New Book By Dr. Hull!

Splenda®: Is It Safe Or Not?
Dr. Janet Hull reveals the scientific evidence strongly suggesting the chemical sweetener sucralose may harm your body. Visit Is Splenda for more information!

View Recent Entries

How Splenda Was Approved

How Splenda Was Approved
By Dr. Janet Starr Hull

Dr. Jacqueline Verett, a FDA toxicologist, told Congress in 1981 that “all aspartame studies were built on a foundation of sand and should be thrown out.” It's all a matter of public record for us to learn from our past mistakes.

Dr. Adrian Gross was the FDA toxicologist who tried to stop the “second” approval of aspartame. He told Congress that aspartame violated the Delaney Amendment that forbid putting anything in food that was suspect of causing cancer. He said thatbeyond any shadow of a doubt, aspartame could cause brain tumors and brain cancer. Because of this, he told Congress they shouldn't be able to set an allowable daily intake. His last words to Congress will always be remembered, " … and if the FDA violates its own law, who is left to protect the public?" 

Stated in the Delaney Clause [section 409(c)(3)(A) of the act], “…no food additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal.” But a loophole exists as the FDA states in the Final Rule report for acesulfame K:

“The Delaney clause applies to the additive itself and not to constituents used to process the additive. Thus, where an additive has not been shown to cause cancer, even though it contains a carcinogenic impurity, the additive is not subject to the legal effect of the Delaney Clause. Rather, the additive is properly evaluated under the general safety standard using risk assessment procedures to determine whether there is a reasonable certainty that no harm will result from the proposed use of the additive (Scott v. FDA, 728 F.2d

322 (6th Cir. 1984)).”

Therefore, even though the constituents methanol and chlorine used to make aspartame and sucralose, respectively, are proven carcinogens, it is not considered as such according to the final product safety rulings for aspartame and sucralose.

Patent Registration

When examining the patent information submitted for Splenda, I discovered some very interesting information surfaced that is not widely known.  The information is technical, yet it is important to transcribe the data as it is written in the patent.

What do these reports reveal?In the Abstract for the International Patent, the company referred to Splenda as chlorinated sucrose, which we have determined is quite toxic. The corporation also lists toxic chemical compounds used in the chlorination of sucrose. When comparing the two CAS Registry Reports, not only do the additional chemicals in the process of formulating sucralose come into the light, but there appear to be conflicts of interest in the promotion of sucralose, as well.

One patent report records sucralose as being 600 times the sweetness of sugar, while a second patent report states sucralose as having the sweetening power four to 2000 times that of sucrose.  Mike R. Jenner, one of the inventors of sucralose, co-authored the report “History and Development of Sucralose” with Samuel V. Molinary.  Molinary is the Research Director for PepsiCo and was the former Director of Scientific Affairs for GD Searle Pharmaceuticals, owner of Monsanto Chemical Company and The NutraSweet Company.  He is also panel Co-Chairman of the International Life Sciences Institute (ILSI).    

What Is The ILSI? As written on their website, ILSI, founded in 1978, “is a global network of scientists devoted to enhancing scientific basis for public health decision-making.”  They work closely with the World Health Organization (WHO), and “receive the majority of their funding and financial support through government funding, corporations, and foundations throughout the world.” Some of their members include:

(A complete list of members is included on this link...)

Foreign Approval Of Splenda

The U.S. Food and Drug Administration and government food authority committees and the Health Ministries in Canada, Mexico, Dominican Republic, Jamaica, Trinidad & Tobago, Argentina, and Brazil have confirmed the safety of sucralose. So have the countries of Colombia, Peru, Venezuela, Uruguay, Romania, Lebanon, Qatar, Bahrain, Pakistan, Tajikistan, China, South Africa, and Tanzania.

Re-read the list of these countries: Mexico, Jamaica, Tajikistan and Tanzania. These are the countries in which Splenda was first marketed. These are the countries used as sites of approval.

These are wonderful countries with vivid cultures and interesting people, but these countries are not nations with the same lifestyle, technology, or mass marketing strategies compared to the United States’. These countries are more concerned with birth control, food staples, hostile take-over, and drought - not diet sweeteners, weight loss campaigns, and soft drink machines placed in every business and school.  Let's compare apples to apples.

Totally And Completely Harmless?

McNeil Nutritionals markets sucralose as flawlessly safe for everyone. They claim it has been repeatedly tested so they can prove it is completely harmless. Nothing is totally and completely harmless. They also claim that sucralose is the most tested food additive in history.  I quote, "...more than one-hundred studies on the safety of sucralose designed to meet the highest scientific standards have been conducted and evaluated over the course of twenty years."  Having worked with the aspartame issue over the past thirteen years, I know this statement is debatable.

McNeil representatives state: “Millions of people have safely enjoyed Splenda, and products made with sucralose, since its introduction more than ten years ago.  It is one of the most tested food ingredients ever introduced and its safety has been confirmed by regulatory authorities in more than sixty countries.”

They also said the same thing about aspartame, which had over 200-documented research studies performed by both corporations and independent researchers. Don’t be fooled by the numbers. A large number of studies usually imply negative results that require more scrutiny. I am suspicious of a product that claims to be safe if an inordinate number of tests are run.  To me, this implies negative results that must be retested.

Consumers are witnessing the same “set-up” with sucralose as with aspartame in so many ways. There are comparisons between sucralose and aspartame throughout this book. As I wrote in my first book, Sweet Poison, no long-term corporate studies on humans have been done, corporate payrolled researchers are responsible for the results submitted to the FDA, to the media, and to scientific journals, only selective results are reported (out of the hundreds of experiments performed), and “government / corporate involvement” is clearly documented.1 We must remember to value independent research results as being just as valid as those funded by the corporations.

Safe And Natural

The corporations maintain sucralose is safe and natural. They said the same thing about aspartame, and after two decades of warnings from independent researchers and consumers, look at the rampant disease and obesity taking over America. We must remember to value independent research results as being just as valid as those funded by the corporations.

"While there are a lot of industry-sponsored safety studies on these substances, I don't believe there is enough independent research to tell us whether we should be using them in moderation or at all," said Dr. Jeanette Newton Keith, a gastroenterologist and an assistant professor of medicine at The University of Chicago's Pritzker School of Medicine. 2

In the absence of independent data, she advises patients to avoid the non-nutritive sweeteners entirely. She accredits anecdotal reports linking aspartame (Equal®) to memory loss, seizures, chronic headaches and neurological disorders. After years of personally working with hundreds of patients suffering from aspartame poisoning, I agree with Dr. Keith and encourage all practitioners to consider artificial sweeteners as a probable cause of illness, especially when their doctor cannot offer any known cause for observable health symptoms.

1. Hull JS. Sweet Poison: How The World’s Most Popular Artificial Sweetener Is Killing Us-My Story. New Horizon Press, 1997.

2. Keith JN. Report 2.1460. Gastroenterology Section, AMB S401F (MC 4080): 188-1477.

Posted on February 7, 2005 in Politics | Link To This Entry | Comments (1)


Posted by: gail on November 6, 2005 6:14 PM

I am allergic to aspartame, BIG TIME! And suddenly I'm finding my throat closing after tasting DOmino's conf. sugar, m&m's and all sorts of things that don't have splenda, or nuri-sweet or sorbitol (yes that causes a reaction for me as well) LISTED! I've found that our oldest daughter, my father and many of my relatives have been having the same reactions to the same products. Can they just put this product into foods without a listing n the label?!!! Is there any legal recourse for me?


Would you like to discuss this article or provide a comment?

Visit Dr. Janet Starr Hull's Alternative Health Web Forum and discuss Splenda toxicity information.


View Recent Entries