Currently browsing posts about: Health-claims

Sep 27 2013

Whole grain chaos: FDA approves qualified health claim, sort of

In 2012, ConAgra petitioned the FDA to approve use of a health claim on labels and advertising for its whole grain products.  Here’s what ConAgra asked for:

Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.

or

Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.

To say that the FDA was less than impressed with evidence supporting this claim is to understate the matter.  After a comprehensive review of the evidence, here’s what the FDA says ConAgra can use:

Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.

or

Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.

No, this is not a joke.

Congress insists that the FDA must approve health claims, whether supported by science or not.

According to FoodNavigator, ConAgra is happy about this decision.  The first thing anyone will read is “whole grains may reduce the risk of type 2 diabetes.”

As I keep saying, health claims are about marketing, not health.  And qualified health claims are the worst examples.  A plague on all of them!

Aug 6 2013

Good news: FDA issues rules for a gluten-free claim on food packages

In what will surely be good news to people with celiac disease and other problems related to gluten intolerance, the FDA has just issued a final rule for defining foods as “gluten-free.”

This, after nine years of work on this issue (see timeline below).

The rule states that companies can label their products gluten-free if they contain less than 20 ppm (parts per million) gluten.  This, says FDA,

is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

As for gluten intolerance: Roughly 1% of the U.S. population has diagnosable gluten intolerance.  For those who do, eating grains containing gluten (wheat and some others) triggers an abnormal immune response that damages the intestinal tract.  To prevent symptoms—of which there can be many, none of them pleasant—people with this condition must scrupulously avoid eating gluten-containing foods.

The new rule will help establish some uniformity in labeling.  Note: gluten-free does not mean sugar-free.

In reading through the FDA’s notice in the Federal Register, I am struck by the complexity of the agency’s processes for doing something like this.

Policy wonk that I am, I immediately made a timeline.  This indicates that the FDA spent nine years getting to this point. Impressive, no?

Timeline: FDA’s Gluten-Free Rule

YEAR Action toward completing the rule
2004 Congress passes Food Allergen Labeling and Consumer Protection Act; instructs FDA to issue rule defining “gluten-free.”  FDA establishes Threshold Working Group to review literature on safety cut point.
2005 Threshold Working Group suggests approaches to defining threshold.  FDA asks for comments on the report.  Asks Food Advisory Committee to consider approaches.
2006 FDA posts report and responds to comments.  Announces public hearing.   Gets 2400 comments related to the hearing.
2007 FDA proposes rule to define gluten-free.  Sets 20 ppm cut point.  Begins Health Hazard Assessment.
2011 FDA publishes Health Hazard Assessment.  Reopens comment period.
2012 FDA responds to about 2000 comments.
2013 FDA publishes final rule.

FDA’s documents on the gluten-free rule:

Jan 17 2013

The FTC says no to POM Wonderful’s health claims

The Federal Trade Commission (FTC) just ruled that POM Wonderful’s claims for the health benefits of its pomegranate juices and products are indeed deceptive.

The FTC also said POM cannot claim that its products do anything special for heart disease, prostate cancer, and erectile dysfunction—unless it produces convincing evidence for these claims through two randomized, controlled clinical trials.

POM

The dispute over POM’s health claims has gone on for more than two years.  The FTC says POM has not proved that drinking its juice will cheat death.

POM says it has spent $35 million on peer-reviewed research proving that the antioxidants in pomegranate products promote health.

Of course they do.  Antioxidants in all fruits and vegetables promote health.

Maybe POM should resort to the defense used by Coca-Cola against charges that Vitamin Water makes deceptive health claims.

As Stephen Colbert reports, Coca-Cola’s argues: “No consumer could reasonably be misled into thinking Vitaminwater was a healthy beverage.”

Once again: health claims are about marketing, not health.

Expect POM to take the FTC to court over this ruling.  Stay tuned.

Aug 23 2012

FDA proposes study of consumer attitudes to fortified snack foods

I can hardly believe it but is the FDA really proposing to test consumer understanding of food industry evasions of the “Jelly Bean Rule?”

The FDA established this “rule” (a principle, actually) in 1994 to prevent food companies from adding vitamins to junk foods in order to allow them to be marketed as healthy.

The FDA said that just because a food is low in fat, cholesterol, and sodium—like a jelly bean—the manufacturer cannot make a health claim for it unless it contains at least 10% of the Daily Value of vitamin A, vitamin C, calcium, protein, fiber, or iron.

But, the FDA also said, companies could not fortify foods with these nutrients for the sole purpose of making health claims.

This is explained in the FDA’s policy on food fortification, given in 21 CFR 104.20(a).

The addition of nutrients to specific foods can be an effective way of maintaining and improving the overall nutritional quality of the food supply.

However, random fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply.

It could also result in deceptive or misleading claims for certain foods.

The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.

Now the FDA announces that it wants to study consumer responses to health claims on fortified snack products:

The FDA has an interest in the American public achieving and maintaining diets with optimal levels of nutritional quality, wherein healthy diets are composed of foods from a variety of nutrient sources.

The FDA does not encourage the addition of nutrients to certain food products (including sugars or snack foods such as [cookies] candies, and carbonated beverages).

FDA is interested in studying whether fortification of these foods could cause consumers to believe that substituting fortified snack foods for more nutritious foods would ensure a nutritionally sound diet.

The makers of fortified junk foods and drinks must be trembling in their boots.  Health claims sell food products.  Health claims are practically the only things that sell food products these days.

And companies will have plenty of time to lobby.

Like all FDA processes, this one is required to move at glacial speed.  It must give 60 days to allow people to comment on the proposal and get their lobbying acts together.

Then, the FDA will have to review the comments and, presumably, include them when it submits its request to do the study to the White House Office of Management and Budget.

No point in holding breath for this one.  The OMB has been sitting on FDA proposals for months.

My prediction: if the FDA ever gets to do the study, it will show that consumers interpret health claims as government guarantees that the products are healthy and, probably, have fewer calories than they actually do.

The makers of such products would prefer that the FDA not have this information confirmed.  Watch the lobbying begin!

If you want to comment, do so by October 15.  Here’s how:

  • File electronic comments here for Docket No. FDA–2012–N–0871.
  • Submit written comments to Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Use Docket No. FDA–2012–N–0871.
Aug 22 2012

Entertaining nutrition research: “nutrifluff”

I consider the results of studies showing remarkable health benefits attributed to single foods or single nutrients to be “nutrifluff”—fun, but not necessarily meaningful unless you are eating a healthy diet anyway.

Here are four recent examples:

Dark chocolate reduces heart disease risk: Everybody loves this one—an excuse to eat chocolate (but only the dark, bitter kind, alas).  This comes from a Cochrane meta-analysis of studies on the role of flavonols in blood pressure.  It concludes that chocolate eating is associated with a small reduction in blood pressure of 2 to 3 mm Hg—but only in short-term trials.  How many of the studies were sponsored by chocolate companies?  The report doesn’t say.

Apple peel extracts reduce blood pressure: Apples also have flavonols.  These were test-tube studies.  Note: Eating fruits and vegetables in general is associated with lower blood pressure.

Walnuts boost semen quality: Here’s a fun one.  Eat 75 grams of walnuts a day, and you improve your sperm vitality, motility, and morphology, at least if you are age 21 to 35 (and male).  This one was sponsored by the California Walnut Commission.  One report on this study has the best title ever: “Nuts for your nuts.”

Goji berries promote immune function in the elderly: This one, done by researchers working for Nestlé  (no relation), tested daily supplements of “lacto-wolfberry” on immune responses to influenza vaccine.  I’m assuming Nestlé must be planning to market this supplement.

What does all this tell us?  These kinds of studies confirm that eating fruits and vegetables is good for health (I think we might have known that already).

But the main (perhaps only) reason for doing such studies is for marketing purposes, which is why food companies sponsor them.

May 24 2012

POM fights back with out-of-context ads

POM Wonderful has a full-page ad in today’s New York Times (how much do these things cost?) titled “FTC v. POM: You be the judge.”  The ad includes selected quotes from the judge’s decision (see yesterday’s post) and refers readers to its wonderfully named website, pomtruth.com, where you can see the quotes and the ads for yourself.

I couldn’t help doing some checking.

The POM ad quotes from Chief Administrative Law Judge’s decision:

Competent and reliable scientific evidence supports the conclusion that the consumption of pomegranate juice and pomegranate extract supports prostate health, including by prolonging PSA doubling time in men with rising PSA after primary treatment for prostate cancer (page 282).

I turned immediately to page 282.  The sentence before the one quoted would seem to support it:

The basic research, the Pantuck Study, and the Carducci Study, relied on by Respondents [POM Wonderful], support the conclusion that pomegranate juice has a beneficial effect on prostate health.

But what follows the quotation makes it clear that although the research claims to support the effect, it really doesn’t.  Here’s what immediately follows the quotation in the same paragraph:

However, the greater weight of the persuasive expert testimony shows that the evidence relied upon by Respondents is not adequate to substantiate claims that the POM Products treat, prevent, or reduce the risk of prostate cancer or that they are clinically proven to do do so.  Indeed, the authors of the Pantuck Study and the Carducci study each testified that their study did not conclude that POM juice treats, prevents, or reduces the risk of prostate cancer.  And, as Respondents’ expert conceded, no clinical studies, research and/or trials show definitely that the POM Products treat, prevent, or reduce the risk of prostate cancer.

I will just do one more of the quotes.  The ad says:

Competent and reliable scientific evidence shows that pomegranate juice provides a benefit to promoting erectile health and erectile function (page 198).

This is indeed on page 198 but is followed immediately by:

There is insufficient competent and reliable scientific evidence to show that pomegranate juice prevents or reduces the risk of erectile dysfunction or has been clinically proven to do so…There is insufficient competent and reliable scientific evidence to show that pomegranate juice treats erectile dysfunction in a clinical sense or has been clinically proven to do so.

Because these statements are attributed to the same expert witnesses, this must mean that while some studies show benefits, the experts do not believe that these studies (many of them sponsored by POM) are scientifically credible.

Pomegranate juice is a juice.  Fruit juices are healthy and especially delicious when fresh.  I happen to like the taste of pomegranate juice.

But does it have any special health benefits as compared to orange, grapefruit, grape, or any other fruit juice?

Would any fruit juice be likely to prevent heart disease or prostate problems on its own?

Despite POM’s out-of-context advertisement, the Administrative Law Judge did not think so, and neither do I.

Addition: I’m indebted to FoodNavigator.com for noticing some of the other ads.

The caption reads: “Natural Fruit Product with Health Promoting Characteristics–FTC Judge.”

May 23 2012

The FTC vs. POM Wonderful: the latest round

I’ve been following the legal battles between the Federal Trade Commission (FTC) and the makers of POM juice and other pomegranate juice products with avid interest, mainly because they deal with the credibility of sponsored scientific research.

This week, an administrative law judge ruled that POM violated federal law when it deceptively advertised  its products as able to “treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction.”

The judge ruled that reasonable consumers would interpret the ads as making such claims but that the company had not produced convincing evidence to support them.

The judge’s decision makes entertaining reading for someone like me who enjoys debates about whether sponsorship of scientific studies influences results and interpretation—as evidence shows they most definitely do.

POM has invested more than $35 million in research to prove that pomegranate juice has health benefits.  It has sponsored about 100 studies at 44 different institutions.  At least 70 of these studies were published in peer-reviewed journals.

It is not difficult to design research studies to give sponsors the answers they want and to make sure they are conducted well.  POM is getting the best research that money can buy.

One such study, of the effects of drinking pomegranate juice on myocardial perfusion (MP, blood flow to the heart), was conducted by Dr. Dean Ornish, who runs a preventive medicine institute in California (the quotes come from pages 268-269 of the decision).

The Ornish MP study was originally designed to last 12 months, with measurements at baseline, 3 months, and 12 months.  [The FTC] charges that the study was cut short when the three-month data came in favorably and Dr. Ornish faced cost overruns.

Dr. [Frank] Sacks [expert witness for the FTC] opined that the shortened study period and failure to report the planned duration are inconsistent with widely accepted standards for conduct of clinical trials and undermine any confidence in the findings.

Dr. Ornish testified that the Ornish MP Study was terminated after three months only because the Resnicks did not provide the funding that they had previously committed to this study….[he said the study]constitutes credible and reliable science showing that pomegranate juice lessens the risk of cardiovascular problems.

The judge found evidence on this study and many others conflicting.  He ruled that this level of disagreement about the quality of the research means that the scientific evidence is not good enough to substantiate the claims.

I was interviewed for a story in Business Week about this decision.

This makes it clear why everyone should be suspicious of the results of sponsored studies…POM-sponsored studies produce results favorable to POM.

POM’s owners have their own spin on the decision.

It says the ALJ’s ruling affirms the scientific validity behind the general health benefits of pomegranates and “completely exonerates” POM regarding its claims in broadcast or print interviews.

Let’s be clear what’s at stake here.  According to the decision document, the owners of POM control 18,000 acres of pomegranate orchards.

From September 2002 through November 2010, sales of POM juice alone totaled nearly $248 million (the supplements and other products add more).

The owners must believe that nobody will buy pomegranate juice and supplements for any reason other than health benefits.

Health claims are about marketing, not health.

Let’s hope the FTC can make the decision stick.

Nov 30 2011

Report from the EU: functional foods, supplements, health claims


Sebastián Romero Melchor writing in Food Chemical News (subscription required, alas) a few days ago points out that the market for functional foods in the European Union is growing.  He advises U.S. firms who want to take advantage of  its €40 billion (equal to roughly $54 billion USD) market to pay attention to some important facts:

  • Novel ingredients: Ingredients that were not consumed to a significant extent in the EU before May 15, 1997 must undergo a costly and lengthy authorization procedure so dreadful that most companies give up and choose not to include them.
  • Supplements: The European Commission has no problem with vitamins and minerals, but marketing of food supplements and fortified foods remains subject to each European country’s separate national laws.  Products legally marketed and/or manufactured in a member-state can be legally marketed throughout the EU, provided that they are (a) safe, (b) not novel, and (3) not medicinal.
  • Health claims: The European Food Safety Authority (EFSA) has issued opinions on health claims for most substances.  It has evaluted about 2,750 petitions for health claims but only approved about 600.

If only the FDA would take as rigorous a stance.

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