For More Information GO TO Aspartame (NutraSweet) Toxicity Home Page: http://www.holisticmed.com/aspartame/ 13. The FDA Response -- Less Than Nothing The U.S. Food and Drug Administration (FDA) is the agency which is supposed to protect the country from health hazards in foods and drugs. How is it possible for the FDA to have less than no response at all to the significant health problems caused by aspartame? Had the FDA avoided the aspartame issue completely, the U.S. public and the rest of the world would have been much better off. Instead, the FDA has actively supressed information, fought against caution and independent research, banned alternatives, and generally acted like an unethical subsiderary of the Monsanto Chemical Company (owner of NutraSweet). After reading about the sordid history of aspartame (see earlier section) and the high-ranking FDA officials, U.S. Attorneys, etc. who set aside all ethics and went to work in the aspartame industry, it is easy to see how the close relationships between these former government officials and current government officials (including those in the FDA) can lead to a situation where the FDA basically becomes and extension of industry. Shortly after the approval of aspartame, as adverse reactions began to pour in, the FDA took steps to reduce the public relations problem by trying to prevent adverse reaction reports from being submitted. We already saw how the FDA transferred victims to the AIDS hotline. In 1985, Rodney E. Leonard and James Turner, Esq. of the Community Nutrition Institute (CNI) wrote the FDA Commissioner, Dr. Frank E. Young, to report other major problems (CNI 1984): "When FDA approved in July 1983 the use of aspartame in liquids, the agency was aware of health concerns expressed both by scientists (particularly the instability of the substance in liquids) and consumers and said it would monitor complaints. "However, no monitoring program was established until February, some eight months later, after we specifically requested its July pledge. We proposed that the Centers for Disease Control be asked to make an epidemiological evaluation of the complaints, and we were subsequently informed that a monitoring program had been initiated--including a CDC evaluation. "We now have learned enough information to question whether an aspartame monitoring program ever has been, in fact, carried out by the FDA. The evidence suggests that FDA has sought to avoid the collection and analysis of complaints, and has instructed regional offices to withhold data from its Washington headquarters. "For example, FDA has informed us and others that it has received some 680 complaints that were forwarded to CDC, with the implied conclusion that this is the total number of complaints. However, in discussions with the staff in the Freedom of Information Office (FIO) at FDA, we now learn that those complaints were all received prior to February or March of this year, and do not include any complaints received subsequently. "In addition, the FIO office said that regional FDA offices had been told that only 'serious' complaints should be forwarded to FDA headquarters; and, for the guidance of regional office staff, a 'serious' complaint is one in which the illness is severe enough to require the attention of a physician. "Thus, no effort has been made since April to determine the actual extent of consumer reactions to NutraSweet, or to analyze and categorize the complaints. In at least one regional office -- located in Philadelphia -- we understand that NutraSweet complaints filed since June have not even been examined. "We also had requested FDA early this year to notify physicians the agency was monitoring complaints of adverse reactions to aspartame, or NutraSweet. We were told that FDA had no intention of inviting physicians to send in reports of complaints. This attitude now seems self-serving on the part of any agency that instructs its field offices to forward only those complaints which have been filed by individuals who sought the counsel of their physicians because of the severity of their reaction. "This also is a self-fulfilling argument for the basic FDA position that complaints about aspartame, or NutraSweet, have no pattern, and that all of them can be explained by the placebo effect--i.e., whenever any new product is introduced, it will be seized upon by the public as the source of their ailment. FDA has made no efforts to alert physicians to its need for information, but instead waits on consumers who seek medical advice about their complaints to make a special effort to alert FDA to the problem. Thus, FDA has consistently limited its knowledge as to whether a problem may or may not exist." Given that the FDA actively made an effort to limit reported adverse reactions, it becomes difficult to accept any figures that the FDA releases regarding adverse reactions to aspartame. Clearly, there has been and currently is too much conflict-of-interest for the FDA to be considered a reputable source of information about aspartame. A person might as well call up the Monsanto/NutraSweet Public Relations department and ask for information on adverse reactions! In 1984, the U.S. Centers for Disease Control (CDC) published an analysis of selected consumer adverse reaction reports to aspartame (CDC 1984). 517 cases were examined by the CDC, 199 of them were fully reviewed. The CDC found that the cases fell into four general categories: Neurological/Behavioral symptoms, Gastrointestinal symptoms, Allergy-like symptoms, and Menstrual symptoms. Most of the complaints were consumer-initiated, probably reflecting the FDA's refusal to request that physicians report adverse reactions as discussed earlier. In regards to the interpretation of the analysis, the CDC stated: "It was not anticipated that this investigation alone could definitively establish whether ingestion of aspartame-containing products did or did not cause the symptoms reported. .... Data from passive surveillance systems can, however, indicate the possibility of an association." Twenty-eight percent (28%) of the cases that were fully reviewed showed that adverse reactions occurred on rechallenges of an aspartame-containing product. Forty-one percent (41%) of the cases had no history of attempted rechallenge. In 32% of the cases, a rechallenge did not reproduce symptoms or a physician stated that the symtpoms probably had a different etiology. Most of the cases examined in-depth occurred before aspartyame was available in carbonated beverages. What follows are a couple of sample cases from the CDC report: A 4-year-old white male had symptoms of insomnia, headache, aggressive behavior, and disorientation. His mother reported that he appeared "glassy eyed" and was "running around wildly...hitting his head against the wall," and that his speech was rapid and slurred. The symptoms first o ccurred whiled he was consuming 2-3 glasses of Kool Aid¨ or Wyler's¨ lemonade daily along with Halfsies¨ cereal 3 times per week. His symptoms stopped approximately 24 hours after he stopped ingesting these products. Since this time, the child has participated in a double-blind, videotaped, observer-validated study. This study reportedly confirmed that the symptoms occur following aspartame ingestion. The symptoms have also consistently recurred on at least three occasions when the child was "accidentally" given three different foods with aspartame -- hot chocolate, bubble gum, and cookies. The child's private pediatrician, who feels that the child's symptoms are due to aspartame, reported that he has observed that the child's symptoms have become more prolonged with increased exposure to aspartame. Relevant Medical History: The child's mother reports that he is allergic to milk protein, but that he has no other allergies. --------------- A 39-year-old white female complained of depression, memory loss, lethargy, irritability, dizziness, and headaches. The complainant's first use of aspartame-containing products was in March, 1983, when she began using approximately 8 packs of Equal¨ per day. During the symptomatic interval, the complainant added other aspartame- containing products to her diet, including Diet Coke¨ and Kool Aid¨. The symptoms started in mid- April and increased in number and intensity in subsequent months. The first symptom to occur was lethargy. Over the ensuing months, irritability, dizziness, depression, and memory loss occurred. She states that when she stopped using aspartame- containing products in mid-September following a news report, the symptoms improved within 1 day and ceased within 1 week. The complainant subsequently rechallenged herself approximately 2 months later with Equal¨, consuming 4 packets per day for approximately 3 days. She stated that she became dizzy on the third day and that the episode was "very frightening." After these symptoms appeared she stated that she stopped consuming Equal¨, and approximately 24 hours later the symptoms subsided. The complainant consulted three physicians during this time. Only her family physician was available for interview, and he stated that he "had no reason to doubt the judgment of the complainant." Relevant Medical History: The patient has a past history of thyroid disease as well as a past history of migraine headaches for which she was on Valium¨ and Cafergot¨ at the time of the symptoms. Thyroid screen at the time of the symptoms was reported to be normal. The only other medical condition reported was an allergy to ampicillin and compazine. The CDC report concludes: "In summary, the quality and type of evidence obtained by a passive surveillance system based on consumer complaints precludes definitive determination of whether these complaints are or are not caused by the agent under question -- in this case, aspartame. .... The only way that these possibilities could be thoroughly evaluated would be through focused clinical studies." Although some of the rechallenge-confirmed adverse reactions discussed by the CDC report included seizures, cardiac arrest, severe mood swings, disorientation, extreme numbness, memory loss, liver impairment, suicidal tendancies, etc., the FDA proceeded to twist the conclusions of the CDC report, which was conducted shortly after aspartame appeared on the market, by stating (Mullarkey 1992, page 70): "In summary, currently available information, based on data with limitations as described in the report, indicated a wide variety of complaints that are generally of a mild nature. Although it may be that certain individuals have an unusual sensitivity to the product, these data do not provide evidence for the existence of serious, widespread, adverse health consequences to the use of aspartame." Beginning around 1987, FDA inspectors started visiting herb companies who were using a safe, natural, no-calorie sweetener called "stevia" and telling them to stop using it because it was an "unapproved food additive" (McCaleb 1995). According to the Herb Research Foundation: "In one case FDA's inspector reportedly told a company president they were trying to get people to stop using stevia 'because NutraSweet complained to FDA.'" The FDA refused to supply to the Herb Research Foundation the name of the company that complained to the FDA despite a Freedom of Information Act request (McCaleb 1995). In May of 1991, the FDA banned the importation of stevia into the U.S. and began warning companies that it was an illegal herb (Import 1991). This act violated laws allowing the use of products with an extensive history of safe use. But since the FDA often has no one to answer to, it can essentially make up the rules as it sees fit, and in this case it saw fit to protect what could be called its "parent company," Monsanto/NutraSweet from competing against a safe, natural product. Stevia has been used extensively in South America for hundreds of years without any reports of adverse reactions (AHPA 1991, HRF 1993, Kinghorn 1985, Kinghorn 1992). It has been used commercially in Japan, South Korea, and other countries without any reports of adverse reactions. In fact, if has already been used for the past 20 years in Japan and has captured over 40% of the Japanese sweetener market (McCaleb 1995). Stevia is safe for all populations, and is particularly recommended by diabetics because it appears to help stabalize blood sugar levels (Kinghorn 1992). Even though Stevia has been proven safe through an extensive history of use, there have been a large number of animal studies on stevia and stevia extracts which also prove it to be extremely safe (Kinghorn 1992, AHPA 1991). Two old animal studies raised questions about stevia's safety, but since that time other studies as well as survey's have more than answered those questions (Kinghorn 1992). Despite an extensive, peer-reviewed analysis of the literature performed by plant-based sweetener expert , Dr. Douglas A. Kinghorn (Professor of Pharmacognosy and Medicinal Chemistry at the University of Illinois College of Pharmacy in Chicago) (Kinghorn 1992) proving stevia's safety, an extensive history of safe use including not a single report of an adverse reaction, a petition submitted to the FDA by the American Herbal Products Association (AHPA 1991) detailing the safety of stevia, a supplement to the AHPA petition further demonstrating stevia's safety, and the law requiring products with a history of safe use before 1958 to be automatically approved, the FDA refused to allow the importation of stevia. After rejecting the AHPA's initial petition, the FDA stated that it needed more information. When asked "how much more?" by Timothy Moley of the AHPA, the FDA responded (Blumenthal 1994): "Well, this may sound flippant, but we'll know it when we see it." On September 18, 1995, the FDA revised their import ban on stevia to allow for the importation only in cases where it is clearly to be used as, or in a "dietary suppliment" (Import 1995). The FDA specifically disallowed stevia's use as a sweetener. This allows the FDA to avoid violating the recently-passed dietary supplement law and still allows them to protect their "client," Monsanto/NutraSweet by severely limiting the use of stevia. Food companies will not begin to use stevia in their products on a large-scale basis until they can be certain that the products will not be seized by the FDA. The enormous positive response by food companies to an article in Food Processing magazine shows that stevia would become widely used if the FDA would stop violating the law by banning its use as a sweetener (Food 1990, Johnson 1990). In 1992, scientists from the FDA Center for Food Safety and Applied Nutrition (CFSAN), performed an analysis of seizures linked to aspartame which had been reported to the FDA (Tollefson 1992). It was a blatantly skewed analysis. The author created several categories for adverse reaction reports. Group A referred to persons whose symtpoms occurred after being rechallenged by different aspartame-containing products. Group B referred to persons whose symptoms occurred after being rechallenged by the same aspartame- containing product. Group C referred to complaints where the person did not rechallenge himself/herself. Group D referred to adverse reactions that were "highly unlikely that the reported symtpoms are associated with" aspartame. After analyzing the cases, the authors concluded: "The findings from FDA's ARMS [Adverse Reaction Monitoring System], however, do not merit a scientific study on the association between seizures in human beings and aspartame ingestion." Flaws ----- i. The authors inappropriately classified subjects as "Group D" if they refused to release their medical reports. This refusal does not mean that the link to aspartame is "highly unlikely." It may mean that in these cases the link is "unknown." Therefore, any conclusions drawn from the number of cases in Group D ("highly unlikely" link to aspartame) is worthless. ii. The authors inappropriately classified subjects as "Group D" if there was any other possible contribuatory factor to the seizures. This simply means that aspartame may have caused the seizures or something else may have caused the seizures or a combination of things. If the person rechallenged themself with aspartame and still experienced seizures despite other possible causes, a categorization of Group D ("highly unlikely" link to aspartame) becomes absurd. iii. The authors made a number of other inappropriate determinations that the cases were not likely linked to aspartame. For example, occurrence of seizures months or years after stopping aspartame was categorized as Group D. However, if aspartame changes brain chemistry and lowers the seizure threshold, it is quite possible for seizures to occur long after aspartame consumption has ceased, especially in the more severe cases. iv. The authors inappropriately declared ineligable, 35% of the non-Group D seizure victims because the seizures occured more than 13 hours after ingestion of aspartame. This is absurd because 1) it is thought that aspartame may lower the seizure threshold and therefore, aspartame- caused seizures could occur long after phenylalanine levels return to normal, 2) aspartic acid can accumulate in areas of the brain not protected by the blood brain barrier and remain there for as much as 24 hours (Inouye 1976), 3) methanol is converted to formaldehyde and formate very slowly and can remain in the blood for more than 16 hours, 4) an article immediately following this lousy analysis, Carroll (1992), points out that food reactions can be delayed up to 48 hours after ingestion. v. The authors claim that only 251 cases of seizures due to aspartame ingestion have been reported to the FDA. In reality, the FDA splits the categories into: "Seizures and Convulsions," "Grand Mal," "Petit Mal," "Complex Partial Seizures," and "Simple Partial Seizures." The 251 cases quoted by the authors referred only to the "Seizures and convulsions" category as of 1992. There have been over 500 seizures reported to the FDA (DHHS 1995) at probably a reporting rate of approximately 1%. vi. The dicussion section listed only industry-funded research. No mention was made of the several independent studies showing adverse reactions to aspartame. For example, the poorly-conducted Schiffman (1987) headache study was cited, but the much better-conducted Koehler (1988) study was not mentioned. Summary ------- The fact that so many cases were inappropriately categorized as "highly unlikely" that they were linked to aspartame, when many of them should have been categorized as "unknown" or "likely" points to the fact that the authors did not know how to properly conduct an analysis. This is frightening considering that one author is a representative of the FDA. Other inappropriate categorizations as well as citing only poorly-conducted industry research proves that this was an extremely biased analysis of the aspartame and seizure issue. This article was published in the Journal of the American Dietetic Association where, apparently, any pro- aspartame article can be published, no matter how absurd its reasoning. On June 12, 1995, an FDA representative was quoted as saying (Food 1995): "FDA has no further plans to continue to collect adverse reaction reports or monitor research periodically done on aspartame." Conclusion ---------- When it comes to the subject of aspartame, the FDA regularly releases inaccurate and extremely biased information to the press and the general public. The news media, foreign government agencies, and a number of organizations (many which are well-meaning), take this information, which amounts to little more than Monsanto/NutraSweet Public Relations, and passes it on to the unsuspecting public. Any statement about aspartame from the FDA should be followed with the question: "And what's the real story?" It has always appeared that the FDA wishes that all of the countless adverse reaction reports submitted by irate citizens would just go away. The FDA made considerable effort to convince the medical community and the general population that aspartame is safe. Despite this effort, there is growing evidence from independent researchers that aspartame is dangerous, especially for long-term use. The reports of very serious health problems caused or contributed to by aspartame which are being received by independent organizations are beginning to confirm this danger. These reports will not go away even if the FDA chooses to try and ignore them.