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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?

Tara Kenny, a postdoctoral researcher in Ireland sent me this one.

The paper: Perspective Nutrition research challenges and processed food and health. Michael J. Gibney and Ciarán Forde. Nature Food, 2022.

Purpose: “If public health nutrition is to consider the degree of food processing as an important element of the link between food and health, certain gaps in research must be acknowledged.”

Method: The paper compares and critiques differing classification systems for processed foods, emphasizes the physical and sensory aspects of food products as reasons for consumption, and suggests areas for further research.

Conclusion: “The NOVA recommendation that HPFs be avoided poses a considerable challenge, given that a wide body of evidence across the globe shows that almost two-thirds of all energy comes from HPFs…Finally, notwithstanding the opposition of NOVA to the reformulation of HPFs, the value of this approach is internationally recognized.”

Competing interests: “M.J.G. has engaged in paid and non-paid consultancy for a wide range of food companies that manufacture processed foods. He has provided online presentations on ultraprocessed foods to the staff of Unilever and Mondelez. C.G.F. is currently a paid member of the Kerry Health and Nutrition Institute.”

Comment: The paper is a critique of the term ultra-processed (the authors prefer Highly Processed Foods or HPF), of the NOVA classification system for levels of food processing, and of the idea that ultra-processed foods continue to remain in the category of ultra-processed even when reformulated.

Dr. Kenny provided a deeper analysis of the conflicts of interest inherent in this paper; she read the references to several statements in the paragraph that follows the subtitle, “First, do no harm”.

• Ample evidence exists to show that there are no differences in postprandial glucose or insulin response following the ingestion of breads, varying from wholegrain to white and to those with and without additives (Breen et al & Gibney, MRC Human Nutrition Research, Government Agency)
• Similarly, studies show that the nutrient intakes of infants fed on home-prepared infant and toddler foods are not materially different to those of infants fed on industrially prepared products with the exception of sodium, which was higher in the infants fed with home-prepared foods (Reidy et al, 2018 – lead author is head of Nutrition Science for Baby Food, Nestlé Infant Nutrition, Global R&D and leads the Feeding Infants and Toddlers Studies globally. Three additional authors are also Nestle employees).
• Breakfast cereals, normally served with milk, make a very important contribution to micronutrient intake (Gibney et al, 2018 – funded by Cereal Partners Worldwide and General Mills Inc.)
• The advent of low-fat spreads optimized for fatty-acid profile have contributed to a substantial reduction in the intake of saturated fatty acids (Li et al & Gibney).
• Beverages sweetened with artificial sweeteners help reduce the intake of added sugars. These filters should also include foods that are generally regarded as ‘treats’ that have a negligible population impact on nutrient intake (for example, ice cream and chocolate). For example, a study of chocolate intake in 11 European countries showed that the contribution of chocolate to added sugar intake averaged 5% (Azaïs-Braesco et al, funded by Danone Nutricia Research)…”.

She also provided a link to a much more detailed conflict-of-interest statement filed as a correction to another paper co-authored by Mike Gibney.

I’ve written frequently about ultra-processed foods and why I think the NOVA classification is so useful.  See, for example, this post (the classification system) and this one (Kevin Hall’s study).

Despite the opinions expressed in the Nature Food paper, reducing intake of ultra-processed foods seems like a really good idea.

HealthyDrinksHealthyKids.org has issued recommendations on what kids should drink in collaboration with impressive co-signers:

• The Academy of Nutrition and Dietetics
• American Academy of Pediatric Dentistry
• American Academy of Pediatrics
• American Heart Association

The recommendations for parents vary by age.  For example, for infants up to age 6 months:

Only breast milk or infant formula (or water)

• No juice
• No milk
• No flavored milks
• No transition formulas
• No plant-based milks
• No caffeinated beverages
• No diet drinks
• No sugar-sweetened beverages

This is an important report.  About half of toddlers are given sugary beverages.  Let’s hope this is an incentive to stop this practice.

Here are the documents:

• The full list of recommendations
• The website
• Drink Guidelines Consensus Statement
• Drink Guidelines 4 Pager
• Drink Guidelines Press Release

Trade rules are not easy to understand because they are so remote from most people’s lives.  But Public Citizen is keeping an eye out on what’s happening in the trade world, and making its meaning clear.

It reports that the Office of the United States Trade Representative (USTR) has just released its latest National Trade Estimate.  This reviews our trading partners’ actions that we think constitute “significant trade barriers” and want to eliminate.

What might these be?

This may be hard to believe but high on the list are other countries’ policies to promote breastfeeding, of all things.

The Trump administration wants to get rid of these “technical trade barriers:”

• Hong Kong draft code designed to “protect breastfeeding and contribute to the provision of safe and adequate nutrition for infants and young children.” This, according to USTR, could reduce sales of food products for infants and young children.
• Indonesia: USTR wants to get rid of a draft regulation to ban advertising or promotion of milk products for children up to two years of age.
• Malaysia: USTR doesn’t like its code restricting corporate marketing practices aimed at toddlers and young children.
• Thailand: USTR wants to eliminate penalties for corporations that violate laws restricting the promotional, and marketing activities for modified milk for infants, follow-up formula for infants and young children, and supplemental foods for infants.

The Rudd Center for Food Policy & Obesity at the Univeristy of Connecticut  produces terrific reports.  The latest is Baby Food FACTS: Nutrition and marketing of baby and toddler foods and drinks:

Infant formula companies have a marketing problem: breast milk is a better option, all formulas have the same nutrient composition by FDA regulation, and babies only need to use formula for a few months.

Baby food companies also have a marketing problem: babies can eat table foods (suitably ground or cut) and don’t really need the stuff in jars (convenient thought they may be).

The Rudd Center report takes a good hard look at the

• Contents of food and drink products marketed to parents for their babies and toddlers (up to age 3)
• The marketing messages used to promote these products
• Degree to which marketing messages correspond with expert advice on feeding young children

The findings: The nutritional quality is pretty much as advertised but nearly 60 percent of advertising dollars go for products that are not recommended for young children such as sugar-sweetened toddler milk, nutritionally poor snack food, and Pediasure, a high-calorie liquid nutrition supplement.

Here’s the full report 

And here’s a summary

Buried in an Institute of Medicine report released today on, of all things, “biomarkers and surrogate endpoints in chronic disease” are some truly astonishing recommendations:

Rec. 3: The FDA should use the same degree of scientific rigor for evaluation of biomarkers across regulatory areas, whether they’re proposed for use in the arenas of drugs, medical devices, biologics, or foods and dietary supplements.

Rec. 4: The FDA should take into account a nutrient’s or food’s source as well as any modifying effects of the food or supplement that serves as the delivery vehicle and the dietary patterns associated with consumption of the nutrient or food when reviewing health-related label claims and the safety of food and supplements.

Translation: The FDA should require the same level of scientific substantiation for health claims as for pharmaceutical drugs, and not assume that a supplement has the same health effect as a food or diet.

As the press release states:

The FDA should apply the same rigor to evaluating the science behind claims of foods’ and nutritional supplements’ health benefits as it devotes to assessing medication and medical technology approvals…There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on people’s well-being.

The committee set out to recommend scientific criteria for evaluating the types of scientific data that companies use to convince the FDA to allow health and safety claims.  Food claims got tossed into the mix. 

The impact of these recommendations could be considerable.  The IOM is saying that health claims need to have rigorous science to back them up, not least because the kinds of claims now used to market foods do not come close to meeting those criteria.

Here’s what the Wall Street Journal has to say about this report (it quotes me).

How right they are, as witnessed by the health claims on chocolate-flavored, sugar-sweetened Enfagrow.

Thanks to my NYU Medical Center colleague, Dr. Melissa Bender for the alert about the blogosphere fuss over Cascadian Farm Purely O’s cereals.  Apparently, Cascadian Farm, now owned by Big Food General Mills:

quietly changed the recipe for its “Purely O’s” cereal — previously an unsweetened favorite among children/toddlers – to include three times the sugar, as well as new fillers/sweeteners such as corn meal and tapioca syrup. They did this with no announcement on the label, taking advantage of those who trusted the brand for its previous simplicity. Loyal customers, particularly parents who had chosen this product because it was one of the few unsweetened options available, are outraged by this secretive yet major reformulation. Many discovered the change when their children spat out the cereal (myself included).

Her note sent me right to the largest of the three Whole Foods stores within walking distance of my Manhattan apartment.  Purely O’s: 3 grams of sugars, 3 grams of fiber, and 160 mg sodium per serving.

Oops: low-sugar, yes, but only medium-fiber and high in sodium.  Even with 0 grams of sugar, it’s not all that great.  Neither, for that matter, is its non-organic analog Cheerios (1 gram sugar, 3 grams fiber, 190 mg sodium).

At 3 grams of sugar per serving, Purely O’s is still lower in sugar than practically every other cereal in Whole Foods.  Whole Foods does not sell Big Food non-organics, so it does not carry Cheerios.  I had to look hard to find the only cereal lower in sugar than the reformulated Purely O’s: Arrowhead Mills Shredded Wheat, Bite Size (2 grams of sugar, 6 grams of fiber, and only 5 mg sodium).  That one, it seems to me, is a much better choice to begin with, pretty much in the same category as oatmeal (1 gram of sugar, 4 of fiber, and 0 mg sodium).  When it comes to cereal, more fiber the better.  Fiber is the point of breakfast cereal.

So I can’t get too upset about the reformulation of Purely O’s.  It’s simply a business decision, entirely to be expected from Big Food.  Cascadian Farms started out with “humble beginnings” as a maker of organic products, none of them cereals.  It was successful enough to be bought first by Small Planet Foods, and later by General Mills, which wanted to get in on the organic market.  Hence: organic Purely O’s.

General Mills is in business to sell cereal, and Purely O’s just didn’t make it past focus groups, as reported in the Boston Globe earlier this year.  General Mills must think there are too few of its deeply loyal customers to matter.  According to a business school case study, it has a history along these lines.  So chalk this one up to corporate imperatives.

Dr. Bender wrote to General Mills and received a reply that said as much:

Our goal is to give consumers quality products at a good value. Prior to introducing any product, extensive consumer testing is done. We conduct market research and product testing continuously to obtain consumer reaction to existing products and to changes being considered. Only when we feel confident that a product change will broaden its appeal will we alter a product’s formulation. We are sorry that you do not agree that the recent change in Cascadian Farm organic Purely O’s cereal was for the better.

If the bloggers are looking for a replacement, try oatmeal or those cute little bite-sized shredded wheat things.