The Panel reiterated that the study design is not reflective of currently accepted toxicological methodologies. Learning to live a healthier lifestyle is easy when you change one small thing at a time. Find recipes and tips to start the change today! Check out the position of several well-known and respected organizations. Substituting aspartame for sugar or other calorie-containing sweeteners allows people to indulge sweet cravings while consuming fewer calories. What is Aspartame? TImeline Brief History of Aspartame.
FDA expands their approval to include carbonated soft drinks. Learn more. Is Aspartame Safe? Separate fact from fiction on the most common myths about aspartame. Should You Avoid Aspartame? What are the Benefits? Just two months after his appointment on July 15, , Hayes disregarded the unanimous decision and recommendations of the Public Board of Inquiry by approving aspartame for use in dry foods. Searle immediately began marketing aspartame as a safe alternative to saccharin. Products containing aspartame did need to be clearly marked, but unlike saccharin, did not require a warning label stating possible side effects.
Even with their recent success, G. Searle was not satisfied with the approval for dry use only and immediately began the process to obtain approval for use in carbonated beverages as well. Searle filed a petition on September 27, , for the use of aspartame in carbonated beverages.
In public statements, Searle declared that the chemical had been tested and found stable in soft drinks. At the time of the petition, South Africa and Canada had already approved the use of aspartame for human consumption in carbonated drinks.
The courts argued that safety issues were resolved during the initial approval of aspartame in and did not need to be revisited. Several months after the approval of aspartame in liquid form, Arthur Hull Hayes Jr.
Accepting incentives from a company so closely related to his recent approval caused the FDA and many of his colleagues to question his neutrality and integrity. In , Hayes accepted a position with E. The public relations firm of Burson-Marsteller represented NutraSweet and several major users of aspartame, but Hayes claimed to not have discussed aspartame during his time at the company and no substantial evidence of misconduct could be documented.
From the initial approval of aspartame in until the final approval in , many changes in FDA personnel occurred. Hayes and Rumsfeld were not the only two officials to be simultaneously involved in government and big business.
Several officials involved in key decisions regarding the status of aspartame left their jobs with the FDA and accepted positions with companies closely linked to aspartame and its production. Stuart M. Pape served as a Special Assistant to the FDA Commissioner from to but later left to take a position with the law firm of Patton, Boggs, and Blow, a firm that worked closely with the National Soft Drink Association, many times addressing aspartame.
Howard R. Roberts worked as the Deputy Director of the Bureau of Foods. During his employment, he worked closely with the Public Board of Inquiry in and personally reviewed G. Robert A. Dormer was formerly the trial attorney for Health and Human Services between and , participating in several cases relating to aspartame.
After leaving his position, Dormer was hired by the law firm of Hyman, Phelps, and McNara, a firm that provided legal advice to G. All four of the men contacted the FDA after their resignations on behalf of their new companies, but only Roberts, Pape and Dormer were confirmed to have discussed aspartame. Ultimately, these men accepted prestigious positions with companies they had communicated with and assisted during their employment with the FDA.
The seemingly quick trust and responsibility given to these men by their new employers further reveals and emphasizes the fine line between big business and government officials. Soft drink companies took notice of the new artificial sweetener and adjusted accordingly. The advantages of switching sugar substitutes included the fact that, unlike saccharin, aspartame required no safety label in Also, aspartame appealed to diabetics because its protein composition did not require insulin to be metabolized.
Lastly, this substitute tasted more like sugar than other sweeteners and cost a fraction of the price of pure sugar. Even so, aspartame was still considerably more expensive than its competitor saccharin. To maximize profits, Coca-Cola and Royal Crown announced they would use a combination of the two artificial sweeteners in their low calorie products. In , just one year after complete approval was granted, 6. Searle regained their momentum. NutraSweet quickly became a highly profitable portion of G.
As the market for diet products rapidly expanded, consumers became less influenced by safety concerns and G. Searle thrived financially. While many US consumers were enthralled with the new artificial sweetener, some skeptics remained unconvinced of its safety and continued to actively research the effects of aspartame, especially in liquid form.
Woodrow Monte dedicated his life to studying food ingredients and products and their impact on human health. After conducting several experiments at Arizona State University, Monte found that aspartame, specifically in unstable, liquid forms, caused health dangers far beyond what was documented.
Ingesting as little as two teaspoons of methanol can be fatal in humans, yet Monte found that methanol is a component found in aspartame. When consumed, methanol is released into the small intestine after the hydrolysis of the methyl group breaks down the dipeptide. Within hours after consumption, approximately ten percent of the aspartame consumed is converted to methanol and enters the blood stream.
Additionally, since aspartame in liquid form is not stable, sodas in storage have the ability to decompose on their own and release methanol, especially when exposed to high temperatures. Monte compared side effects of excessive exposure to methanol found in Public Health Service reports to the symptoms reported in complaints from aspartame users. After studying individuals exposed to environments with high methanol content, Public Health Services found that methanol exposure could lead to headaches, dizziness, numbness, and a multitude of vision problems.
Hundreds of aspartame consumers reported similar symptoms to the Centers for Disease Control in Atlanta. Though he recognized that drinking a diet soda occasionally, or even regularly, would not be lethal, the lack of long-term experiments documenting the effects of regular methanol consumption concerned him.
Searle responded to the findings by claiming that more naturally occurring methanol is released from fruits and vegetables than from aspartame. Monte retorted by explaining the methanol released naturally from fruits and vegetables is also accompanied by a release of ethanol, which counteracts the methanol in the body, making the consumption far less dangerous.
Aspartame decomposition contains no ethanol to counteract the methanol. Even so, his research and conclusions were widely noticed, encouraging the government to once again investigate the safety of aspartame. Even today, Monte is still conducting research and publishing books and articles to inform the general public of the potential health risks of aspartame. Ohio Senator Howard Metzenbaum proposed the Aspartame Safety Act of , which required a disclosure of the quantity of aspartame present in any product.
He thought warning consumers of the amount of aspartame found in food products could help educate the public without banning the substance altogether. With the existence of several lawsuits against G. Searle, along with hundreds of complaints filed to the Centers for Disease Control and the potential for brain damage found after consuming large amounts of aspartame, Metzenbaum strongly emphasized the need for adequate labeling.
Unfortunately, after being sent to the Senate floor, the bill failed by a vote. When questioned about the backlash and complaints from users of aspartame, G. Searle responded that they actually expected more complaints than they received. Out of 70 million users, only six hundred consumers formally filed complaints. In all interviews referencing the harmful side effects caused by aspartame, G. In , Dr. Sturtevant of G. Even without support from the FDA, skeptics of aspartame have continued to research its undesirable effects throughout the last few decades.
In an article in the Star Tribune, the National Institutes of Environmental Health Sciences revealed that their scientists had requested grants to further investigate aspartame without the influence of the NutraSweet Company. These requests were filed between and , but the FDA denied all four proposals because officials insisted the product was already proven safe and unless new scientific evidence was brought forward extra tests would be redundant.
Rall and many other scientists agreed that updated testing on such a popular product was absolutely necessary to ensure safety. John Olney also continued his research and in published his results in the Journal of Neuropathology and Experimental Neurology.
Olney was convinced of the link between the two. Although a great deal of controversy continues to surround aspartame, health concerns have failed to hinder the success of G.
Indeed, NutraSweet has become an international billion-dollar company. Their tactics have been wildly successful. In America, approximately 17,, pounds of aspartame were consumed in , and a majority of that intake was in the form of diet carbonated beverages. This contract guaranteed that NutraSweet would maintain their monopoly on aspartame production even after their patent expired. According to Richard Nelson, a spokesperson for NutraSweet, by soft drinks were responsible for seventy-five percent of the aspartame consumed in the United States.
A contract with the two largest soft drink companies solidified the prolonged success of NutraSweet. Although little legal action has been taken against aspartame recently, the growing popularity of the internet over the past twenty years has enabled consumers to become more aware of its possible harmful side effects. In , an internet hoax was created to warn consumers of the dangers of aspartame.
The website and emails were highly inaccurate and biased, but the email sparked conversation about possible symptoms related to the consumption of the substance. If the reader can successfully navigate between the facts and embellishment, these websites can be useful resources.
Janet Starr Hall, writer of Sweet Poison, has dedicated her life to warning the public about aspartame through her book and website. While her website is obviously anti-aspartame, she strives to utilize facts to validate her claims. Technology has exposed American society to an infinite number of daily dietary choices.
With the plethora of opportunities and options, consumers must make educated decisions about what they put into their bodies. In May , EFSA was asked by the European Commission to bring forward the full re-evaluation of the safety of aspartame from to after concerns were raised by Members of the European Parliament.
Topic: Food additives — EU framework. EFSA published its scientific opinion on the safety of aspartame in December In January , EFSA launched a online public consultation on its draft opinion, inviting all stakeholders and interested parties to comment by 15 February Alongside scientific excellence, independence and responsiveness, openness and transparency are key values at EFSA and help to underpin consumer confidence in the EU food safety system.
In addition, consulting on draft scientific outputs is important to gather views, data sources and comments that can in turn ensure the completeness, clarity and effectiveness of the final outputs. EFSA regularly consults the scientific community and other stakeholders on its guidance documents and, when compatible with the procedures and deadlines laid down in the relevant EU legislation, also on important scientific outputs of keen public interest such as its opinion on aspartame.
This ensures that EFSA considers the widest possible range of views and scientific information. Feedback from the public consultation is then compiled in a report and, where appropriate, incorporated into the final scientific output. During the public consultation, the Authority received a total of comments on its draft opinion. The majority of these were submitted by NGOs and members of the public with most others originating from academia, national food safety agencies, the food industry and journalists.
Comments were grouped according to the following main topics: scientific aspects of the opinion; toxicity of methanol a breakdown product of aspartame and formaldehyde a metabolite of methanol ; consumer exposure to aspartame; editorial changes; as well as related policy issues for example, comments mistakenly directed at EFSA about the regulation of aspartame, such as requests to ban this sweetener which are not considered by EFSA given its role as scientific risk assessor.
The Panel considered all comments received. Prior to its authorisation and since its market introduction, the safety of aspartame has sparked interest and at times controversy. Questions have primarily been raised about some of the early experimental animal studies utilised to evaluate the safety of aspartame. In EFSA published a full risk assessment of aspartame. Extensive reviews on aspartame have been carried out by many national and international regulatory and advisory bodies.
All have concluded that the scientific evidence is sufficient to confirm that aspartame is safe for human consumption. Lists of published and unpublished studies and data files available for download: Results of the Call for scientific data on aspartame June Results of the Call for data on DKP and other potential degradation products of aspartame July EFSA considers all available scientific data and scientific literature in its risk assessments and takes account of all evidence that is produced to internationally recognised scientific standards.
The Authority may also decide on a case-by-case basis to use data from studies not performed according to current standards when new data are lacking as long as the design of such studies and the reporting of the data are considered appropriate and sound. This holds true whether the source is industry, the public sector, academia or other scientific organisations. It is a fundamental principle of EU legislation that the organisations or companies set to profit from food additives and other regulated substances and products e.
GMOs, active substances used in pesticides , must provide the evidence to prove that these substances are safe. Where new research on a specific substance is required to demonstrate its safety, manufacturers must bear the cost of producing the required data for the risk assessment. Regardless of the source, EFSA critically and rigorously evaluates all the data submitted as well as the design of the studies that produced them to ensure that they meet the standards required to ensure consumer protection.
EFSA provides guidance which lays down the specific requirements for the risk assessment of regulated substances and products such as food additives, flavourings, GMOs and food contact materials. No one expert, including the Chair, can unduly influence the decisions of the Panels.
In those cases where Panels cannot reach consensus on a subject, experts can express minority views which are recorded in the scientific opinions. EFSA is constantly vigilant to potential conflicts of interest whilst recognising that the top scientific experts in Europe can only gain their expertise by being active in their fields.
The independence of scientific experts and all those involved in the activities of EFSA is ensured by one of the most rigorous Declaration of Interest policies in force in the world. Topic: Independence. Observations of these key events in human and animal studies are compared to determine the relevance for human health. The Authority neither authorises nor bans the use of substances in foods.
It is the responsibility of risk managers in the European Commission, the European Parliament and the EU Member States to define and agree measures as and where required, taking into account scientific advice and other considerations. What are the main conclusions of the opinion? The current ADI is considered to be safe for the general population including infants, children and pregnant women and consumer exposure to aspartame is below this ADI. This new piece of scientific work has involved the a rigorous review of all available scientific research on aspartame and its breakdown products, covering data and studies from the s to the present.
Also, while previous safety evaluations of aspartame derived the ADI from long-term toxicity studies in animals, the new risk assessment also uses information from studies in humans. The opinion explores the potential safety concerns relating to toxicity, carcinogenicity and genotoxicity as well as possible reproductive and developmental effects related to aspartame, its breakdown products.
Based on its comprehensive review, EFSA concludes that aspartame and its breakdown products pose no safety concern for consumers at current levels of exposure.
The Panel also confirmed that the ADI, while protective of the general population including infants, children and pregnant women , is not applicable to people who suffer from PKU, as they require strict adherence to a diet low in phenylalanine PKU is an inherited disorder which increases blood phenylalanine concentrations to levels toxic to the developing brain.
The weight of evidence suggests that aspartame ingestion has no effect on behaviour or cognitive function. There is no evidence that consuming aspartame causes seizures. There is no convincing evidence that consuming aspartame causes headaches. The weight of evidence shows that aspartame is not associated with allergic type reactions.
Methanol derived from aspartame is a small portion of total exposure to methanol from all sources. The contribution of breakdown products of aspartame phenylalanine, methanol and aspartic acid to the overall dietary exposure to these substances is low. In addition, available data do not indicate a genotoxic concern for aspartame i. In , publication of two studies influenced the timing of the re-evaluation of aspartame.
The studies looked at possible health risks related to the consumption of artificial sweeteners including aspartame: namely an epidemiological study on the association between intakes of artificially sweetened soft drinks and increased incidence of preterm delivery Halldorsson et al.
The ANS Panel assessed potential risks of aspartame for pregnant women by evaluating the safety of concentrations of the breakdown product phenylalanine in blood following the consumption of aspartame-containing products. Phenylalanine is known to be toxic at high intake levels, in particular to the developing fetus in women suffering from the medical condition phenylketonuria PKU.
The Panel concluded there is no safety concern for pregnant women at current levels of exposure. In fact, this was not as strong as the association with sugar-sweetened soft drinks. The ANS Panel considered findings from long-term studies conducted in experimental animals related to toxicity and carcinogenicity on the developing fetus.
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