New Rules on Food Health Claims

The retail highway to health is increasingly crowded with science-backed and government-allowed health claims. But then, what’s in a claim?

By Kantha Shelke and Rakesh Amin

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Contrary to the labeling of our pseudo-product (above), new rules urge food processors to be scientifically accurate and conscientious in developing and substantiating health claims.

Since 1930, the FDA has regulated how foods are made and sold in the U.S. New rules allowing the use of food claims before comprehensive FDA review and approval put greater obligation on manufacturers. While the relaxed regulation is a boon for the food and dietary supplement industry, creating a flood of foods with all kinds of health-benefit claims, understanding the current regulatory environment and anticipating the market accurately is imperative for those seeking to maximize opportunities.

Consumers say health claims are useful and help with food selection. Universally, they prefer succinct wording rather than long and complex statements. But they want government approval to ensure the health claims are honest.

Most consumers cannot distinguish between nutrient content, structure-function and health claims. Food companies, however, invest considerable efforts and resources to get claims approved and align their marketing strategy accordingly.

The new regulations are a call for food companies to be scientifically accurate and more conscientious in the development and substantiation of claims. This is especially important when considering that the "halo" effect of health claims diverts consumers from seeking further nutrition information.

Writing marketing messages that resonate with consumers can be challenging, which makes the current health-claim approval process expensive. Counterintuitively, provisions in the law allow the FDA to authorize health claims if supported by an authoritative statement currently in effect and published by a U.S. government scientific body or the National Academy of Sciences. The FDA has 120 days to disallow it; otherwise, the manufacturers’ claims automatically prevail.

What Health Claims Can Do for the Food Industry

When America’s largest juice maker, Tropicana (, Bradenton, Fla., received FDA permission in 2000 to use a health claim linking orange juice potassium content with reduced risk of stroke, it helped revived overall orange juice sales. The generic health claim benefited every orange juice company and consumers quickly came to regard orange juice as a functional food.

Health claims such as these plus those promoting such benefits as bacterial anti-adhesive properties (cranberries) and cardiovascular health properties (pomegranates and some tropical fruits) all have a common theme: Their health benefits are intrinsic. Nutrition science is helping to uncover the intrinsic health benefits of many foodstuffs such as tea, olive oil, blueberries, barley, oats and whole grains, all to the excitement of food formulators.

Generic claims - those not tied to a specific branded product or ingredient - can be useful to food manufacturers. But they can be a disadvantage for some ingredient vendors. The petition from Pittsburgh’s H.J. Heinz Co. ( and Lycored Natural Products Industries Ltd., (, La Crosse, Wis., submitted to the FDA addresses the cancer-fighting properties of lycopene via Lycored’s natural tomato complex, Lycomato.

Because the petition is related to Lycomato (a Lycored product), synthetic lycopene formulators may be precluded from applying it to their products. The pending FDA decision has immense ramifications for the lycopene market, valued at $34 million and estimated to double annually.

A Grain of Truth

Grain-food manufacturers are delivering heart-health benefits simply by using whole-grain ingredients, intrinsically healthy foodstuffs that bring scientifically proven health benefits without adding excess cost.

If a processed food label lists whole grains, the "whole-grain" part of the food is required to have virtually the same proportions of bran, germ and endosperm as the harvested kernel does before it is processed. However, with no universally accepted definition of whole grains and whole-grain foods, the FDA relies on the American Assn. of Cereal Chemists’ definition: "Foods made from the entire grain seed, usually called the kernel, which consists of the bran, germ and endosperm. If the kernel has been cracked, crushed or flaked, it must retain nearly the same relative proportions of bran, germ and endosperm as the original grain in order to be called whole-grain."

Sara Lee has jumped on the whole-grain bandwagon, but more stealthily than some, with its new Soft and Smooth bread. The product resembles white bread but is made with ConAgra Foods Ingredients' Ultragrain white whole wheat flour.

Foods that carry the whole-grain health claim are required to contain 51 percent or more whole-grain ingredients by weight, and they must also be low in fat. There is no current test to measure the whole-grain levels the FDA approves for whole-grain claims (fiber content is used instead). This has led to abuse of the whole-grain claim by some manufacturers.

Many health experts regard the whole-grain health claim to be flawed. They argue that if there is no test, there should be no claim. They recommend instead that foods fortified with whole grains make a fiber health claim if that’s what is being measured.

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