Stevia as a Sweetener

While I continue to work on my memories lists, and devising my new plan, I share with you my thoughts and experience on sugar substitutes.  I have been using stevia as a sugar substitute for years now.  I steer far away from aspartame having been addicted to aspartame Diet Coke through the 1980's and 1990's.  I stopped all aspartame cold turkey the day I commenced my studies in Traditional Chinese Medicine in 2001.  Within days my mind came out of a fog, I had more energy, and was very glad I ended that relationship with Diet Coke.  Now that stevia finally can be (and is) incorporated into food products, as it has been since the 1970's in Japan, it is exciting to watch the possibilities unfold, including the availability of stevia sweetener packets at a few restaurants - I've always had to bring my own stash.  I am appalled that saccharin still appears as an option on restaurant tables.  This stuff has been long proven to cause cancer.  Our other option on the tables is Splenda, aka sucralose, which in larger servings than about a teaspoon cause severe intestinal angish, for me anyway.  Plus, it is not a natural substance like stevia.  Anyhow, I am creating a recipe book of my favorite stevia recipes and other healthy options. 

Below is a paper I wrote last year for our Pharmacy Management class.  This paper is an overview of the convoluted history of the natural sweetener, stevia, and the FDA. 

As reported on December 18, 2008, in the Wall Street Journal, the Food and Drug Administration declared a natural zero-calorie sweetener derived from the herb Stevia

rebaudiana Bertoni from the Compositae family to be safe for use in foods and beverages, which cleared the path for Coca-Cola Co., PepsiCo Inc. and other companies to market the herbal constituent in a variety of products.¹   More specifically, "no objection" letters were faxed for each of two GRAS notices to Cargill and Merissant (the companies that market the sweetener for Coca-Cola and Pepsi).² Technically, the FDA hasn’t granted approval for use of the stevia plant, rather it has affirmed that it will not object to companies using a component of it, rebaudioside A, in foods and beverages.

Rebaudioside A is a highly purified form of stevia, a plant that originated in South America and is traditionally known for its sweetening and herbal medicinal qualities. Only the constituent rebaudioside A has been given the “no objection” status, whereas foods and beverages made with whole stevia leaves continue to be banned from importation and from use as a food additive or sweetener in the U.S. ³  Proponents of the natural sweetener have been waiting a long while for an opening in the use of the plant.  The stevia plant is naturally grown, and is neither a drug nor a food, thus it has traveled a long and ambiguous journey through the regulations and shifts within the FDA.

The public safety concerns with the stevia plant have been controversial throughout decades, ranging from potential mutagenic properties from a portion of the stevia plant, steviol (which more recent studies have shown to been to be inaccurate in in vivo studies), to potentially reducing fertility in both female and male lab animals, and including the purposed political threat of the “newly discovered” sweet herb to the sugar producers and artificial sweetener manufacturers, such as saccharin and aspartame.  If there is a natural sweetener containing zero calories, with no known harmful effects, might that be a better choice for the American public than the consumption of refined sugars with their well-known, undisputed ill health effects, or the consumption of artificial sweeteners, such as saccharin, and especially aspartame, which have been shown to be carcinogenic and cause neurological problems, respectively?  

Since 1985, studies have shown the absence of harmful effects (no genotoxic activity) for both stevioside and rebaudioside A (both extracted components of the stevia plant).   There have been no reported harmful effects in over thirty years of use of the herb in Japan.  In fact, as more studies were required through the years and were done on the parts of the stevia plant, researchers began to find beneficial health qualities, such as the stabilizing of blood sugar in diabetics, and with helping to lower blood pressure in hypertensive patients.⁴  It was not until the larger soft drink companies responded to the public’s increasing health concerns about aspartame as a sweetener in their products that the FDA was convinced to not object to the use of the herb as a sweetener, and food additive, in products. 

Since the time of the Pure Food and Drug Act of 1906, herbal and natural remedies that were supplemental to the diet have been confusing to regulators, because these herbs were neither food nor medicinal substances and their main concern, especially originally, was to clean up the dangerous additives and preservatives that were rampant at the time in foods consumed by the American people.⁵   It wasn’t until the Delaney Clause of the 1958 Food Additives Amendment, that known carcinogens were prohibited in processed foods.   The controversial and eventual ban on saccharin in the 1970s was indicative of the country’s new awareness of the possibility of assessing the risks versus the benefits of a chemically produced product.  On one hand saccharin was proven to cause cancer in rats; on the other it was far cheaper to put into foods than sugar, and did not have the deleterious effects of sugar on one’s health in terms of weight gain, diabetes development, etc.⁶ It was this awareness of the health issues these artificial sweeteners caused that led Japan to greatly restrict the use of artificial sweeteners and turn to cultivating stevia as the main sweetener in their own products and consumption.⁷  

 In 1991, the FDA labeled stevia as an “unsafe” food additive and banned the import of the herb.  Protestors to this move demanded that the FDA was violating its own guidelines from the 1958 statement that natural substances used prior to 1958, with no reported adverse effects, should be classified as GRAS, as long as the substance was used in the same way and format as prior to 1958.⁸ More claims were made that the FDA was responding to pressure by the artificial sweetener manufacturers for their benefit. 

Then, in 1994, the Dietary Supplement Health and Education Act was passed, but had been opposed by all public health, medical and nutritional groups, because companies were permitted to market their “health” remedies with no safety testing or review by the FDA, which was akin to the exilir sulfonamide days.  The burden of proof fell on the FDA if a substance began to show “unreasonable risk of injury or illness”, and in an emergency involving one of these substances, the FDA is not allowed to remove it from the market.⁹ In 1995, the FDA was forced to allow stevia to be used as a dietary supplement, but the FDA still deemed it as “unsafe” as a food additive and companies were not able to sweeten their beverages and baked products and sell them to the public.  Stevia supporters, who wanted to have the choice to have the herb in their sodas and baked goods, did not have the financial means to move stevia through the FDA approval process.

By the 1990’s the FDA was requiring that all foods be labeled.  According to Hilts, the supplement companies, which by this time were often as large as the pharmaceutical companies, requested exemption from all the safety and effectiveness testing that was required of the drug companies, rather, they wanted a “more lenient standard.”  The supplement companies claimed the benefits of supplements and herbal remedies and the fact that they have been safely used for centuries.¹⁰ This is one of the same arguments that the stevia proponents have claimed about the stevia plant.  Scientific testing on the supplement and herbal products began and showed that in some cases, the argument that “centuries of use” was meaningless.  As further testing progressed more evidence was obtained proving the hazards and less evidence that the substances were actually beneficial.  While this was true for many herbal substances, it did not hold for stevia.

In 2006, the World Health Organization (WHO) did a thorough review of the most recent experiments and determined that stevioside and rebA are not genotoxic, and it has been shown to have beneficial effects in patients with hypertension and type-II diabetes.¹¹  This significant step, along with the major soda companies finally taking an interest in developing and patenting a new form of sweetener for their products in light of declining soda sales, helped pave the way to the first sign of acceptance by the FDA of this herbal sweetener in 2008.

The first sign of a threat to American (and European) industry came when there was a big stir over the sweet South American herb.  Several promoters at the time were sure there was a fabulous market for stevia in the U.S., however sugar cane growers in both in Europe and in the U.S. in 1913 had become aware of the herb.  By the time stevia was presented in 1921 to the USDA by American Trade Commissioner potential U.S. companies were not interested.¹² It wasn’t until the mid 1980’s that the herb caught the attention of the American marketplace, and almost immediately, the FDA began its crackdown on the use of the herb, including actions taken against firms using stevia in their products, embargoes, searches, seizures of products and cookbooks listing stevia as an ingredient, and an “import alert” which barred stevia shipments into the U.S.  Unsubstantiated rumors of a “trade complaint” by the manufacturers of the new artificial sweetener, aspartame (NutraSweet), were thought to have been the impetus for the FDA to suppress the use of the stevia plant.¹³

Meanwhile, the artificial sweetener, aspartame, was in the approval process with the FDA, even though there were several scientific advisors that recommended otherwise, these advisors were eventually overridden by the FDA commissioner, Arthur Hull Hayes, in the Reagan administration.  Many ill effects came to be revealed by consumption of aspartame, including stimulating weight gain, neurological disorders, and addiction to the substance, and the FDA had refused to approve aspartame for more than eight years because of these health concerns. Aspartame's manufacturer, G.D. Searle, hired former defense secretary Donald Rumsfeld as its CEO in 1977, at which point he promised to get aspartame approved via political connections. In 1980, a public board again voted to keep aspartame off the market. That ban was eventually overruled by Arthur Hull Hayes, the new FDA commissioner. In 1983, the chemical was approved for use in soft drinks despite the continuing objections.¹⁴   According to Philip Hilts, this approval came at a time during the deregulation era of the Reagan administration.  Through the halt on new regulations and cutting of current regulatory agency budgets, the FDA felt the cuts deeply in terms of budget and staff to accomplish their goals.  There was much controversy regarding the long lag time of approval on drugs, as well as labeling requirements for patient information and Hayes experienced much political pressure to decrease the standards by which drugs were approved.  He held true to his beliefs in requiring clinical trials for all new drugs.  This struggle had some negative consequences in his ability to take action on the labeling in the Reye’s- aspirin danger because Bayer, a large company that manufactured aspirin, was able to squelch the information through the Center for Disease Control regarding the harmful effects of and likelihood of developing Reye’s Syndrome in children with viral infections who also took aspirin.  The CDC approached the FDA in hopes that Hayes could help.  At this time, Reagan’s Office of Management and Budget were greatly influenced by large corporations, and very little was heard from consumer or health organizations.¹⁵  Did this also hold true for Rumsfeld’s interest in G.D. Searle, and the approval of aspartame?

Proponents of stevia have complained bitterly that aspartame’s odd approval exemplified the forgotten chief lesson of the FDA’s creator, Dr. Wiley, “the principle that the right of the consumer is the first thing to be considered”, as the perceived corporate power was typified by the ascent of aspartame and suppression of stevia.¹⁶ One author’s statements, even though he views the “no objection” status of rebA as a great step forward, he is very clear how he feels about the FDA’s motives:

“The U.S. Food and Drug Administration has issued letters of non-objection for the use of a natural, zero-calorie sweetener it once sought to wipe out from the U.S. marketplace.  Following political pressure from powerful consumer product corporations (Coca-Cola and Pepsi, primarily), the FDA has once again fallen in step with the interests of Big Business and legalized a food and beverage ingredient that it once aggressively oppressed…”

“…Realize this crucial point:  The FDA’s decisions these days are based entirely on corporate profits and have absolutely nothing to do with science, safety or consumer interests.  So don’t be fooled for a minute into thinking that the FDA’s approval of stevia has anything to do with serving the People.”¹⁷

I believe it took the FDA an inordinate amount of time to not object to the use of the herb for common use in foods and beverages, especially as proven detrimental artificial sweeteners are still widely available and aggressively promoted.  As with every story, there are exaggerations, and deeper knowledge to gain as to motives and restrictions that are beyond the scope of this paper.  After reading the Hilts book, I can more fully understand from where these pressures might have arisen, and the need for the FDA to find balance between committing to the safety of the people and pressures from drug companies and corporate America.  However, the sheer length of time, and seemingly needless overt suppression and threats and the coincident approval process of aspartame, definitely causes me contemplate the possibilities of large corporate influence over the FDA’s “no objection” status.   Now that the FDA has recognized rebA as potentially safe and products can be created with the herb and present a potentially healthful and beneficial alternative to refined sugar and the artificial sweeteners that are already widely available, it seems that this resolution so far, does help protect the ordinary citizen, and will likely even benefit the ordinary citizen, and, at minimum, allows another alternative sweetener to be considered, one in which the benefits may be shown to far outweigh the minimal risks. In the event the conversation about sweeteners would arise in my pharmacy practice, I would discuss all of the sweetener options, providing as much unbiased information as I could, especially with patients I would counsel regarding their desires to lose weight and/or manage their blood sugar levels.

References:

1)      FDA Clears Use of Herb as Sweetener. The Wall Street Journal. December 18, 2008: B3.

2)      Food and Drug Administration website, available at: http://www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000278.pdf, page 9. Accessed January 15, 2010.

3)      Food and Drug Administration website, Warning Letters, available at:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076475.htm.       Accessed January 15, 2010

4)      Food and Drug Administration, GRAS Notices website, available at: http://www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000253.pdf.  Accessed on February 1, 2010 

5)      Hilts, Philip J.  Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation.  Chapel Hill, NC:  University of North Carolina Press; 2003; 280.

6)      Ibid: 202-206.

7)      Bonvie,  Linda, Bonvie, Bill, Gates, Donna.  The Stevia Story:  A Tale of Incredible Sweetness and Intrigue.  Atlanta, GA:  B.E.D. Publications Co; 1997:26.

8)      Ibid: 28.

9)      Hilts, Philip J.  Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation.  Chapel Hill, NC:  University of North Carolina Press; 2003; 288-289.

10)  Ibid: 280-284.

11)  The World Health Organization website, available at:

http://whqlibdoc.who.int/trs/WHO_TRS_952_eng.pdf.  Accessed on February 1, 2010.

12)  Bonvie,  Linda, Bonvie, Bill, Gates, Donna.  The Stevia Story:  A Tale of Incredible Sweetness and Intrigue.  Atlanta, GA:  B.E.D. Publications Co; 1997:25-26.

13)  Ibid; 27

14)  New York Post Online: Diet Soda Diatribe Posted: 5:10 AM, July 21, 2009 Last Updated: 7:02 PM, August 15, 2009.  Accessed February 1, 2010.

 http://www.nypost.com/p/lifestyle/health/item_FtTTER85xFjEBrQpgcwCMK

15)  Hilts, Philip J.  Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation.  Chapel Hill, NC:  University of North Carolina Press; 2003; 216-218.       

16)  Bonvie,  Linda, Bonvie, Bill, Gates, Donna.  The Stevia Story:  A Tale of Incredible Sweetness and Intrigue.  Atlanta, GA:  B.E.D. Publications Co; 1997:47. 

17)  Natural News.com:  FDA Approves Stevia, Ends the Era of Oppression of this Herbal Sweetener - UPDATE 1, December 19, 2008 Available at:  http://www.naturalnews.com/News_000626_stevia_Truvia_FDA.html.  Accessed on January 15, 2010.