From: Gerald Hernesmaa [healthwise933@shaw.ca] Sent: Wednesday, June 09, 2004 1:39 AM To: fdadockets@oc.fda.gov Subject: Fw: G and D Petition submission to FDA ( Docket # 2004Q-0151 ) - Solae Corporation Requests Health Claim, re: Qualified Health Claim: Soy Protein and Cancer . Importance: High ----- Original Message ----- From: Gerald Hernesmaa To: fdadockets@oc.fda.gov Sent: Sunday, June 06, 2004 3:00 PM Subject: G and D Petition submission to FDA ( Docket # 2004Q-0151 ) - Solae Corporation Requests Health Claim, re: Qualified Health Claim: Soy Protein and Cancer . . To: Ms Shellee Anderson Team Leader; Nutrition Policy, Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, MD 20852, USA fdadockets@oc.fda.gov Phone: (301) 827-6860 ( by FedEx ) .......... ( by E-mail ) June 4, 2004 and June 6, 2004 Dear Ms Anderson, Re: The attachment ... Please accept this submission of our Petition to FDA ( Docket # 2004Q-0151 ) - Solae Corporation Requests Health Claim, re: Qualified Health Claim: Soy Protein and Cancer . (Suggesting the consumption of soy protein-based foods may reduce the risk of certain types of cancers including breast, prostate and colon cancer.) You will be able to see from the scientific research, the evidence, which includes but is not limited to the evidence in this petition of objection to Solae Corporation’s request for a "Qualified Health Claim," that the research we have presented here is from well-designed studies, from around the world, conducted in a manner which is consistent with generally recognized scientific procedures and principles which show that there does exist significant scientific agreement among experts qualified by scientific training and experience, from around the world, a very strong statistically significant association of harm to human and animal health from the consumption of soy and soy protein ingredients in our food supply and an INCREASED RISK of a variety of cancers and other major and life threatening health problems, referred to in this submission as "Hidden Harm," which includes but is not limited to breast cancer, prostate cancer, increased cancer cell proliferation, tumor growth, DNA and chromosome damage, immune system damage-(including T-cell production, activity), DNA double strand breaks, thyroid damage and thyroid cancer, and damage to the myelin sheath surrounding the nerves, etc. All abstracts presented here are also published in the NIH Medline data base, (and elsewhere), and are representative of current and past research from around the world, in 2004 and going back to 1953, even as far back as 1925. The full research is also available via these abstracts. Notice that some of the research studies included with this petition are from the US Department of Energy and NCTR which are Federally operated and funded, and other very reputable research institutions from around the world. (Personally, we have collected over 200 abstracts documenting the many serious, harmful and sometimes deadly side-effects of eating soy, including Soy Protien Isolate, SPI, in our food supply. This collection of ours represents only some of those available in the scientific community, world wide.). It is a shame and a black mark onto the good name of scientific community as a whole that the Solae Corporation has not included these abstracts, and others like them, in their research data used for their petition for a Qualified Health Claim to the FDA. In this, our petition of objection, we will also point out, what are in our opinion, based on publically known facts, several serious errors, flaws, misrepresentations, in Solae Corporation’s application requesting a Qualified Health Claim for Soy Protein and Cancer. Since the Solae Corporation is newly formed in around April of 2003, less than a year before they made their application to the FDA this year, 2004, I would expect that their lack experience and knowledge would mostly, but not completely, accounts for these errors, misrepresentation(s) of the facts in their application to the FDA, as well as, their narrow focus on their selection of research, (from that which Solae used. Such "other" scientific research is easily and widely available world wide from many sources), used in trying to justify and prove their flawed argument for a Qualified Health Claim for Soy and Cancer P. S. This PS paragraph here is added June 6, 2004 to the email copy, page 23, as the printed copy had already been sent by FedEx on June 4 th. . My wife Deanna-(Deonaa) Hernesmaa died from breast, bone, liver cancer while and from eating soy ingredients like Soy Protein Isolate, SPI, in her food. She died on Dec. 15, 2002. She also had 3 reoccurrences of cancer while and from eating these soy ingredients. Because we "never gave our consent" to have soy ingredients in her food, because of our lack of knowledge of the dangers of soy ingredients in food, and inability to avoid soy in our food because of "the all pervasive persence of soy ingredients in our food supply, labeled and unlabeled," and based on Dr. Samuel Epstein comments page 17 of this petition of objection to the FDA, and "the evidence"-(which includes but is not limited to what is presented here), "...the estrogens in soy ingredients and the soy industry who puts them in our food, poisoned then murdered my wife, in much in the same way the estrogens in Hormone Replacement Therapy is killing women-(with cancers)... and why the HRT trials were halted in June of 2002 because of these and the other health hazards to women ...". Einstein said, "...the world is a dangerous place to live in, not because of the people who are evil, but because of the people who don’t do anything about it...". It is our understanding from the information posted on the FDA website that the deadline for submissions is June 9, 2004 Have a nice day, Sincerely, Mr. and Mrs. Gerald and Deanna-(Deonaa) Hernesmaa .