Currently browsing posts about: Health-claims

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.

And here’s another reason why:

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

FDA: get to work!

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!

It 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.

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.

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.

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.”

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.

Actually, they are more or less here already, but the USDA National Organic Standards Board has just given them a big OK.   According to yesterday’s Food Chemical News, the Board approved (13 to 1) a rule to allow “farmed carnivorous fish to eat meal and oil derived from sustainably wild-caught fish — a practice to be phased out over 12 years until non-organic fish feed is no longer needed” (huh?).  It also approved a more controversial recommendation (the vote was 10 to 4) to “allow use of open net pens in organic aquaculture, but with restrictions to prevent escapes of farmed fish and recycling of nutrients. Net pens would only be allowed in specified areas to avoid lice contamination.”

USDA-approved agencies have been certifying farmed fish as organic for several years now, so the Board was forced to take a stand on this question.  As I have mentioned in previous posts on this topic (and written about extensively in What to Eat), organic rules are supposed to be about the conditions of production.

Since when is ocean water organic?   And isn’t feeding “sustainably wild-caught fish” to farmed fish something of an oxymoron? The producers of farmed fish are desperate to be able to market them as organic.  So isn’t this move more about marketing than about producing fish sustainably and healthfully?

While we are on the subject of marketing, I’ve just gotten a press release from a company selling what it says is the first certified organic bottled water.  Since when is water not organic?  And what’s so special about this one?

The National Organic Program says it welcomes feedback and comments.  Here’s where to send them.