Wisdom Natural Brands Begins Marketing SweetLeaf® Stevia as a Sweetener

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Wisdom Natural Brands Begins Marketing SweetLeaf® Stevia as a Sweetener

Other Companies Announcing Plans to Launch Stevia Sweeteners

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After many years of regulatory hurdles and setbacks, stevia (Stevia

rebaudiana) has finally begun to enter the mainstream sweetener market.

The company Wisdom Natural Brands (Phoenix, AZ) announced in June that

its stevia product SweetLeaf® has been self-affirmed as being generally

recognized as safe (GRAS), allowing the company to immediately begin

marketing SweetLeaf as a sweetener rather than as a dietary supplement.1

Several other companies, including Cargill (Minneapolis, MN) and Corn

Products International (Westchester, IL), have also recently announced

plans for marketing their own stevia-based sweeteners and products in

the near future.2,3

The leaves of the South American plant stevia have an extremely sweet

taste that is far more potent than sucrose (table sugar).4 In addition

to being a naturally-derived sweetening agent, stevia is non-caloric,

making it particularly appealing to food and beverage companies catering

to health-conscious consumers. Stevia was declared an “unapproved food

additive” by the US Food and Drug Administration (FDA) in 1991. Since

1995 it has only been marketed in the United States as a dietary

supplement, an exception allowed under the provisions of the Dietary

Supplement Heath and Education Act of 1994 (DSHEA), which specifically

exempts dietary supplements from the type of regulation—including

pre-market approval—required for food additives. There has been

speculation by some people in the natural products industry and beyond

that producers of synthetic sweeteners may have initially pressured the

FDA into designating stevia as an illegal food additive in order to keep

stevia off the market as a competitor.5

Although Wisdom Natural Brands first introduced stevia into the US

market in the form of ground or whole leaves in 1982, SweetLeaf has been

sold as a dietary supplement for over a decade due to the marketing

restrictions placed on stevia by the FDA. “My dream and my vision has

always been to have SweetLeaf as a sweetener,” said May, president

and CEO of Wisdom (oral communication to C. Cavaliere, June 12, 2008).

Wisdom decided to utilize the GRAS self-affirmation process, which the

FDA made available to companies in 1997 and involves having an

independent group of qualified scientists review the available data on

an ingredient’s safety and determine whether that ingredient is

considered safe for its intended use and meets strict FDA requirements.

The company ultimately hired 2 groups of independent scientists to

review the available worldwide data on stevia, both groups containing

former FDA officials familiar with the GRAS process. Both groups

determined that SweetLeaf stevia meets safety and production

requirements necessary for GRAS status, and this status was officially

given to Wisdom on March 5.

SweetLeaf is 98% pure stevia glycosides (the sweet components of the

stevia leaf). In its efforts to ensure that SweetLeaf would obtain GRAS

status, Wisdom developed a new method for extracting glycosides from

stevia leaves that involves a water-membrane filtration system. “We’ve

really met heightened or superior standards for the manufacturing of the

product,” May stressed.

“We’re on absolutely solid ground in this self-affirmation of GRAS,” he

said. May explained that the FDA is not required to review or approve

the decision made by the independent scientists who provided the GRAS

status. However, the only way for the FDA to reverse the scientists’

GRAS determination would be to take the company to court and prove that

stevia is harmful to the human body. According to May, over 1200 studies

have now been published verifying the safety of stevia for human

consumption.

Although Wisdom has become the first company to market a stevia-based

sweetener, several other companies have announced plans for introducing

their own stevia sweeteners in the near future. Cargill announced in May

that it plans to release its stevia-based sweetener Truvia by the end of

2008.6 Cargill funded studies exploring the safety of rebiana (the

common name for the stevia constituent rebaudioside A, from which Truvia

is composed), which were published electronically in the journal Food

and Chemical Toxicology in May.2 According to Ann Tucker, a spokesperson

for Cargill, Cargill has notified the FDA that research data concerning

the safety of rebiana has been completed and is available, which is one

step of a multistage process in obtaining US regulatory approval (A.

Tucker, oral communication to C. Cavaliere, June 12, 2008).

Tucker claimed that Truvia is distinguished from other stevia products

in that it is a fully-characterized product that promises consistency

and high-quality. She added that such consistency is what food companies

typically look for in a sweetener, since these companies also want their

finished products to be consistent. “All stevia isn’t the same,” said

Tucker. “Unlocking the taste and getting it to be consistent was the

hard part.”

Cargill has been collaborating with Coca-Cola Co. (Atlanta, GA) in

developing its stevia-based sweetener, which Coca-Cola intends to use in

beverages and Cargill plans to use in various food products, in addition

to marketing the table-top sweetener Truvia.7 Coca-Cola filed 24 patent

applications in May of 2007 to give the company exclusive rights to

develop and sell beverages containing the stevia-based sweetener it has

developed with Cargill.

Another company, Corn Products International (CPI), has also indicated

that it plans to add a stevia-based ingredient to its list of

sweeteners.3 CPI announced in April that it has entered into an

agreement with the Japanese company Morita Kagaku Kogyo Company Ltd.,

which has been producing stevia sweeteners since 1971, to market that

company’s patented stevia strain. CPI has announced that it will also

make a $20 million investment to build a stevia extraction factory in

Brazil. CPI plans to initially market the stevia-based ingredient,

called EnlitenTM, in select Latin American and Asian countries, where

the sweetener is already approved for use in foods. The company

reportedly will also file for regulatory approval of Enliten in the

United States and Europe.

Rodes of Stevita Co Inc., (Arlington, TX), a distributor of stevia

products manufactured by Steviafarma S/A of Brazil, is also developing,

in conjunction with the Brazilian manufacturer, a table-top sweetener to

be released in 2009. Rodes expects that, Steviafarma will have had its

steviosides reviewed and affirmed as GRAS by that time. Rodes has

intended to market stevia as a sweetener and food additive for the last

20 years, but when he met with the FDA in 1989, he learned that there

were concerns about the product’s use as a table-top sweetener without

having first undergone some rigorous safety studies. Conducting such

studies would have totaled an estimated $10 million; Rodes decided this

was too high a cost for his small company at that time. However, now

Stevita and Steviafarma are working with a large US-based food

manufacturer (name undisclosed), which has reportedly spent over $6

million testing the safety of the product and will spend an additional

$40 million in a project to launch its own stevia-based table-top sweetener.

“Ten million doesn’t seem like so much now,” said Rodes (oral

communication to K. Saxton, June 16, 2008). According to Rodes, this

product is going to be at least 95% pure glycosides extracted from

special stevia cultivars with a particularly high concentration of

rebaudioside A. The company’s extraction process uses water filtration

and natural resins instead of solvents or chemicals.

Although various stevia sweeteners may therefore enter US stores in the

near future, Wisdom’s May argued that not all of these sweeteners are

prepared in the same fashion and can promise the same health benefits.

May explained that a blending agent must be used (to bulk up the product

to enable packaging in sachets for single servings) when manufacturing

stevia products, and many companies utilize a carbohydrate-based

compound such as maltodextrin, sorbitol, dextrose, erithrytol, lactose,

etc. Some of these blending agents could prevent the stevia products

from providing zero carbohydrates or a zero score on the glycemic index.

Wisdom’s SweetLeaf stevia is blended with inulin, a prebiotic

carbohydrate that is beneficial for gastrointestinal flora and can help

improve immune system function. “We’ve blended our stevia with something

that also is extraordinarily good for the human body,” said May. He

stated that consumers should be careful to read labels and learn the

facts about various stevia products.

Consumer interest in stevia sweeteners is expected to be rather high.

Tucker stated that Cargill has received very few questions from industry

members or the public concerning the science behind stevia. “The

majority of questions have been ‘Where can I get it?’ ‘When can I taste

it?’—which has been very interesting!” she said.

May stated that the new designation of “sweetener” could possibly raise

SweetLeaf’s sales substantially, particularly since the product can now

be sold in the baking aisle rather than the herbal dietary supplements

aisle.

More information regarding the regulatory history of stevia is available

in an article published in the October 2007 issue of HerbalEGram,

accessible here.4

— Cavaliere and E. Saxton

References

1Starling S. Has stevia broken US dietary supplement shackles?

NutraIngredients.com. June 4, 2008. Available at:

http://www.nutraingredients-usa.com/news/ng.asp?id=85710. Accessed June

5, 2008.

2Cargill introduces Truvia natural sweetener brand, the first natural,

zero-calorie, great tasting sweetener [press release]. Wayzata, MN:

Cargill; May 15, 2008.

3Corn Products International adds stevia-based, high-intensity sweetener

to its ingredient portfolio [press release]. Westchester, IL: Corn

Products International; April 22, 2008.

4Cavaliere C, Blumenthal M. Coca-Cola and Cargill developing new natural

sweetener from stevia. HerbalEGram. October 2007;4(9). Available at:

http://abc.herbalgram.org/site/PageServer?pagename=04_10_Stevia_Coke & autologin=t\

rue.

Accessed June 5, 2008.

5Bonvie L, Bovie B. Sinfully sweet? New Age Journal. Jan/Feb 1996.

6Cargill sees Truvia on US market by year end. Reuters. May 15, 2008.

Available at:

http://uk.reuters.com/article/governmentFilingsNews/idUKN1527123920080515.

Accessed May 23, 2008.

7Etter L, McKay B. Coke, Cargill aim for shake-up in sweeteners. Wall

Street Journal. May 31, 2007;A1.

--

ne Holden, MS, RD

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