Botanical Ingredients’ GRAS Status Key To Establishing Supplements’ Safety

Functional ingredients that have been affirmed generally recognized as safe by FDA actually have a higher standard of safety assurance than food additives, according to an industry consultant.

GRAS status is even more significant because it applies to a use, not a substance alone, James Heimbach, PhD, maintained at the Hepatotoxicity Assessment for Botanical Dietary Supplements conference in Bethesda, Md. Sept. 8.

Both food additives and GRAS substances have the same safety standard of "'reasonable certainty of no harm' under the intended conditions of use," Heimbach pointed out.

However, while both GRAS and food additive petitions must specify the name of the ingredient, its technical effect and the product for which it is intended for use in, GRAS applications also include published literature on the substance.

The fact that the published literature has been peer-reviewed by a panel of experts creates the higher standard, Heimbach maintains. "The scientific community at large contains a core, wider range of expertise than any single government agency that assists the [FDA] can have available."

GRAS "proposals are about...being able to bring to bear the full power of the scientific community through peer review by getting things out here for an opportunity for peer review," Heimbach said, adding the literature should be "out there for some length of time."

Heimbach is founder and president of JHeimbach LLC, a food and nutrition consulting firm in Washington, D.C.

In materials presented at the meeting, Heimbach points out the "evidence of safety...is the same as is required to support approval of a food additive petition" in terms of the "breadth and quantity" as well as "quality of information."

Botanical ingredients essentially are functional ingredients, he points out, since they are "intended to have a significant impact on at least one biological structure or function of the individual consuming it."

Since dietary supplements may affect the structure or function of the body, it follows that GRAS status for botanical ingredients is of utmost importance.

However, achieving GRAS status for botanicals is difficult for two reasons, according to Heimbach. First, ingredient and composition consistency and safety is difficult to achieve. In addition, minimum levels of effects are hard to establish for functional ingredients.

Functional ingredients and their intended effects figure prominently into labeling of both foods and dietary supplements, the consultant noted, although the guidelines for each differ greatly.

You "cannot label your way to food ingredient safety," Heimbach told attendees, acknowledging the extensive warnings and claims on supplement packages. Food labels do not contain information on recommended dose, drug and food interactions, side effects, disease contraindications, study results and populations or subgroups at risk, he pointed out.

Dietary supplement labels, however, may include such information, which implies that the definition of safety runs along a "risk/benefit" ratio, whereas the standard for foods is "risk only," Heimbach explained. "Neither is a 'zero risk' standard," he noted.

"One thing that is of concern is that when we look at safety for something used in food, you have to take into account that some people may eat a lot of that food, and may have far-above average levels of exposure to the substance that we're talking about here."

However, with dietary supplements, "according to the law, the safety only has to be evaluated at the level of exposure that will be based on what the label says...and overdosing is something not unknown," Heimbach concluded. Therefore, when functional ingredients are added to food, they must be safe even for "heavy users" of the food, and cannot be limited by label statements.

Functional foods also present a potential safety hazard in that they "tend to bring together the worst" attributes of both drugs and food additives, Heimbach asserted.

For example, while drugs are given under medical supervision for a period of time that often varies, food additives are given in doses that vary for an unknown period of time. Thus, for functional ingredients, "we have unregulated consumption with potential lifetime exposure," he notes.