VERY IMPORTANT, WHEN YOUR CHILDREN'S CHEWABLES OR ANYTHING THEY TAKE SAYS: * CONTAINS ASPARTAME. ** PHENYLKETONURICS: CONTAINS PHENYLALANINE. DO NOT LET THEM EAT IT!
Everything seems to contain aspartame today. I have an eight-month-old son. Is aspartame safe for use in children?
PEDIATRICIAN DR.PAUL Answers: A very good question which makes me think of a few other "inactive" ingredients found in food and drug products.
In fact, there are over 700 chemical agents including aspartame, coloring dyes, preservatives in food and asthma medications which have been FDA approved for use as "inactive ingredients". They are labeled as inactive, as they presumably do not have any effect on the people consuming them.
For example, the active ingredient in a chewable fever tablet, would be acetaminophen. The aspartame, an inactive component, acts as an artificial sweetener but presumably has no other effects.
Looking specifically at your concern, aspartame is being increasingly used in chewable tablets and other sugar-free medications, as well as in diet sodas, gum and sweetened foods such as pudding and cereal. While considered safe in children, there have been some concerns about aspartame in children with in-born metabolic problems such as PKU (or phenylketonuria).
In normal children, it can be taken safely in small amounts. However, when a small child drinks a 12-ounce can of diet soda he consumes almost twice the daily amount considered safe.
What are the effects of aspartame? Although there are not that many studies, some reports suggest symptoms that may include headache (especially in patients prone to migraines), mood changes, dizziness and panic attacks. There is no link between aspartame use and aggressive or hyperactive behaviors in children. The bottom line is: taken in small amounts, such as in medications I think aspartame is safe. But we should not take the fact that it is labeled as inactive at face value.
How Safe IS Aspartame?
WARNING: Side effects may include: Seizures. Depression. Brain damage. Memory loss. Migraine headaches. Numbness. Blindness (57-66). Serious sounding repercussions. Surely the FDA would warn you if it knew a common product might trigger reactions like these.
NOT SO. This substance, sweetly packaged, rests quietly on tabletops, in soft drinks, chewing gum, vitamins and in medicines (37-55). The illusion it portrays is as free of warning as a Sunday stroll in the park. Consumers recognize it by its attractive red and white swirled logo, and are drawn by its promise of an all-natural, low-calorie, sweet flavor. In a country obsessed by dieting and abhorrent of the perceived sins of sugar, this product has gained unprecedented popularity since it was discovered accidentally thirty years ago by a chemist mixing chemicals in search of a medicine to relieve ulcers. NutraSweet. Equal. Equal Measure. Spoonful. Its brand names are ubiquitous in food and food products as it corners the market on low calorie sweeteners. Aspartame, as it is known generically, skyrocketed to its position as the most popular sugar substitute in the world shortly after it gained approval for public consumption. Worldwide, the aspartame industry's sales of the product amount to over $1 billion yearly. (58) In the United States, NutraSweet enjoys a $700 million sales share, and shows no signs of retreat. (58,68)
The NutraSweet group became a part of G.D. Searle Company, a pharmaceutical business, after one of its chemists discovered the sweetener, and realized the sales potential of a sugar substitute. Searle and NutraSweet are now owned by Monsanto Company. Producers of NutraSweet maintain their platform that the safety of aspartame has been confirmed. They cite affirmation of aspartame by a number of agencies and organizations nation-wide, including the American Medical Association, the World Health Organization, the American Academy of Pediatrics, the American Diabetes Association, the American Dietetic Association, and the American Epilepsy Association. Yet aspartame came amazingly close to not being approved by the Food and Drug Administration (FDA) in the first place. What aspartame actually is, and how it affects certain individuals, is at the heart of a continuing controversy over its increasing distribution in food (including food served in hospitals), medicine, candy, confections, cereal, soft drinks, and scores of other products.
Known chemically as aspartame (C14H18O5), NutraSweet is a compound composed of the following chemicals by weight: methanol (10%), aspartic acid (40%), and phenylalanine (50%). In dry form, the composition is stable, however, when placed in liquid it can break down into its component parts (methanol, aspartate, and phenylalanine). Heat will speed its breakdown. Another breakdown product is diketopiperazine (DKP). In certain combinations these elements can results in adverse reactions in some people. Methanol further breaks down into formaldehyde and formic acid, both known to cause serious side effects in sensitive individuals. (58,64,67,69)
The RANDOM HOUSE DICTIONARY defines methanol (also known as methyl alcohol) "as a colorless, poisonous liquid used chiefly as a solvent, fuel, etc." (70) Methanol is on the Environmental Protection Agency's (EPA) Community Right to Know List, and is reported in EPA's Toxic Substances Control Act Inventory. Sax's Dangerous Properties of Industrial Materials states methanol is "a human poison by ingestion." (71)
The levels of methanol are quite low in a single serving of a product containing aspartame, provided that it has not been exposed to heat or left for a long time on the shelf. Because these factors promote the breakdown of aspartame into its component parts, researchers are concerned that high consumption levels combined with aspartame's unstable shelf life may allow methanol to reach toxic levels in some cases. (21,72) Human systemic effects from methanol include changes in circulation, cough, headache, nausea and vomiting, optic nerve neuropathy, respiratory effects, and visual field changes. In experiments, it has shown teratogenic (birth defects) and adverse reproductive effects.
Genetic mutations from methanol have been reported in human tissue. Methanol is classified as a narcotic. (71) According to Sax, methanol's "main toxic effect is exerted upon the nervous system, particularly the optic nerve, and possibly the retinae which can progress to permanent blindness. Once absorbed, methanol is only very slowly eliminated. Coma resulting from massive exposures may last as long as 2-4 days. In the body, the products formed by its oxidation are formaldehyde and formic acid, both of which are toxic. Because of the slow elimination, methanol should be regarded as a cumulative poison. Though single exposures to fumes may cause no harmful effect, daily exposure may result in the accumulation of sufficient methanol in the body to cause illness. Death from ingestion of less than 30 ml (milliliters) has been reported." (71) Phenylalanine is an amino acid. However, in high levels it can cause brain damage. People with phenylketonuria are at risk for brain damage if they consume even just one liter of aspartame sweetened soda pop in a day, because the disease inhibits the body's ability to metabolize it. (67,72)
The FDA and the Centers for Disease Control have received nearly 7,000 complaints, including five deaths, attributed to the use of aspartame in food products since the FDA first permitted limited use in 1981. (39,47,56) A number of researchers and doctors around the country object not only to the product itself, but to the questionable preliminary research that led FDA to approve it for use in dry products in 1981. Aspartame was the accidental discovery of chemist Jim Schlatter, who was working or Searle on an anti-ulcer drug. It was December 1965; Schlatter licked his finger and tasted the substance that had spilled on his flask. It's sweetness stunned him, and he realized that tiny amounts of the chemicals he'd been mixing were powerfully sweet. Searle began testing the chemical mixture - aspartame - and it eventually gained FDA approval, but not without concerns about its safety. A consumer hot line was organized in 1987 to answer questions about the sweetener and its potential deleterious effects. (74) Doctors and researchers have protested both its us and the research that led to its approval. A number of books have been published denouncing and challenging its self-portrayed description as an innocuous food additive. And victims of its side effects are listed in doctors' case studies. (1.57-66,75,76,79)
After reviewing scientific and medical literature on aspartame published since 1970, Cherry Gaffney, the Armed Forces Institute of Pathology concluded aspartame’s ingestion may lead to blood pressure instability and perceptual disorders in some persons. She said that additional studies were necessary to evaluate the impact of aspartame on aviation. (65) Her warning was directed to pilots whose performance could be affected by using the substance. The organization of the Aspartame Consumer Safety Network in 1987 was the direct result of the founder's nightmarish encounter with aspartame.
In 1989 Mary Stoddard related her physical and emotional decline in 1984 during an attempt to lose weight. She said she experienced dozens of symptoms that she'd never had before. She described ringing in her ears, tremors, weakness in her limbs, muscle cramping, twitching, blocked ears, skin lesions, depression, sinus congestion, blurred vision, joint pains, and hearing loss. Stoddard did not have symptoms until she started using diet products, like soft drinks, which contained aspartame. As she continued to use more and more diet products containing aspartame, she observed her symptoms worsened. Stoddard did not initially link aspartame to her symptoms. She believed that a healthy diet and regular exercise would make her feel physically better, but she continued to have health problems that had no apparent source. She said that she sought medical help, but received conflicting advice. She said she eventually began to suspect the products containing aspartame in her diet were creating her problems after she traced the onset of the symptoms to aspartame use, and on that hunch she decided to eliminate NutraSweet from her diet. She began to feel better immediately after removing the products containing aspartame from her diet, but Stoddard said it took six months for the symptoms to completely recede. At one point during her recovery she inadvertently ingested a food product containing aspartame, and had a recurrence of the symptoms. She then had no doubt that aspartame was the root cause of her unusual reactions. In 1987, three years after her own adverse reactions to NutraSweet, Stoddard formed the Aspartame Consumer Safety Network to help others afflicted with aspartame sensitivity problems. Some specialist in food and nutrition have spoken out against aspartame use.
Woodrow Monte, R.D., Ph.D., director of the Arizona State University Food Sciences and Nutrition Laboratory, is uncomfortable with the methanol content of aspartame. In a 1986 interview, Monte called aspartame "a crime against humanity." "Humans are 100 times more sensitive to methanol than animals. When you ingest aspartame, it breaks down into methanol within one hour of ingestion. Methanol forms as soon as aspartame goes into solution and increases the longer it is in solution." according to Monte. Because heat speeds the breakdown of aspartame into methanol, if aspartame is added to coffee or tea at 80 degrees C (145 degrees F), one half of the amount breaks down into methanol in 10 minutes, according to Monte. This raises serious concern about ASPARTAME 'S 1993 approval for use in baked goods and other heated products, like hot cocoa and tea. Although aspartame came about as the result of a search for a drug, and its compounds were the basis for a potential prescription medication, the petition for approval of NutraSweet was based on the premise that it was a food additive. The FDA followed its precedent of permitting manufacturers to conduct their own product safety research.
Monte feels that aspartame was mislabeled from the beginning. "Aspartame is a drug, not a food additive," he said. "One hundred million people, from little babies to the elderly, are consuming this stuff in mega doses, more than they ever would if it were labelled a drug."
Dr. Jacqueline Verrett, a former FDA toxicologist, and member of an FDA task force that investigated the authenticity of research done by Searle to establish the safety of aspartame, says she believes the original aspartame studies were "built on a foundation of sand." (20) She testified in front of a U.S. Senate hearing in 1987 that flawed tests conducted by Searle - used as the basis of FDA approval - were a "disaster" and should have been "thrown out." She said she believed the studies left many unanswered questions about possible birth defects and the safety of aspartame. (20)
Verrett said the team was instructed not to be concerned with, or comment upon, the overall validity of the study. She said a subsequent review discarded or ignored the problems and deficiencies outlined by her team's original report. She said, "serious departures from acceptable toxicological protocols" that her investigative team noted in the revaluation of these studies were also discounted. (20)
She warned that any of the improper practices would compromise and negate a safety study of a food additive. Verrett concluded the data in the study was worthless, and the safety of aspartame and its breakdown products have therefore not been determined. (20) She emphasized that aspartame exists in the marketplace without basic toxicity information. She said there are not data to assess the interactions with DKP, excess phenylalanine, other aspartame metabolites, additives, drugs, or other chemicals. In her testimony, Verrett elaborated on DKP problems, including significant increases of uterine polyps and changes in blood cholesterol. DKP is formed when liquids in particular are pre-sweetened with aspartame. The production of DKP is vulnerable to increase in temperature and higher temperatures produce increasing amounts of DKP. She reminded members of the Congressional Committee "that is why initially, aspartame was not intended or not planned to be used in liquids because of this decomposition...it was decided it was too unstable to be used in hot preparations, hot liquids, and also in diet drinks." (20)
Senator Howard Metzenbaum (D-OH), chairman of the hearing when Verrett testified, asked her if she disagreed with the FDA's position that tests for aspartame safety were credible. Verrett succinctly said she disagreed. (20) Dr. H. J. Roberts, a Florida internist and author, cites cause studies of individuals adversely affected by aspartame use. (75) In one case described by Roberts, the destruction left in the wake of aspartame use was so debilitating that a college honor student deteriorated from the brain damage and finally had to be institutionalized because her mental retardation was so severe. Roberts said he treated the 18-year-old student in 1986 because of "profound intellectual deterioration" that followed her use of aspartame products for weight control The young woman suffered mental incapacitation that destroyed her academic goal when she had a drop of 20 IQ points, according to Roberts, who said prior to use of the aspartame she had been an outstanding student at a major university, as well as a skilled typist and pianist. Her skills had rapidly declined according to Roberts, by the time of her first visit to his office. Her physical complaints included headaches, decreasing vision in one eye, dizziness, intense drowsiness, tremors, insomnia, suicidal depression, itching, burning on urination, personality change, abdominal pain, recurrent nausea, loss of menstrual cycle, and an ironic 15-pound weight gain. Roberts said extensive neuro-physical tests were conducted on the woman, and no consistent patterns were found for a primary disorder or schizophrenia. When he noted the woman experienced drowsiness after ingesting aspartame drinks and dozed while driving, he advised her to avoid aspartame, and to follow an anti-hypoglycemic diet with medication. Avoidance of aspartame relieved her symptoms, but the apparent brain damage remained, requiring her placement in a facility for the mentally retarded. (75)
In a recent study investigating the consequences of aspartame on people with mood disorders, Ralph Walton, M.D., Robert Hudak, Ph.D., and Ruth J. Green-Waite concluded "individuals with mood disorders are particularly sensitive to this artificial sweetener (aspartame) and its use in this population should be discouraged." (60) Walton said their study was terminated after only 20 days by the Institutional Review Board of Western Reserve Care System, Youngstown, Ohio because the reactions (including a detached retina and conjunctival hemorrhage) among the patients with a history of depression were so severe they could not "ethically continue the study." (60) The study included a total of 13 subjects. Eight of the subjects were patients, ranging in age from 24 to 60 years. All suffered from recurrent major depression. Five healthy hospital employees, including the hospital administrator, volunteered as a control group for the study. Each participant was asked to monitor his or her own symptoms for a checklist of headache, nervousness, dizziness, memory problems, binge eating, lower back pain, nausea, upset stomach, depression, insomnia, uncontrollable temper outburst, or other symptoms. The hospital's pharmacy prepared 300-mg capsules of aspartame for some participants, and sugar placebos for others. (NutraSweet Company denied the request from the researchers to purchase the aspartame for the study, so capsules were provided by Schwiezerhall, Inc., of New Jersey.) A 154-pound person ingested seven of the prepared capsules daily - the approximate aspartame equivalent would be 10 to 12 cans of diet soda.
Although the study was abbreviated because of the severity of the subjects' symptoms, the researchers did find the incidence of headaches in participants taking aspartame increased and that persons with a history of depression demonstrated significant adverse reactions while taking aspartame. They also reported adverse symptoms for the group taking aspartame increased significantly. (60) Walton, then chief of psychiatry at New York's Jamestown Hospital and Chautauque County mental health commissioner, reported a case study of a patient who reacted adversely to aspartame. His 54-year-old female patient "suddenly experienced a grand mal seizure followed by profound behavior changes." Some of the personality changes included euphoria, flight of ideas, increased motor activity and insomnia. A history of the woman's eating habits revealed she had been accustomed to drinking about a gallon of sugar-sweetened iced tea daily. In the weeks before her seizure, she had switched from sugar-sweetened tea to an iced tea product containing aspartame. After reviewing her case, Walton advised her to eliminate the aspartame product, upon which she returned to normal and the symptoms subsided. (66) Walton questions the reliability and validity of studies for the safety of aspartame funded by the NutraSweet Company. "I'm absolutely convinced," he says. "I know it causes seizures. I'm convinced also that it definitely causes behavioral changes. I'm very angry that this substance is on the market. I personally question the reliability and validity of any studies funded by the NutraSweet Company." In the 1987 proceedings of the First International Meeting on Dietary Phenylalanine and Brain Function, he also presented either other seizures cases, along with case studies of mania, panic attacks and weight gain induced by aspartame use.
In 'NO-NONSENSE NUTRITION FOR KIDS' Annette Natow and Jo Ann Heslin write "animal and human studies have shown that aspartame cause chemical changes in the brain. More research is needed to determine if aspartame is a health hazard." (76) The questions about the validity of the Searle research and tests of aspartame date back to 1976 when FDA was uncertain about the animal test data provided by Searle. The FDA administrators asked Sam Skinner, former U.S. attorney in the Northern District of Illinois, to convene a grand jury to investigate discrepancies in the animal test data provided by Searle. (15) On January 10, 1977, RDA chief counsel, Richard Merril, sent a 33-page letter to Skinner repeating the request for the grand jury investigation "into apparent violations of the Federal Food, Drug, and Cosmetic Act...and False Reports to the Government Act...by G. D. Searle Company". (12) The letter also charged that Searle concealed material facts and made false statements in reports of animal studies conducted to establish the safety of the food additive aspartame. The studies cities for investigation had been conducted in 1972, and five-year statutes of limitation for criminal prosecution were due to expire on October 10, and December 8, 1977. (7) The statutes of limitation ran out before any criminal charges were ever filed. In 1977 Skinner was offered and accepted a job with Sidley and Austin, the law firm that represented Searle. While still U.S. district attorney, Skinner did eventually excuse himself from the Searle investigation.
The next U.S. attorney, Tom Sullivan, then dropped NutraSweet from the grand jury investigation. (7) In 1988 Senator Metzenbaum challenged Skinner's nomination for appointment as U.S. Secretary of Transportation. Metzenbaum issued a press release that said Skinner "failed to launch a grand jury probe of G.D. Searle, the manufacturer of NutraSweet, which was requested by the Food and Drug Administration. A year after the FDA brought Skinner allegations of fraudulent safety tests by Searle, Skinner took a job with the law firm that defended Searle in the case." (7) Although Metzenbaum did later say he would not object to the nomination to the position of Secretary of Transportation, he said that Skinner told him that "he may have made mistakes in his handling the NutraSweet investigation." The studies under scrutiny were the purview of Dr. Harry Waisman, a researcher at the University of Wisconsin's Regional Primate Center. He was asked to compare toxicity effects from aspartame (particularly seizures and learning defects from brain damage) with those from phenylalanine, a primary ingredient in aspartame. Waisman's 52-week toxicity study on seven infant Rhesus monkeys fed a diet containing aspartame did not include a control group for comparison. The results of the study, submitted to Searle in 1972, showed the death of one monkey after 300 days, the administration of aspartame halted on two monkeys after 200 days, and four monkeys that received aspartame for 365 days. The FDA, in a report on the tests, said that no behavioral or learning tests were undertaken on the monkeys. Former FDA Commissioner Alexander Schmidt, now deceased, said the tests were "shoddy" and "far less than perfect "(79)
A second study initiated by Searle was to have been a 104-week toxicity study on the effects of aspartame on hamsters. The study was halted prematurely after 46 weeks because of the unexpectedly high mortality rate in both control and treated animals following an outbreak of diarrhea among the test animals. The FDA, including submission of false information noted other inconsistencies in the tests upon review, and reports that were written to convey impressions more favorable than underlying data would support. (7,16) The FDA researchers also said that their agency needed more adequate and better controlled studies. They said the FDA must base its recommendations on sound data because the substance could be part of the daily diet of every American. (25) Schmidt commented that "if you're approving a food additive that will be taken by children around the world, you will accept absolutely no risk, particularly if it's a non-nutritive sweetener." (7)
The FDA task force observed laboratory methods at Searle from April 25 to August 4, 1977. The Bressler Report (named for team leader Jerome Bressler) identified major discrepancies, including "substantial differences between gross observation on pathology sheets when compared with those submitted to the FDA" in a rat toxicology test of aspartame. (16) According to the Bressler Report, one rat even appeared resurrected. It stated, "Observed records indicated that animal A23LM was alive at week 88, dead from week 92 to week 104, alive at week 108, and dead at week 112." (16) The actual meal fed to the rats was also in question. Raymond Schroeder, a former Searle employee, said in an FDA interview on July 13, 1977 that "the particles of DKP were large enough to allow the rats to discriminate between the DKP and the basal diet." In 1982, representatives of the carbonated beverage industry asked Monte to evaluate the scientific data for aspartame. Monte said "I was stunned by the poor quality research and recommended against aspartame's use in carbonated beverages. I understood that the industry was going to abide by my evaluation but something turned them around."
In 1984, Florence Graves, vice president of COMMON CAUSE wrote "NutraSweet has been touted as the most tested food additive in history, but our investigation reveals such serious flaws in the government's approval of NutraSweet that Congress should begin its own investigation immediately." (38) A 1987 report released by the General Accounting Office, "FDA Food Additive Approval Process Followed for Aspartame," included information that waved red flags of potential calamity.
Some of the findings in the report: (11)
The rat DKP Study showed a significant incidence of uterine polyps in rats fed at the two highest dose levels as compared to rats not fed DKP. Review teams later said the polyps were not cancerous, precancerous, or potentially cancerous.
The Center for Safety and Nutrition advised Searle that because it had not submitted studies for evaluating long-term effects of DKP, aspartame was not approved for products that could have an appreciable breakdown to DKP.
An investigative team report showed that examination of rat fetuses and the reporting of the results in two teratology studies were inadequate.
Dr. John Olney, psychiatrist, neuro-pathologist, and professor at Washington University in St. Louis found 12 brain tumors in 320 dosed rats and none in 120 control rats when he examined FDA files on aspartame animal studies in 1978.
Olney advised that the high number of brain tumors was unusual. Olney voiced another concern based on his research. He showed that when glutamate and aspartic acid are ingested together each agent augments the neurotoxic effects of the other.
In a 1981 interview at Washington University, Olney said, "Chemicals marketed as food additives are consumed without supervision by hundreds of millions, most of whom do not know they are ingesting the additive, do not derive health benefits from it and have no understanding of its adverse effects." Olney, along with consumer activist attorney James Turner, initiated court action over aspartame. In a 1986 interview Turner said he had spent 15 years battling approval of aspartame because "it's hurting people." Monte also called the scientific data supplied on aspartame as "poor quality research" and said he recommended against aspartame's use in carbonated beverages. Dr. Jeffrey Bada, a chemistry professor at the University of California at San Diego, warned against heating aspartame and the resultant internal rearrangement of its chemical structure.
The late Dr. M. Adrian Gross, an FDA toxicologist, spoke out against aspartame in the August 1, 1985 Congressional Record. Gross, who took part in on-site investigations at Searle laboratories, said the study carried out by Searle to show the safety of aspartame were "to a large extent unreliable." He said "at least one of those studies has established beyond any reasonable doubt that aspartame is capable of inducing brain tumors in experimental animals and that this...is of extremely high significance."( 42) Gross also testified that because aspartame was capable of producing brain tumors and brain cancer, FDA should not have been able to set an allowable daily intake of the substance at any level. He said at least one of Searle's studies "has established beyond any responsible doubt that aspartame is capable of inducing brain tumors in experiments animals and that this predisposition of it is of extremely high significance..."
In view of these indications that the cancer causing potential of aspartame is a matter that had been established way beyond any reasonable doubt, one can ask: "What is the reason for the apparent refusal by the FDA to invoke for this food additive the so-called Delaney Amendment to the Food, Drug and Cosmetic Act?" The Delaney Amendment makes it illegal to allow any residues of cancer causing chemicals in foods. In his concluding testimony Gross asked, "Given the [cancer causing potential of aspartame] how would the FDA justify its position that it views a certain amount of aspartame as constituting an allowable daily intake or 'safe' level of it? Is that position in effect not equivalent to setting a 'tolerance' for this food additive and thus a violation of that law? And it the FDA itself elects to violate the law, who is left to protect the health of the public?"