The Coming of Health Claims

The Coming of Health Claims

by Gloria Bucco

The health claims currently featured on product packaging are only the tip of a very large iceberg, according to industry experts. And most agree that we can expect more petitions for new claims to be submitted to the U.S. Food and Drug Administration (FDA) as more supporting research becomes available. So while both natural products and mainstream food companies gear up to offer a wide range of soy products following the FDA's recent approval of a heart-healthy claim for soy, many manufacturers appear ready to incorporate allowable claims into their marketing strategies.

Why Make Claims

Putting an allowable health claim on a product accomplishes two things: first, it communicates information to the consumer about the health benefits of that product. According to the FDA, the intended purpose of health claims is to benefit consumers by providing information on healthful eating that may help reduce the risk of disease. While dedicated to providing this important information, manufacturers are also interested in the second reason for using a health claim: it gives the product a competitive advantage. Once a claim has been approved, as in the most recent case of soy, the question may well be, why not make the claim.

The Kellogg Company in Battle Creek, Mich., has been making health claims since NLEA was passed in 1990. "Claims are a great way to educate consumers about the nutritious contribution cereals make to a healthy diet," explained Karen Kafer, director of marketing communications at Kellogg. Kellogg didn't petition the FDA for any claims but it is taking advantage of approved claims if they fit with the marketing strategy of a particular brand, Kafer said.

"Kellogg has taken a leadership role and worked with the National Cancer Institute to put information about fiber on our packaging even before that claim was approved," she noted. "We certainly plan to continue using health claims. We believe that claims add value for consumers." Kellogg recently acquired Worthington Foods, a soy-based manufacturer, and plans to begin adding the soy claim to its products, Kafer said. Kellogg has nearly a dozen ready-to-eat cereals carrying either the whole grains, fiber and cancer, or fiber and heart disease claims.

Another Michigan company, The Organic Garden in Ann Arbor, is a little smaller than Kellogg but no less enthusiastic about using health claims on its products. "Large and small companies, if they have good marketing people, would be foolish not to take advantage of what's allowed by the law and communicate the health benefits of their food products," said Dennis Singsank, president of The Organic Garden. The Organic Garden has two products currently carrying the whole grains claim: a ready-to-eat soy breakfast cereal and a toasted soy nuts product. Singsank decided to use the whole grains claim rather than the soy claim because the whole grains claim addresses two diseases, heart disease and cancer.

Scott Polisky, a New York-based attorney specializing in food and drug law, agrees that using an approved claim if your product meets the FDA's criteria is practically a no-brainer. "It's logical that companies would want to take advantage of the most expansive language possible under the law and communicate the maximum benefits of their products," Polisky said. He added that the more information that's out there, the more choices consumers will have. "People want to know more about the role a food or supplement will play in their health," he noted.

One of the largest companies using claims is Quaker Oats. In January 1997, the FDA approved a health claim for oats. Quaker had submitted a petition for the claim 2 years earlier, according to Cathy Kapica, Ph.D., R.D., a senior scientist with Quaker in Chicago. "Our products carrying the claim have been on the market about three years," Kapica said. "We believe claims educate consumers about the health impact of a product. Plus, consumers have the assurance that the science behind a product is absolutely true." Quaker cooked oatmeal, instant oatmeal and oatmeal ready-to-eat cereals are currently carrying the oat claim.

Claims may also create a new kind of playing field, according to Frank Lampe, editorial director at Natural Business Communications in Boulder, Colo. "Companies using a claim will have a marketing advantage over companies not making claims," Lampe said. He firmly believes more companies will use claims and more claims will be approved by the FDA. "As the media and science begin to understand the link between nutrition and health, claims will be the manifestation of that understanding," he added.

Lampe also brought up another cogent point. Besides helping consumers make healthier food decisions, claims could very well be the impetus behind new foods in the future. "The required 6.25 grams of soy protein per serving will drive the development of future soy products which will undoubtedly be based on these standards," he added.

Why would a company spend big bucks conducting and sponsoring research to support a claim, then go through the daunting FDA petitioning process attempting to demonstrate "significant scientific agreement" to have the claim approved when, literally the next day, everyone else who meets the criteria can use the claim? The answer may be "market share."

Marc Ullman, a partner in the law firm of Ullman, Shapiro and Ullman in New York City, expects more petitions for claims but doesn't think there is going to be a huge explosion of petitions. "Oat and soy companies have a large percentage of their markets so if they can get a claim approved it behooves them to get it," Ullman explained. "For example, Quaker controls most of the market on oats, and some big soy companies have a large enough portion of the soy market to benefit from getting the soy claim approved. However, it's a different story with something like vitamin E." Ullman noted that no one company has a large enough share of the vitamin E market to have the incentive to get a health claim approved.

Georgina Sikorski, senior director of marketing for Protein Technology International in St. Louis, agrees. PTI submitted the petition for the soy claim, after 20 plus years of work, and is currently conducting further research to possibly support future claims for soy. "We are willing to make this investment because we think we have the competitive advantage," Sikorski said. "We also believe there is opportunity around health foods for consumers. We know heart disease is our number-one killer and soy protein can address this problem." PTI manufactures and markets isolated soy protein which is used in powdered beverages, food bars, liquid ready-to-drink beverages, and processed meat and poultry products.

Agreeing that getting a health claim approved by the FDA is a formidable undertaking, Quaker's Kapica said: "At the time our petition was submitted for an oat health claim, there were 37 studies that showed oat fiber reduces cholesterol (and thereby helps reduce heart disease). First we submitted the petition requesting the claim along with the clinical studies proving the science behind the product. The FDA reviewed everything, asked for public comment and then approved the claim. The entire process took two years, and I can tell you it generated tons and tons of paper, but we believe being able to make a claim provides a competitive advantage."

Lampe added that brand equity also plays a role in a company's decision to petition for a claim. He cited the intense competition among drug companies once a product patent has expired (20 years after the patent application is submitted to the FDA). "If a company can create equity around its brand and convince the public why it's better than everyone else's product, it may be worth it for the company to petition the FDA for a new claim," Lampe said.

While allowing that small to medium companies may not have the money to petition the FDA for an allowable claim, Polisky still believes more claims will be added to the list of approved claims. "It's inevitable. There will be more opportunity in the future to make disease claims," he said.

Ed Cabelera, vice president of marketing for Genisoy Products in Fairfield, Calif., agreed with Polisky. "If the results of new studies continue to be the same as previous studies, I think we will see more claims being submitted and approved by the FDA in the future," Cabelera said. Genisoy is a fairly new player that entered the industry in 1997 after several years of making soy bars to be used in clinical studies. Four Genisoy products are currently making the soy claim: shakes, protein powder, bars and soynuts.

Acknowledging that once a health claim is approved everyone whose product meets the established criteria can use it, Tony Young, a partner in the law firm of Piper, Marbury, Rudnick and Wolfe in Washington, D.C., still believes companies should petition for a health claim. "It's worth it to a company to pay for the research because the claim is enhancing the value of the product they sell to their customers," he said.

Supplement Claims

Even though foods and supplements can make both health and structure-function claims if they meet the criteria, supplements for the most part have avoided health claims to focus instead on structure-function claims, according to Young. "The food industry found the (health claim) language so long that they couldn't use it to sell product," Young explained. "The people who put products in packages shied away. The supplement industry has been in the same boat--the language is too long to use effectively. Supplements have moved more toward structure-function claims. You'd have to ask a marketing person but I believe you might be able to sell as much product with structure-function claims as health claims."

Ullman agreed. "Some companies aren't using the health claims because they're too long," he said, adding that the soy claim is relatively short, making it more label-friendly.

Polisky characterized the present industry atmosphere as a "shakedown period." Noting that NLEA was passed in 1990, DSHEA in 1994, and in January 2000, with its most recent ruling, the FDA is still trying to figure out how to implement the law. "It's very confusing and we still don't know how it's going to turn out," Polisky said.

For example, the industry is still waiting for the FDA to reconsider four claims made in the 1994 lawsuit, Pearson vs. Shalala.

• Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.
• Consumption of fiber may reduce the risk of colorectal cancer.
• Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.
• A supplement with 0.8 mg of folic acid is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.

And, legislation that would give supplement manufacturers more leeway in their labeling process, introduced last year by Sen. Michael Crapo (R-Idaho) as the Dietary Supplement Fairness in Labeling Advertising Act, is in committee and awaiting a hearing.

But one thing's for sure: consumers like claims and claims sell product. "Claims mean more choices for consumers," PTI's Sikorski said. "There will be many new products on the market that contain soy protein. This is where the market is headed." Ullman summed it up when he added, "It's in the public interest for the consumer to be told about these benefits. Consumer health should be our ultimate goal," he said.

Gloria Bucco is a Colorado-based independent journalist and copywriter specializing in natural health and alternative medicine.

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