2.6 Stevia Leaf - Too Good To Be Legal?

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 under

wholesale 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 the

Twentieth 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 and

used 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:

 

1. It is not toxic but, on the contrary, it is healthful, as shown

by long experience and according to the studies of Dr. Rebaudi.

2. It is a sweetening agent of great power.

3. It can be employed directly in its natural state, (pulverized

leaves).

4. It is much cheaper than saccharine."

 

Unfortunately, this last point may have been the undoing of stevia.

Noncaloric sweeteners are a big business in the U.S., as are caloric

sweeteners like sugar and the sugar-alcohols, sorbital, mannitol and

xylitol. It is small wonder that the powerful sweetener interests

here, 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 much

less of the bitter aftertaste prevalent in most noncaloric sweeteners.

In addition to Japan, other governments have approved stevia and

stevioside, including those of Brazil, China and South Korea, among

others. 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 to

prevent 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 of

stevia. 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 a

chemical 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 Act

of 1994 may prevent the FDA from treating stevia and other natural

herbs as "food additives."

 

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