mo.gov/1fij1SA

New Jersey: SR 44 calls on state and local government entities to purchase locally made food and products: http://bit.ly/1dG8XX4

Rhode Island: H7494 would create a task force for developing recommendations on how to improve the nutrition of food sold at state facilities, including promoting locally grown products: http://bit.ly/1fwAA0W

Lest we forget, the Center for Responsive Politics produced these statistics on farm bill lobbying:

  • 325. Number of companies and organizations registered as lobbyists in 2013 to work on the Senate’s farm bill through the end of October 2013 — the fifth-most of any legislation
  • 111.5 million.  Amount “agribusiness” spent on lobbying in the same period, more than even the defense industry and labor unions.
  • 93 million.  Amount companies and individuals in agriculture made about in campaign donations during the 2012 presidential campaign.

If we want the next farm bill to promote fruits and vegetables (a.k.a. specialty crops), we need to start working on it right now.

Mar 7 2014

Universal school meals? Not quite, alas.

Last week during the rollout of all the accomplishments of Let’s Move!, I wrote enthusiastically about one of them: universal school meals.

I pointed out that schools in which 40% or more of children are eligible for free or reduced-price meals will now be permitted to serve free breakfasts and free lunches to every student in the school, regardless of family income.  Oops.

And I said: This program, which will affect 22,000 U.S. schools and 9 million children, is cost-neutral.  Oops again.

Ain’t necessarily so, not so simple, it’s complicated—objected four readers who know a lot more about the arcane rules for school meal reimbursement.

  • My first error: the 40% refers only to kids eligible for free meals, not reduced-price.
  • Second error: because of the reimbursement formula used by USDA, cost-neutrality does not kick in until 60-65% of the kids are eligible for free meals.

Let’s hope I get it right this time.

Readers explained that the Healthy, Hunger-Free Kids Act of 2010 authorized a Community Eligibility Provision.  This allowed schools serving mostly low-income children to serve all meals to all children at no cost.

USDA reimburses the schools using a formula based on the percentage of students identified as eligible for free meals as certified by some other means-tested program such as SNAP or being homeless.

USDA rolled the program out gradually in pilot projects.  Seven states participated in 2013.

The idea was that if the pilot projects were successful–which they were–the program would be available to all states by 2014-15.

My take: school districts with lots of low-income kids ought to be doing this, but making the programs pay for themselves requires high levels of outreach and involvement.

Advocates:

  • Get your school districts to apply.
  • Work with the schools to make the food so good that all kids will want to eat it.
  • Tell USDA you want to get rid of the complications: authorize universal meals for all school children

A challenge?  Yes, but worth it.

As I pointed out, universal school meals put an end to:

  • USDA paperwork requirements for ensuring eligibility.
  • Parents having to fill out complicated eligibility forms.
  • Schools having to monitor to make sure kids’ families have turned in the paperwork or paid.
  • Schools turning away kids whose families haven’t paid.
  • Schools destroying the meals of kids whose families haven’t paid.
  • Students knowing who gets free meals, and who does not.

These new rules are a step in that direction and deserve advocacy support.

Mar 6 2014

WHO tries added sugar guideline again: 10% of daily calories!

While I’m on the topic of sugars (see yesterday’s post), the World Health Organization (WHO) has just called for public comment on proposed new guidelines for intake of “free” (added) sugars:

  • Added sugar intake should be less than 10% of total calories per day (50 grams for a 2000 calorie-a-day diet)
  • Intake below 5% of calories would confer additional benefits (25 grams)

Although the announcement casually mentions that the draft guidelines reaffirm a previous WHO sugar guideline from 2002, it just as casually fails to mention what happened to that guideline.

I, however, have perfect recall, particularly because I wrote about these events in the Afterword to the 2013 edition of Food Politics:

In the early 2000s, the World Health Organization (WHO) began work on a global strategy to reduce risk factors for chronic disease, obesity among them. In 2003, it published a research report that advised restricting intake of “free” (added) sugars to 10% or less of daily calories. Although this percentage was similar to that embedded in the USDA’s 1992 Pyramid (7–13% of calories, depending on total intake), sugar industry groups strenuously objected, enlisted senators from sugar-growing states to pressure the DHHS secretary to withdraw funding from WHO, and induced the DHHS chief counsel to send a critique of the report to WHO that had essentially been written by industry lobbyists. When released in 2004, WHO’s Global Strategy on Diet, Physical Activity, and Health omitted any mention of the background report or the 10% sugar recommendation.

“Strenuously objected” vastly understates what happened.

Why was the sugar industry so concerned?  One 12-ounce Coke or Pepsi contains about 40 grams of sugars.  Have one, and you’ve just about done your added sugars for the day.

WHO must either think that the research basis of the 10% sugar guideline is much stronger now (see references below), or that the political landscape has shifted so far in the direction of reducing sugar intake that governments will ignore industry groups this time.

I’m not so sure.  I think WHO needs all the help it can get with this one.

Submit comments here.  Now!

References

Reports commissioned by WHO

What happened to the previous guideline

Mar 5 2014

Oops. WIC rules for yogurt permit loads of added sugar

After my post earlier this week about the USDA’s final rules for the WIC program, I heard from Tracy Fox, who heads a food and nutrition policy consulting firm in Washington, DC.

She wrote: “Did you see the amount of total sugar they are allowing in the yogurt provision?  Up to 40 grams per 8 ounces.”

Oops.  She’s right.

The sugar rules for WIC yogurt

The rules say:

As recommended by the IOM, yogurt must conform to the standard of identity for yogurt as listed in Table 4 of 7 CFR 246.10(e)(12) and may be plain or flavored with ≤ 40 grams of total sugar per 1 cup of yogurt.

The IOM reference is to the Institute of Medicine’s 2005 report, WIC Food Packages: Time for a Change.  On page 221, this report says:

Yogurt (must conform to FDA standard of identity…plain or flavored with ≤ 17 g of total sugars per 100 g yogurt.

Let’s do the math

The standard serving size for yogurt in these rules is 8 ounces, or 226 grams.  At 17 grams of sugar per 100 grams, this allows for 38.4 grams of sugar per 8 ounces.  USDA must have rounded this up to 40.

But plain yogurt is already sweet.  It contains 16 grams of lactose sugar in 8 ounces.

The rules allow for an additional 24 grams of sugar per 8 ounces—6 teaspoons!

But most yogurt comes in 6 ounces containers

In 2003, yogurt makers shrunk the package size to 6 ounces as a cost-saving measure.

A 6-ounce yogurt contains 12 grams of lactose. 

So the rules allow for 18 grams of added sugars in 6 ounces—4.5 teaspoons.

The new Nutrition Facts label may help

  • It requires listing the amount of added sugars.
  • This may discourage government agencies from buying highly sweetened yogurts.
  • It may encourage yogurt makers to cut the sugar.

In the meantime, what to do?

  • Encourage the WIC program to buy plain yogurt.
  • Ask USDA to amend the regulations.
  • Make sure added sugars stays on the FDA’s proposed rules (file comments here)

 

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Mar 4 2014

Food industry puts $50 million into another end run around the FDA

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.

Mar 3 2014

Let’s Move! scores one more: No white potatoes in the WIC package

On Friday afternoon (that slow news moment), Let’s Move! and the USDA announced the release of the long-awaited Final Rules governing foods eligible for purchase by participants in WIC–The Special Supplemental Food Program for Women, Infants, and Children.

These are the first such revisions since 1980.  The rules:

  • Increase the dollar amount for purchases of fruits and vegetables.
  • Expand whole grain options.
  • Allow for yogurt as a partial milk substitute.
  • Allow parents of older infants to buy fresh produce instead of jarred infant food
  • Give states and local WIC agencies more flexibility in meeting the nutritional and cultural needs of WIC participants.

These are good moves but the big news is that the USDA stood up to lobbyists for the potato industry who have pushed the White House and Congress to allow participants to buy white potatoes with their WIC funds.

As I noted in an earlier post, the exclusion of white potatoes follows recommendations of the Institute of Medicine based on observations that WIC mothers already buy plenty of them.

Potato lobbyists got Congress to insert language in the 2014 Agriculture Appropriations bill urging the USDA to allow white potatoes in the package.

The USDA responded by asking the Institute of Medicine to reexamine the WIC food package in time for reauthorization of child nutrition programs in 2015.  This is now underway.

Although WIC is a small program relative to SNAP, it still provides about $7 billion a year for its nearly 9 million participants.

Food companies fight fiercely to ensure that their products are eligible to be purchased with WIC funds.  The potato lobbyists got Congress to intervene in USDA rules on school meals.

They must have thought they could win this one too.

It’s encouraging when public health wins out over industry lobbying.

But this one is small potatoes.  How about a few wins against Big Food?