The American Botanical Council has called on the US Food and Drug Administration (FDA) to rescind its "outdated import alert" on stevia.
In the upcoming issue of HerbalGram, ABC’s publication, Mark Blumenthal, ABC’s founder and executive director, calls FDA’s 1991 Import Alert on stevia for use as a food additive "unreasonable and illogical" given the "current scientific and medical information supporting the safety of stevia when consumed in relatively small amounts in foods to give them a sweet taste."
Steviol glycosides - the extract of the leaves of the plant Stevia rebaudiana - are a group of intense sweeteners.
Stevia, which is permitted for sale in the US as a dietary supplement on the basis of its low glycemic index, is yet to have FDA GRAS status for use in food and beverages.
The importation of stevia for use as a food sweetener was banned by FDA following the import alert on May 17, 1991. However, since 1995, the sweetener is allowed to be imported if it is labelled as a dietary supplement, or if a specific extract has self-affirmed GRAS.
ABC’s Blumenthal is calling on FDA to rescind this ban, noting "the FDA’s import alert is an outdated policy, based on the market and regulatory conditions in the late 1980s…
"Is FDA were to rescind its stevia import alert, importers of stevia would still have the burden of confirming safety for use in conventional foods by conducting GRAS reviews," he added.
The changing global regulatory landscape
The road to FDA GRAS determination has been relatively long. Previous unsuccessful attempts to affirm GRAS status include the American Herbal Products Association’s 992 petition, and Lipton-Unilever’s 1994 petition. On both occasions FDA refused to accept the petitions, said Blumenthal.
The global regulatory climate is changing, however. The Australian and New Zealand food standards authority approved steviol glycosides for use in foods just over a week ago, while in June 2008 the United Nations Food and Agriculture Organisation’s Joint Expert Committee on Food Additives (JECFA) concluded that stevia extracts containing 95 percent steviol glycosides are safe for human use in the range of four milligrams per kilogram of body weight per day.
"This paves the way for more regulatory approvals around the world," wrote Blumenthal.
Calls to maintain import restrictions
Somewhat ironically, ABC’s call to rescind the import alert overlapped with the submission of a citizen’s petition to FDA that contends stevia glycosides (SGs) are drugs and therefore cannot be legally added to conventional foods.
The petition, by Coburn & Coffman PLLC, a two-man law firm from Washington DC, calls on FDA to: "Seize, and obtain injunctions against distribution of, food other than dietary supplements to which have been added stevioside, rebaudioside A, or any other steviol glycoside, on the grounds that such violate § 301 (ll);
"Refuse admission to the United States of any food other than dietary supplement that appears to contain a steviol glycoside, on the ground that such food appears to violate § 301(ll)"
The petition focuses on § 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA), and was made on the grounds that steviol glycosides have been studied for therapeutic uses, such as effects on blood pressure and blood sugar levels, with clinical trials supporting these therapeutic uses.