FDA Press Release |
||
The U.S. Food and Drug Administration today issued a final guidance for industry on the regulation of genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). The guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," clarifies the FDA's statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it is called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits. “Genetic engineering is a cutting edge technology that holds substantial promise for improving the health and well being of people as well as animals. In this document, the agency has articulated a scientifically robust interpretation of statutory requirements," said Randall Lutter, Ph.D., deputy commissioner for policy. “This guidance will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy." The FDA released the draft guidance in September 2008 with a 60-day public comment period, and received about 28,000 comments. The agency has summarized and responded to these comments on the Web site listed below. The FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals on both early stage and more mature applications. “At this time, it is our intent to hold public scientific advisory committee meetings prior to making decisions on GE animal-related applications" said Bernadette Dunham, D.V.M., Ph.D., director of CVM. The FFDCA defines “articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. An rDNA construct that is in a GE animal and is intended to affect the animal's structure or function meets the definition of an animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and any new products expressed from the inserted construct are safe for the health of the GE animal and, if they are food animals, for food consumption. The guidance also describes the manufacturer's responsibility in meeting the requirements for environmental review under the National Environmental Policy Act. For more information, see www.fda.gov/cvm/GEanimals.htm. # Link to original FDA press release here.
Are you concerned about the potential ramifications genetically engineered animals may have on your health? If so and you'd like to learn more about this controversial subject, download our book "GMOs - Beware of the Coming Food Apocalypse!" here. |
||
|
|
|
Other Related Articles
• FDA Says That Trace Levels Of Melamine Poison In US Made Baby Formula Are Safe• S.1082 The FDA Revitalization Act of 2007 Scheduled For Vote on Monday - One Mouse Click Opposes Health Freedom Killing Bill! Act Now!
• New FDA Rules On 'Frankenanimals'
• Consumer Action Needed To Amend the FDA Globalization Act of 2008
• FDA Unleashes Mass Irradiation of Spinach, Lettuce and Other Vegetables
• FDA HARASSES DAIRY COMPANY EMPLOYEES
• 90 Percent of U.S. Infant Formula May Be Contaminated with Melamine; FDA Abruptly Declares Chemical Safe for Babies
• FDA Tyranny To Become Law
• We Win -- FDA Must Classify Mercury Fillings
• FDA May Approve Stevia-Based Sweeteners
• FDA Ineptitude Costs Many Lives
• Action Alert -- New Senate Bill Threatens Small Farmers
• How The FDA Is Becomming A Drug Company - Part 1 of 2
• How The FDA Is Becomming A Drug Company - Part 2 of 2
• FDA Collaboration With Big Pharma Raises Eyebrows
• Sweet Misery, A Poisoned World - FDA Apartame Conspiracy - Part 2 of 9
• Melamine Found in U.S. Baby Formula, FDA Says
• Senate HELP Committee Unanimously Approved an Amended Version of S.510
• Sweet Misery, A Poisoned World - FDA Apartame Conspiracy - Part 1of 9
• Stop Excessive FDA Regulation
• FDA Chief In Very Hot Water With Congress
• An FDA-Created Health Crisis Circles the Globe
• FDA Urged To Remove Synthetic Dyes From Food
• Sweet Misery, A Poisoned World - FDA Aspartame Conspiracy - Part 7 of 9
• FDA Approves FluMist For 2 To 5-Year-Olds
• Sweet Misery, A Poisoned World - FDA Aspartame Conspiracy - Part 8 of 9
• The FDA Is Sued
• FDA Set to Give OK to Cloned Meat and Milk
• FDA To Shove Cloned Meat Down America's Throat!
• FDA Absurdity Continues - Natural Sweetener Stevia Under Attack While Aspartame, Splenda & Other Artificial Sweeteners Get Free Pass
• Sweet Misery, A Poisoned World - FDA Apartame Conspiracy - Part 5 of 9
• FDA Releases GMP Regulations For Supplements
• Top Heart Expert Urges FDA to Retract Health Claim for Soy Protein
• How Many More Will Die Before FDA Ghouls Are Held Accountable?
• FDA Admits Cloned Meat, Milk May Have Already Entered Food Supply
• Fight For Your Health,
Exposing The FDA's Betrayal of America
• Sweet Misery, A Poisoned World - FDA Aspartame Conspiracy - Part 9 of 9
• FDA Provides Few Details On Its Food Protection Plan
• Citizen Petition Filed With The FDA Seeks To Reclassify All Weight-Loss Claims As Disease Claims
• US Supreme Court Ruling Opens Gateway For Further FDA Attacks On Supplements
• FDA Approves Food from Cloned Animals
• FDA Plans To approve Milk & Meat From Cloned Cows
• Judicial Watch Uncovers Shocking New FDA Documents Related to Gardasil
• The FDA Is Marching
• Sweet Misery, A Poisoned World - FDA Aspartame Conspiracy - 6 of 9
• Sweet Misery, A Poisoned World - FDA Apartame Conspiracy - Part 3 of 9
• FDA Stuns Scientists, Declares Mercury In Fish To Be Safe For Infants, Children, Expectant Mothers!
• FDA Should Reconsider Aspartame Cancer Risk, Say Experts
• URGENT ALERT: FDA Has Gone Into Stealth Mode In An Attempt To Target Dietary Supplements & Alternative Medicine
• FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications
• FDA To Defy Congress By Closing Food Safety Test Labs
• FDA Destroys Incriminating Records On Aspartame
• What's The Real Truth About FDA's Guidance
Document That's Causing An Uproar
Over The Internet?
• FDA Approved Drugs Worse Than 'Made In China' Goods
• FDA Relies on Bogus Industry Studies to Conclude that Plastics Leaching Carcinogenic Chemicals Into Baby Bottles Are Safe
• Controversial Carcinogen Benzene Cover-Up By FDA, Soft Drink Industry
• Sweet Misery, A Poisoned World - FDA Apartame Conspiracy - Part 4 of 9
• Much Ado About Nothing - Let's Get The FDA/CAM Issue Put To Rest
• Is The FDA Still Lying About Aspartame?
• FDA Proposes Calling Irradiated Foods 'Pasturized'
• How Far Will The FDA Go To Restrict Health Freedoms? New Guidelines Would Also Attack Religious Freedoms
• Pets, Food Safety, China, The FDA, And Your Health
• Mutiny By An FDA Advisory Panel
• Mercury Madness - FDA Still In Denial
• FDA Attacks Small Nutrition Companies
Related Products
|
|
|
News and Article Tools
2010 Product Catalog
View our latest product catalog for 2010 online. Loaded with new products and specials. Download for FREE now!
Featured Products!
| SLEEP (w/Valerian & Melatonin) Liquid Veggie Caps 60 ct. |
| Our Price: $22.00
|
|
| MICROPLANT POWDER (2.5 LB CAN) |
| Our Price: $40.00
|
|
| SUPER SEA VEG BY FARMASEA (90 VEGICAPS) |
| Our Price: $39.95
|
|
Free GMO Book!
This powerful book exposes the lies told to the American people about the hazards of consuming Genetically Modified Organisms! A must read for those who are conscience of what they put into their bodies - which should be everyone!