by Marion Nestle

Currently browsing posts about: FDA

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!

Nov 20 2010

Another reason to pass S. 510

Today’s New York Times has a story about the travails of the Estrella Family Creamery, makers of artisanal cheeses found repeatedly by the FDA to be contaminated with Listeria.

The FDA asked for a recall.  Estrella refused.

Whether Estrella should be considered heroic for fighting Big Government, as the article suggests, or instead is allowing dangerous products to go into the marketplace depends on point of view.

Mine is that every producer—large and small—who makes food should be producing it safely under a HACCP plan or its equivalent.  If the product carries special risks, as cheeses sometimes do, the producer ought to be testing to make sure it is safe.

I have visited plenty of artisanal makers of raw and Pasteurized cheeses who produce them safely.  These makers worry constantly about how to make sure that their cheeses are—and stay—safe.

If you have a strong immune system and are not pregnant, Listeria is unlikely to make you sick.  If not, however, watch out: Listeria can be fatal, especially to unborn infants.

In a column I wrote for the San Francisco Chronicle last March, I responded to a question about Listeria from a reader who lost a baby after eating a Listeria-contaminated Pasteurized cheese (the contamination must have occurred later). See correction below.

Listeria has the terrifying property of flourishing at refrigerator temperatures.  In this particular case, neither Pasteurization nor refrigeration were enough to save her baby.

As I said in my column:

Without federal requirements, you are on your own to keep yourself and your unborn infant safe from food pathogens, especially Listeria…. Listeria preferentially affects pregnant women. If you are pregnant and want to stay pregnant, you must avoid Listeria.  This will not be easy.  Listeria is widely dispersed in foods. Infections from it may be rare, but they are deadly. Listeria kills a shocking 25 percent of those it infects and is particularly lethal to fetuses….With so much at stake, and so many other food choices available, why take chances?

That is why allowing Listeria-contaminated cheeses into the food supply is not a good idea.  It is also why the FDA is so concerned that Listeria-contaminated foods do not get into the food supply.

This cheesemaker’s refusal to recall Listeria-contaminated products is another reason why so many of us who care deeply about food safety want the Senate to get busy and pass S.510.

Correction: the writer of that letter has written to explain that the source of her Listeria infection was never determined.  She had eaten a Pasteurized Stilton cheese, a goat cheese, and a rare steak among other suspected foods but none was proven to be the source.  For the record, the CDC says to prevent Listeria, pregnant women should avoid eating:

  • Hot dogs, luncheon meats, or deli meats (unless reheated to steaming hot).
  • Soft cheeses such as feta, Brie, Camembert, blue-veined cheeses, and Mexican-style cheeses such as “queso blanco fresco.”
  • Refrigerated pâté or meat spreads.
  • Refrigerated smoked seafood unless cooked to steaming hot.  This includes salmon, trout, whitefish, cod, tuna, and mackerel which are most often labeled as “nova-style,” “lox,” “kippered,” “smoked,” or “jerky.”
  • Raw (unpasteurized) milk or foods that contain unpasteurized milk.
Nov 19 2010

Senate stalls action on S. 510

The Senate debated S. 510, the FDA Food Safety Modernization Act, yesterday.  I was not able to watch the debate  and was disappointed to find not one word about it in today’s New York Times. I guess it doesn’t count as news when Senators stall legislation that would give the FDA the authority it needs to ensure safe food.

Fortunately, Helena Bottemiller of FoodSafetyNews is on the job. She reports:

  • The Senate is unlikely to do anything with the bill until after Thanksgiving recess, November 29th at the earliest.
  • Sen. Tom Coburn (R-OK) is trying to block the bill by forcing a vote on an amendment to ban all earmark spending through 2013.
  • Although the bill ostensibly has wide bipartisan support in the Senate and the House, big agricultural groups are unhappy about the recent Tester amendment mandating exemptions for small farms. Twenty produce groups signed a letter to Senate leadership arguing against the exemptions.
  • The Senate may resume debate on the bill today.
  • All bets are off on what will happen next.

The House passed its version of the bill in July 2009.  The increasingly dysfunctional Senate has been sitting on it ever since.

Why?  The reason seems ludicrous but it’s what everyone is telling me: the Republicans do not want the Democratic administration to get credit for passing the food safety bill.

Senators: Grow up!  Lives are at stake here.

Citizens: Act up!  Tell your senators to get this bill passed.

Today’s additions: Here’s Bill Marler’s update on the competing amendments.  Apparently Coburn thinks we don’t need a food safety bill because Marler’s lawsuits will keep industry in linePhil Brasher explains all the steps that will need to be taken for this bill to get passed by the Senate and become law.

Nov 17 2010

FDA and FTC get tough on caffeine-alcohol drinks!

The FDA held two conference calls today to announce action on caffeine-alcohol beverages. It is sending warning letters to four companies that make this collection of caffeinated alcoholic beverages:

  • Core High Gravity HG Green
  • Core High Gravity HG Orange
  • Four Loko
  • Joose
  • Lemon Lime Core Spiked
  • Moonshot  (This product is labeled as “premium beer with caffeine”)
  • Max

The FDA says:

The manufacturers of these products have failed to show that the direct addition of caffeine to their malt beverages is “generally recognized as safe” by qualified experts.  Rather, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern….The agency has given the firms 15 days to respond to the warning letters and then may proceed to court to stop their sale. In addition, other alcoholic beverages containing added caffeine may be subject to agency action in the future if scientific data indicate that the use of caffeine in those products does not meet safety standards.

The FTC issued similar warnings to the same four companies because “marketing of such beverages may constitute an unfair or deceptive practice that violates the FTC Act.  Companies receiving letters include: United Brands Co (Joose and Max), Phusion Products (Four Loko and Four Maxed), Charge Beverages Corporation (Core High Gravity, Core Spiked, and El Jefe), and New Century Brewing Company (Moonshot).

What this is about:

Ever ahead of the game, the New York Times announced yesterday that the FDA would soon be doing something about the caffeinated alcohol beverages that have caused so much trouble on college campuses recently (see previous post on this).

Today, Four Loko says it will voluntarily take the caffeine out of Four Loko.

Why?  In a statement, Phusion Projects, the maker of Four Loko explains:

We are taking this step after trying – unsuccessfully – to navigate a difficult and politically-charged regulatory environment at both the state and federal levels….We have repeatedly contended — and still believe, as do many people throughout the country — that the combination of alcohol and caffeine is safe…If it were unsafe, popular drinks like rum and colas or Irish coffees that have been consumed safely and responsibly for years would face the same scrutiny that our products have recently faced….By taking this action today, we are again demonstrating leadership, cooperation and responsible corporate citizenship.

Yeah, right.  Irish coffees are hardly considered party drinks.

Phusion Projects is acting because it is being forced to.   FoodSafetyNews has kept score, based on data collected by the Marin Institute, which has been on top of this issue for years (thanks to Michele Simon and others).

So far, Oklahoma, Michigan, Utah, and Washington have banned drinks that combine caffeine with alcohol.  New York’s largest beer distributors have stopped selling the drinks. And several colleges have banned the drinks on campuses.

And where are the regulatory agencies in all this?  Alcohol beverages are not regulated by the FDA.  They are regulated by theTobacco Tax and Trade Bureau (TTB) of the Treasury department.  From the government’s standpoint, alcohol is about tax revenues, not health.  As Phusion Projects explains, all this is TTB’s fault:

If our products were unsafe, we would not have expected the federal agency responsible for approving alcoholic beverage formulas – the Tobacco Tax and Trade Bureau (TTB) – to have approved them.   Yet, all of our product formulas and packaging were reviewed and approved by the TTB before being offered to consumers.

Why is the FDA involved in this at all?  Because it regulates food additives—like caffeine and the other supplements put into energy drinks.

If this incident illustrates anything, it’s that alcohol beverages require the same kind of scrutiny given to any other food product and their regulation needs to move to an agency that cares about their effects on health.

Additions, November 18: The California Department of Health Services says caffeine-alcohol beverages can no longer be sold in the state.  And TTB has come out with its own warnings.

Addition, November 23: I’ve been sent the Saturday Night Live skit on Four Loko, and particularly appreciate the comment on portion size—120 servings per can!

Nov 9 2010

Two reports on marketing food to kids: international and U.S.

The World Health Organization (WHO) has a new, tough report out: “Set of recommendations on the marketing of foods and non-alcoholic beverages to children.

It’s policy aim: to reduce the impact on children of marketing of foods high in saturated fats, trans-fatty acids, free sugars, or salt.

Here are some of its recommendations (edited):

  • Given that the effectiveness of marketing is a function of exposure and power, the overall policy objective should be to reduce both the exposure of children to, and power of, marketing of foods high in saturated fats, trans-fatty acids, free sugars, or salt.
  • To achieve the policy aim and objective, Member States should consider different approaches, i.e. stepwise or comprehensive, to  reduce marketing of foods high in saturated fats, trans-fatty acids, free sugars, or salt, to children.
  • Settings where children gather should be free from all forms of marketing of foods high in saturated fats, trans-fatty acids, free sugars, or salt.
  • Governments should be the key stakeholders in the development of policy and provide leadership, through a multistakeholder platform, for implementation, monitoring and evaluation. In setting the national policy framework, governments may choose to allocate defined roles to other stakeholders, while protecting the public interest and avoiding conflict of interest.
  • Considering resources, benefits and burdens of all stakeholders involved, Member States should consider the most effective approach to reduce marketing to children of foods high in saturated fats, trans-fatty acids, free sugars, or salt.
  • Member States should cooperate to put in place the means necessary to reduce the impact of crossborder marketing (in-flowing and out-flowing) of foods high in saturated fats, trans-fatty acids, free sugars, or salt to children.

The Rudd Center at Yale has just released Fast Food F.A.C.T.S., a thoroughly comprehensive report on the marketing of fast food to children and adolescents.

The report lavishly illustrates and extensively documents the ways in which fast food companies market to kids, the strategies they use, and the effects of these efforts on kids’ diets.

Readers: add it to your library!  FDA and FTC: get busy!

Addition: Advertising Age reports on the fast food industry’s response to the Rudd Center report.  All the industry can come up with, says Advertising Age, is a “canned response.”  Looks like the Rudd Center got it right.

Oct 28 2010

Food, grocery trade associations preempt FDA labeling plans

In a online press release yesterday, the Grocery Manufacturing Association (GMA) and Food Marketing Institute (FMI) announced a new labeling initiative for their member companies:

America’s leading food and beverage manufacturers and retailers joined forces today in the fight against obesity and announced their commitment to develop a new front-of-package nutrition labeling system. The unprecedented consumer initiative will make it easier for busy consumers to make informed choices when they shop….America’s food and beverage manufacturers and retailers have agreed to support the change to their product labels with a $50 million consumer education campaign.

Forget the consumer-friendly rhetoric.

There is only one explanation for this move: heading off the FDA’s Front-of-Package (FOP) labeling initiatives.

Only two weeks ago, the Institute of Medicine released its first FDA-sponsored FOP labeling report.  The IOM committee recommended that FOP symbols only mention calories, sodium, trans fat, and saturated fat.  This led William Neuman of the New York Times to summarize its approach as: “Tell us how your products are bad for us.”

GMA and FMI would much rather label their products with all the things that are good about them, like added vitamins, omega-3s, and fiber.  If they must do negatives, they prefer “no trans fat” or “no cholesterol.”

What they especially do not want the FDA to impose is “traffic-light” symbols.  These U.K. symbols, you may recall from previous posts, discourage consumers from buying anything labeled in red, and were so strongly opposed by the food industry that they caused the undoing of the British Food Standards Agency.

GMA and FMI, no doubt, are hoping the same thing will happen to our FDA.

In today’s New York Times, Mr. Neuman quotes a GMA representative:

Mary Sophos, an executive vice president for the group, said the label would not characterize a food’s overall nutritional qualities as good or bad — like the traffic signal label in Great Britain that displays a red circle for less healthy nutrient levels and a green circle for healthier levels.

“We’re not going to get into interpreting elements of the food,” Ms. Sophos said.

This move is all the evidence the FDA needs for mandatory FOP labels.   GMA and FMI have just demonstrated that the food industry will not willingly label its processed foods in ways that help the public make healthier food choices.

Let’s hope the GMA/FMI scheme goes the way of the ill-fated, not-so-Smart Choices program.

FDA: you should be outraged by this move.  Say so!

Oct 13 2010

IOM Front-of-Package Label Committee releases Phase 1 report

The Institute of Medicine (IOM) released its first Front-of-Package (FOP) labeling report this morning. Phase I is a tough, detailed examination of about 20 of the existing FOP schemes along with some recommendations about what such schemes ought to do.

FOP labels are those little spots, check marks, and tokens that are all over food packages these days and that are supposed to indicate that the product is especially healthy for you.  They may seem utterly trivial, but they are of desperate importance to food companies.  FOP labels sell food products.  Food marketers love them and need them.  The FDA worries that having so many of them confuses the public, and that the schemes are based on criteria that serve industry purposes more than to promote public health.

As the IOM press release explains:

A multitude of nutrition rating, or guidance, systems have been developed by food manufacturers, government agencies, nutrition groups, and others in recent years with the intent of helping consumers quickly compare products’ nutritional attributes and make healthier choices. Ratings are typically communicated to shoppers through symbols placed prominently on food packaging, usually on the front, or on retail shelf tags. Unlike the Nutrition Facts panel, these rating systems and symbols are unregulated, and different systems focus on different nutrients. The variation may confuse consumers, and questions have been raised about the systems’ underlying nutritional criteria.

The committee did a terrific analysis of current FOP schemes.  My favorite parts are its

  • Clear, concise histories of nutrition and FOP labeling (students: take note!)
  • Detailed evaluation of the strengths (few) and weaknesses (many) of the existing schemes
  • Demonstration of the inconsistent results of applying the schemes to specific foods

The report gives examples of the inconsistent results of three scoring schemes: Guiding Stars, NRFI [Nutrient-Rich Foods Index], and Nu-Val

  • Instant oatmeal received 3 Guiding Stars, and scores of 87 by NRFI and 39 by NuVal.
  • Non-instant oatmeal received 2 Guiding Stars, and scores of 22 by NRFI and 57 by NuVal
  • Toasted oat cereal received 2 Guiding Stars, and scores of 84 by NRFI and 37 by NuVal
  • Fat free milk, 1% fat milk, and fat free plain yogurt received 3 Guiding Stars, but fat free milk was scored 56 by NRFI and 91 by NuVal; 1% fat milk was scored 30 by NRFI and 81 by NuVal, and fat free plain yogurt was scored 43 by NRFI and 96 by NuVal.

The committee’ key recommendation: FOP labels should deal with just four nutrients: calories, saturated fat, trans fat, and sodium.

These nutrients, says the committee, “are routinely overconsumed and associated most strongly with diet-related health problems affecting many Americans, including obesity, heart disease, high blood pressure, Type 2 diabetes, and certain types of cancer.”

Comment: Trans fat seems unnecessary here.  It is already out of most packaged foods.   Or maybe the committee thinks that leaving it off will give food companies permission to put hydrogenated oils back in?

The committee chose not to add sugars to this list:

The committee concurred that both added and naturally occurring sugars contribute to the caloric content of foods and beverages and overconsumption of high-calorie products can lead to obesity.  Highlighting calories per serving in nutrition rating systems would address this concern.

Comment: I think consumers want to know about added sugars in food products.  I certainly do.

Phase II comes next

It will examine designs and look at consumer understanding of the labels, and will discuss “the pros and cons of having a single, standardized front-label food guidance system that is regulated by the Food and Drug Administration.”

Presumably, Phase II will deal with questions that are not addressed in the Phase I report:

  • Will this scheme supersede all of the other labeling systems currently on food packages?
  • Will it be voluntary or mandatory?  For all food products, or just selected ones?
  • If the scheme is voluntary, why would food companies choose to use it since it mostly highlights the negatives—the nutrients to be avoided?
  • How will it affect the nutrient-content claims currently on food packages?  (Examples: “Contains 8 vitamins!”  “100% vitamin C!” “High fiber!”)
  • How will it affect shelf-labeling schemes such as the Nu-Val system used at Price Chopper supermarkets and the ANDI system used by Whole Foods?

FOP labels are about marketing, not health

This scheme, like the many others developed by food companies singly or together, is designed to help the public decide whether one highly processed, packaged food product is nutritionally better than another.

As I have discussed many times on this site, this approach raises a philosophical question: Is a slightly “better for you” food product necessarily a good choice?

I hope the committee will ponder this and some of my other questions as it enters Phase II.

Addendum: I gather from what I’ve heard about the press conference this morning that some of my questions were answered.  The FOP proposal will not affect nutrient content claims on the front of packages.  Companies will still be able to proclaim the nutritional benefits of their products in words and banners.  They just won’t be able to use them in whatever symbol gets chosen.  So what difference will this report make?  Not much, alas, except to get rid of the silly symbols in use right now.

Update, October 14:  William Neuman’s account of this event in the New York Times starts with this: “Tell us how your products are bad for us.”

Oct 3 2010

San Francisco Chronicle column: whole wheat is not the whole story

My first-Sunday-of-the-month San Francisco Chronicle Q and A column, Food Matters, is out.  This month it’s about figuring out what “whole wheat” labels mean on food packages.

Q: I pay $4 for multigrain or whole wheat breads because I’ve heard white bread isn’t as healthy. But when I compare nutrition labels, $2 white breads look much the same. Are they?

A: My Talmudic answer: yes and no. You are asking about commercial sliced breads. Bread may be the staff of life, but you would never know it from reading the ingredient lists of most commercial products.

Commercial breads are indeed much the same, with only a few differences that matter.

To decide whether these have anything in them worth eating beyond their calories, you must inspect labels to make sure the first ingredient is whole grain, the total number of ingredients is small and devoid of unpronounceable chemicals, the fiber content is at least 2 grams per 1-ounce serving and the label says 100 percent whole wheat. Anything less is reconstituted white bread with occasional pieces of the original grain added back.

And then there is taste. Artisanal breads begin with just four ingredients – flour, water, salt and yeast – and turn them into loaves so crusty, chewy and fragrant that you cannot stop eating them. If they have some whole grain in them, even better.

But handmade breads take forever to make and quickly go stale. Commercial bakeries deal with these problems by rushing the bread-making process and compensate for the loss of flavor by adding stabilizers, dough softeners and preservatives, and covering up the chemical tastes with sweeteners. Breads with 30 or more ingredients are not unusual and violate my rule: Never buy processed foods with more than five ingredients.

To compare breads, you must read labels. Bread companies do not make this easy. Some list the serving size as one slice, some two, and their weights can vary by twofold. When you convert everything to ounces, the nutrient content of supermarket breads looks much alike.

An ounce provides 70 to 80 calories, a trivial difference. The grain is what counts.

Wheat grains have three components – the nutrient-rich bran and germ (“chaff”), and the endosperm, which is mostly starch and protein. One hundred percent whole wheat flour contains all three in the same proportion as in the original grains.

White flour contains about 80 percent of the original components. It is mostly endosperm.

Nutrients in the chaff are lost, so bakers are required to replace the five nutrients least likely to be available from other foods: niacin, riboflavin, thiamin, folic acid and iron. The others are not replaced.

Neither is fiber. White flour contains only trace amounts of fiber.

Because high-fiber diets promote healthy bowel function and appear to reduce risks of heart disease and bowel cancers, dietary advice is to eat at least three daily servings of whole grains – 3 ounces of 100 percent whole wheat bread, for example.

Food labeling rules do not make it easy to figure out fiber content. Some white breads list 1 gram of fiber, but watch out for serving size. It takes two slices to reach half a gram, which can be rounded up to 1.

Whole wheat bread with 2 grams of fiber per 1-ounce slice may have four times as much fiber as white breads. But watch out for breads listing 3 grams fiber; their slices may weigh nearly 2 ounces.

In response to dietary advice, commercial bakeries have introduced whole grain breads acceptable to white bread eaters. These grind the wheat bran super fine, add extra dough conditioners to keep the bread soft, and toss in some bran or cracked wheat to make the bread look like whole wheat. Check for fiber grams and the position of chaff ingredients on the list. The further down the list, the smaller their contribution.

And where is the Food and Drug Administration to help with whole grains? Alas, the FDA has not set rules for grain content. It permits manufacturers to make statements such as “100 percent whole grain” as long as the statement is true and does not imply that the food is an “excellent source.”

The FDA’s nonbinding guidance says anything labeled “100 percent whole grain” must contain all three components of the original wheat seed, in proportion.

This regulatory gap permitted creation of the industry-sponsored Whole Grain Council. The council issues a certifying stamp in two forms: 100 percent and Basic. One hundred percent means all grains are whole. But the more prevalent Basic stamp allows refined grains and disproportionate additions of bran or germ.

This article appeared on page K – 3 of the San Francisco Chronicle.

Note: E-mail your questions to food@sfchronicle.com, with “Marion Nestle” in the subject line.  Read previous columns at sfgate.com/food.

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