Splenda® has become one of the more popular artificial sweeteners in use today. The marketing campaign for Splenda® has centered around the fact that sucralose, the main ingredient in Splenda®, is made from sugar. So, the marquee of the marketing campaign is “Made from sugar, so it tastes like sugar.”
The clear implication is that since sucralose is made from sugar it must be good for you. And, since the FDA (Food & Drug Administration) has given its approval for sucralose it has to be safe for human consumption. Even McNeil, the maker of sucralose, touts that it is “extremely proud of the strong clinical database that supports the safety of sucralose.”
Because of statements like this and the FDA approval, millions of people are now taking doses of Splenda® on a daily basis without concern for any potentially negative impact on their future health. Fortunately, though, many have become untrusting of the FDA and its approval process and are at least asking the question of whether Splenda® is really completely safe to consume. I have read the FDA’s multi-page final ruling for the approval for Splenda® (sucralose) and am deeply disturbed. I will share my concerns with you in just a moment.
There is an old saying of, “What you don’t know can’t hurt you.” Splenda® is a great example of how this saying could not be further from the truth. So, I am going to give you facts about Splenda® 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:
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, 6-chloro-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.
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. Part of that question was just answered in that the body no longer uses the molecule to make energy. Since most of us have a problem with getting too much energy from the foods we eat, this first characteristic change is not necessarily bad.
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 have been 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 way 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 the results of their studies were negative, 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:
Cancer Causing Potential
Immune System Toxicity
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 abberation assay in cultured human lymphocytes, the sex-linked recessive lethal assay in Drosophila melangaster, and the covalent DNA binding potential study in rates. 1-6-DCF (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 in just two years. 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? Do you really think that the FDA is looking out for your best interests or for that of the company about to make billions?
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. Here are the findings as reported by the FDA:
“Animals receiving sucralose or an equimolar mixture of sucralose hydrolysis products…did not exhibit any clinical signs of neurotoxicity. The agency concludes that the lack of neurotoxic effects by both sucralose and its hydrolysis products at the tested dose levels in these studies provides assurance that sucralose used as a food additive under the proposed condition of use will not produce neurotoxic effects.”
In layman’s terms the FDA stated that 28 days of testing in monkeys and mice was enough proof for them that there would not be neurotoxic effects in humans. The important differences are that we are not monkeys or mice and that humans now use sucralose daily for years and years. 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, case studies from 2006 and 2007 where presented in the peer-reviewed journal of Headache showing that sucralose was a trigger for migraine headaches (Headache. 2006 Sep,46(8): 1303-4. and (Headache: The Journal of Head and Face Pain, Volume 47, Issue 3, page 447, March 2007) But wait, the FDA stated that sucralose was not neurotoxic. 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 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 Splenda® 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. And recent studies show that artificial sweeteners actually cause more problems for weight loss than benefits. So, the lack of calories is no real benefit.
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!
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!
Why would anyone continue to use Splenda®?
My answer: I have no idea!
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. Look at the available facts and be critical when you are evaluating anything in the health care arena.
So, what do you use instead of chemical sweeteners? You have many choices including regular sugar, raw sugar, honey, xylitol, or stevia, to name just a few. You can Google® “natural sweeteners” to get a more complete list.