by Marion Nestle

Currently browsing posts about: FDA

Feb 18 2011

Michael Taylor goes international

Michael Taylor, the FDA’s Deputy Commissioner for Foods, gave a talk in London yesterday at a meeting of the Global Food Safety Initiative (GSFI).

GSFI, for the policy wonks among you, is a project of the Paris-based Consumer Goods Forum (formerly CIES), which brings together CEO-level food industry executives to discuss topics of mutual interest—a World Economic Forum for food companies, as it were.

I’ve given several talks at these meetings over the years, presumably because the organizers like to stir up some controversy once in a while.

Mr. Taylor’s speech, which you can read here in its entirety, does not seem particularly controversial—unless you think that making business responsible for ensuring food safety is controversial:

For those of you who live and work in the European Union countries, imported food is a fact of daily life.

And many emerging economies recognize that food exports can help drive their economic growth.

It is for these reasons – high public expectations and expanding trade in food – that the effort to improve food safety and to build prevention in from farm to table is a global movement…and is good business.

It is a global movement that, very importantly, recognizes that the primary responsibility for prevention rests with business – with those who produce, process, import, and market food.

Consumers certainly have a role to play as food handlers and preparers.

And, of course, government plays a vital role in providing scientific leadership, setting standards for effective prevention of food safety problems, and ensuring through inspection and other means that those standards are understood and met.

But everything we do to improve food safety rests on the foundation of the food industry fulfilling its duty to do everything it reasonably can to make food safe.

FoodSafetyNews has more details on what the meeting was about.   Taylor’s speech is a sign that the FDA is on the job.

Jan 26 2011

FDA withdraws menu labeling guidance. Will work on rules instead.

The FDA announces that it is immediately withdrawing its guidance to the food industry issued in August about how companies should do menu labeling. It will start formal rulemaking instead.  Try some FDA-speak:

As stated in the draft guidance, certain provisions of section 4205 of the Affordable Care Act became requirements immediately upon enactment of the law. FDA also stated that it anticipated issuing the final guidance and enforcement policy in December 2010.FDA received many comments on the draft guidance and on a public docket which FDA opened to solicit comment.

Based, in part, on these comments, FDA now intends to complete the notice and comment rulemaking process for section 4205 before initiating enforcement activities and will not be publishing a final guidance on menu labeling at this time. FDA is required to issue proposed regulations to carry out provisions of section 4205 no later than March 23, 2011. FDA intends to meet this statutory deadline.

FDA believes that the expeditious completion of the rulemaking process for section 4205 will minimize uncertainty and confusion among all interested parties. This approach to implementing section 4205 will most rapidly lead to full and consistent availability of the newly required nutrition information for consumers.

I’m not sure how to translate this.  I think it means that companies currently posting calories should continue to do so.

The FDA still needs time to work out some of the sticky details—calorie ranges like the ones used by Chipotle, for example.  It intends to meet the legislated deadline for issuing rules a year from now.  States and local communities currently requiring calorie labeling should continue to do so but should off on enforcement until then. 

Let’s not hurry these things.

Unsurprisingly, the restaurant industry “supports this approach.”  As The Packer put it, “Don’t sweat menu labeling just yet. Thise just in from the FDA…”

Patience is a virtue.  This willl happen.   Eventually.

Jan 25 2011

“Singing Kumbaya,” GMA/FMI displays preemptive label design

I listened in on the conference call at which the Grocery Manufacturers of America and the Food Marketing Institute announced their new Nutrition Keys design for front-of-package labels.

My favorite comment: We are all “singing kumbaya” here.  Nutrition Keys, they said, was the result of a” monumental, historic effort” in which food companies “stepped up to the plate in a big way,” “with 100% support.”

Why did they go to all this trouble?  Because “A healthy consumer makes for a happy consumer.”

Kumbaya, indeed.

The real reason, as I explained yesterday, is to preempt the FDA’s front-of-package food labeling initiatives which might make food companies reveal more about the “negatives” in processed foods.

Here’s what GMA and FMI say the new label will look like:

Four of these things are required: Calories, Saturated fat, Sodium, and Total (not added) sugars.  Packages can also display up to two “nutrients to encourage” picked from this collection:  protein; fiber; vitamins A, C, and D; and potassium, iron, and calcium.

Let’s give these food trade associations credit for listing sugars instead of the Institute of Medicine’s recommendation for trans fat.  Trans fats are already gone from most processed foods.  Everyone cares about sugars.  But these are total sugars, not added sugars, which is what really matters.

And protein?  Since when does protein need to be encouraged in American diets?  We already eat twice the protein we need.  The rationale?  Vegetarians.   I repeat.  Since when don’t vegetarians get enough protein?  Never mind, protein makes the products look better.

Nutrition Keys merely repeats what’s on the Nutrition Facts labels, only worse.  It makes the percent Daily Values practically invisible.  Which is better?  High or low milligrams or grams.  You have to know this, and Nutrition Keys doesn’t help with that problem.

Nutrition Keys, says the industry, is about “more clarity in labeling.”  Really?  Here’s what it will look like on a food package.

I’ve been collecting reactions.

Although GMA and FMI insist they they are doing this in response to the First Lady’s Let’s Move campaign, the White House issued this statement:

The White House, including the First Lady, recognizes these companies for the leadership they have shown in advancing this initiative. We regard their commitment to dedicate space, for the first time, to an industry-wide front-of-pack label as a significant first step and look forward to future improvement. The FDA plans to monitor this initiative closely and will work with experts in the field to evaluate whether the new label is meeting the needs of American consumers and pursue improvements as needed. We will continue to work on seeking solutions for the problem of childhood obesity in America.

Congresswoman Rosa DeLauro was more forthcoming:

The industry’s unveiling today of its front-of-package labeling system is troubling and confirms that this effort should not circumvent or influence FDA’s effort to develop strong guidelines for FOP labels.

Given that negative and positive nutrients will not be differentiated on the package, there is significant risk that these labels will be ignored.  An adequate labeling system must clearly alert consumers about potentially unhealthy foods, and should not mislead them into believing that some foods are healthy when they clearly are not.

Reporters asked tough questions on the conference call about preemption of FDA efforts to do front-of-package labeling in a rational way (see my post from yesterday).  Perhaps space limitations made full accounts impossible:

Jan 19 2011

Surprise! Most “better-for-you” kids’ foods aren’t

The Oakland-based Prevention Institute has just released its new research report: Claiming Health: Front-of-Package Labeling of Children’s Food.  The report summarizes the Institute’s investigation of whether kids’ foods with “better-for-you” front-of-package labels meet dietary recommendations and nutrition standards.

Bottom line: they don’t.

Researchers bought 58 kids’ food products made by companies who have promised to meet certain nutritional criteria.  All had front-of-package labels that indicate healthier options.

The researchers measured the contents of these foods against a fairly standard—and quite generous—set of nutrient criteria.

The criteria allow products to have up to 25% of the calories from added sugars, up to 480 mg of sodium, and as little as 1.25 grams of fiber per serving.

Even so, the data show that:

  • 84% of the study products could not meet one or more of the nutrient criteria
  • 57% of the study products were high in sugar
  • 53% of the study products were low in fiber
  • 93% of cereals were high in sugar and 60% were low in fiber
  • 36% of prepared foods and meals were high in sodium, 24% were high in saturated fat, and 28% were low in fiber
  • 90% of snack foods were high in sugar, and 90% were low in fiber

Nutrient criteria make it easy to game the system, and front-of-package labels do exactly that.

The Institute of Medicine (IOM) will soon release its second report on front-of-package labels, this one recommending what the FDA should do about them.  Let’s hope the IOM committee pays close attention to this report.

Claiming Health makes it clear that without rigorous nutrient standards, plenty of not-so-good-for-you foods will be labeled as better for children.

As I keep saying, alas, front-of-package labels, like health claims, are about marketing, not health.

Jan 18 2011

GAO takes on health claims. Yes!

Let’s hear it for the Government Accountability Office, the congressional watchdog agency that has still managed to remain independent of the more corrupt aspects of Washington food politics.  In its most recent investigation, the GAO took a tough look at the inability of the FDA to hold health claims on food packages to reasonable scientific standards.

The new GAO report, Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims, appeared on January 14.

The report reviews the history of health claims on food labels.  By law, these must be supported by “significant scientific agreement,” but court decisions in 2002 led the FDA to allow “qualified health claims.”  These claims have less—and, sometimes, no—scientific support.

Parke Wilde, who writes the U.S. Food Policy Blog, brilliantly parses the categories of health claims now allowed by the FDA:

  • Health claims — aka REAL health claims — which must have evidence that meets a standard called “significant scientific agreement”
  • Qualified health claims — aka WISHFUL health claims — which can meet a weaker standard of evidence, so long as the company admits the weaker evidence on the label.
  • Structure / function claims — aka STEALTHY health claims — which purport not to be health claims (for example, a high-fiber product that “keeps your bowels moving” without explicitly claiming to “treat constipation”; or a high-calcium product that “builds strong bones” without explicitly claiming to “prevent osteoporosis”)

The GAO reviews evidence that consumers can’t tell the difference between one kind of health claim and another (I could have told them that).

Food companies take advantage of this confusion and increasingly use the stealth structure/function claims, which the FDA pretty much ignores.

The FDA has to ignore them.  It doesn’t have much choice.  The FDA has no authority to require companies to submit evidence of scientific substantiation.  The FDA is permitted to ask for the information, but it has no legal authority to force companies to provide it.

GAO says this situation does not sufficiently protect the public from unscrupulous marketers.  It says the FDA should:

  • Ask Congress to grant it the authority to access companies’ evidence for the scientific support of potentially false or misleading structure/function claims on foods.
  • Provide guidance to industry on the evidence it needs to support such claims.
  • Provide direction to FDA inspectors to help identify claims for further review.

FDA: Do this, please, and right away.  Congress: Pay attention and act.

Imagine: health claims on food packages that actually have some science behind them.  What a concept!


Dec 13 2010

FDA says 29 million pounds of antibiotics used in food animals last year

I was interested to read FoodSafetyNews this morning and learn about the FDA’s new count of the number and pounds of antibiotics used to promote the growth of farm animals used as food.

Because this is the first time the FDA’s Center for Veterinary Medicine has produced such a count, it is not possible to say whether the numbers are going up or down.  But the agency is now requiring meat producers to report on antibiotic use so we now have a baseline for measuring progress.

The FDA has been concerned about the use and misuse of animal antibiotics for some time now, so much so that in June it issued guidance on The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.

In the Federal Register notice announcing the guidance, the FDA explains:

Misuse and overuse of antimicrobial drugs creates selective evolutionary pressure that enables antimicrobial resistant bacteria to increase in numbers more rapidly than antimicrobial susceptible bacteria and thus increases the opportunity for
individuals to become infected by resistant bacteria. Because antimicrobial drug use contributes to the emergence of drug resistant organisms, these important drugs must be used judiciously in both animal and human medicine to slow the development of resistance. Using these drugs judiciously means that unnecessary or inappropriate use should be avoided….

In regard to the use of antimicrobial drugs in animals, concerns have been raised by the public and components of the scientific and public health communities that a significant contributing factor to antimicrobial resistance is the use of medically important antimicrobial drugs in foodproducing animals for production or growth-enhancing purposes.

The overuse of antibiotics in farm animal production was a key focus of the 2009 report of the Pew Commission on Industrial Farm Animal Production. Our conclusion: the overuse of antibiotics in animal agriculture is an enormous risk to public health and should be stopped.

The FDA report may be short and issued without comment, but it is a sign that the FDA is taking steps to address this serious public health problem.

Nov 24 2010

Facts and rumors: the current status of S. 510

Following the ongoing saga of S. 510, the Food Safety Modernization Act, is like taking a graduate course in political science.   And sociology graduate students everywhere should be writing dissertations on how a bill designed to help protect the public from food hazards like Salmonella and E. coli O157:H7  became a flashpoint for debates about the role of government in personal choice.

Let’s start with the rumors.   I’m hearing from sources inside the Beltway that the Senate and House have agreed to pass S. 510 in part because they can use it to get something else they want: repeal of an annoying provision in the health care reform act passed last spring that requires 1099 tax reports for business purchases.

The Senate is said to be dealing with S. 510 late in the afternoon or early evening of Monday, November 29.  It is supposed to work like this:

  • There will be a cloture motion, which will pass with 60 votes.
  • The Senate will agree that all amendments to S. 510 will require 67 votes.
  • Senator Coburn will offer amendments, but they will not get 67 votes.
  • The Senate will add language repealing the 1099 tax provision.
  • The Senate will pass the bill (this needs 51 votes)
  • The House will agree to accept the Senate bill as written with no changes.
  • The bill will get sent to President Obama to sign before Congress adjourns.
  • The President will sign the bill.

Maybe, but this does not sound like a done deal to me.  For one thing, opposition to S. 510 seems to be getting noisier.  Remember the adage “politics makes strange bedfellows?”  Take a look at the groups who now oppose the bill, united in their opposition to giving the FDA or government any additional authority:

  • The health food industry
  • The dietary supplement industry
  • The meat industry: American Meat Institute, Cattlemen’s Association, etc.
  • The Tea Party
  • The raw milk community and its legal arm, the Farmer to Consumer Legal Defense Fund
  • Some, but by no means all, small farmers and advocates for them

Missing from this list is Big Agriculture, an absence explained by the fact that the bill does not apply to feed commodities or to seeds.

As for the Tester amendment exempting small farms from certain provisions of the bill: It is opposed by 20 organizations of vegetable growers, and is also is likely to be opposed by companies like Monsanto which do not want the FDA making safety decisions based on size or anything else except risk.

Caroline Scott-Thomas writes in FoodNavigator-USA that all food producers, large and small, should be producing food safely, not least because bacteria do not care how big a farm might be: 

Think about it: If a large-scale cheese maker refused to recall potentially tainted products for financial reasons, as the Estrella Family Creamery is doing, would it inspire dewy-eyed sympathy? I doubt it.

I agree, and also with the comments of Bob Whitaker, the Produce Marketing Association’s Chief Science Officer, who points out that plenty of growers are already using preventive controls like the ones requires by S.510:

There are a lot of very small growers who are already doing this.  I think there is plenty of evidence where growers have already made this a priority and they have been able to do so in a pretty innovative manner. There is a cost to this…But it doesn’t have to be overwhelmingly expensive. A lot of this is common sense.  People need to dive in and understand that this is food and you have to take responsibility for the safety of our food, to the extent that you can… Consumers have to be confident that our products are safe.

I’ve seen this too.  Lots of small food producers do everything they can to reduce microbial risks.  They don’t need a government agency to tell them what to do.

Others, however, won’t take safety steps unless forced to.  That’s why we need this bill to pass.

In the meantime, the debate continues. USA Today, long concerned about food safety, favors the bill. Senator Coburn, however, does not.

Happy Thanksgiving holiday, everyone.

And special thanks to Carol Tucker Foreman of Consumer Federation of America for cluing me in on the latest developments.

Addition: Safe Tables Our Priority (STOP), a food safety advocacy group formed originally by parents of children harmed by eating fast-food hamburgers, strongly favors S. 51o.  Under its auspices, 80 victims of foodborne illness have written a letter to the Senate in the hope that this will help solidify support for passing this bill.

Many of us have traveled to Washington D.C. numerous times to meet with lawmakers, sharing our personal stories as to why stronger food safety laws are necessary; others of us have written opinion pieces, letters, and blog entries urging action on this important legislation. S. 510 would be the first major overhaul of the FDA’s food-safety authorities in decades. It is time to pass this legislation.

Nov 23 2010

Kellogg settles class-action health-claims suit

Kellogg has had a bad year on the truth-in-advertising front.

First, It took the brunt of the furor over the late and unlamented Smart Choices fiasco, when the program’s first logo turned up on Froot Loops of all things and was attacked by the Connecticut attorney general.

Next, the IMMUNITY banner on Cocoa Krispies drew fire from the San Francisco city attorney’s office.

Both boxes are now collectors’ items.

Now, FoodNavigator-USA reports that Kellogg has taken another expensive beating, this time on its health claim for Mini-Wheats.

In 2009, Frosted Mini-Wheat boxes sported this health claim:  “Clinically shown to improve children’s attentiveness by nearly 20%.”

Of course this cereal can do that, especially when kids eating it are compared to kids who don’t eat any breakfast at all—which is what this study did.

But that’s not what the adorable television advertisements imply, as shown in exhibits A and B in the summary of the class-action decision.

Last April, Kellogg settled a dispute with the FTC over this claim.  The FTC did not argue that the claim was inherently absurd because of the lack of an appropriate control group for the study.  Instead, it took the study at face value and charged Kellogg with exaggerating the results because hardly any children—only 11%—improved attentiveness by 20% or more.

Kellogg has just settled a class-action suit over this claim that will cost the company $2.75 million in order to pay customers between $5 and $15 each in compensation.  The company also will give $5.5 million to charities.

Because of city and state attorneys and the FTC, the most egregious health claims are slowly disappearing from cereal boxes.     But lawsuits do not constitute policy.  What goes on the front of food packages is FDA territory.

FDA: Get to work!

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