With the explosion of nutraceuticals and functional foods, new ingredients—many of which were previously found only in dietary supplements—have found their way into foods. But just because an ingredient is acceptable for use in supplements (under the Dietary Supplement Health and Education Act) does not necessarily mean it is Generally Recognized as Safe for use as a food additive.
?If you want to put that herbal or nutraceutical ingredient into a food, whether a juice or cracker or any other conventional food, it?s no longer approved as a dietary supplement unless you?re marketing the whole product as a dietary supplement,? says Mark Blumenthal, executive director of the American Botanical Council, based in Austin, Texas. ?It becomes a food additive and has to be considered GRAS.?
Whether a product will face scrutiny by the U.S. Food and Drug Administration depends on the nature of the ingredient in question. For example, arrowroot is widely used in foods and has never been challenged. On the other hand, the inclusion of exotic botanicals that don?t have a history of food use is open to question.
There are two processes by which a manufacturer can get an ingredient established as GRAS. The simplest procedure is self-affirmation. There are two approaches to the self-affirmation process, according to Kerry Hughes, an ethnobotanist and founder of Ethnopharm Consulting based in Vallejo, Calif. ?One route is through scientific procedure, and this is the route most companies go for,? she says. ?To go this route, many companies create a GRAS panel ? including a toxicologist, a pharmacologist and others, which will then review research and toxicology studies. It?s not a simple process.
For larger companies concerned about liability issues, another process may be costlier but safer. ?A higher level of evidence is to perform the self-affirmation process with notification to FDA,? Blumenthal says. ?Essentially, a company presents its research to FDA and asks them to sign off on it. If FDA signs off on your safety review, that?s called ?affirmation with notification.? If you?re a manufacturer or raw materials supplier and you want to shop your product or ingredient to a company like Kraft, this process can take you a lot further, because large companies won?t touch an ingredient that you?ve self-affirmed.?
This process doesn?t mean FDA has reviewed and approved the ingredient; it simply means that it has no further questions about the ingredient. If the FDA finds a company?s data insufficient, it can request further information. A company can also withdraw a notification request if FDA signals that it won?t accept the supporting evidence.
Hughes says raw materials suppliers have a great deal to gain by pursuing the notification procedure. ?If you?re the first raw-materials supplier identified with an ingredient,? she says, ?you can turn around, tell manufacturers that you came up with the idea and the FDA has examined your application.?
Mitchell Clute is a free-lance writer and musician in Crestone, Colo.
Natural Foods Merchandiser volume XXV/number 7/p. 30