March 1, 2000

11 Min Read
The Coming of Health Claims

The Coming of Health Claims

by Gloria Bucco

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

Why Make Claims

Putting an allowable health claim on a product accomplishes two things: first, itcommunicates 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 byproviding information on healthful eating that may help reduce the risk of disease. Whilededicated to providing this important information, manufacturers are also interested inthe 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 wellbe, why not make the claim.

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

"Kellogg has taken a leadership role and worked with the National Cancer Instituteto 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 claimsadd value for consumers." Kellogg recently acquired Worthington Foods, a soy-basedmanufacturer, and plans to begin adding the soy claim to its products, Kafer said. Kellogghas nearly a dozen ready-to-eat cereals carrying either the whole grains, fiber andcancer, or fiber and heart disease claims.

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

Scott Polisky, a New York-based attorney specializing in food and drug law, agrees thatusing an approved claim if your product meets the FDA's criteria is practically ano-brainer. "It's logical that companies would want to take advantage of the mostexpansive language possible under the law and communicate the maximum benefits of theirproducts," Polisky said. He added that the more information that's out there, themore choices consumers will have. "People want to know more about the role a food orsupplement will play in their health," he noted.

The FDA initially authorized seven health claims in 1993 as part of the 1990 Nutrition Labeling and Education Act (NLEA). Since 1993, FDA has authorized five more including the most recent claims for whole grains and soy, approved in 1999.

Health claims show a relationship between a nutrient or other substances in a food and a disease or health-related condition. They can be used on conventional foods or dietary supplements. Following is a list of the health claims currently approved by the FDA:

One of the largest companies using claims is Quaker Oats. In January 1997, the FDAapproved a health claim for oats. Quaker had submitted a petition for the claim 2 yearsearlier, according to Cathy Kapica, Ph.D., R.D., a senior scientist with Quaker inChicago. "Our products carrying the claim have been on the market about threeyears," Kapica said. "We believe claims educate consumers about the healthimpact of a product. Plus, consumers have the assurance that the science behind a productis absolutely true." Quaker cooked oatmeal, instant oatmeal and oatmeal ready-to-eatcereals are currently carrying the oat claim.

Claims may also create a new kind of playing field, according to Frank Lampe, editorialdirector at Natural Business Communications in Boulder, Colo. "Companies using aclaim 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 theFDA. "As the media and science begin to understand the link between nutrition andhealth, claims will be the manifestation of that understanding," he added.

Lampe also brought up another cogent point. Besides helping consumers make healthierfood 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 offuture 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 aclaim, then go through the daunting FDA petitioning process attempting to demonstrate"significant scientific agreement" to have the claim approved when, literallythe 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 explosionof petitions. "Oat and soy companies have a large percentage of their markets so ifthey 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 companieshave a large enough portion of the soy market to benefit from getting the soy claimapproved. However, it's a different story with something like vitamin E." Ullmannoted that no one company has a large enough share of the vitamin E market to have theincentive to get a health claim approved.

Georgina Sikorski, senior director of marketing for Protein Technology International inSt. Louis, agrees. PTI submitted the petition for the soy claim, after 20 plus years ofwork, and is currently conducting further research to possibly support future claims forsoy. "We are willing to make this investment because we think we have the competitiveadvantage," Sikorski said. "We also believe there is opportunity around healthfoods for consumers. We know heart disease is our number-one killer and soy protein canaddress this problem." PTI manufactures and markets isolated soy protein which isused in powdered beverages, food bars, liquid ready-to-drink beverages, and processed meatand 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 healthclaim, there were 37 studies that showed oat fiber reduces cholesterol (and thereby helpsreduce heart disease). First we submitted the petition requesting the claim along with theclinical 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 makea claim provides a competitive advantage."

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

While allowing that small to medium companies may not have the money to petition theFDA for an allowable claim, Polisky still believes more claims will be added to the listof approved claims. "It's inevitable. There will be more opportunity in the future tomake 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 asprevious studies, I think we will see more claims being submitted and approved by the FDAin the future," Cabelera said. Genisoy is a fairly new player that entered theindustry 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 andsoynuts.

Acknowledging that once a health claim is approved everyone whose product meets theestablished 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 ahealth claim. "It's worth it to a company to pay for the research because the claimis 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 ifthey meet the criteria, supplements for the most part have avoided health claims to focusinstead on structure-function claims, according to Young. "The food industry foundthe (health claim) language so long that they couldn't use it to sell product," Youngexplained. "The people who put products in packages shied away. The supplementindustry 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 amarketing person but I believe you might be able to sell as much product withstructure-function claims as health claims."

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

Polisky characterized the present industry atmosphere as a "shakedownperiod." 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 thelaw. "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 madein 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 labelingprocess, introduced last year by Sen. Michael Crapo (R-Idaho) as the Dietary SupplementFairness in Labeling Advertising Act, is in committee and awaiting a hearing.

But one thing's for sure: consumers like claims and claims sell product. "Claimsmean more choices for consumers," PTI's Sikorski said. "There will be many newproducts 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 tobe told about these benefits. Consumer health should be our ultimate goal," he said.

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

With passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress amended the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act to include several provisions that apply only to dietary supplements. DSHEA gave manufacturers the ability to describe a supplement's effects on the "structure or function" of the body or the "well-being" achieved by consuming the dietary ingredient.

These structure-function claims, which may appear on food or dietary supplement labels, differ from health claims in that they don't deal with disease risk reduction. For example, the statements "calcium builds strong bones," "antioxidants maintain cell integrity," and "fiber maintains bowel regularity" are all structure-function claims. Manufacturers can use structure-function claims without FDA authorization. However, they must base their claims on their review and interpretation of the scientific literature. Like all label claims, structure-function claims must be true and not misleading. Structure-function claims are also easy to spot because they must be accompanied by the disclaimer, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

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