by Marion Nestle

Currently browsing posts about: FDA

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!

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.

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