Distancing your food and beverage products from the competition is often based on how you communicate health benefits. Listening to daily newscasts, you may come to the conclusion that any functional food can prevent disease and true longevity comes in a pastel-colored, vitamin-fortified water. Now you're thinking how to parlay this healthfulness into your promotional claims.

There really are clear—albeit scientific and regulated—guidelines for how to properly state "good-for-you" claims in marketing. Companies are often surprised that federal rules govern this playing field. This first installment in a series will introduce the U.S. rules of claiming health benefits from foods and food ingredients.

The most recent rules for what, how and where you can say food and food ingredients are good for you came about in 1990 and 1994. Despite the 16-year presence of the legislation, people are still in the dark about this.

Learning the Hard Way
If a cherry product manufacturer hears a TV reporter say that cherries reduced inflammation in a recent university study, it would think it would be truthful enough to put on its cherry based drink.

Surprisingly, the news report can make the statement, but a beverage or food manufacturer could be slapped with a shocking letter from a government agency for doing so.

That's exactly what happened to 29 Michigan-based companies in October 2005. Collectively, they were reprimanded for making unproven claims on their labels.

The warning letters told the firms to "stop making unproven claims on the firms' Web sites and product labels" that their cherry and fruit products treat or prevent disease, including cancer, heart disease and arthritis. The FDA letters warned that if the firms failed to take prompt corrective measures, they might face enforcement action without further notice, including seizure of the products, as well as injunctions or criminal sanctions.

A list of firms receiving warning letters regarding cherry and other fruit-based products with disease claims in labeling is at www.cfsan.fda.gov/~dms/chrylist.html.

FDA Rules
The cherry industry players were notified by The Food and Drug Administration (FDA), which regulates everything from tortilla chips to heart pacemakers. The organization sets the regulations based on the laws enacted by Congress. Companies' freedom of speech is tempered by these FDA regulations to ensure no harm will come to consumers and only truthful and nonmisleading statements are made on products.

What's wrong—according to the FDA—with calling cherries a "functional food," "nutraceutical" or "disease-treating fruit?" Well, inflammation is a dysfunction of the body associated with diseases like arthritis.

Diseases are treated with drugs, not food, and cherries are food. Basically, the FDA's playbook recognizes substances that go into your mouth as foods or drugs. Period. There is no other FDA definition for those fanciful terms you heard in the newscasts.

Foods vs. drugs
In 1989, Stephen L. DeFelice, M.D., coined the term "nutraceutical" as it now appears on www.websters.com: "A food or naturally occurring food supplement thought to have a beneficial effect on human health."

"Functional foods" became synonymous with this term through the years. Both terms are missing from the FDA regulations.

If your product is a vitamin C or zinc chewable tablet made with cherry fruit, it is technically a subcategory of "foods." Make a claim that the vitamin C product is "intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals", and your product has likely joined the ranks of a drug.

Different rules now apply. The FDA regulators will have you on their mailing list if you decide to promote any vitamin or mineral for cancer, arthritis or diabetes. Sure, the regulations will allow you to inform customers that the vitamin C product will fight the vitamin deficiency disease scurvy.

However, how many customers really could relate to the largely irrelevant disease European sailors faced when they explored the New World?

Hidden Language
Hiding promotional language or your product claims about diseases on the World Wide Web is no longer a safe haven from the FDA, either.

Check out www.fda.gov/foi/warning.htm for numerous cyber warning letters that are the epitome of failed marketing tactics. Even the tactic of promoting dietary supplements in Spanish is no longer a way to evade the regulatory reach.

How do you know whether you are stretching the limits of FDA regulations or actually breaking them? It's based on the claims for your product as much as the ingredients and intended use.

You'll find a limited list of pre-approved food and disease claims available to companies, listed under the FDA's regulations as "health claims," at www.cfsan.fda.gov/ ~dms/lab-hlth.html. Each claim has taken a large investment in time and money to pass through approval processes. Your marketing materials or Web site text may not deviate very far from the approved wording, which often frustrates creative types.

Caught in the Act
You should think twice about tinkering with the rules because government agencies will now partner up. The FDA and the Federal Trade Commission (FTC) now dole out the consequences and penalties, especially if a company televises their sales campaign.

On June 16, 2003, at the FDA's request, U.S. marshals seized 132,480 bottles of Seasilver, worth nearly $5.3 million, from Seasilver USA's San Diego headquarters. Under a settlement with the FTC, entered on March 4, 2004, the Seasilver defendants and the individual distributors agreed to pay $4.5 million in consumer redress.

And to further encourage companies to use caution, consider that competitors may be vicarious watchdogs for the agencies.

Defining Terms
On a simplistic level, keep these distinctions in mind:
· A food has "flavor," "aroma" or "nutritive value" and is consumed by mouth.
· A dietary supplement is consumed by mouth and supplements the body's nutritional needs with vitamins, minerals, amino acids, herbs, animal glandulars or enzymes.
· A drug can be consumed by mouth, topically applied or injected into the body, but it is going to alter a disease state or prevent a disease condition.
Unfortunately, ignorance is not bliss when selling products that pass the lips and head for the gut. The next installment of this series will cover the label claims and nutritional differences for vitamins, minerals and phytochemicals.

Debra K.W. Topham, MS, CNS, is the director of Knowledge Bank, based in Huntington Beach, Calif. Contact her at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .