Docket Management
Docket: 02N-0007 - Agency Info Collection Activities; CGMP Regulations for Finished Pharmaceuticals
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. Jacek Nowicki Date/Time 2002-03-04 04:32:25
Organization self
Category Individual

Comments for FDA General
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? I am trying to reach: Dockets Management Branch (HFA305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20057. Submit electronic comments to http:// FOR FURTHER INFORMATION CONTACT: Susan Runner, Center for Devices and Radiological Health (HFZ410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 3018275283.
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? In reference to: Proposed Rules Federal Register 7620 Vol. 67, No. 34 Wednesday, February 20, 2002 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 872 [Docket No. 01N0067] Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy AGENCY: Food and Drug Administration, HHS. Problems mercury can cause Mercury can cause a bewildering variety of problems. In fact, one of the major criticisms of amalgam illness is that it is cited as the cause of so many things. But, like the parable of the blind men and the elephant, mercury can indeed cause many diseases. Modern physicians are not trained to find the root cause of a sick person's problems. They are trained to translate what they see into latin, look it up in their textbook, and apply a cookbook treatment. With a toxin that poisons fundamental metabolic processes different people will experience different symptoms to start off, depending on their own individual biochemistry. As the poisoning becomes more and more serious, further symptoms surface and the modern doctor adds more diagnoses - a patient who starts with depression might later be considered to have hypothyroidism, allergies and asthma in addition. But no thought is given to why one person should develop more and more diseases, when a single diagnosis - chronic mercury poisoning - could account for them all. Some of the diseases a modern physician might mistakenly misdiagnose chronic mercury poisoning as are: Toxic Encephalopathy, Chronic fatigue Immune Dysfunction Syndrome, Autoimmune disorders and disease, Multiple chemical sensitivities, (Environmental illness), Fibromyalgia, Endocrine disorders, Thyroidsm, Irritable bowel syndrome, High Blood pressure, Rheumatoid arthritis, Food Sensitivities, Acne, Psoriorisis, Sciatica, Allergies, Panic attacks, Anxiety, Colitis, Prothralgia, Parkinson's disease, Amylotrophic lateral sclerosis, Alzheimer's' disease, Hypothyroidism, Infertility, Neuropathy, Erectile dysfunction disorder, Polineuropathy, Peripheral neuropathy, Computer vision Syndrome, Alleged and frequently misdiagnozed misdiagnosed for MENOPAUSE, Gastritis, Crohn's disease, Addison's disease, Carpal Tunel, Tersal Tunel, Allergies, Hypogonadism, Ankylosing spondylitis, Insomnia, Anorexia nervosa, Juvenile arthritis Asthma, RAIDS, RADS, RUDS, Learning disabilities, Attention deficit hyperactivity disorder, Lupus erythromatosus, Manic depression, Bipolar disorder, Multiple sclerosis, Bulimia, Myasthenia gravis, Sleep disorders, Candidiasis, Yeast syndrome, Pervasive developmental disorder, Depression, Psychosis, Obsessive-compulsive disorder, Borderline personality disorder, Schizophrenia,
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? I believe this proposed rule is a joke! WE MUST BAN IMMEDIATELY MERCURY FROM ANY DENTAL APPLICATION. WE shall criminalize use of mercury since it is causing severe illnessess and disabilities. Since 1997 I contacted White House, and several US senators, I delt with FDAs own: 1. Leonard, Nancy M. FDA - Public Health Advisor 1-800-638-2041 ext. 141 US 2. Alderton, Bonnie J. FDA - CDRH Small Manu. Assistance, FDA US 3. Auerbach, Jessica B. FDA, Consumer Section, CDRH (HFZ-210) 301-443-7491, ext.138 US To be told bullshit by FDA employees. I am severly disabled after poisoning by dental mercury amalgam fillings after occupational exposures to H2S which reacted with my mercury fillings disolving them totally. There is NO DOUBT that GULF WAR ILLNESS is caused by MERCURY poisoniong (dental mercury amalgam reaction with hydrogen sulfide leaking from OIL WELLS on fire, and additional mercury boost from vaccines (thimerosal) causing severe brain injury, including Parkinson's like trembling, and lobar perfussion. Mercury fillings are the sole cause of Carpal Tunel, erectrile dysfunction alleged menopause, Fibromyalgia, Chronic Fatigue immune dysfunction syndrome, Multiple Chemical Sensitivity... and more! See: 42360 Federal Register / Vol. 59, No. 158 / Wednesday, August 17, 1994 / Notices ENVIRONMENTAL PROTECTION AGENCY [FRL-5050-09] Final Report: Principles of Neurotoxicity Risk Assessment AGENCY: U.S. Environmental Protection Agency. ACTION: Final Document. SUMMARY: The U.S. Environmental Protection Agency is publishing a document entitled Final Report: Principles of Neurotoxicity Risk Assessment, which was prepared by the Working Party on Neurotoxicology under the auspices of the Subcommittee on Risk Assessment of the Federal Coordinating Council for Science, Engineering, and Technology (FCCSET). Industrial Exposure and Control Technologies for OSHA Regulated Hazardous Substances U.S. Department of Labor Elizabeth Dole, S Secretary March 1989 Volume II of II Substances K-Z and Indices Occupational Safety and Heath Administration John A. Pendergrass, Assistant Secretary Mercury vapor HEALTH EFFECTS Lorscheider, F.L., Vimy, M.J., and Summers, A.O. Mercury Exposure from Silver Tooth Fillings: Emerging Evidence Questions a Traditional Dental Paradigm. FASEB Journal (April 1995). Dr. Michael F. Ziff, D.D.S publications Amalgam Illness: Diagnosis and Treatment What you can do to get better How your doctor can help by Andrew Hall Cutler, PhD, PE ISBN 0-9676168-0-8 Neurotoxicity: Identifying and Controlling Poisons of the Nervous System U.S. Office of Technology Assessment April 1990 OTA-BA-436 NTIS order #PB90-252511 (361 pages) TESTIMONIALS:
4. What are ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology? Reply to me from PENTAGON (General Rostker): Summers (1994) has proposed that set of unexplained symptoms in PGW veterans (skin rashes, chronic fatigue, headaches, sore joints, hair loss, irritability, insomnia, diarrhea, and depression) are related to mercury toxicity as result of installation of dental amalgams just prior to or immediately after service in PGW. This hipotesis asserts that installation of these amalgams resulted in clinically evident elemental mercury toxicity that continues as patients have ongoing exposure to mercury. It is clear that the placement of dental amalgams results in systemic exposure to mercury (Gross and Harrisson, 1989; Researchers suggest that Gulf War veterans and others who meet the diagnostic criteria for more than one of CFS, FMS and/or MCS may all be suffering from dental amalgam poisoning but as yet not undefined common syndrome. Summers et al. 1993). It is also clear that significant exposure to elemental mercury results in toxic syndrome with complex clinical presentation (Wyngaarden et al. 1992.) At the same time, relatively few human studies of adverse effects of amalgams have been done. Interest in diminishing elemental mercury exposure has resulted in proposals in Sweden, Denmark and Germany for restrictions on the use of mercury - containing dental amalgams. To date, the hypothesis of unexplained symptoms in PGW veterans associated with the recent installation of dental amalgams has not been directly investigated to the best of our knowledge. __ It is evident that all, for example, seem to share heightened sensitivity to a diverse range of stresses, from physical exertion and infection to environmental exposures. In addition to chemical sensitivity, they often also report heightened sensitivity to bright lights, loud noises, hot and/or cold weather, and/or being touched. Until further research clarifies the nature of this overlap, however, the majority of physicians, insurers, attorneys and support groups continue to regard CFS, FMS, MCS and GWS for legal claims are trying to define as separate and distinct conditions.
5. General Comments The legal position of the American Dental Association (ADA) on the safety of mercury containing dental amalgam and the use of the material by dentists in the United States was recently stated as follows: The ADA owes no legal duty of care to protect the public from allegedly dangerous products used by dentists. The ADA did not manufacture, design, supply or install the mercury-containing amalgams. The ADA does not control those who do. The ADA's only alleged involvement in the product was to provide information regarding its use. Dissemination of information relating to the practice of dentistry does not create a duty of care to protect the public from potential injury. Source: Legal brief filed in 1995 by attorneys for the ADA in W.H. Tolhurst vs. Johnson and Johnson Consumer Products, Inc.; Engelhard Corporation; ABE Dental, Inc.; the American Dental Association, et al., in the Superior Court of the State of California, in and for the County of Santa Clara, CA, Case No. 718228. It is mandatory that MERCURY WILL BE IMMEDIATELY BANED AS SEVERE NEUROTOXIC SLOW ACTING POISON, and use of mercury in dentistry must be criminalized!

EC -1