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Aspartame’s Dangers, Side Effects and FDA Approval Explained

July 31, 2010 | 404,479 views
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Aspartame, Brain Cancer & the FDA Approval Process



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The artificial sweetener aspartame gained FDA approval in 1981, and was perhaps the most hotly contested FDA approval in history, for good reason. The toxic additive has been silently destroying people's health ever since.
 

Dr. Mercola's Comments:

The first video above -- which contains highlights of Cori Brackett's documentary film Sweet Misery -- is an excellent summary of the problems with aspartame. I strongly urge you to watch it, or read through the transcript, as it offers additional and supporting information to what I'll discuss below. You can also obtain the entire DVD if you enjoy these clips.

Aspartame Consumption

By 1984, three years after its initial approval for use in tabletop sweeteners and dry food, US consumption of aspartame had already reached 6.9 million pounds per year. This number doubled the following year, and continued to climb well into the 90's.

According to statistics published by Forbes Magazine[i] based on Tate & Lyle estimates, aspartame had conquered 55 percent of the artificial sweetener market in 2003. One of the driving factors behind aspartame's market success is the fact that since it is now off patent protection, it's far less expensive than other artificial sweeteners like sucralose (Splenda).

2003 sales of artificial sweeteners by region

Today, the statistics on the aspartame market are being kept so close to the vest, it has proven to be virtually impossible to find current data on usage, unless you're willing to pay tens of thousands of dollars for a market analysis reports and I felt there were better uses for the money than to purchase the answer to that question..

However, a 2009 FoodNavigator article[ii]cites the current global market for aspartame as being less than 37.5 million pounds and worth $637 million.

According to aspartame.org[iii], diet soda accounts for 70 percent of the aspartame consumed. A 12 ounce can of diet soda contains 180 mg of aspartame, and aspartame users ingest an average of 200 mg per day.

However, it can be quite difficult to calculate just how much you're really ingesting, especially if you consume several types of aspartame-containing foods and beverages. Dosing can vary wildly from product to product. For example, the amount of aspartame will vary from brand to brand, and from flavour to flavour. Some can contain close to twice the amount of aspartame as others, and some contain a combination of aspartame and other artificial sweeteners.

Interestingly, aspartame consumption now seems to have stalled, and there is some indication it may even be on the decline. Perhaps sufficient numbers of people are finally waking up to the unsavoury truth about this chemical sweetener.

It is my intention to educate you about the truth of this harmful and toxic ingredient and drive sales down even further. I have no ulterior motives other than to warn you so that you can protect your and your family's health, and I sell no competing products.

The only alternative sweetener I recommend is natural stevia, especially the flavoured ones which avoid many of the aftertaste objections some people have about using stevia. It is interesting to note that the powerful food industry has made it illegal to sell natural stevia as a sweetener. If I recommended to use stevia as a sweetener and sold it, the government would immediately file criminal charges and confiscate our product.

On December 17, 2008, the FDA did grant GRAS (Generally Recognized as Safe) status to rebaudioside , which is one component of the whole stevia plant, and this specific purified component of stevia may be used as a food additive and sold as an alternative sweetener. Examples of include Truvia and Purevia. The jury is still out, however, on whether consuming this one component of stevia is as safe as consuming extract from the whole plant, as all the synergistic, protective factors have been removed in these refined products.

Thankfully there is a loophole that allows vendors to sell extract of whole stevia as a dietary supplement. Since virtually everyone knows it is a sweetener it doesn't have to say it on the label, so you can still bypass this industry initiated censorship.

Ajinomoto, one of the leading aspartame manufacturers in the world next to NutraSweet, actually rebranded aspartame to AminoSweet[iv] last year, in order to dissociate itself from the negative associations of aspartame.

It also wanted to "remind the industry that aspartame tastes just like sugar, and that it's made from amino acids – the building blocks of protein that are abundant in our diet," – as opposed to a concoction of chemicals never before consumed by man, some ingredients of which are more toxic than others.

They will probably deceive some consumers with this newer, more sweetly innocent name that does not bear the same controversial past as the word "aspartame." But I sincerely doubt they'll fool anyone even remotely aware of its dangers.

Aspartame can already be found in some 6,000 food products and beverages, and the list is about to get even longer, I'm sure, as Ajinomoto announced a global R&D alliance agreement with Kellogg Company[v] earlier this month.

Researchers Continue to Contest 'the Most Contested' FDA Approval in History

Concerned scientists and researchers fought and were successful in keeping aspartame out of the food supply for over ten years, ever since it was first considered as a potential food additive, and many of those still alive continue to speak out against it today.

If we fail to learn from history we are doomed to repeat the mistake we made. Many readers have long forgotten what the 60-Minutes' correspondent Mike Wallace stated in his 1996 report on aspartame – available to view in this 2009 article – that the approval of aspartame was "the most contested in FDA history." And for good reason.

At the time, independent studies had found it caused brain cancer in lab animals, and the studies submitted by G.D. Searle to the FDA for the approval were quickly suspected of being sloppy at best...

In that 60-Minutes video, former Senator Howard Metzenbaum states:

"According to the FDA themselves, Searle, when making their presentation to the FDA, had willfully misrepresented the facts, and withheld some of the facts that they knew would possibly jeopardize the approval."

Metzenbaum's staff investigated the aspartame approval process. He goes on to explain that:

"FDA officials were so upset they sent the file to the US Attorney's office in Chicago for the purposes of presenting it to the grand jury as to whether or not there should be indictments.

But it wasn't presented. It was delayed."

Samuel Skinner, the US attorney who led the grand jury probe ended up withdrawing from the case when he entered into job discussions with Searle's Chicago law firm, Sidley & Austin – a job he later accepted. Subsequently, the investigation stalled until the statute of limitation ran out, at which point the investigation against Searle was dropped.

For more details on the story of how aspartame made it through the FDA approval process despite warning signs of potential health hazards and alleged scientific fraud, please watch the 60-Minutes report, as Wallace does a nice job of summarizing an otherwise long story.

There are a number of well-written books on the market that detail the twists and turns of this part of history. This Harvard law summary of the legal wrangling[vi] that took place is also a worthwhile read.

Those who claim that aspartame watch-dogs are somehow engaged in conspiracy theories, perhaps do not understand the word "conspiracy," the simplest definition of which is: "a secret agreement between two or more people to perform an unlawful act."

In the case of aspartame, it sure does look as though it was a conspiracy -- by G.D. Searle & Co., to get a tremendously profitable product to market, no matter what the potential cost in terms of human health.

The FDA itself suspected Searle had unlawfully produced "evidence" to support its claims of safety, and FDA officials were sufficiently disturbed by what they received to launch its first-ever criminal investigation .

A section in the Harvard Law School summary on the history of aspartame states:

"Another study that engendered severe criticism from the Department of Health Education and Welfare was the 46- week toxicity study performed on the hamster.

Although the data appears to be faulty and incomplete, Searle argues that any falsehood in the study is not material to the appraisal of the safety of aspartame."

How's that for assurance?

"…In addition to criticizing the study as a whole, the Department alleges that Searle violated Title 18, Section 1001 by falsifying data. The report alleges that the testing ran into problems and instead of correcting them, Searle covered the problem up."

FDA toxicologist, M. Jacqueline Verrett, Ph.D., discussed what she knew about some of these concerns in her testimony before Congress on November 3, 1987 (S.hrg;100-567).

Verrett's individual testimony is reprinted here, in which she states:

"From 1957-1977 I was employed as a Biochemist/Toxicologist in what is now designated the Center for Food Safety and Applied Nutrition of the Food and Drug Administration.

… In the early l970's, I examined the animal studies submitted by G. D. Searle and Co. on aspartame prior to the initial approval by FDA in l974... these studies raised numerous questions in a number of areas that needed to be resolved before approval of aspartame for any food additive use.

In 1977 I served as a member of an FDA team… charged with examining three studies… to determine if they were 'authentic'. I wish to emphasize at this point that we were specifically instructed not to be concerned with, or comment upon, the overall validity of the study, this was to be done in a subsequent review carried out at the Bureau level.

It is apparent that that review, on a point by point basis, discarded or ignored the problems and deficiencies outlined in this Team report, and concluded that, even in toto, these problems were insufficient to render the study invalid. It also appears that the serious departures from acceptable toxicological protocols that were noted in the reevaluation of these studies were also discounted."

Verrett goes on to point out a number of the "deficiencies and improper procedures encountered" by her investigative team, which included but were not limited to:

  • Animals were not permanently tagged to avoid mix-ups
  • Tumors were removed and the animals returned to the study
  • Animals were recorded as dead, but subsequent records, after varying periods of time, indicated the same animal was still alive (almost certain evidence of mix-ups)
  • Many animal tissues were decomposed before any postmortem examinations were performed

"Almost any single one of these aberrations would suffice to negate a study designed to assess the safety of a food additive," Verrett said, "and most certainly a combination of many such improper practices would, since the results are bound to be compromised.

It is unthinkable that any reputable toxicologist, giving a completely objective evaluation of data resulting from such a study, could conclude anything other than that the study was uninterpretable and worthless,and should be repeated.

This is especially important for an additive such as aspartame, which is equally vital since DKP is a major breakdown product of aspartame in liquid media.

Not only is aspartame being used in the absence of basic toxicity information, but there is also no data to assess the toxicity of the interactions of DKP with the excess phenylalanine generated, with any other metabolite of aspartame, and its interactions with other additives, drugs, or other chemicals which may be present simultaneously in persons exposed to high levels of DKP in presweetened liquids such as diet drinks."

Many critics are using the lack of toxicity data as proof that aspartame is safe, when in fact aspartame appears to have been approved WITHOUT such data – which in my opinion is just another sign of aspartame's inherent LACK of empirical safety record…

Which brings us to a crucial point.

If you do not know this fact, you may never be able to extract the truth, because the 200+ studies that form the basis of aspartame's multiple FDA approvals DO exist. Those studies were published, and are quite easy to find as they're cited by every single conventional health agency and every single aspartame peddler across the world. No one is trying to refute the fact that they exist.

However, they were ALL funded by the aspartame industry.

And guess what happens when you remove corporate interest and influence from the equation…

All Industry-Funded Studies Give Aspartame Clean Bill of Health, While Majority of Independent Research Find Indications of Hazards

A 1996 review of 165 studies[vii] [viii] believed to be relevant to human safety, by Dr. Ralph G. Walton, a professor of Clinical Psychiatry, showed a remarkable discrepancy between study results and their source of funding.

Of the 165 studies, 74 had industry related funding (such as Searle, Nutrasweet®, Ajinomoto, and the International Life Sciences Institute Nutrition Foundation), and 91 were independently funded.

Of those:

  • 100 percent of the industry funded studies supported aspartame's safety, while
  • 92 percent of the independently funded studies identified at least one potential health concern

However, Dr. Walton also pointed out that of the seven remaining non-industry funded studies, which supported aspartame's safety, six were done by the FDA, and the seventh was a literature review of mostly industry sponsored research.

Considering the long-standing revolving door between various industries (especially Monsanto, which acquired G.D. Searle in 1985) and the FDA, it's questionable as to whether an FDA study can be considered truly "independent," even though they were counted as independent in Walton's review.

If you give that concern any merit, you'd more or less be looking at 100% of industry related studies claiming aspartame to be safe, and 100% of independent studies flagging some sort of health concern.

If this doesn't make you raise an eyebrow, then no need to read any further. You've slipped comfortably into the all-accepting fold of corporate self-interests, created by massively successful propaganda and public relations efforts, backed by powerful political lobbying.

Only you can decide whether or not you find this discrepancy to be acceptable evidence of rigorous scientific inquiry.

If it makes you question the validity of aspartame's "100% safe" designation, then read on…

Your Brain on Aspartame

In the Sweet Misery video above, Dr. Russell Blaylock, a recently retired board-certified neurosurgeon and author of the book Excitotoxins: The Taste That Kills, says that because aspartame is "a poison that affects protein synthesis; affects how the synapses operate in the brain, and affects DNA, it can affect numerous organs. So you can get many different symptoms that seem unconnected."

However, "when looking at the list of symptoms submitted to the FDA, most of them are neurological," Dr. Blaylock says.

He's referring to a Department of Health and Human Services report that categorizes 10,000 adverse reaction reports logged by the FDA (Department of Health and Human Services Quarterly Report on Adverse Reactions Associated with Aspartame Ingestion, DHHS, Washington, DC, October 1, 1986), published here in a 24-page primer on aspartame by Donald Harkins[ix], the former editor and publisher of the Idaho Observer.

Two years prior to that, a CDC MMWR dated November 2, 1984[x], discusses several hundred adverse reaction reports received, and at that time, the majority -- 67 percent – of complainants also reported neurological/behavioral symptoms.

Some of the most commonly reported neurological symptoms include:

  • Headaches
  • Changes in behavior or mood
  • "Fuzzy" thinking
  • Seizures
  • Depression[xi]

A 1987 study published in the journal Environmental Health Perspectives[xii] states:

"If only 1% of the 100,000,000 Americans thought to consume aspartame ever exceed the sweetener's ADI, and if only 1% of this group happen coincidentally to have an underlying disease that makes their brains vulnerable to the effects of an aspartame-induced rise in brain phenylalanine levels, then the number of people who might manifest adverse brain reactions attributable to aspartame would still be about 10,000, a number on the same order as the number of neutrally related consumer complaints already registered with the FDA and other federal agencies."

[Note: the ADI for aspartame is 50 mg/kg of body weight in the US. ADI in Europe and Canada is 40 mg/kg of body weight. ]

Published in the European Journal of Clinical Nutrition in 2008[xiii], a South African study offers further information on the potential workings of aspartame on your brain:

"Phenylalanine plays an important role in neurotransmitter regulation, whereas aspartic acid is also thought to play a role as an excitatory neurotransmitter in the central nervous system.

Glutamate, asparagines and glutamine are formed from their precursor, aspartic acid.

Methanol, which forms 10 % of the broken down product, is converted in your body to formate, which can either be excreted or can give rise to formaldehyde, diketopiperazine (a carcinogen) and a number of other highly toxic derivatives.

Previously, it has been reported that consumption of aspartame could cause neurological and behavioral disturbances in sensitive individuals. Headaches, insomnia and seizures are also some of the neurological effects that have been encountered, and these may be accredited to changes in regional brain concentrations of catecholamines, which include norepinephrine, epinephrine and dopamine.

The aim of this study was to discuss the direct and indirect cellular effects of aspartame on the brain, and we propose that excessive aspartame ingestion might be involved in the pathogenesis of certain mental disorders (DSM-IV-TR 2000) and also in compromised learning and emotional functioning."

There has been loads of conflicting "science" regarding the metabolism of methanol. The emerging evidence suggests that it may be a toxic poison that is one of the leading contributing factors for MS, and that some of the research is subsidized by the producers of methanol to make it appear less harmful.

I hope to an interview in the near future with an expert to review and clarify these details.

 

Aspartame and Headaches

The Sweet Misery documentary also includes Dr. H.J. Roberts M.D., a board-certified internist and author of Aspartame Disease: An Ignored Epidemic, who does a fine job of explaining, in layman's terms, what aspartame is made of, and how patients have, and can, test their vulnerability to this chemical using cessation and rechallenge. (I will also offer further suggestions on how to do this at the end of this article.)

This type of anecdotal evidence, which critics love to dismiss as silly nonsense, can nonetheless be invaluable to the individual in question, as you can clearly discover whether there's a direct cause and effect on your body from consuming aspartame.

Dr. H.J. Roberts is one of several expert investigators on aspartame and has testified before congress on the topic of aspartame safety.

In a document titled, Professional Opinion of H.J. Roberts, M.D., F.A.C.P., F.C.C.P., Concerning Headaches Caused by the Use of Products Containing Aspartame, he states that:

"People who suffer aspartame-induced headache are likely to encounter denial of this condition by physicians, the FDA and manufacturers.

This situation is largely influenced by "negative scientific studies" sponsored by corporate interests.

I have repeatedly challenged the nature of such studies, especially when the aspartame was administered as capsules or freshly-prepared cool solutions rather than "real world" products, namely soft drinks and other products sold in markets that undergo changes on exposure to high temperature or with storage of more than one or two months."

One study commonly cited by industry to refute the claim that aspartame causes headaches is the 1987 NEJM study[xiv] which concluded that "aspartame is no more likely to produce headache than placebo."

However, this study, again, has financial ties to Monsanto (owner of G.D. Searle), and the aspartame was given in capsule form, for one day…

There are a number of studies that point to concerns related to aspartame's detrimental impact on neurological function.

Under Sources above, you will find a link to a page on my site where I've created a list of studies, sorted by the health concern they pertain to, and headaches is just one of many potential concerns. That page is evolving, and I will continue to add to it as I find more relevant studies.

In my follow-up article, I will foray into a couple of the other health problems associated with aspartame.

Taking the Precautionary Principle into Account

Any good scientist, and any skeptic worth their own weight, would follow the evidence to its logical conclusion, no matter where it leads. Unfortunately, we have overwhelming evidence showing that it's nearly impossible to be impartial when your paycheck is on the line. Any corporation that pays you to investigate their product wants you to produce favorable results, and we know that powerful corporations can make these desires well understood by those who work for them.

Likewise, any good doctor or health professional would adhere to the Hippocratic Oath that says, "First, do no harm." Yet here we have a chemical sweetener being added to some 6,000 food products, which, due to its sheer prevalence and fervent backing by the conventional medical industry and health agencies, has the potential to harm a vulnerable section of the population.

You're told it is perfectly safe. (Unless you have a genetic disease called phenylketonuria (PKU), which prevents you from digesting the amino acid phenylalanine. An estimated 1 out of every 15,000 people are born with PKU. This is why aspartame containing products bear a warning label stating the product contains phenylalanine.)

But do you know whether or not you have phenylketonuria, or are part of any other "generally vulnerable" group of people?

Wouldn't you want to know if you might be at risk?

And if you knew you were vulnerable to its toxic effects, would you still consume high amounts of aspartame?

If you were not, but you knew that a family member or friend was part of that vulnerable subgroup, would you warn them?

These are simple questions that tend to get completely lost in the pro- versus anti-aspartame debate.

Do you think it's acceptable to willfully sacrifice those who are more vulnerable by issuing no warnings whatsoever? And worse -- pulling the wool over their eyes and saying aspartame has no related health hazards whatsoever, even at very high amounts?

I think not.

Consider the 1986 review of 231 adverse reactions to aspartame[xv], which found "no clear symptom complex that suggests a widespread public health hazard associated with aspartame use." Yet in the following sentence, the researchers admit that:

"…in some case reports… the symptoms may be attributable to aspartame in commonly-consumed amounts.

The systematic application of pre-defined review criteria, such as those described here, to monitor consumer complaints related to food additives will help identify products that warrant more focused clinical studies."

Staunch aspartame promoters pay no attention to that part – the part that states a certain number of individuals may indeed suffer health consequences, even from commonly-consumed amounts.

They also pay no attention to the fact that this review occurred a mere three years after the US became saturated with aspartame-containing beverages. Today we have thousands upon thousands of adverse reaction reports, anecdotal reports, and physician's case histories…

These people are indeed being sacrificed, without remorse whatsoever, by those hiding behind supremely biased, profit-driven, industry-funded research.

The conventional medical establishment and our health agencies are frightfully resistant to the possibility that aspartame may have anything to do with health problems – after all, aspartame is FDA approved and has been "safely used" for years!

I have one word for you – Vioxx.

Just one of a multitude of FDA-approved products that -- lo and behold – killed tens of thousands of people while the establishment reiterated the industry-funded "scientific evidence" that was the basis for its widespread use.

Are Your Health Problems Related to Aspartame Consumption?

You might not realize you're having a reaction to aspartame. In fact, most people don't make the connection, and a tremendous amount of time and money is spent by aspartame "reactors" (people sensitive to the chemical), trying to find out why they are sick.

To determine if you're a reactor, take the following steps:

  1. Eliminate all artificial sweeteners from your diet two weeks. (Note: If you typically consume aspartame in caffeinated drinks, you'll want to gradually reduce your intake in order to avoid caffeine withdrawal symptoms.)
  2. After two weeks of being artificial sweetener-free, reintroduce aspartame in a significant quantity (about three servings daily) and avoid other artificial sweeteners during this period.
  3. Do this for one to three days and notice how you feel, especially as compared to when you were consuming no artificial sweeteners.
  4. If you don't notice a difference in how you feel after re-introducing aspartame, it's a safe bet you're able to tolerate aspartame acutely, meaning your body doesn't have an immediate, adverse response. However, this doesn't mean your health won't be damaged in the long run by this chemical and its breakdown products.

I'm not trying to deny anyone the pleasure of life that is generated from consuming sweets. However, to promote aspartame to the population at large, without warning that a certain percentage of people may suffer terribly from its consumption is a reckless, irresponsible ethical breech, and clearly contributes to much unnecessary suffering in exchange for hundreds of millions of dollars of profit..

In the end it's up to you to decide what you want to put into your body. Just make it an educated decision.

For more information on the dangers of aspartame, visit http://aspartame.mercola.com.


References


 

[i] Forbes Magazine, Sweet Stuff, Michael Freedman, January 10, 2010,

[ii] Foodnavigator-usa.com, Ajinomoto embarks on green marketing campaign, Caroline Scott Thomas, January 20, 2009,

[iii] http://www.aspartame.org/index.html

[iv] FoodBev.com, Ajinomoto brands aspartame 'AminoSweet', Shaun Weston, November 17, 2009

[v] Ajinomoto Co. Inc. Press release, Ajinomoto and Kellogg Company Create Research and Development Alliance, July 12, 2010

[vi] LEDA at Harvard Law School, The History of Aspartame

[vii] Worldstar.com, Aspartame Studies: Correlation of Funding and Outcome, John McCrione

[viii] SURVEY OF ASPARTAME STUDIES: CORRELATION OF OUTCOME AND FUNDING SOURCES, Ralph G. Walton, M.D.

[ix] The Artificially Sweetened Times -- An expose' of the hidden addiction killing people worldwide, Donald Harkins

[x] CDC, Evaluation of consumer complaints related to aspartame use. Morbidity Mortality Weekly Report, 1984;33:605-7

[xi] Biological Psychiatry, Adverse reactions to aspartame: Double-blind challenge in patients from a vulnerable population, Ralph G. Walton, Robert Hudak, Ruth J. Green-Waite, July 1, 1993; 34(1): 13-17,

[xii] Environmental Health Perspectives, Possible neurologic effects of aspartame, a widely used food additive, Timothy J. Maher, Richard J. Wurtman, 1987, Volume 75, pp. 53-57

[xiii] European Journal of Clinical Nutrition, Direct and indirect cellular effects of aspartame on the brain, P Humphries, E Pretorius and H Naudé, 2008; 62, 451–462, published online 8 August 2007,

[xiv] The New England Journal of Medicine, Aspartame and susceptibility to headache,SS Schiffman, CE Buckley, HA Sampson, EW Massey, JN Baraniuk, JV Follett, and ZS Warwick, November 5 1987; 19(317):1181-1185,

[xv] American Journal of Clinical Nutrition, Evaluation of reactions to food additives: the aspartame experience, Kirsten Bradstock, Mary Serdula, James Marks, Robert Barnard, Nancy Crane, Patrick Remington, Frederick Trowbridge, March 1986, Volume 43, pp. 464-469,


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