• Breached EFSA guidelines on risk assessment transparency on multiple grounds;
• Adopted a low-hurdle for the acceptability of negative studies - including studies previously dubbed "woefully inadequate" and "worthless" by experts;
• Applied unreachably high hurdles for 'positive' studies indicating adverse effects - even though many of those 73 studies were far more reliable than most of the studies that provided no indication of risk; and
• Demonstrated puzzling anomalies including inconsistent and unacknowledged assumptions.

JAMES D. BOWEN, M.D. 3118 S Logan Ste.3 Lansing, MI 48910

My statement for the public record regarding food labeling and the aspartame issue is serious if not somewhat facetious at times. The reason for this is because I have found little evidence of honesty, integrity or stability on the part of Food & Drug Administration officials regarding the aspartame issue, since its approval in 1981.

This attitude is largely shared by the general public. I come in contact with approximately two new people each week who are now being or who have in the past been poisoned by aspartame.All of them share the same reactions that it is not worth writing to the FDA or NutraSweet, because you and your agency have run amuck and are no longer a valid public benefactor.

The recent revelations about the problems surrounding generic drug approvals are compelling evidence of what happens when an agency considered itself above the law in dealing with these matters. In my opinion, this has resulted in the mass poisoning of the American public as well as seventy-plus countries in the rest of the world. Watching FDA officials walk through the revolving door and be further rewarded by being promoted to other positions of high public responsibility is clear evidence of a government out of control.

For this reason, I am opposed to labeling aspartame content of food and drinks. To do so would imply that the government is taking some sort of responsible action...when the only responsible action would be to immediately take aspartame off the market, fully disclose its toxicities, offer full compensation to the injured, public and criminally prosecute anyone who participated in the fraudulent placement of aspartame on the marketplace. That includes those who work so diligently to keep in on the market as well. Further, to label the purported aspartame content of a product would cover a number of toxic flaws in the product and its allowable daily intake (ADI) as follows:

1. That the amount stated on the label was accurate and factual rather than theoretical. Aspartame breaks down relatively quickly in solution. Given the well established modus operandi of the manufacturer, there is no concern given the ultimate consumer. And cover-ups seem to be a part of the routine of doing business. The public should be well advised that the amounts really used in liquid products are relatively greater than those stated to accomplish a relative compensation for the loss of product sweetness occurring during storage in solution.

2. That the ADI presently allowed is 50% greater than that expected to cause a reversal of the phenylalanine/tyrosine ratios in the human brain. This has profoundly bad implications for the human being, including dopamine and serotonin synthesis inhibition, causing depression, appetite changes, mental inabilities, increased susceptibility to seizures and a host of neurohormonal problems.

3. Every known metabolite of aspartame is of marked or questionable toxicity and patently unsafe for human use. Methyl alcohol is metabolized to nascent formaldehyde in the eye, nervous system and other metabolically active organs. It immediately attacks and denatures the tissue structure proteins in which is metabolized to nascent formaldehyde. This stimulates specific organ and subcellular autoimmunity which seems to be a preponderant source of the bad experiences reported by NutraSweet victims. Aspartic Acid is a neuroexcitotoxic present in damaging amounts, it own right, at the ADI for aspartame. Simple logic tells one that it will vastly increase the metabolism of methyl alcohol to formaldehyde attach there. This corresponds well with the symptomalogies often experienced, such as Lou Gehrigs Disease (ALS), bulbar palsies, neurohormonal disorders, diketopiperazine issue remains totally unresolved and dangerous. The amino acids that are released by hydrolysis, form eimers and isomers that are either not sufficiently studied, or which are known substrates in undesirable pathological states such as Alzheimers disease.

4. There is the issue of the approval of aspartame for market, which has violated every principle of responsible science and responsible government. Everyone responsible for this hearing should at least completely review the approval process and the comments of the participants and observers who have so excellently elucidated all the malfeasance for the public record, such as Dr. Adrian Gross and many, many others (all on the public record).

In light of the above 4 points, I highly recommend that you deny in every way possible any subterfuge of respectability that the aspartame people have enshrouded themselves and their product within hopes of quickly denying its access to the worldwide marketplace. I write this, not believing that it will do the slightest bit of good in the sense of affecting the labeling issue per se, but that instead, it might reach some honest, concerned, conscientious individuals in the process.