According to the U.S. Food and Drug Administration, a product is either a food or a supplement. It can't be both. And there is no statutory definition for "functional food," in spite of the popularity of this term in the marketing arena.

"There is no legal definition of functional foods," says Kathy Jordan, general manager for dietary supplements certification at NSF International, an Ann Arbor, Mich.-based company specializing in product testing and certification. "Here, they're regulated like conventional foods, unlike Canada, which has a natural health products regulation."

In the United States, nutrition claims for foods fall under the Nutrition Labeling and Education Act of 1990, while structure/function claims for supplements fall under the Dietary Supplement Health and Education Act of 1994.

At the ends of the spectrum, the difference between a food and a supplement is fairly clear-cut: Something that comes in a capsule filled with herbs is a supplement, while something that comes in a can filled with soup is a food. But there are several categories in which products could conceivably be marketed as either a supplement or as a food, including fortified juices and waters, powdered beverages and protein bars. This determination is based not only on ingredients, but also on claims made for the product by the manufacturer.

The FDA pays careful attention to claims and labeling when deciding if a product is properly branded. "Sometimes you get into areas with word games that would make you roll your eyes," says Marc Ullman, a partner at the Ullman Shapiro & Ullman law firm in New York. "For example, FDA's official position is that you can't have a dietary supplement water, but you can have a dietary supplement in a water base. You can't call it 'herbal supplement water,' but you can call it a water-based herbal supplement."

Retailers helping customers navigate the confusing naturals world should keep in mind the following guidelines when determining whether a particular product meets FDA regulations and is properly labeled and advertised.

If it looks like food, it's food
In recent years, the natural products marketplace has seen such innovations as soup with echinacea and cereal with gingko. The soup was marketed as a supplement, the cereal as a food, but neither passed FDA muster. FDA ruled that something in the form of soup, which clearly resembles a conventional food, cannot be marketed as a supplement. In the case of the cereal, the problem was that many of the herbal ingredients were not on the list of approved food additives or GRAS (generally recognized as safe) ingredients.

Another example is found in the story of Benecol, a margarine-like spread containing plant stanol esters, which have been shown to lower cholesterol. When this product first came to market, it was promoted as a dietary supplement because the manufacturer wanted to make a statement about the link between plant stanol esters and cholesterol reduction. FDA determined that the product was really a food, largely because it looked like a food and was used as a food. FDA has since approved qualified health claims for a number of foods and substances, so that products like Benecol can now make a health claim and still be labeled and marketed as a food.

Not GRAS? It can't be food
When DSHEA passed in 1994, it grandfathered in all dietary supplements ingredients on the market prior to the date of passage. Although some of those grandfathered dietary supplementary ingredients—ginger and garlic, for example—are also approved for use in foods, the majority are not. Ingredients such as echinacea and gingko biloba are perfectly acceptable as dietary supplements ingredients, but are not allowed in products marketed as food because they're not on the GRAS list.

However, even if an ingredient included in a food is GRAS, a manufacturer can't make claims about its benefits unless it has nutritive value based on established "percent daily value" found, for instance, on food labels. For example, it's fine for a food high in vitamin C to make a statement such as "rich in the antioxidant vitamin C." But a food high in garlic can't make a statement regarding the link between garlic and a healthy circulatory system, because structure/function claims for nonnutritive ingredients (even GRAS ones) are not allowed in foods.

If it has a structure/ function claim, it (probably) can't be a food
As created under DSHEA, classic structure/function claims describe how a dietary supplement affects the structure or function of the body; for example, "helps support a healthy immune system" or "helps maintain joint health." Supplements may also make structure/ function claims relating to nutritive value. All dietary supplements with a structure/function claim must also include the standard disclaimer stating that the product is not intended to "diagnose, treat, cure or prevent any disease," and that the claim has not been evaluated by the FDA.

"There is some debate among lawyers as to whether or not one may make a structure/function claim for a functional food," says Susan Brienza, a Denver-based attorney who specializes in regulatory compliance at the law firm Patton Boggs. "I believe not. The letter of the law is that claims for food are limited to taste, aroma and nutritive value. But some lawyers argue that one can make structure/function claims for food as long as the claim is about the product's nutritive value."

FDA's online guidance on such claims seems to suggest leeway for food manufacturers and marketers. FDA states:
Structure/function claims and disease claims for conventional foods focus on effects derived from nutritive value, while s/f claims for dietary supplements may focus on nutritive, as well as nonnutritive, effects. FDA is likely to interpret the dividing line between s/f claims and disease claims in a similar manner for conventional foods as for dietary supplements. FDA does not require conventional food manufactures to notify FDA about their s/f claims and disclaimers are not required for conventional foods. (www.cfsan.fda.gov/~dms/labstruc.html)

If it's marketed as a supplement, it has to look like a supplement
In this scenario, serving size plays a role in FDA's determination. A quart-sized drink would be too large to be considered anything but a beverage, while a concentrated 4-ounce drink would likely qualify as a supplement. An 8-ounce bar containing a high percentage of daily nutritional needs would likely be viewed as a meal replacement, while a smaller bar would have a better chance of being viewed as a supplement. "If it's marketed as a supplement but it looks too much like a conventional food, you run the risk of FDA saying it's not a supplement," Jordan says.

How a product is marketed also plays a role in whether a product is accepted by the FDA as a supplement. For example, because statements about flavor and aroma are strictly limited to foods, a dietary supplement in the form of a powdered shake cannot make a statement such as "rich, chocolaty taste." No product can be both a supplement and a food; thus any product that contains both a Supplement Facts box and a Nutrition Facts box is mislabeled.

For companies whose products can legitimately be categorized as either a food or a supplement, the question to answer is which marketing approach will work best. Products labeled as foods may achieve higher market penetration and visibility, while those marketed as supplements can often command much higher prices per serving. As an example, look at exotic juices that are high in antioxidants. Some of these products, including many pomegranate juices, are marketed as foods; others, including mangosteen juices, are marketed as supplements. Whichever route a company chooses, the key is to ensure that all labeling and marketing meets FDA requirements for the chosen category.

Mitchell Clute is a freelance writer in Crestone, Colo.

Natural Foods Merchandiser volume XXVII/number 7/p. 38