Currently browsing posts about: Health-claims

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.

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.

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.”

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.

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.

The California-based Marin Institute, “the alcohol industry watchdog,” has issued an enlightening new report: Questionable Health Claims by Alcohol Companies: From Protein Vodka to Weight-Loss Beer.

According to the Institute’s press release, “Major alcohol companies are exploiting ineffective or non-existent regulatory oversight with deceptive marketing and potentially dangerous products.

Some examples described in the report:

• Devotion Vodka (“Infused with Casein”)
• Fragoli strawberry liqueur (promoted with antioxidants)
• Absolut, Skyy, and Finlandia vodkas (“infused with natural flavors”)
• Michelob Ultra, and MGD 64 beer (promoted as fitness and weight-loss aids)

Or how about vodka advertised as “no sugar, gluten free, low calorie?”  The Marin Institute points out that terms like these are “promoted as logical compliments to a healthy, fitness-oriented lifestyle, without a hint of irony.”

Irony?  Check the illustrations!

As the report concludes, such marketing messages when applied to alcoholic beverages are “legally tenuous, morally unsound, and potentially dangerous.”

But don’t blame the FDA for this one.  Alcoholic beverages are regulated by the Treasury Department because they are a lucrative source of revenue.  Health claims sell products.

Treasury benefits more when companies sell more.  This sounds to me like a clear conflict of interest.  You?

Yesterday’s New York Times displayed a full-page advertisement for Gerber baby food (owned by Nestlé, no relation):

Gerber is taking more than baby steps to reduce the risk of certain allergies

.…The FDA concludes that current scientific evidence is appropriate for consideration of a claim regarding the relationship between the consumption of 100% whey-protein partially hydrolyzed infant formula and reduced risk of atopic dermatitis.

….We’re proud to say that Gerber Good Start is the first and only formula brand made from 100% whey-protein partially hydrolyzed.  In contrast, most other routine milk-based formulas are made with intact cow’s milk protein.

Translation: Some infants are allergic to the proteins (whey) in cow’s milk.  Treating the proteins so they are split apart into smaller fragments (partial hydrolysis) apparently destroys some of their ability to elicit allergic immune reactions in the skin.

But here’s where the ad gets totally weird:

The FDA has concluded that the relationship between 100% whey-protein partially hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.  Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.

Huh?

Blame Congress for this one.  It insists that the FDA allow “qualified” health claims” for which scientific evidence is uncertain.

If you want to know why the FDA can’t seem to get anything done, take a look at what it’s staff had to do to respond to the Gerber petition.  Graduate students take note: this is an exhaustive review of scientific studies on the relationship between hydrolyzed whey protein and infant skin allergies.

Here is the FDA’s conclusion, written in FDA-speak, about Gerber’s petition for a health claim:

In light of the above considerations, FDA intends to consider the exercise of its enforcement discretion for the following qualified health claims (my emphasis):

1. “Very little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.”

2. “Little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life.”

3. “For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is very little scientific evidence for the relationship.”

4. “For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.”

Why would Gerber’s place a hugely expensive full-page ad in national newspapers to celebrate a decision like this?  Because it knows that any health claim, no matter how poorly substantiated by science, gives it a competitive advantage.

This is reason enough to promote breastfeeding.

On May 24, an administrative law judge will deal with the matter of the Federal Trade Commission’s (FTC) complaints that health claims made for POM Wonderful pomegranate juice are unsubstantiated by science.

To review:  last September, the FTC complained that the company was advertising its juice with unsubstantiated claims like these:

• Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat heart disease, including by decreasing arterial plaque, lowering blood pressure, and improving blood flow to the heart;
• Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat prostate cancer, including by prolonging prostate-specific antigen doubling time;
• Clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction.

The FTC argues that these claims are false because POM Wonderful’s studies do not prove what the company claims.  The FTC particularly takes exceptions to the company’s advertisements:

• Washington Post Advertisement
• Banner Advertisement
• Fitness magazine Advertisement

If you want to follow the legalities, the FTC provides a handy summary.

According to FoodNavigator.com, this company must be supporting armies of lawyers:

POM is currently embroiled in a complex web of litigation, having itself launched legal action against the FTC alleging it had exceeded its statutory authority by establishing a two-clinical trial standard to back claims.

It has also filed actions against Coca-Cola Minute Maid, PepsiCo Tropicana and Ocean Spray alleging misleading claims about the contents of their pomegranate-containing juice products.

Separately, POM is itself accused of misleading consumers in a class action lodged in a Florida state court.

Leaving this particular company’s legal strategies aside, at issue is whether food health claims need to be backed up by science.   POM says it has the science.   The FTC says it doesn’t.   I will have more to say about that issue in subsequent posts.

In the meantime, it will be interesting to see what happens at the hearing.  Stay tuned.