Tuesday, November 18, 2008

The Truth about Sucralose (Splenda)

Sucralose is the new rave in artificial sweeteners. Many believe it to be a healthy alternative to proven neurotoxic substances like aspartame. But not so fast. One cannot base one's opinion on the healthfulness of an artificial sweetener (or anything else, for that matter) based upon the marketing hype of the manufacturer.

I'm offering today's post with the help of my friend, Dr. Ed Zimmer, who wrote an excellent detailed article on this some time ago. What you see here are excerpts from Dr. Zimmer's article.

From the article:
I have read the FDA’s multi-page final ruling for the approval for Splenda® (sucralose) and am deeply disturbed. There is an old saying: “What you don’t know can’t hurt you.” Splenda® is a great example of how this statement could not be further from the truth. So, I am going to give you facts about Splenda® and the man-made chemical, sucralose, and allow you to come to your own conclusion as to whether you think it is a good idea to allow yourself, your children, or anyone you care about to be dosed with this chemical on a regular basis.

Understanding The Chemistry
The first thing that you need to know is that sucralose is not a natural molecule. All you need to do is to take a look at the chemical name for sucralose to understand that it is not natural (see diagram). It is a man-made chemical that falls into the class of chemicals known as chlorinated hydrocarbons. Other chemicals that fall into this same category include many dangerous pesticides like dioxin and DDT. The chlorinated monosaccharide, 6chloro-6-deoxy-D-glucose is a known neurotoxin. Thus, sucralose falls into a category of molecules that should immediately raise serious questions about potentially deadly health concerns.

To be fair, however, you need to know that not all chlorinated molecules are toxic to humans. We cannot, in good faith, immediately make the connection that sucralose is a toxin just because it is a chlorinated hydrocarbon.

Not So Splendid...
To be a little more specific about how sucralose is made, man has taken a natural sugar molecule and forced three chlorine groups to be unnaturally added. The addition of these three chlorine groups causes the body to not recognize the molecule as sugar any longer. The benefit of this for the marketplace is that it creates a molecule about 600 times sweeter than sugar that is not used by the body to make energy. Thus, it has no calories.

The logical question to ask next is how the addition of these three chlorine groups affects the natural sugar molecule. The only way to assess what this new, unnatural molecule will do to humans is to perform studies. This is where the scary part begins.

You would assume that in order to gain FDA approval there would have to be numerous independent studies done to prove the safety of this chemical. You would also assume that if the studies performed raised any questions about potential health concerns that the FDA would err on the side of safety and would not approve a questionable chemical as being safe for consumption.

You assume too much!

As you read about the following information, remember that McNeil is extremely proud of the studies they have done on sucralose.

The Testing of Splenda®
As is common with the FDA approval process, the only testing and studies supplied for consideration were done by the very same company that had financial interests in the product. The truth is that if their study results were negative in nature they would stand to lose billions of dollars. This is quite a motivation to design studies in a way that would decrease the chances of negative results. And, as you will soon see, any negative results were vigorously defended and explanations were quickly formulated.

The studies supplied to the FDA by McNeil (the maker of Splenda®) addressed a number of concerns including but not limited to:

• Fetal Toxicity • Reprodcutive Toxicity • Cancer Causing Potential • Immune System Toxicity • Brain Toxicity • Kidney Toxicity • Diabetic Effects • Environmental Effects
As I stated earlier, you would expect that the results from these studies would have shown no real concerns, as the FDA did approve sucralose for human consumption. This, unfortunately, was not the case and the FDA went out of its way to defend the negative study results instead of erring on the side of safety for consumers.

What The Studies Revealed...
All of the studies submitted to the FDA for approval were animal studies. So, we really do not know what sucralose does to humans from these studies. The studies submitted by McNeil revealed some very disturbing findings. I will use direct quotes from the FDA Final Report so that you can see exactly what the results were. The partial list of negative findings follows.

The testing for gene toxicity (cancer potential) revealed:

“...sucralose and its hydrolysis products showed weakly genotoxic responses in some of the genotoxicity tests.”

“Tests for clastogenic (capable of causing breaks in chromosomes) activity of sucralose in a mouse micronucleus test and a chromosomal abberration test in cultured human lymphocytes were inconclusive. Sucralose was weakly mutagenic in a mouse lymphoma mutation assay.”

“Results of three other genotoxic tests were inconclusive: The chromosomal abberration assay in cultured human lymphocytes, the sex-linked recessive lethal assay in Drosophila melangaster, and the covalent DNA binding potential study in rates. 1-6DCF (a by-product of sucralose) was weakly mutagenic in the Ames Test and the L5178Y TK+/- assay.”

So, sucralose and its by-products did show some toxicity to genes. This is not a good thing as it could potentially lead to the development of cancer. The FDA simply dismissed these finding stating that the 2 year cancer studies done in rats were negative and thus, the findings of gene toxicity were insignificant. This was quite a leap of faith taken by the FDA. In other words, The FDA suggested that since limited tests done in rats did not show any increased cancer rates, the actual finding of gene toxicity should be completely dismissed. And, they were.

I ask you to think about how cancer develops in people who are exposed to cancer-causing toxins. Take asbestos exposure for example. When did people exposed to this toxin develop cancer? Did it take months, a couple of years, or many years? The answer is many years. Most people did not develop cancer for over a decade.

So, how can the FDA simply dismiss findings of gene toxicity through a two-year rat study and conclude that sucralose will not cause cancer in the long-term?

The testing for immune toxicity revealed that sucralose caused damage to the immune system:
“...when rats were fed sucralose in a 4 to 8 week range finding study the following effects were noted: Decreased thymus and spleen weights (immune tissues) , lymphocytopenia (reduced white blood cells), and cortical hypoplacia of the spleen and thymus.”

In an effort to reduce the negative impact of these findings, McNeil then followed this up with a study that only lasted 28 days. This new study again showed disruptions in immune functions at higher dose sucralose fed rats, but not in lower dose groups. The FDA found this 28 day study to be sufficient in defining the safety of sucralose for dosing in humans to not cause immune function disruptions. The bottom line is that the studies conclusively showed that sucralose could have a negative effect on the immune system.

One of the more disturbing findings revealed through the FDA Final Report concerned the testing to determine the neurotoxicity (brain toxicity) of sucralose. Remember that sucralose is of the same family of chlorinated hydrocarbons as are many dangerous pesticides. The question of neurotoxicity is a big one.

McNeil conducted two neurotoxicity studies, one in mice and one in monkeys. The tests were performed for only 21 and 28 days, respectively. How in the world would a 28 day study give the FDA enough comfort to make their conclusion that sucralose is not neurotoxic for long-term use by humans?

Interestingly enough, a 2006 peer-reviewed study in the journal of Headache presented a case study where sucralose was a trigger for migraine headaches (Headache. 2006 Sep,46(8): 1303-4.)
But wait, the FDA stated that sucralose was not neurotoxic. Testing for brain toxicity was done in monkeys for only 28 days! Could they have been wrong?

Are you comfortable with the conclusion that sucralose has no neurotoxicity? Instead of rushing to approve this chemical, why didn’t the FDA call for longer term human trials? Again, is the FDA looking out for you, or for the company?

Because of space restraints, I will summarize the other negative findings from this FDA report. The FDA dismissed all of these findings as not having been substantive.

• Enlarged liver and kidneys • Reduced growth rates • Decreased red blood cell count • Extension of pregnancy periods • Decreased fetal body weights • Subcutaneous Fetal edema (swelling of the fetus) • Increase in HbA1C (Hemaglobin A1C a marker for bad sugar control)

The bottom line is that the limited amount of studies performed on sucralose have raised serious questions about this chemical’s negative effects on immune system function, brain function, fetal toxicity, and the increased risk for cancer. These are not conspiracy theories. These facts are found in the FDA’s own report. The FDA simply doesn’t think these facts are important.

McNeil, for obvious reasons, wants you to believe that their product is safe. I am frightened by what I have learned and am far from convinced.

As you sort through the data I have provided for you in this article I would like you to consider a number of important questions.

Is sucralose natural in any way? My answer: No, it is a man-made chemical in the same class as many pesticides.

Is Splenda® (sucralose) good for you in any way? My answer: No. Your body can’t even use it to make energy.

Have there been legitimate questions raised regarding the safety of Splenda® for human consumption? My answer: You bet there have!

When those questions are raised, do you feel that the FDA errs on the side of safety for consumers? My answer: Not by a long-shot! Why not call for additional INDEPENDENT long-term studies to completely answer the legitimate questions that have been raised?

Have there been any human studies completed with Splenda® to address these major concerns?
My answer: None after 8 years!

Knowing about the potential negative effects on the immune system and the nervous system would you give this chemical to your children or to the child growing in your womb? My answer: No way!

Final Thoughts
Most of us have an inherent trust that our health care system, as a whole, is looking out for our best interests. In general, I have to say that I do not necessarily disagree with this statement. However, you should not be blinded by the fact that many aspects of our health care delivery system regard profit over your well-being. In my opinion, the FDA too many times is one of those organizations.

I am dismayed by how many of my patients and my close friends dismiss any negative information about a product if it has been approved by the almighty FDA. I urge you as a consumer of health care to guard against falling into a false sense of security simply because something has FDA approval. There are hundreds of drugs that have been approved by the FDA only to have been removed from the market many years and many deaths later. (This concludes Dr. Zimmer's article.)

My Concluding Remarks

Some alternative natural sweeteners to consider are Stevia and Xylitol, fructose and honey. But steer clear of anything that was made in a laboratory and that is a chemical. I would encourage you to check the labels of your chewing gums, commercial teas and colas, and anything packaged, because nearly all commercial products that don't contain sugar contain at least one chemical sweetening agent.

Again, I would like to thank Dr. Zimmer for thoroughly researching this issue.

Dr. Zimmer received his undergraduate degree in Chemistry from DePauw University in Greencastle, Indiana. His Masters work in Nutrition was completed at Bridgeport University in Connecticut. He graduated Summa Cum Laude from the National College of Chiropractic and was voted outstanding graduate by the faculty. He and his wife, Sherri, have five children.