by Marion Nestle

Search results: Immunity

Jun 8 2010

FTC goes after Kellogg’s Immunity claim, but why?

The FTC has imposed new advertising restrictions on Kellogg because of the Immunity claim on Rice Krispies.  The company is not to make claims about “any health benefit of any food  unless the claims are backed by scientific evidence and not misleading.”

Under a previous order dealing with Frosted Mini-Wheats, Kellogg was not supposed to make claims about benefits to cognition on any of its cereals or snack foods unless the company could prove that the claims were backed by real science. This new decision extends that ruling to include any claim at all.

OK, but I’m confused about several aspects of this decision:

  • How come the FTC is doing this and not the FDA?  At some point years ago, regulatory responsibility was split between FDA and FTC.  Since then, the FDA regulates claims on food package labels, whereas the FTC regulates advertising claims.  I realize that food labels are a form of advertising, but it’s unusual and surprising for the FTC to get involved in FDA-regulated matters.
  • As FoodNavigator also wonders, why didn’t the FTC fine the company and, instead, write a harsh letter? [see update below]
  • Why is the FTC doing this?  Kellogg agreed months ago to withdraw its Immunity claim ( see my November 5 post about the withdrawal).  The Immunity boxes gradually disappeared from supermarket shelves and I haven’t seen one for a long time.

So what’s going on here?  Is the FTC getting serious about regulation (and about time, too)?  Or is FDA sitting back and letting the FTC do its enforcement work?

Could this be why the FDA hasn’t sent a warning letter to Mead-Johnson, the maker of the chocolate toddler formula with three health claims aimed at kids ages 1 to 3.  I posted about this product on April 26, but haven’t heard whether the FDA is doing anything about it.  Can the FTC be on this case but waiting for investigations to be completed before taking action?

Kellogg, it seems, is under fire on all fronts.  CSPI’s Margo Wootan sent me the recent decision by the Children’s Advertising Review Unit of the Better Business Bureau that Kellogg must stop advertising Pop-Tarts to kids:

CARU was concerned that the product packaging, which features berries and states “Made with Real Fruit” for several of Kellogg’s Pop-Tarts®  products that have fruit in their names, impliedly represents to children that the products contain substantial amounts of fruit.

In fact, according to CARU, Pop-Tarts contain less than 6% fruit and less than 2% of the fruit shown in the advertising. Kellogg claimed that its marketing was not aimed at kids, but lost that one.

It’s great that regulatory agencies like FTC and FDA (and voluntary agencies like CARU) are regulating but it’s hard to keep track of who is doing what.   Nothing to do but wait and see what happens next.  Stay tuned.

Update, June 8: CSPI’s Margo Wootan writes that FTC can’t impose fines because it does not have the authority to issue civil penalties.  Ted Mermin of Public Good Law concurs.  He says:

Companies fight hard to make FTC (and similar) orders as narrow as possible, in large part to avoid precisely the situation in which they are held responsible for violating an existing injunction/order.  Since (in the Commission’s view, at least) Kellogg hadn’t violated an existing order, the FTC did not have the authority to fine them without first going to the US Department of Justice to get DOJ to take the case (a matter of a 45 day delay, if DOJ takes it at all).  The burden of that delay (and of needing to get authority from DOJ in the first place) is precisely what is driving the congressional charge for enhanced FTC authority as part of the financial reform legislation.

If the House version of financial reform legislation had been in effect, the FTC would have had the authority to seek civil penalties (i.e., fines) and the outcome here might have been different.  As it was, the fact that Kellogg had stopped the practice…kept the Commission (at least the three commissioners in the “majority”) from focusing on any remedy other than injunctive relief–that is, a broadening of the existing order from the Mini-Wheats case, with the threat of that $16,000 per violation (and an expanded area of prohibited activity) running into the future.

Update, June 11: In an editorial titled “Snake oil for breakfast,” the New York Times explains why health claims matter so much.  If you can’t believe health claims, what part of the food label can you believe?:

Businesses have been making dubious claims about their products at least since the 17th century, when the British clergyman Anthony Daffy sold Daffy’s Elixir as a cure for scurvy as well as agues, gout, rheumatism, rickets, worms and other ailments. Hucksterism — no matter how implausible the claim — lives on…[for example] POM Wonderful claimed its pomegranate juice helps treat, prevent or cure hypertension, diabetes and cancer.  This might be par for the course for an era of swift-boating political ads and a torrent of television commercials plumping for myriad wonder drugs (sudden death may result). It leaves the consumer in a quandary: what part of the label can be believed?

Dec 1 2009

San Francisco attorney vs. Kellogg’s immunity claim

My latest column in the San Francisco Chronicle deals with the immunity health claim on boxes of Kellogg Cocoa Krispies (see previous posts).  I’ve been writing the column for the last year at irregular intervals of about once every three weeks.  Beginning in January 2010, it has its own slot and will appear on the first Sunday of the month.  Here’s this one:

Q: It’s great that San Francisco City Attorney Dennis Herrera put a stop to the absurd “immunity” claim on Kellogg’s Cocoa Krispies, but how do companies get away with this?

A: I confess; I’m a health-claims junkie. I snatched up the immunity-claiming box of Cocoa Krispies the minute I saw it in a supermarket last August. I consider it a treasure: “Now helps support your child’s IMMUNITY.”

How does Cocoa Krispies perform this miracle? The cereal contains 25 percent of the daily value of antioxidant vitamins A, B, C and E per serving instead of the old 10 percent. Vitamins, Kellogg points out, play an important role in immunity.

Of course they do. All nutrients are involved in immune function. But is it remotely possible that Cocoa Krispies might protect your child against colds or swine flu? I wish.

Antioxidants present an unparalleled marketing opportunity. Kellogg does not have to prove that its cereals are protective. Immunity claims fall into a Food and Drug Administration regulatory gray area. “Supports immunity” is a “structure-function” claim, so called because it promises to support a structure or function of the human body. However you might interpret such claims, they do not really promise to prevent, treat or cure disease.

Congress expressly authorized structure-function claims when it deregulated dietary supplements in 1994. But that law did not apply to foods. Food companies wanted to use these claims, too. At first the FDA balked. When faced with further legislation and court overturns, the FDA gave up. Now it merely says that structure-function claims on supplements must be truthful and not misleading. The FDA says nothing about structure-function claims on food products. It mostly looks away when they appear.

“Misleading” is inevitably in the eye of the beholder. Herrera turns out to be a skeptic.

“The Immunity claims,” he said, “may falsely suggest to parents that cereals like Cocoa Krispies are more healthy for their children than other breakfast foods … [and] mislead parents into believing that serving this sugary cereal will actually boost their child’s immunity.” Kellogg, he said, must produce the evidence or have the claim subject to “immediate termination or modification.”

Faced with this threat and with ridicule in the press, Kellogg wisely decided to phase out the immunity-labeled Cocoa Krispies packages. Consider them collectors’ items.

Much is at stake. Ready-to-eat cereals produce more than $8 billion a year in sales. Kellogg spent about $32 million in 2008 to promote Rice Krispies cereals, and $4 million of that amount went to advertise Cocoa Krispies alone.

Shoppers care about health. If cereals can be advertised with special health benefits, more boxes will fly off the shelves. Food companies consider health claims essential for marketing their products.

This explains why so many companies are adding omega-3 fats, probiotics and antioxidants to so many foods. These ingredients make foods “functional,” meaning that the foods contain something beyond their usual nutritional value. Although little evidence shows that functional foods make healthy people healthier, companies can use functional ingredients to make health claims, no matter how far-fetched. These days, functional foods are about the only processed foods with increasing sales.

Kellogg has plenty of company with functional ingredients and health claims. See, for example, the claims on Nestlé (no relation) Juicy Juice products targeted to toddlers. One product adds antioxidants to “help support immunity.” The other adds omega-3s to “aid brain development.”

Think about it: Will feeding your toddler a sugary juice product really make her smarter? Face it. You are not supposed to think about it. You are supposed to buy – and feel good about doing so.

Absent the FDA, Herrera stepped into the breach. He does not care whether the claims are on Kellogg cereals or Juicy Juice cartons. If companies make such claims, he insists that they produce the evidence for them.

This will not be easy to do. It is one thing to find evidence that specific nutrients are involved in immune function. It is quite another to show that people who eat sweetened cereals or juices containing such nutrients are healthier than those who do not.

That is why the European Food Standards Agency denied hundreds of company petitions for health claims. The agency cannot find much evidence for the health benefits of foods with added functional ingredients. Its decisions have put European food marketers into crisis. How are they supposed to sell products without health claims?

As I keep saying, health claims are about marketing, not health. If it were up to me, I would remove all health claims from food packages. Foods are not drugs. Health claims cannot help but mislead.

So let’s congratulate Herrera for filling a regulatory gap. His colleagues – and the press – are doing their job on this one. FDA: Get to work!

Nov 5 2009

Kellogg’s withdraws IMMUNITY claim!

Kellogg’s says it will phase out boxes of Cocoa and other Rice Krispies cereals with the IMMUNITY claim on them.

Withdrawn, November 4, 2009

Withdrawn, November 4, 2009

The Immunity claim falls into an FDA regulatory grey area.  It is a structure-function claim, meaning that the product is supposed to support a structure or function of the human body – not treat or cure a disease. If Cocoa Krispies were a dietary supplement, the claim would be completely legal because Congress authorized structure-function claims for supplements when it passed the Dietary Supplement Health and Education Act of 1994.

Over the years, food makers complained that if supplements could use such claims, they could too.  At first, the FDA issued warning letters to food companies using structure-function claims.  It stopped after the courts ruled that food companies could make claims for the health benefits of their products on First Amendment grounds.

Now FDA says structure-function claims are OK to use as long as they are truthful and not misleading.  Misleading, of course, is in the eye of the beholder.  Evidently, the San Francisco city attorney thought this claim was misleading and demanded the evidence to back it up.  USA Today wrote about this on the front page (I’m quoted in it).

Wisely, Kellogg’s is going to find another design for its Rice Krispies packages.  Consider this particular box a collector’s item.

The lesson: In the absence of FDA action, food marketing is allowed to run rampant, and city and state attorneys are doing the FDA’s job.  Good for them.  And let’s hear cheers for the power of the press.

Feb 9 2016

Studies funded by a garlic supplement maker find specific health benefits for garlic. The score: 119/11.

I’m having trouble keeping up with industry-sponsored nutrition research so will use this week’s posts to catch up.  I’ll start with this one.

Nutrition journals often publish supplements on specific themes that are paid for by outside parties, food industry groups among them.  The February 2016 issue of the Journal of Nutrition contains a supplement with the papers from the 2014 International Garlic Symposium: “Role of Garlic in Cardiovascular Disease Prevention, Metabolic Syndrome, and Immunology.”

To distinguish supplement papers from peer-reviewed journal articles, citations give page numbers with the letter S.  The Journal of Nutrition’s exceptionally clear policy on supplement publications explains that organizers are expected to pay page charges of $75 per article and $300 per published page plus additional editorial costs as needed.  It views supplements as paid advertisements and requires full disclosure of funding sources.

Here’s the disclosure for the garlic supplement.

The symposium was sponsored by the University of California, Los Angeles School of Medicine and the University of Florida and co-sponsored by the American Botanical Council; the American Herbal Products Association; the ASN [American Society for Nutrition]; the Japanese Society for Food Factors; the Japan Society for Bioscience, Biotechnology, and Agrochemistry; the Japan Society of Nutrition and Food Science; and the Natural Products Association. The symposium was supported by Agencias Motta S.A.; Bionam; Eco-Nutraceuticos; Healthy U 2000 Ltd.; Magna; Mannavita Bvba; MaxiPharma; Medica Nord A.S.; Nature’s Farm Pte. Ltd.; Nature Valley W.L.L.; Organic Health Ltd.; Oy Valioravinto Ab; Purity Life Health Products L.P.; PT Nutriprima Jayasakti; Vitaco Health Ltd.; Vitae Natural Nutrition; Sanofi Consumer Health Care; Wakunaga Pharmaceutical Co., Ltd.; and Wakunaga of America Co., Ltd. The Chair of the conference and Scientific Program Coordinator for the supplement publication was Matthew J Budoff, Harbor-UCLA Medical Center, Torrance, CA. Scientific Program Coordinator disclosures: MJ Budoff has been awarded research grants from Wakunaga of America Co., Ltd., and received an honorarium for serving as Chair of the conference. Vice-Chair and Supplement Coordinator for the supplement publication was Susan S Percival, University of Florida, Gainesville, FL. Supplement Coordinator disclosures: SS Percival has been awarded research grants from Wakunaga of America Co., Ltd., and received an honorarium for serving as Vice-Chair of the conference. Publication costs for this supplement were defrayed in part by the payment of page charges. This publication must therefore be hereby marked “advertisement” in accordance with 18 USC section 1734 solely to indicate this fact. The opinions expressed in this publication are those of the authors and are not attributable to the sponsors or the publisher, Editor, or Editorial Board of The Journal of Nutrition [my emphasis].

Comment on scoring: Because they were presented at a symposium sponsored by food and supplement companies, all papers raise questions about industry sponsorship.  That is why the Journal requires every paper in the supplement to repeat this funding disclosure in its entirety.

But for this particular symposium, some of the papers report additional funding by Wakunaga of America, a company that, no surprise, manufactures garlic supplements.

All of the papers produced results useful to the sponsor.  Some of them, however, were independently funded and the authors report no links to the sponsor other than having given a talk at the meeting.  They did not disclose who paid for travel and hotels and without any way to check, I must assume that they paid their own expenses to the meeting in San Diego.  For the purposes of scoring, I’m not counting them as industry-funded, even though their presence at the symposium made it seem more scientifically credible.

Garlic Lowers Blood Pressure in Hypertensive Individuals, Regulates Serum Cholesterol, and Stimulates Immunity: An Updated Meta-analysis and Review.  Karin Ried.  J Nutr. 2016; 146:389S-396S doi:10.3945/jn.114.202192.

  • Conclusions: Our review suggests that garlic supplements have the potential to lower blood pressure in hypertensive individuals, to regulate slightly elevated cholesterol concentrations, and to stimulate the immune system. Garlic supplements are highly tolerated and may be considered as a complementary treatment option for hypertension, slightly elevated cholesterol, and stimulation of immunity.
  • Author disclosures: K Ried, no conflicts of interest. K Ried received travel sponsorship from Wakunaga of America Co. Ltd. to attend the 2014 International Garlic Symposium.
  • Score: industry-positive

Chemical Assignment of Structural Isomers of Sulfur-Containing Metabolites in Garlic by Liquid Chromatography−Fourier Transform Ion Cyclotron Resonance−Mass Spectrometry.  Ryo Nakabayashi, Yuji Sawada, Morihiro Aoyagi, Yutaka Yamada, Masami Yokota Hirai, Tetsuya Sakurai, Takahiro Kamoi, Daryl D Rowan, and Kazuki Saito.  J. Nutr. 2016; 146:397S-402S doi:10.3945/jn.114.202317.

  • Conclusion: The ability to discriminate between such geometric isomers will be extremely useful for the chemical assignment of unknown metabolites in MS-based metabolomics.
  • Supported, in part, by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan; Japan Advanced Plant Science Network; Japan Science Technology Agency (JST), Strategic International Collaborative Research Program (SICORP); and JST, Strategic International Research Cooperative Program (SICP).
  • Score: industry-neutral

Garlic-Derived Organic Polysulfides and Myocardial Protection.  Jessica M Bradley, Chelsea L Organ, and David J Lefer.  J. Nutr. 2016; 146:403S-409S doi:10.3945/jn.114.208066.

  • Conclusion: The beneficial health effects of garlic on cardiovascular health are dependent on multiple mechanisms. Furthermore, the mechanisms of action may be mediated by the active components in garlic.
  • Supported by grants from the National Heart, Lung, and Blood Institute (1R01 HL092141, 1R01 HL093579, 1U24 HL 094373, and 1P20 HL113452; to DJL) and by the Louisiana State University Health Foundation in New Orleans.
  • Score: Industry-neutral

Aged Garlic Extract Inhibits Human Platelet Aggregation by Altering Intracellular Signaling and Platelet Shape Change.  Khalid Rahman, Gordon M Lowe, and Sarah Smith.  J. Nutr. 2016; 146:410S-415S doi:10.3945/jn.114.202408

  • Conclusion: These results indicate that AGE [Aged Garlic Extract] inhibits platelet aggregation by increasing cyclic nucleotides and inhibiting fibrinogen binding and platelet shape change.
  • Funding: Supported by a grant from Wakunaga of America Co. Ltd.  K Rahman and GM Lowe were in receipt of a grant from Wakunaga of America Co., Ltd. S Smith, no conflicts of interest.
  • Score: industry-positive

Garlic and Heart Disease.  Ravi Varshney and Matthew J Budoff.  J. Nutr. 2016; 146:416S-421S doi:10.3945/jn.114.202333

  • Conclusion: We conclude that garlic supplementation has the potential for cardiovascular protection based on risk factor reduction (hypertension and total cholesterol) and surrogate markers (CRP, PWV, and CAC) of atherosclerosis.
  • Disclosures: The authors report no funding received for this study.  R Varshney, no conflicts of interest. MJ Budoff receives funding from Wakunaga of America Co., Ltd.
  • Score: industry-positive

The Role of Adiponectin in Cardiometabolic Diseases: Effects of Nutritional Interventions.  Patricio Lopez-Jaramillo.  J. Nutr. 2016; 146:422S-426S doi:10.3945/jn.114.202432

  • Conclusions: Recently, it was reported that the administration of aged garlic extract and a single food intervention with pistachios can increase adiponectin concentrations in individuals with metabolic syndrome. Moreover, the Mediterranean diet is associated with higher adiponectin concentrations. Additional studies are needed to evaluate the potential benefits of increasing adiponectin by nutritional interventions in the treatment and prevention of cardiometabolic diseases.
  • Funding: The author reports no funding received for this study.
  • Score:  Industry-neutral

Aged Garlic Extract Reduces Low Attenuation Plaque in Coronary Arteries of Patients with Metabolic Syndrome in a Prospective Randomized Double-Blind Study.  Suguru Matsumoto, Rine Nakanishi, Dong Li, Anas Alani, Panteha Rezaeian, Sach Prabhu, Jeby Abraham, Michael A Fahmy, Christopher Dailing, Ferdinand Flores, Sajad Hamal, Alexander Broersen, Pieter H Kitslaar, and Matthew J Budoff.  J. Nutr. 2016; 146:427S-432S doi:10.3945/jn.114.202424

  • Conclusions: This study indicates that the %LAP [Low Attenuation Plaque] change was significantly greater in the AGE group than in the placebo group. Further studies are needed to evaluate whether AGE has the ability to stabilize vulnerable plaque and decrease adverse cardiovascular events.
  • Disclosures: While the study was funded by Wakunaga of America Co., Ltd., the authors are solely responsible for the design, all study analyses, the drafting and editing of the paper and its final contents…S Matsumoto, R Nakanishi, D Li, A Alani, P Rezaeian, S Prabhu, J Abraham, MA Fahmy, C Dailing, F Flores, S Hamal, and A Broersen, no conflicts of interest. PH Kitslaar is employed by Medis Medical Imaging Systems and has a research appointment at the Leiden University Medical Center. MJ Budoff receives funding from Wakunaga of America Co., Ltd.
  • Score: industry-positive

Aged Garlic Extract Modifies Human Immunity.  Susan S Percival.  J.  Nutr. 2016; 146:433S-436S doi:10.3945/jn.115.210427

  • Conclusions: These results suggest that AGE supplementation may enhance immune cell function and may be partly responsible for the reduced severity of colds and flu reported. The results also suggest that the immune system functions well with AGE supplementation, perhaps with less accompanying inflammation.
  • Funding: Support for this research was provided by Wakunaga of America Co., Ltd.  Author disclosures: SS Percival received travel expenses to the conference where this work was presented.
  • Score: industry-positive

Bioavailability of Alfrutamide and Caffedymine and Their P-Selectin Suppression and Platelet-Leukocyte Aggregation Mechanisms in Mice.  Jae B Park.  J. Nutr. 2016; 146:437S-443S doi:10.3945/jn.114.202473

  • Conclusions: These data show the adequate bioavailability of alfrutamide and caffedymine and their different mechanisms of suppressing PSE and PLA: alfrutamide exerts its effects only via COX inhibition, whereas caffedymine works through both COX inhibition and cAMP amplification.
  • Funding: Supported by the USDA (project 8040-51000-057-00).
  • Score: Industry-neutral

Garlic Influences Gene Expression In Vivo and In Vitro.  Craig S Charron, Harry D Dawson, and Janet A Novotny.  J. Nutr. 2016; 146:444S-449S doi:10.3945/jn.114.202481

  • Conclusion: Measuring mRNA gene expression in whole blood may provide a unique window to understanding how garlic intake affects human health.
  • Support: CSC, HDD, and JAN were supported by the USDA.
  • Score: Industry-neutral.

Development of an Analytic Method for Sulfur Compounds in Aged Garlic Extract with the Use of a Postcolumn High Performance Liquid Chromatography Method with Sulfur-Specific Detection.  Toshiaki Matsutomo and Yukihiro Kodera.  J. Nutr. 2016; 146:450S-455S doi:10.3945/jn.114.208520

  • Conclusion: We developed a rapid postcolumn HPLC method for both qualitative and quantitative analyses of sulfur compounds, and this method helped elucidate a potential mechanism of cis-S1PC and SAMC action in AGE.
  • Acknowledgment: The authors thank Takami Oka of Wakunaga Pharmaceutical Co., Ltd. for his kind guidance for this study and critical review of the manuscript.
  • Score: Industry-positive

Pharmacokinetics of S-Allyl-L-cysteine in Rats Is Characterized by High Oral Absorption and Extensive Renal Reabsorption.  Hirotaka Amano, Daichi Kazamori, and Kenji Itoh.  J. Nutr. 2016; 146:456S-459S doi:10.3945/jn.114.201749

  • Conclusion: The pharmacokinetics of SAC in rats were characterized by high oral absorption, limited metabolism, and extensive renal reabsorption, all of which potentially contribute to its high and relatively long-lasting plasma concentrations.
  • Acknowledgment: We thank Takami Oka of Wakunaga Pharmaceutical Co. for his valuable advice, critical reading of the manuscript, and helpful suggestions.
  • Score: Industry-positive

Aged Garlic Extract Suppresses the Development of Atherosclerosis in Apolipoprotein E–Knockout Mice.  Naoaki Morihara, Atsuko Hino, Takako Yamaguchi, and Jun-ichiro Suzuki. J. Nutr. 2016; 146:460S-463S doi:10.3945/jn.114.206953

  • Conclusion: These data suggest that the antiatherosclerotic activity of AGE is at least partly due to the suppression of inflammation and lipid deposition in the vessels during the early stage of atherosclerotic development in ApoE-KO mice.
  • Acknowledgment: We thank Takami Oka of Wakunaga Pharmaceutical Co., Ltd., for his helpful advice, encouragement, and critical reading of this manuscript; Yukihiro Kodera of Wakunaga Pharmaceutical Co., Ltd., for the preparation of AGE; and Tadamitsu Tsuneyoshi of Wakunaga Pharmaceutical Co., Ltd., for his technical advice.
  • Score: Industry-positive

This makes 8 industry-positives from this journal supplement.

But let me add one more on this topic, sent by a reader:

The effect of aged garlic extract on blood pressure and other cardiovascular risk factors in uncontrolled hypertensives: the AGE at Heart trial.  Karin Ried Nikolaj Travica, Avni Sali.  Integrated Blood Pressure Control, 27 January 2016.

  • Conclusion: Our trial suggests that aged garlic extract is effective in reducing peripheral and central blood pressure in a large proportion of patients with uncontrolled hypertension, and has the potential to improve arterial stiffness, inflammation, and other cardiovascular markers in patients with elevated levels. Aged garlic extract was highly tolerable with a high safety profile as a stand-alone or adjunctive antihypertensive treatment.
  • Funding: This trial was supported by a grant from Wakunaga of America Co Ltd, who sup­plied trial capsules and provided funding for costs of tests and research assistance. Wakunaga of America was not involved in study design, data collection, analysis, or prepa­ration of the manuscript…The authors report no conflicts of interest in this work.
  • Score: industry-positive, of course.

This brings the score since last March to 119 industry-positives/11 industry-negatives.

Apr 6 2015

Is SmartCandy smart policy?

I was surprised by FoodNavigator-USA’s story about “SmartCandy,”—a “vitamin-infused snack.

smart candy

Could the name and contents of this candy be violating the FDA’s “jelly bean” rule?

The “jelly bean” rule refers to FDA’s fortification policy,* which aims to discourage food and beverage makers from adding vitamins to “foods of minimal nutritional value” (a.k.a. junk foods) so they can be marketed as healthy.

The policy is explicit.  The FDA does not consider it appropriate to add nutrients to candies and beverages.

Here’s what the article says about what’s in it:

Smartcandy is formulated with a blend of Vitamin A for eye health, three B vitamins to support converting sugar and carbohydrates into sustained energy, and vitamin C for immunity. The trans fat-, high-fructose corn syrup-free candies come in four varieties: sweet and sour gummies; and Froot, a proprietary snack with a candy shell and a layer of yogurt encasing a strawberry or orange center.

Here’s the Nutrition Facts label (thanks to a reader for sending).

Here’s what the website says Orange Froot candy can do:

This is the visionary leader of the snacking world, it’s the one they listen to and admire. He can make a three point shot with his eyes closed, build the best fort you’ve ever seen, or solve an algebra question like it was a nursery rhyme, this flavor packed snack will push you to achieve anything!

If SmartCandy can get away with this, won’t Coca-Cola and Pepsi be next?

Candy is candy and has an place in kids’s diets—occasionally.  But a health food that makes kids do better in school?  I’d like to see the evidence for that.

FDA: take a look please.

*Thanks to Michael Jacobson for forwarding.

Update, April 13: The New York State Attorney General has filed a complaint.

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 5 2010

Obama’s food tasters in India: Uh oh

I am indebted to FoodSafetyNews for a curious item about President Obama’s food tasting problem in India.  I can understand why the White House would be concerned.  It is easy for Americans unused to the local bacteria to get food poisoning while traveling anywhere, and such things happen in India (I have some personal experience with this problem, alas).

The Indian government has recruited twelve somewhat reluctant doctors at a hospital in Mumbai to join the tasting staff that usually travels with the President.  [Aside: I wonder how one gets a job like this.  It could be a lot of fun].  The Indian doctors’ view, however:

This job is often annoying because we are not professionals and are used as guinea pigs. However, it is exciting to work for Obama,” one anonymous doctor told the Mirror. “We have already started doing our homework on what he will be eating. We will be meeting the hotel chefs tomorrow.”

“We taste samples and also store some for the cops,” explained one doctor on the assignment. “If anything goes wrong, we can use these samples for investigation.”

These physicians live in India and must have built up some immunity to the local flora.

And I can’t figure out how the tasting would work.  It often takes some hours after eating before the effects of food poisoning to show up.  Just because a food is safe early in the day does not necessarily mean it would still be safe after sitting around for some hours.

I’m guessing the President has to follow the same food safety rules as the rest of us when traveling in tropical countries with questionable water supplies:

  • Do not drink tap water and do not use it to brush your teeth.
  • Do not drink bottled water if the seal on the bottle has been broken.
  • Do not use ice unless you’re sure it’s made from purified water.
  • Do not drink milk or eat dairy products that have not been pasteurized (heated to a temperature that kills all germs).
  • Do not eat raw fruits or vegetables unless they can be peeled and you are the one who peels them.
  • Do not eat cut-up fruit salad.
  • Do not eat lettuce or other leafy raw vegetables (such as spinach).
  • Do not eat raw or rare (slightly cooked) meat or fish.
  • Do not eat food from people who sell it on the street.

I hope he enjoys his trip.  The food is likely to be supremely delicious—as soon as it cools down enough to enjoy.

Aug 2 2010

Why the FDA must act on health claims

On July 30, Center for Science in the Public Interest (CSPI)—in collaboration with representatives of a long list of distinguished health and consumer organizations (see below)–wrote Martha Coven of the Domestic Policy Council and Ezekiel Emanuel of the Office of Management and Budget urging them to encourage the FDA to take more vigorous enforcement action against misleading health claims on food packages.

Their petition responds to comments by the FDA’s Michael Taylor (discussed in a previous post) in a July 19 article for the Atlantic Food Channel, titled “How the FDA is picking its food battles.”   In explaining why the FDA is backing off from doing anything about unsubstantiated health claims on food products, Taylor said:

FDA must pick its battles—and set its priorities—in a way that will best benefit the public health….We have no pre-market review authority over such claims, and, under prevailing legal doctrines concerning “commercial free speech,” the evidentiary requirements placed on FDA to prove that such claims are misleading are significant and costly to meet. Moreover, meeting them requires tapping the same team of nutritionists, labeling experts, and lawyers who are working on our other nutrition initiatives.

We’re also conscious of the cleverness of marketing folks, who, once we prove today’s claim is misleading, can readily come up with another one tomorrow. Going after them one-by-one with the legal and resource restraints we work under is a little like playing Whac-a-Mole, with one hand tied behind your back.

So, we must make choices….especially considering the other high-priority nutrition and food safety initiatives that compete for FDA’s finite resources. We’ll consider all possibilities, but, in the meantime, we call on the food industry to exercise restraint, and we welcome the scrutiny CSPI and the media give to this issue.

Clearly, I was not the only one dismayed by this statement, which appears to be an open invitation to food companies to do whatever they like with health claims.  Indeed, Taylor’s statement reminded me of the Bush Administration’s FDA which, in 2003, announced that it had lost so many first amendment  health claims cases in court that it no longer intended to fight them.

But Taylor’s statement is also an open invitation to food advocates to get busy, as CSPI and the other signers of this letter have now done. The letter, dated July 30, 2010, is a follow up to a June 11 meeting on FDA/USDA Food Labeling Reform Efforts:

At Zeke’s suggestion, we are attaching a Priority List/Timetable Chart that provides an overview of the recommendations we made at our meeting and delineates how those recommendations intersect. As we discussed:

• We commend the Food and Drug Administration (FDA) for increasing the number of enforcement actions it has taken against misleading food labeling, and we urge the agency to increase those efforts. We also commend the FDA’s initiative to develop a system for disclosing key nutrition information on the fronts of food labels. However, we emphasize that the existing Nutrition Facts panel must also be modernized. In particular, nutrition information must be based on up-to-date serving sizes, a Daily Value for added sugars must be established and added to the existing Nutrition Facts panel, and “Calories per serving” must be displayed more prominently. Revisions to the Nutrition Facts panel and the development of a front-of-pack disclosure system are closely intertwined and should be developed concurrently.

• We urge the Domestic Policy Council to ask the FDA to ensure that any front-of-pack labeling scheme is not undercut by deceptive health-related claims on the fronts of food packages. Such claims, if unabated, will divert attention from any front-of-pack scheme the FDA develops. Since our meeting, the Federal Trade Commission (FTC) issued a consent order prohibiting claims that a food product could strengthen immunity because the claim lacked sufficient clinical evidence. Such claims are called “structure/function” claims by the FDA. The FDA should take a consistent position regarding the use of those claims. In addition, the FDA should address claims exaggerating the presence of healthy ingredients stressed in the U.S. Dietary Guidelines such as whole grains, fruits, and vegetables. For example, failure to remedy claims such as “Made with real fruit” on products that contain little fruit will detract from a declaration of sugar content that the FDA may specify in a front-of-pack labeling scheme, thus frustrating the Administration’s attempts to reduce childhood obesity.

• One way to remedy exaggerated claims for healthy ingredients (other than prohibiting them completely) is for the FDA to revise the ingredient list to require that the percentage of key ingredients such as fruit be disclosed in a clear, easily readable manner. FDA could also require that ingredient lists group all sources of added sugars to provide consumers with a clearer indication of the amount of added sugar in a product. The First Lady has recognized that ingredient labeling reform is an integral part of the Administration’s broader efforts to combat childhood obesity. The U.S. Department of Agriculture (USDA) is already working on new formats for ingredient labeling. We support those efforts and request the Council to encourage the FDA to follow USDA’s approach.

• In regard to a timetable, the recommendations we have made are closely intertwined with efforts already ongoing at the FDA. In some cases, they are necessary to ensure that those ongoing efforts by FDA succeed. We, therefore, urge the Council to recommend that the FDA expand its food labeling reform initiatives to include these additional issues and address them concurrently. Additional efforts that complement existing FDA labeling reform initiatives should commence as soon as the first set of initiatives is published in the Federal Register. All initiatives should be finalized by October 2012. This request is based on the fact that the FDA implemented the Nutrition Labeling and Education Act of 1990 in two years. The reform efforts we request are more limited than the requirements of the 1990 Act, and the FDA should be able to accomplish them by 2012 based on the agency’s previous performance on such matters.

• Rep. DeLauro, Chair of the House Agriculture Appropriations Subcommittee, asked the FDA how many FTEs the agency would need to issue regulations to revise the Nutrition Facts panel, increase the prominence of calories per serving, require caffeine labeling, and establish a daily value for added sugars, as well as other issues. The FDA stated that approximately “10-12” additional FTE’s would be necessary to address such concerns. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2005: Hearings Before a Subcomm. of the House Comm. on Appropriations, 108th Cong. 2d Sess. 323 (2004). While the FDA’s response at the time involved some issues not covered by our current requests, we believe that the FDA’s estimate is still reasonable, and we urge the Council and the Office of Management and Budget to work with the FDA to ensure that the FDA devotes additional resources to this effort.

We welcome the opportunity to assist the Administration and look forward to continuing our dialogue.

The letter is signed by Bruce Silverglade, Director of Legal Affairs, CSPI and representatives of Consumers Union, American Public Health Association, American Medical Association,  American Cancer Society Cancer Action Network, American Heart Association,  American Society of Bariatric Physicians, American Diabetes Association,  American Dietetic Association, Alliance for Retired Americans, Society for Nutrition Education, American Institute for Cancer Research, and Directors of Health Promotion and Education.

Let’s hope the FDA pays attention and gets busy on these issues.

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