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Inflammation and the FDA

Published August 18th, 2014 in Alternative Perspective

by Tammera J. Karr, PhD

Inflammation is a sore subject these days, yes the pun was intended. Every year more individuals come to me with chronic inflammation concerns. Most of these folks can and do successfully reduce their inflammation through diet and lifestyle modifications, myself included.

Why is this more than just a physical sore point with me on a hot summer afternoon? The information shared by the ANH-USA came in just as I was finishing revisions to my book we are preparing to release this summer, the folks at the Beacon have played an instrumental role in the writing, as have the readers of the paper. Within this book, I have outlined several ways individuals can take back control of their health and reduce inflammation. It seems like pregnancy and a few other normal physical conditions; the FDA has labeled inflammation as a disease. Now remember for every disease there is a lot of money to be made in treatments, medications, therapies, and even research. Along with the label comes a very strong arm to pummel anyone who dares to suggest otherwise.

So here is the scoop as provided by the Alliance for Natural Health on what the FDA is up to while we are all about to celebrate our freedom from the chains of tyranny.

The FDA Calls One of the Body’s Basic Healing Functions a “Disease” Posted By ANH-USA On July 1, 2014
Inflammation is the body’s complex biological response to harmful stimuli such as pathogens, irritants, or injuries. It’s a natural, protective attempt by the body to remove the stimuli and start the healing process. When this inflammation becomes too intense or chronic, the inflammatory response itself can damage tissues. Atherosclerosis, asthma, allergies, autoimmune disorders, celiac disease, rheumatoid arthritis, sarcoidosis, and even cancer are all triggered or caused by or involve inflammation.
Although it is a natural protective response of the human body, the FDA has decided that inflammation is, in and of itself, a disease, and that statements about the ability of a supplements to treat inflammation are “implied disease claims.” FDA issued at least ten warning letters [1] in 2013 to companies for making alleged disease claims correlating dietary supplements to inflammation. Moreover, more than 150 companies—many in the practitioner channel—also received warnings [2] from FDA in the early months of 2013 demanding that the companies discontinue all product claims related to inflammation. Based on these actions, the agency may consider any mention of “inflammation” to be a disease claim.
Remember a couple years ago I told you about cherry and blueberries farms being fined by the FDA over drug claims – all for mentioning the health properties of foods that fight inflammation!
A source told ANH-USA that the FDA rejected a supplement company’s pre-marketing application which said that the product “supports healthy inflammatory response.” Under the landmark Dietary Supplement Health and Education Act of 1994, supplements are allowed to make claims about how a supplement may affect the structure and function of the body (“structure/function” claims), and this statement would seem to fall squarely in the structure/function category—but that’s not how the FDA is treating it.
Why is the FDA doing this? Because Big Pharma has some anti-inflammatory drugs in the pipeline, and they want a monopoly on its treatment. So they pressure the FDA, which receives an inordinate percentage of its operating budget from the pharmaceutical industry, and the FDA issues its warning letters. Here are just a few of the products being developed:
• Five new drugs for inflammatory bowel disease [3], together with four new applications for existing drugs, are currently under investigation.
• The FDA just approved Entyvio, which treats inflammation connected to Crohn’s disease [4].
• Pharmaceutical company Gilead has nine drugs in various stages of clinical trials for inflammation in relation to cancer [5]. Two of them have already been submitted to US and EU regulatory agencies for approval.
• Evidence from clinical trials suggests that statin drugs, which claim to treat high cholesterol, are also anti-inflammatory [6]. If statins gain new traction as anti-inflammatory drugs, drug companies may have found an additional way to further reduce competition from supplements. Of course, as our readers know, statins come with serious side effects, such as muscle pain and depletion of the vital heart nutrient CoQ10. Since the heart is a muscle and depends on CoQ10, the current rise in heart failure could well be linked to statin use.
Whatever the prospective merits or demerits of these drugs, inflammation is not an abnormal “disease” state of the body. It’s part of the body’s underlying maintenance system, and can be triggered by something as simple as stubbing your toe. By the FDA’s ludicrous definition, we wonder if the inflammation that results from stubbing your toe would be considered a disease too!
I would have to agree with the last statement of the article – what is next? As long as I can I’ll keep writing about how you can take back control of your Health and Freedom.
To Your Good Health, and the Freedom of the Written Word.

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Article printed from The Alliance for Natural Health USA: http://www.anh-usa.org
[1] warning letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm307676.htm
[2] received warnings: http://www.nutraceuticalsworld.com/issues/2014-01/view_columns/2013-regulatory-review/
[3] drugs for inflammatory bowel disease: http://www.mayoclinic.org/medical-professionals/clinical-updates/digestive-diseases/expanding-pipeline-inflammatory-bowel-disease-drugs
[4] inflammation connected to Crohn’s disease: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm398065.htm
[5] for inflammation in relation to cancer: http://www.gilead.com/research/pipeline
[6] are also anti-inflammatory: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC59622/

 

 

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