And the Orphan Drug Act
Hope for the Genetically Disabled?
WHO and FAO, the World Health Organization and the Food and Agriculture Organization, two primary UN organs, told the world in 2002 what holistic doctors and scientists have been saying for decades: wholesome food prevents what the agencies call the “preventable, non-communicable diseases of mal and under-nutrition:…” These include heart disease, diabetes, cancer, obesity; all the chronic diseases of modern life. 1
Ground-breaking Journalist Jeffrey M. Smith, in a widely-shared Internet article, explains that advanced health care practitioners are achieving astounding results in cases of chronic disease by helping people change their eating habits to reject all GMO “phude” (Genetically Modified Organisms). He wrote,
“Are genetically modified (GM) foods making you sick – I mean really sick? Up until recently, all that we could say was thank goodness you’re not a lab rat; GM feed messes them up big time. GMOs (genetically modified organisms) appear to trigger the immune systems of both mice and rats as if they were under attack. In addition, the gastrointestinal system is adversely affected, animals age more quickly, and vital organs are damaged. When fed GM foods, lab animals can also become infertile, have smaller or sterile offspring, increased infant mortality, and even hair growing in their mouths. Have I got your attention?” 2Among those holistic scientists is respected psychiatrist and environmental physician Rima E. Laibow, MD, Medical Director of the Natural Solutions Foundation. Dr. Rima has defined the overall symptom complex that GMOs and other genomic disruption technologies cause: Genome Disruption Syndrome. She has written:
“Genomic Disruption through the introduction of novel genetic material (principally through GMO – Genetically Modified Organisms – intake) results in a wide variety of acute, chronic and multigenerational dysfunctions, ranging from the trivial to the lethal. For this reason I call the downstream health consequences of genetic disruption the “Genomic Disruption Syndrome.” (GDS).
“Common expressions of GDS, which are widely scientifically validated, include cancer, cardio-vascular disease, metabolic syndrome, diabetes, obesity, infertility, sterility, fetal malformation, birth defects, autism and other neurological disorders, lethal allergies, immune system dysfunction, premature aging, and a host of other serious conditions.
“The human and economic consequences of GDS are almost impossible to calculate. GDS, however, can be managed, and in many cases, reversed through dietary management which provides strict avoidance of Genomic Toxins and Incitents including genetically damaged ‘foods’ (GMO), excess nuclear exposure, toxic pharmaceuticals (including vaccines) and similar agents which damage DNA.
“The distinctive nutritional requirements, based on recognized scientific principles, needed to treat GDS, include strict adherence to a diet free of any genomic toxins to allow detoxification and repair. In addition, high levels of specific anti-oxidants, minerals and biochemical cofactors can be used in a targeted fashion to manage, repair and remediate both the cause and the expressions of GDS. Wholesome food is now a “medial food” necessary for your health!”Natural Solutions Foundation President, Maj. Gen. Bert Stubblebine (US Army ret) identified the four technologies that he calls the "Genomicidal Technologies" which Dr. Rima has shown to be at the root of GDS. These are GMO fake food, with their "novel" alien proteins, prescription drugs (and especially vaccines) with the horrendous toxic load, nuclear power and the environmental toxins to which we are all exposed.
Knowledge is power and understanding GDS is very powerful knowledge, in deed.
How can you benefit from this powerful new understanding pioneered by doctors like Dr. Rima and those she is teaching? By sourcing as much of the food you and your family eat from low-radiation, organic and biodynamic sources. Under the language of the 2005 Orphan Drug Act, food that is prepared for use as a Medical Food to manage a syndrome is now a valid therapy under Federal Law.
It’s not just GMO “food” that can trigger GDS. Since March 11, 2011, the Day Everything Changed, when the Fukushima reactors in Japan were destroyed, setting in motion the most serious technological threat ever faced by humanity, that means, primarily, sourcing food from the “deep South” – South America and Africa.
As Natural Solutions Foundation develops these sources, they will become available at www.FriendlyFoodCoOp.org . Dr. Rima has identified the medical syndrome and the dietary management of that syndrome. As noted above, Congress, in 2005, created the regulatory category that permits the development of the Dr. Rima Protocol – the strict adherence to toxin-free food. In truth, this is the only logical solution to what is the greatest threat to people like us and families like ours. Read more here: www.GDS-Therapy.com. What Congress told us, in the Orphan Drug Act, is that a Medical Food is:
"a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation....” Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3))Responding to Congress’ instruction, the FDA published a short FAQs,
"Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods a. be intended to meet distinctive nutritional requirements of a disease or condition, b. used under medical supervision and c. intended for the specific dietary management of a disease or condition."The FDA FAQs further inform us,
"The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed … for the patient who is seriously ill or who requires the product as a major treatment modality." 3And the agency concludes:
"In general, to be considered a medical food, a product must, at a minimum, meet the following criteria: a. the product must be a food for oral or tube feeding; b. the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and c. the product must be intended to be used under medical supervision..."One of the problems with sourcing truly wholesome food from the deep South is that fresh food which enters the United States must be irradiated or fumigated. If the food is certified organic, it is exempt from irradiation, but not fumigation. Thus, while, for example, much of our winter fruit and vegetables come from Chile, the honest organic producers there will not ship to the USA. As a Medical Food, however, such food would be exempt from fumigation, in order to maintain its integrity. The legal method for importation may be through the FDA “compassionate use” rule, RPM Ch. 9-71, Coverage of Personal Importation, which allows Americans to import up to a three month’s supply of health remedies not available in the USA, for personal use. I can deduce from the FDA materials several points of note:
(1) the agency has not yet prepared comprehensive regulations regarding Medical Foods;
(2) products protected under the Dietary Supplement Health and Education Act of 1994 (DSHEA) can be considered Medical Foods,
(3) fresh foods that are specially prepared and packaged to manage GDS can be considered Medical Foods, and
(4) it is appropriate for health care providers to recommend such wholesome food for the dietary management of various nutritional and metabolic syndromes that are being identified by advanced health care practitioners, which can be subsumed under the overall Genomic Disruption Syndrome identified by Dr. Rima.Jeffrey Smith concludes:
“Fortunately, as people learn about the health dangers of GMOs, feel better from non-GMO diets, and tell others, the non-GMO movement grows. There are now millions who seek healthier non-GMO foods. Since GMOs offer no consumer benefits…”We can advance this understanding by educating decision makers, including our legislators, about the dangers of GMOs.
Knowledge is power and the powerful must be made aware of the risks to which their policies are exposing us all.
Easily and quickly send them messages through Natural Solutions Foundation’s Educate Decision Makers system: http://tinyurl.com/GMOTruthLabel.
And watch for the definitive White Paper on GDS, currently in preparation by the Trustees of Natural Solutions Foundation, which will help guide those who seek remediation for the disabilities that arise from GDs, and those physicians and other healers who seek to provide those remedies.