by Marion Nestle

Currently browsing posts about: Health-claims

Nov 4 2009

Europe rejects droves of health claims

In what the functional food industry refers to as a “bad day at the office,” the European Food Standards Agency (EFSA) rejected hundreds of health claims, particularly those for probiotics.  More recently, it rejected a claim that glucosamine prevents cartilege degeneration.  Hard as it may be for the food and supplement industries to believe, EFSA just can’t find scientific evidence to support those claims.

A representative of the company that applied for the glucosamine claims says his company now anticipates a loss in product sales, and complains that it had “invested quite heavily in this submission, in terms of effort and financial outlay.”

Too bad.

Why can’t they come up with the science to support those claims? For one thing, who would want to do the research?  Danone and Yakult have just announced two $50,000 grants to study probiotics.  This won’t go far and the sponsorship is an almost certain guarantee that the results will be just what the companies paid for.

Independent research is much more complicated.  Consider folic acid, for example.  The latest clinical trial of folic acid and colon cancer went to a lot of trouble to prove that folic acid supplements are harmless.  In most people, they have no effect on colon cancer, neither benefit nor risk.  Among the few people who had unusually low levels of the vitamin in their blood, the supplements appeared to have some protective effect.  You can interpret results like this either as evidence for no benefit or as evidence that folic acid supplements might benefit some people under some circumstances.

And that brings us to supplements again.  A trade association for supplement manufacturers says:

While it cannot be denied the food and supplement industry has entertained its fair share of cowboys, our concern is that the [EFSA] regulation goes so far as to throw the baby out with the bathwater. At the very point in time when consumers need most information to help them make the right food and supplement choices to help them offset largely preventable chronic diseases, we see the industry being gagged.

“Cowboys” are indeed a problem, and one well known to the American supplement industry. Says the head of the Council for Responsible Nutrition, the euphemistically named supplement trade association:

Fifteen years ago, our biggest threat was an over-reaching FDA….More recently, the problem has been an FDA that’s under funded and lacks the political will to do what it needs to do. And as a result today, many of the problems that burden the dietary supplement industry are ones that come from within the industry itself from that lack of oversight….Companies… intentionally – or inadvertently – put prescription drugs or anabolic steroids into their products and call them dietary supplements; products that just don’t do what they claim.  Also some companies practice economically motivated adulteration, passing off shoddy products as something more than they are … and ignore the new GMP requirements in hopes that they will fall under the radar screen.

Perhaps in response, the Boston Globe says we should repeal the 1994 law that deregulated dietary supplements and give the FDA some regulatory teeth.  Good idea.

Please forgive my endless repetition of this mantra: health claims are about marketing, not health.

Sep 29 2009

Health claims for yogurt? Really?

I like yogurt.  But do probiotics – those “friendly” bacteria in yogurt and  increasingly added to other foods – do anything for you beyond making yogurt taste good?  I wrote about probiotics in What to Eat at some length.  Tara Parker-Pope has a quick summary of the state of the research in today’s New York Times.

The quick answer is mixed.  It includes a lot of  “maybe” or “probably,” always a sign that whatever probiotics might do isn’t going to be much.  The answer is probably yes for infant diarrhea and, maybe, irritable bowel syndrome, and maybe or no for just about everything else.

In the absence of FDA action to regulate misleading health claims, lawyers have jumped into the breach.  They have just won a large class-action settlement – $35 million – against Dannon for claiming that Activia yogurt promotes immunity.   According to one news account, Dannon spent $100 million marketing the immunity-promoting effects of Activia ignoring the results of its own company-sponsored research which inconveniently showed few benefits.  (Did they not pay enough for the research?).

Dannon is working hard to get an approved health claim from the European Standards Agency which annoyingly wants to see some science behind health claims before approving them.  Dannon has now added a tomato extract to its yogurts with the idea that this substance, which appears to help deal with diarrhea, will strengthen its bid for a health claim.

Probiotics are another reason why the FDA needs to set better standards for health claims.  If it were up to me, food packages would have no claims on them: none at all.  Foods are not drugs.

cocoa Krispies

And here’s another reason why:

Will Cocoa Krispies  be the next target of those pesky lawyers?

FDA: get to work!

Sep 7 2009

FDA to research food labels

The FDA just announced in the Federal Register that it plans to take a good hard look at public understanding of what’s currently on food labels.  It says it will do an Internet survey of 43,000 people to:

  • Identify attitudes and beliefs to do with health, diet and label usage
  • Determine relationships between these attitudes and beliefs, demographics, and actual label use
  • Look at the relevance of these attitudes
  • Identify barriers to label use

I hope they ask me!

What is this about?  Let me take a wild guess: Health claims?  Smart Choices labels?  Anything that makes people think highly processed foods are good for them?  Or distracts from the Nutrition Facts panel?

The FDA is required to allow 60 days for comment.   Tell the FDA you think the more research it does on food labels, the better!

May 13 2009

The FDA is going after health claims? At last!

cheerios1It looks like the FDA is finally getting around to looking at the absurd health claims on boxes of breakfast cereals.  And about time too, I’d say.  For starters, the FDA picked on General Mills’ Cheerios.  Cheerios boxes display banners claiming that if you eat this cereal, you will reduce your cholesterol by 4% is 6 weeks (see previous post on this).  This, General Mills says, is “clinically proven.”  Yes, but the trial on which General Mills bases this claim substitutes one serving of Cheerios for each of two meals a day.  Hey – that ought to work!

In its warning letter, the FDA says that if Cheerios lowers cholesterol, it is claiming to work like a statin drug.  If Cheerios acts like a drug, it has to be treated like a drug.  Cheerios, says the FDA, “is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore…it may not be legally marketed with the above claims in the United States without an approved new drug application.”

So what’s going on here?  I collect cereal boxes and I’m guessing that I bought the one shown here at least two years ago.  The boxes have changed since then but similar claims appear on the Cheerios website.  Maybe in this new administration the FDA can get a grip on silly and misleading health claims.  Let’s hope.

Update May 18: Advertising Age advises marketers about how to avoid FDA interference: know the rules, don’t assume that breaking them is OK even if you have done so for a long time, follow the rules.  Seems like good advice.

Update May 25: Europeans applaud this FDA action. They think we have gone much too far with health claims.

Update January 18, 2010: At a visit to the FDA last week, I saw a more recent Cheerios box that I somehow missed – lower your cholesterol by 10% in one month.  This one disappeared quickly, but I found a good description of what happened on the Consumer World Mouse Print site.  General Mills sponsored a study and rushed the box into print.

Apr 16 2009

Europe demands scientific support for health claims. Why can’t we?

The European Food Safety Authority (EFSA) has just rejected a proposal from Merck to allow it to use a health claim stating that omega-3 supplements promote  eye and brain health in infants.  Merck wants moms to take omega-3 supplements during pregnancy and give such supplements to their infants.  EFSA reviewed nearly 90 studies on this topic and concluded that the study results were not “informative.”    In other words, they showed no benefit.  Imagine.  The EFSA demands scientific substantiation of health claims.  I wish we could do that.

Here’s another example from the pomegranate folks.  They do brilliant advertising, but this time the British are complaining that these marketers went too far when they posted billboards stating that pomegranate (“antioxidant powerhouse”) juice will help you cheat death.  The British advertising standards agency balked.  Here too, pesky science gets in the way.  Studies not only fail to support a benefit of antioxidants but sometimes show harm.

Our Congress, however, forces FDA to permit health claims, no matter how absurd.  Try the FDA-allowed “qualified” health claim for omega-3’s: “supportive but not conclusive evidence  shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease” [my emphasis].  The FDA allows omega-3’s to be added to infant formulas, but here’s what it says about them:  “The scientific evidence is mixed…There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist.”

The EFSA interprets all this as unworthy of a health claim.

What can the FDA do?  If it says there isn’t enough evidence, it gets sued and loses.  The courts tend to rule that food companies can say whatever they like about health benefits on the grounds of free speech and the First Amendment.

In January, the FDA published “guidance” for industry about how it plans to evaluate the scientific basis of health claims.     Guidance is just that.  It is non-binding.

Hello new administration.  How about taking a fresh look at the health claims situation and paying close attention to what regulators in Europe are doing.  How about considering just saying no to health claims.

Jan 1 2009

Happy new year: Top food safety crises of 2008

Bill Marler, of the legal firm specializing in food safety cases, lists his top 10 picks for the food safety scandals of 2008, beginning with globalization and ending with pet food.

And Food Chemical News (December 31) says the FDA will be testing for melamine in farmed fish and fish feed from China.  When Hong Kong officials said they found melamine at 6.6 ppm in fish feed, the FDA wondered whether melamine could accumulate in fish tissues.  Apparently, that is exactly what it does.  The Los Angeles Times  (December 24) says FDA testing found whopping amounts of melamine – 200 ppm – in catfish, trout, tilapia and salmon that had eaten melamine-tainted fish feed.  This is way higher than the maximum “safe” level of 2.5 ppm in food.  So put fish from China on your list of what not to eat.

Let’s hope the new president picks someone for USDA undersecretary and FDA commissioner who takes food safety seriously.  That’s my wish (well, one of them) for the new year. Peace to all.

Dec 16 2008

FDA says it’s OK for women and children to eat more fish (oops)

The Washington Post says the FDA has breached the policy on fish consumption that it worked out with the EPA in 2004 and now proposes – in the last days of the Bush administration and without discussing the matter with EPA –  to increase the amount of fish considered safe for women and children.   Why?  Because, it says, the benefits of omega-3s in fish outweigh the risks of methylmercury contamination.  The EPA and environmental groups that work on fish safety are outraged, and with good cause, I’d say.  Check out the arguments.  You know this is about politics (translation: support of the fisheries industry) when the FDA says this is “science-based” policy (always a dead giveaway) and the Environmental Working Group says the FDA is nothing more than a “patsy for polluters.”

Nov 22 2008

Upgraded health claim for omega-3?

Yes Virginia, there is indeed a trade association for everything and omega-3 fats have their very own.  This one is hard at work trying to get the FDA to approve a full health claim (as opposed to the current qualified claim) for omega-3 fatty acids and heart disease risk.  The FDA now allows this statement: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease” (my emphasis). I can understand why the omega-3 industry wants something stronger.  Health claims, as I keep insisting, are about marketing, not health.