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FDA crushes patient access to nutritious medical foods that help prevent and reverse disease

Big Government

(NaturalNews) The most oppressive force when it comes to standing between Americans who want to make many of their own decisions about their health, and nutritional intake, isn't Big Pharma or the medical establishment. Believe it or not, it's the federal government.

In particular, it is the various federal government bureaucracies and agencies, whose nanny-state tendencies prevent thinking, thoughtful, free people from making up their own minds about what to put into their own bodies.

One of the most onerous of these agencies when it comes to nutrition and health, is the Food and Drug Administration. And now, the agency is standing in the way of doctors who want to assist their diabetic patients in managing their disease with specially formulated foods.

"What does your doctor know about nutrition and its ability to heal illness? That's a good question for many conventional doctors, but most integrative doctors actually know a lot about it. And the FDA has no business telling them what to do," says an "Action Alert" from the Alliance for Natural Health USA (ANH-USA).

Recently, the non-profit group noted, the FDA issued its final guidance on so-called medical foods, essentially ignoring a number of very passionate pleas from members of ANH-USA and their allies, by placing severe restrictions on consumer access to medical foods and banning medical foods altogether for diabetics.

Rules 'dramatically limit' medical foods

"Why? Presumably because the use of medical foods might interfere with Big Pharma profits," ANH-USA opined in its alert.

"With the FDA, money always seems to be the same transparent motivation. In 2010, Americans spent $34.4 billion on prescription diabetes drugs. The drug industry is expected to make as much as $54 billion on diabetes drugs alone within the next four years," the group said.

By federal definition, "medical foods" are not just diet plans that doctors prescribe. They are foods specially formulated and processed for sick patients.

Medical foods do not require FDA premarket approval, ANH-USA noted. As such, makers of these foods can assert claims without having performed random controlled trials. However, such foods must follow presently accepted good manufacturing practices, facility registration and additional safety requirements, the non-profit noted.

But the FDA's final rules dramatically limit the specific medical conditions that medical foods can claim to help manage. Specifically, as ANH-USA noted:

-- The guidance uses "inborn errors of metabolism" (IEMs) as the criterion for determining which diseases or conditions are included on the list.

-- For example, inherited biochemical disorders in which absence of an enzyme interferes with the metabolism of protein, fats, or carbohydrates would be treatable with medical foods.

-- Don't get too excited, though—the guidance specifically excludes diseases resulting from essential nutrient deficiencies like scurvy and pellagra.

-- More to the point, the examples given by the agency that fit the new IEM standard are restricted to rare genetic conditions that affect a small fraction of people, and are not applicable for patients who have more common disorders, no matter how controllable the condition might be with medical foods.

'Another instance' of govt. interference in 'doctor-patient relationship'

What is even more outrageous is that the rules exclude both types – 1 and 2 – of diabetes, as well as gestational diabetes because, the FDA says, diabetes can be brought under control just by managing or tweaking a diabetic's normal diet (in addition to using FDA-approved medications, of course).

"According to the FDA, type 1 diabetics should use carbohydrate counting or the carbohydrate exchange system to match their insulin dose to their carbohydrate intake," says ANH-USA. "And type 2 diabetes patients should simply restrict calories, eat regularly, increase fiber intake, and limit their intake of refined carbohydrates and saturated fats—in addition to taking prescription diabetes drugs."

While the group says it is all in favor of a food-based approach to controlling many chronic diseases, and diabetes in particular, the FDA's advice to diabetics is "woefully out of date—and therefore is bad medicine. ...

"This is yet another instance of the FDA inserting itself into the doctor-patient relationship—an illegal federal infringement on the practice of medicine, which is supposed to be regulated at the state level," the group notes.





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