Currently browsing posts about: FDA

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.

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!

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:

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 line.  Phil Brasher explains all the steps that will need to be taken for this bill to get passed by the Senate and become law.

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!

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.

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!

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.”