This is a guest blog-post by  Professor Timothy D. Lytton

At the top of the FDA’s agenda for 2010 is regulating front-of-package nutrition labels.

Proponents of symbols like the Heart Check mark and the Smart Choices logo and rating systems like Guiding Stars and NuVal argue that they offer a quick way to help consumers identify foods that contribute to a healthy diet. Critics allege that the labeling schemes are confusing and misleading and have called for stricter government regulation. The Center for Science and the Public Interest (CSPI) recently released a report advocating that the FDA to develop a uniform, mandatory front-of-package labeling system.

But before the FDA gets into the business of creating its own front-of-package labeling scheme, it should first consider how existing regulations could be used to clamp down on misleading front-of-package labeling information. Better use of existing regulations would be a prudent first step in reigning in the current front-of-package free-for-all.

The FDA has promulgated extensive regulations governing the use of nutrient content claims on food labels—claims describe the level of a nutrient in a food. FDA regulations distinguish several different categories of nutrient content claims, and most front-of-package nutrition labels fall into one of three categories.

1. Simple Quantitative Statements: The Nutrition Highlights Panel

Some front-of-package nutrition labels present nutrient information in the form of simple quantitative statements concerning the amount of one or more nutrients in the food. General Mills’ Nutrition Highlights panel is an example of this type of label.

Existing FDA regulations allow for simple quantitative statements provided that they are accurate.

2. Rating Individual Nutrients: The Traffic Light Label

A second type of front-of-package nutrition label rates the level of individual nutrients on a scale. The British Food Standards Agency (FSA) traffic light label provides an example.

Under FDA regulations, any label claim that employs descriptive terms to characterize the level of a nutrient, such as “low in sodium” or “high in fiber,” may be made only for nutrients for which FDA has established a Daily Value (DV), may be used only if the food meets specified threshold requirements for the nutrient, and may employ only descriptive terms approved by the FDA. For example, a tub of yoghurt labeled “high in calcium” must contain at least twenty percent of the DV of calcium per 225 grams of yoghurt. Any front-of-package label that rates individual nutrients must conform to these strict guidelines. (Note: A daily value for sugar has not been established by the FDA.)

3. Seals of Approval: The Heart Check Mark & The Smart Choices Logo

A third type of front-of-package nutrition label combines analysis of nutrients to suggest that a food satisfies some minimum standard of overall nutritional value, such that it contributes to a healthy diet. The American Heart Association (AHA) Heart Check mark is an example.

The AHA explains on its website that the underlying nutrient criteria for the label are based on the Association’s dietary recommendations which it explains are consistent with federal dietary guidelines and health recommendations. The mark is intended to convey that a food is of high nutritional value by these standards.

Symbols like the Heart Check mark are functionally equivalent to label claims that a food is “healthy.” Under FDA regulations, foods labeled “healthy,” or any derivative of the term such as “healthier” or “healthful,” must not exceed specific thresholds of fat, saturated fat, sodium, and cholesterol and must contain requisite amounts of other nutrients such as vitamin A, vitamin C, calcium, iron, protein, and fiber, depending upon the food. “[T]he purpose of the ‘healthy’ claim,” explains the FDA, “is to highlight those foods that, based on their nutrient levels, are particularly useful in constructing a diet that conforms to current dietary guidelines.” This is precisely what symbols like the Heart Check mark are intended to convey, and this is how consumers understand them. They should, therefore, be required to meet FDA standards for “healthy” claims.

Some front-of-package nutrition labels place symbols of approval on products within a food category that have comparatively better overall nutritional value, although they may be foods of low nutritional value. The symbol is meant to indicate not that a food is healthy in the absolute sense but merely healthier in a relative sense. For example, the Smart Choices logo has appeared on cereals such as Cocoa Krispies and Froot Loops based on their relatively lower sugar content when compared to other highly-sweetened children’s cereals.

FDA regulations prohibit this type of relative healthy claim, explaining that,

“[t]he usefulness of a food labeled ‘healthy’ is not based on how it compares to a similar food, but on how it contributes to achieving a total diet consistent with dietary recommendations.”

Foods that are healthy only in a relative sense do not contribute to a total diet consistent with dietary recommendations and are, therefore, misleading. Under existing FDA regulations, front-of-package labeling schemes that make this type of relative “healthier” claim should be prohibited.

In a subsequent post, I will address how the FDA could further develop its regulations governing the use of healthy claims to regulate more complex front-of-package labels that rate the overall nutritional value of foods.

Timothy D. Lytton is the Albert and Angela Distinguished Professor of Law at Albany Law School where he teaches regulatory law & policy, constitutional law, administrative law, and tort law. His article “Signs of Change or Clash of Symbols? FDA Regulation of Nutrient Profile Labeling” (forthcoming in Health Matrix, vol. 19, no. 2) is available online by clicking here. He is also working on an article about regulation of nutrition standards for school food. For more information, visit his Albany Law School faculty website.

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Remember the absurd immunity claims on Kellogg’s cereals last year? The company added some vitamins and minerals to its sugary kids cereals and plastered a huge “Immunity” logo on the front of Cocoa Krispies and three other products. A public uproar ensued, especially given raging swine flu, and Kellogg’s announced in November it would pull the claim from its packaging.

Concurrently, Oregon’s Attorney General subpoenaed Kellogg’s and asked for the scientific evidence behind the claim. The company preferred not to answer that question but rather:

• stop shipping cereal boxes with immunity language by January 15
• destroy more than 2 million boxes (sans krispies)  with the immunity claim
• donate 108,000 boxes of cereal to the Oregon Food Bank
• donate 372,000 boxes to  Feeding America.

That’s quite an effort just to evade answering a question for which obviously Kellogg’s should have been prepared.

What you need to know:

Cocoa Krispies, as we wrote, is a terrible cereal to feed your kids. The krispies are over 40% sugar by weight. They contain trans fats. They carry artificial flavorings, and less than 1 gram of fiber. Immunity? Ha! This was sheer chutzpah on Kellogg’s part. Good for Oregon!

We hope that the donated cereal is the plain unsweetened variety of Rice Krispies.

What to do at the supermarket:

Hard as it may be, ignore all the marketing messages on product packaging. Go straight to the nutrition panel and the ingredient list.

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The FDA has been more assertive this year with regards to health claims on food products. Here’s an example – the heavyweight bout with cereal giant General Mills:

Round 1: In May, the FDA asked General Mills to explain why its Cheerios packages carried a claim “Lower your cholesterol 4% in 6 weeks” which is more appropriate for a drug, not a food product.

Round 2: In June, the FDA received copies of 4 studies from General Mills substantiating the percentage reduction claims.

Round 3: It took several months to review, but in October the FDA sent its response to those studies. The bottom line – One study was OK, but that’s not enough for a health claim to be approved. Three studies  were not conclusive enough. This is the FDA’s summary:

In conclusion, in determining whether … to authorize the soluble fiber/coronary heart disease claim to include a statement about a specific percentage reduction in LDL cholesterol, FDA would need to consider the totality of the publicly available scientific evidence to support such a statement and also how to convey information in a way that is not misleading.

Round 4: On November 3rd, General Mills responded [PDF] with further clarifications.We won’t go into the details, although we’re sure the company firmly stands behind the research.

Round 5: Yesterday, the FDA published the letter it has sent in October. General Mills decided to respond immediately – a good PR tactic – by publishing its response and a press release:

“discussions with the U.S. Food and Drug Administration (FDA) regarding the cholesterol-lowering benefits of the soluble oat fiber in Cheerios continue.”

Ironically, as these discussions are going on, Cheerios is running a new promotion, with an even bolder claim of 10% reduction in cholesterol in just one month.

What you need to know:

The argument between the FDA and General Mills over what wording is to be allowed may seem like nit-picking to some, but you need to understand that a lot of money is at stake.

Manufacturers use health claims as a marketing tool to increase sales, and have been doing so since for ages. Up until 1991, it was pretty much a wild west when it came to health claims. Manufacturers would claim almost anything they liked. When the Nutrition Labeling and Education Act was passed in the early 1990’s, it seemed as though the claims would go away. The law provided the framework for the FDA to require standardized nutrition facts labels and ingredient list for virtually all packaged foods.

But pressure by food industry lobbies on Congress allowed the manufacturers to add health claims to packages as well. Thankfully though, the claims had to be thoroughly substantiated by scientific research and consensus. The language of the claims was also addressed in the law. There are certain things that can be said, while other can’t. And there’s a way to say it. In the Cheerios example, the FDA warned that the cholesterol reduction wording is more like that of a statin drug than of a food, and therefore out-of-bounds.

Nobody is arguing that Cheerios (the plain unsweetened version) is one of the better cereals out there, with a relatively low sugar count, and high fiber content. But the studies, funded by General Mills, showed that the control groups who ate other cereal products also reduced their cholesterol intake when both groups ate the cereals instead of some other non-fibrous meal. Hey, eating even Sugar Smacks daily, as “part of a healthy, balanced diet including regular exercise” will lead to better heart health.

Incidentally, just a few weeks ago Kellogg’s retracted it’s “Immunity” claims from packages of Cocoa Krispies.

What to do at the supermarket:

While the scientists on both sides of regulation battle it out, here’s the deal when it comes to breakfast cereals - best to ignore health claims. The information you need is on the nutrition facts panel and ingredient list. Look for:

- fiber at more than 3 grams per serving

- sugar at less than 6 grams per serving

- no artificial colors (Yellow 5, Red 40, etc…)

- no partially hydrogenated oils

All the other fortifications (B vitamins, etc..) are nice to have but very similar across the board.

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Health claims on processed food packages are usually nothing more than marketing messages. So when Kellogg’s plasters the word “IMMUNITY” in quadruple font on the front of its Rice Krispies breakfast cereal, we just have to take a peek (thanks to Fooducate reader TD for the heads up).

We took a look at the product nutrition information and at the Rice Krispies website. We’re not sure if this is a new formulation or just a new marketing campaign, but this is what Kellogg’s boasts:

“Now each and every box is fortified with vitamins and nutrients that work together to help support your child’s immunity.”

“The cereal you love, invisibly better”.

Great pitch folks. Now let’s analyze the facts…

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