Thursday, October 29, 2015

The FDA regulatory functionality

What's a drug? I'm not being facetious, most people don't have any idea what the legal definition of a drug actually is. Nor do they understand the processes (or costs) involved with creating, testing and receiving approval for new drugs. Well, the feds define a "drug" in the 21st US Code of Federal Regulations 802 section 321 G subsections A, B, C, and D. You can read them at the bottom. Of particular interest is subsection B that states drugs are articles for use in prevention of diseases. Things like Vitamin C that prevents scurvy, or the B vitamins that prevent blindness, rickets or a number of bone problems. These are proven cures and preventative measures any person can use to prevent specific diseases. However, the FDA has added in there the famous subsection D to the Code and that part disallows any manufacturer that produces any vitamin or supplement or dietary product from adding information to the label that would in any way make a claim as to whether or not the vitamin or supplement would be beneficial for any disease. That's sort of counterintuitive though, as we know, there is absolute proof that certain substances will indeed prevent or even CURE a large number of diseases. However the CFR was amended to prevent any manufacturer from making such a claim.

The purpose for that of course is to never again have snake oil sales in this country. Snake oil. Sort of a generic term used to categorize the huge numbers of unscrupulous charlatans that concocted home brewed elixirs that contained widely varied ingredients from wood alcohol to cocaine to mercury to powdered skunk glands to just about anything. The movie version is of old by traveling side shows complete with fast talking gentlemen, testimonials and often free drinks and food. Hmmm, sounds like detail men doesn't it? If you don't know or never heard the expression, detail men or women, they are sales staff from the big drug companies that go into doctor's offices and dispense promises of wondrous health benefits of their employer's new drugs along with prizes, money, food and free samples. ((just for fun watch the movie 'Love and other Drugs' and watch the Jake Gylenhaal character when his company invents the boner pill))  Actually when you get right down to it, Coke, Dr. Pepper and a surprising number of now large drug manufacturers got their start in business by hawking the snake oil products of the day. 

The way to prevent Snake Oil in America is pretty simple. The FDA has decreed that anyone making and marketing any drug cannot put any claims of health benefits unless that drug manufacturer puts the stuff through a somewhat rigorous (and expensive) process that will definitively show that the substance is not harmful and indeed does exactly what the maker claims. No more Snake Oil. Well, sort of. The FDA does sort of tip the scales towards the really big drug companies and allows them to bring drugs out into the world that do seem to not have been all that rigorously tested after all. A lot of recalls and black box warnings. Which realistically the end consumer never gets to see. However, the FDA allows the big guys to market those drugs to doctors and hospitals and of course now days, to patients everywhere via the wondrous concept of mass media. TV, magazines, coupons in newspapers, wherever advertising space is available, drugs will be hawked to the world. 

Now the problem for me is that I have for some time now realized that human health depends almost entirely with how your body is fed and cared for. Feed it crap, you get a crappy body. And of course the more crap, ie. chemicals, additives, toxic pesticide residues etc going into the body, then the more the body has to work to eliminate the crap and has little left over to create healthy new cells and cure any problems that might be showing up. Probably from too much crap, but that's the way it works. So the problem is a simple one. The FDA means well, but the restrictive rulings about the claims vitamin and supplement manufacturers want to make about their products prevents people from understanding that simple supplements can help the body get past the crap; especially when all you put into the body is crap. There are others that the FDA has stopped, like the cherry juice processor that labeled their juice with the statement that it helps gout. They got shut down pretty quick, even though virtually every doctor in the world knows that information. The little company never spent the 5 to 8 HUNDRED million dollars for the report that would verify the claim. 

So, what to do. Should you take vitamins, or not. And if you think the above statements about crap in makes for a crappy person and want to at least try something different; well, you will find that the labels do not in any way give you any information. 

I think that's wrong. I believe basic science has justified many many many of the benefits of modern supplements and that the continued ban is just one more example of the FDA harassment of small businesses. 


(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343 (r)(1)(B) and 343 (r)(3) of this title or sections 343 (r)(1)(B) and 343 (r)(5)(D) of this title, is made in accordance with the requirements of section 343 (r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343 (r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

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