'Stevia is a drug', says FDA citizen’s petition

The petitioner, identified as Coburn & Coffman PLLC, contends that stevia glycosides (SGs) are drugs and therefore cannot be legally added to conventional foods.

The petition focuses on § 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA), and was made on the grounds that SGs have been studied for therapeutic uses, such as effects on blood pressure and blood sugar levels, with clinical trials supporting these therapeutic uses.

FoodNavigator.com contacted Coburn & Coffman but the firm refused to provide any comment whatsoever. It is unknown if the law firm is operating on behalf of a client or independently.

According to the petition, the FDA is asked to:

"​1. 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);​

2. 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); and​

3. Abstain from issuing a letter of no objection to any pending GRAS notification that addressed any use of steviol glycoside in food, on the ground that issuance of such a letter would effectively sanction a violation of law."​

Serious issue for industry​

Responding to the petition, Bob McQuate, PhD., from GRAS Associates, an Oregon-based consultancy, told NutraIngredients-USA.com that he expected the petition to be unsuccessful "in the short term."​

"​In the long term, I think the petition has weaknesses but this needs to be studied out more,​"​​ he said.

Dr. McQuate told attendees at the SupplySide West stevia workshop in Las Vegas that the FDA had four options open to it: Approve, deny, provide a tentative response explaining FDA’s position, or state that a response will come forth within 180 days.

"​Industry has to take this seriously,​"​ he added.

Stevia facts​

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 receive FDA GRAS status for use in food and beverages.

The US market for stevia is estimated to be worth about $60m, a figure analysts say could triple with FDA GRAS. Currently the biggest markets for stevia are Japan and Korea.

In July, it was announced that PepsiCo has joined with the Whole Earth Sweetener Company (a subsidiary of Merisant Company) to launch its rebiana sweetener PureVia.

Meanwhile Coca-Cola has teamed up with Cargill to use its rebiana brand, called Truvia.

Cargill and Merisant have notified the FDA that rebiana should be GRAS.

Leslie Curry, director of regulatory and scientific affairs, Cargill Food Ingredients and Systems, told this website: "Rebaudioside A is clearly a food ingredient."​

Approvals​

The petition comes hot on the heels of the Australian and New Zealand food standards authority, FSANZ, approving steviol glycosides for use in foods, and a few of months after 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.

"​JECFA is critically important and needs to be given great weight and deference,​"​​said Dr McQuate.

FDA’s response to Cargill and Merisant’s GRAS petitions was expected before the end of the year, although some are now suggesting that the announcement will be made early in 2009.

However Dr McQuate is not expecting that the law firm potential on stevia glycosides as a drug to have an impact on approval.

"​I don’t think the citizen’s petition will have much effect on GRAS because GRAS notifications do make reference to § 301(ll),​"​ said Dr McQuate.