Stevia Leaf - Too Good To Be Legal?

Here is an article that I found to be of interest. A few things are dated but you get the point.

Rob McCaleb

Herb Research Foundation

For hundreds of years, people in Paraguay and Brazil have used a sweet leaf to sweeten bitter herbal teas including mate. For nearly 20 years, Japanese consumers by the millions have used extracts of the same plant as a safe, natural, non-caloric sweetener. The plant is stevia, formally known as Stevia rebaudiana, and today it is underwholesale attack by the U.S. Food and Drug Administration.

Stevia is a fairly unassuming perennial shrub of the aster family (Asteraceae), native to the northern regions of South America. It has now been grown commercially in Brazil, Paraguay, Uruguay, Central America, the United States, Israel, Thailand and China. The leaves contain several chemicals called glycosides, which taste sweet, but do not provide calories. The major glycoside is called stevioside, and is one of the major sweeteners in use in Japan and Korea. Stevia and its extracts have captured over 40% of the Japanese market. Major multinational food companies like Coca Cola and Beatrice foods, convinced of its safety, use stevia extracts to sweeten foods for sale in Japan, Brazil, and other countries where it is approved. Europeans first learned of stevia when the Spanish Conquistadors of the Sixteenth Century sent word to Spain that the natives of South America had used the plant to sweeten herbal tea since "ancient times".

The saga of American interest in stevia began around the turn of theT wentieth Century when researchers in Brazil started hearing about "a plant with leaves so sweet that a part of one would sweeten a whole gourd full of mate." The plant had been described in 1899 by Dr. M. S. Bertoni. In 1921 the American Trade Commissioner to Paraguay commented in a letter "Although known to science for thirty years andused by the Indians for a much longer period nothing has been done commercially with the plant. This has been due to a lack of interest on the part of capital and to the difficulty of cultivation.

"Dr. Bertoni wrote some of the earliest articles on the plant in 1905 and 1918. In the latter article he notes: "The principal importance of Ka he'e (stevia) is due to the possibility of substituting it for saccharine. It presents these great advantages over saccharine:

• It is not toxic but, on the contrary, it is healthful, as shown by long experience and according to the studies of Dr. Rebaudi.


• It is a sweetening agent of great power.


• It can be employed directly in its natural state, (pulverized leaves).


• It is much cheaper than saccharine.

"Unfortunately, this last point may have been the undoing of stevia. Non caloric sweeteners are a big business in the U.S., as are caloric sweeteners like sugar and the sugar-alcohols, sorbital, mannitol andxylitol. It is small wonder that the powerful sweetener interest shere, do not want the natural, inexpensive, and non-patentable stevia approved in the U.S.

In the 1970s, the Japanese government approved the plant, and food manufacturers began using stevia extracts to sweeten everything from sweet soy sauce and pickles to diet Coke. Researchers found the extract interesting, resulting in dozens of well-designed studies of its safety, chemistry and stability for use in different food products. Various writers have praised the taste of the extracts, which has muchless of the bitter after taste prevalent in most noncaloric sweeteners. In addition to Japan, other governments have approved stevia and stevioside, including those of Brazil, China and South Korea, amongothers. Unfortunately, the US was destined to be a different story. Stevia has been safely used in this country for over ten years, but a few years ago, the trouble began.

FDA ATTACK ON STEVIA

Around 1987, FDA inspectors began visiting herb companies who were selling stevia, telling them to stop using it because it is an "unapproved food additive". By mid 1990 several companies had been visited. In one case FDA's inspector reportedly told a company president they were trying to get people to stop using stevia "because Nutra Sweet complained to FDA." The Herb Research Foundation (HRF), which has extensive scientific files on stevia, became concerned and filed a Freedom of Information Act request with FDA for information about contacts between Nutra Sweet and FDA about stevia. It took over a year to get any information from the FDA, but the identity of the company who prompted the FDA action was masked by the agency.

In May, 1991 FDA acted by imposing an import alert on stevia toprevent it from being imported into the US. They also began formally warning companies to stop using the "illegal" herb. By the beginning of 1991, the American Herbal Products Association (AHPA) was working to defend stevia. At their general meeting at Natural Products Expo West, members of the industry pledged most of the needed funds to support work to convince FDA of the safety ofstevia. AHPA contracted HRF to produce a professional review of the stevia literature. The review was conducted by Doug Kinghorn, PhD., one of the world's leading authorities on stevia and other natural non-nutritive sweeteners. Dr. Kinghorn's report was peer-reviewed by several other plant safety experts and concluded that historical and current common use of stevia, and the scientific evidence all support the safety of this plant for use in foods. Based on this report, and other evidence, AHPA filed a petition with FDA in late October asking FDA's "acquiescence and concurrence" that stevia leaf is exempt from food additive regulations and can be used in foods.

FDA, apparently attempting to regulate this herb as they would a new food additive, contends that there is inadequate evidence to approve stevia. However, because of its use in Japan, there is much more scientific evidence of stevia's safety than for most foods and additives. The extent of evidence FDA is demanding for the approval of stevia, far exceeds that which has been required to approve even new synthetic food chemicals like aspartame (Nutra Sweet).

AHPA's petition points out that FDA's food additive laws were meant to protect consumers from synthetic chemicals added to food. FDA is trying, in the case of stevia to claim that stevia is the same as achemical food additive. But as the AHPA petition points out, Congress did not intend food additive legislation to regulate natural constituents of food itself. In fact, Congressman Delaney said in 1956, "There is hardly a food sold in the market today which has not had some chemicals used on or in it at some stage in its production, processing, packaging, transportation or storage." He stressed that his proposed bill was to assure the safety of "new chemicals that are being used in our daily food supply," and when asked if the regulations would apply to whole foods, he replied "No, to food chemicals only." AHPA contends that stevia is a food, which is already recognized as safe because of its long history of food use.Foods which have a long history of safe use are exempted by law from the extensive laboratory tests required of new food chemicals. The AHPA petition, however, supports the safe use of stevia with both the historical record, and references to the numerous toxicology studies conducted during the approval process in Japan, and studies by interested researchers in other countries.

To date, the FDA still refuses to allow stevia to be sold in the U.S.but the recently-enacted Dietary Supplement Health and Education Actof 1994 may prevent the FDA from treating stevia and other naturalherbs as "food additives."

rmccaleb@herbs.org -- [also herbal@netcom.com]