Comments on: FDA Is Strongarming The Vitamin Industry http://livinlavidalowcarb.com/blog/fda-is-strongarming-the-vitamin-industry/1752 To educate, encourage, and inspire the world to start low-carb living Thu, 24 May 2012 00:33:00 +0000 hourly 1 http://wordpress.org/?v= By: CBhttp://livinlavidalowcarb.com/blog/fda-is-strongarming-the-vitamin-industry/1752#comment-5379 CB Wed, 02 May 2007 02:57:00 +0000 http://livinlavidalowcarb.wordpress.com/2007/04/29/fda-is-strongarming-the-vitamin-industry/#comment-5379 Hey Jimmy, sorry, but I have to disagree with you on this one.<br/><br/>Full disclosure: I work in an FDA-regulated industry (pharmaceutical) - though I work for a small- to mid-size pharma company. My job duties revolve completely around 21 CFR Part 211 (current Good Manufacturing Practices).<br/><br/>That said, I don't work *for* the FDA; so I certainly no shill for the agency.<br/><br/>On to my point: the original (and fundamental) purpose of the Food and Drug Act is to ensure the safety and efficacy of drug products.<br/><br/>My company sells, among other things, prescription vitamins. Seeing the difference in regulation between our vitamins and our more regulated drug products, I shudder to think of the state of non-regulated OTC vitamins.<br/><br/>I am all for taking OTC vitamins. I, like probably most of the rest of your readers, take supplements. But the truth is, a non-regulated OTC vitamin comes with absolutely NO guarantee of its purity, potency, identity, strength, or quality.<br/><br/>If you would like a more in-depth description of what such regulation would mean, I would be happy to try to help answer questions. But IMHO, expanding FDA regulation to OTC vitamins would be a good - not a bad - thing. Hey Jimmy, sorry, but I have to disagree with you on this one.

Full disclosure: I work in an FDA-regulated industry (pharmaceutical) – though I work for a small- to mid-size pharma company. My job duties revolve completely around 21 CFR Part 211 (current Good Manufacturing Practices).

That said, I don’t work *for* the FDA; so I certainly no shill for the agency.

On to my point: the original (and fundamental) purpose of the Food and Drug Act is to ensure the safety and efficacy of drug products.

My company sells, among other things, prescription vitamins. Seeing the difference in regulation between our vitamins and our more regulated drug products, I shudder to think of the state of non-regulated OTC vitamins.

I am all for taking OTC vitamins. I, like probably most of the rest of your readers, take supplements. But the truth is, a non-regulated OTC vitamin comes with absolutely NO guarantee of its purity, potency, identity, strength, or quality.

If you would like a more in-depth description of what such regulation would mean, I would be happy to try to help answer questions. But IMHO, expanding FDA regulation to OTC vitamins would be a good – not a bad – thing.

]]> By: Jimmy Moorehttp://livinlavidalowcarb.com/blog/fda-is-strongarming-the-vitamin-industry/1752#comment-5378 Jimmy Moore Mon, 30 Apr 2007 20:56:00 +0000 http://livinlavidalowcarb.wordpress.com/2007/04/29/fda-is-strongarming-the-vitamin-industry/#comment-5378 PERFECT example, Ed! Those OTC digestive enzymes that help you so much now would rise in cost to the same price as the prescription version if the FDA gets their grubby hands on them. This isn't a game--we need to let them know how much we abhor what they are proposing. I shared my story, how about you? PERFECT example, Ed! Those OTC digestive enzymes that help you so much now would rise in cost to the same price as the prescription version if the FDA gets their grubby hands on them. This isn’t a game–we need to let them know how much we abhor what they are proposing. I shared my story, how about you?

]]> By: Ed Bellingerhttp://livinlavidalowcarb.com/blog/fda-is-strongarming-the-vitamin-industry/1752#comment-5377 Ed Bellinger Mon, 30 Apr 2007 20:45:00 +0000 http://livinlavidalowcarb.wordpress.com/2007/04/29/fda-is-strongarming-the-vitamin-industry/#comment-5377 Hi Jimmy,<br/>I take over the counter digestive enzymes because they cost less than 20 dollars a month I was using perscription enzymes but they cost over 400 a month and I have no insurance. The over the counter ones actually work because I no longer have any pacreatic action because of cancer and surgury. They are a life saver even though the FDA claims there is no proof they work. Hi Jimmy,
I take over the counter digestive enzymes because they cost less than 20 dollars a month I was using perscription enzymes but they cost over 400 a month and I have no insurance. The over the counter ones actually work because I no longer have any pacreatic action because of cancer and surgury. They are a life saver even though the FDA claims there is no proof they work.

]]> By: Science4u1959http://livinlavidalowcarb.com/blog/fda-is-strongarming-the-vitamin-industry/1752#comment-5376 Science4u1959 Mon, 30 Apr 2007 18:29:00 +0000 http://livinlavidalowcarb.wordpress.com/2007/04/29/fda-is-strongarming-the-vitamin-industry/#comment-5376 von Eschenbach? Sounds very German to me. Hmmm. Like I said before, there are no good Government intentions anymore. <br/><br/>Pot Kettle Black: Did you read the actual text of S1082? It is not exactly reassuring. In fact it would completely defunct Dietary Supplement Health and Education Act of 1994 (also called the DSHEA). What is more, however, is that S.1082 would actually create a pharmaceutical company inside the FDA called the Reagan-Udall Foundation for the Food and Drug Administration, and it gives them incredible powers. In fact so many powers that it is un-democratic. And the way they are pushing this is highly suspect too. It is scheduled for an unrecorded voice vote in the Senate. Apparently Sen.Kennedy (who should be ashamed to blemish his famous family name on this) doesn't want us to see how our Senators voted on this voluminous 262 page piece of legislation. <br/><br/>I've already seen it called "easily the most Orwellian piece of legislation to come at us since the Patriot Act" and I've heard comments from several legal experts in the same vain. Not very reassuring either. <br/><br/>I think Jimmy is right... this legislation is a very real threat to your and our health, and to democracy. Again, there are no good Government intentions anymore... von Eschenbach? Sounds very German to me. Hmmm. Like I said before, there are no good Government intentions anymore.

Pot Kettle Black: Did you read the actual text of S1082? It is not exactly reassuring. In fact it would completely defunct Dietary Supplement Health and Education Act of 1994 (also called the DSHEA). What is more, however, is that S.1082 would actually create a pharmaceutical company inside the FDA called the Reagan-Udall Foundation for the Food and Drug Administration, and it gives them incredible powers. In fact so many powers that it is un-democratic. And the way they are pushing this is highly suspect too. It is scheduled for an unrecorded voice vote in the Senate. Apparently Sen.Kennedy (who should be ashamed to blemish his famous family name on this) doesn’t want us to see how our Senators voted on this voluminous 262 page piece of legislation.

I’ve already seen it called “easily the most Orwellian piece of legislation to come at us since the Patriot Act” and I’ve heard comments from several legal experts in the same vain. Not very reassuring either.

I think Jimmy is right… this legislation is a very real threat to your and our health, and to democracy. Again, there are no good Government intentions anymore…

]]> By: Pot Kettle Blackhttp://livinlavidalowcarb.com/blog/fda-is-strongarming-the-vitamin-industry/1752#comment-5375 Pot Kettle Black Mon, 30 Apr 2007 17:42:00 +0000 http://livinlavidalowcarb.wordpress.com/2007/04/29/fda-is-strongarming-the-vitamin-industry/#comment-5375 So, here are your choices:<br/>1- An unregulated market (current state)<br/>2- A market with regulation similar to pharmaceuticals (proposed state)<br/><br/>I will take choice #2. Why? <br/>1- Statements. There is currently no regulatory body watching the claims made by the vitamin and supplement community to make sure they actually do what they claim to. I would greatly prefer a world with a third party lab test for efficacy required before statements are made. <br/>2- Quality. Currently, there is no way for you to know if you are getting what you are paying for when you buy a supplement. You don't know about concentration, quality, etc. <br/><br/>Jimmy, I think you are giving in to some fear mongering from the CORPORATE ENTITIES who produce vitamins and minerals. Key line: "With one out of every three Americans using nondrug treatments for their health at an estimated cost of $5 billion annually..." This is a BIG Business that is:<br/>a) Involved in people's health<br/>b) completely unregulated as to quality<br/>c) completely unregulated as to claims<br/>d) currently due to b&c possessed of a huge competitive advantage over the traditional medical produce establishment. <br/><br/>As to your fear mongering:<br/>"Do you own a home gym for medical purposes? It would need FDA approval for use or commerce. How about heading down to your local drugstore to find your favorite vitamins? Good luck because the FDA would need to give their go-ahead. In fact, any store caught selling vitamins without the FDA's magic stamp could be prosecuted for 'practicing medicine.'"<br/><br/>#1 - gym equipment (ie weights) are outside the purview of the FDA, even with this proposed change in the law. <br/>#2 - Use is not personal use. The phrase 'use & commerce' means trade. If you don't sell admissions to your home gym, there is no 'use and commerce'. <br/>#3 - As to Vitamins, why shouldn't someone regulate the claims and quality of them? What if taking alpha-tocopherol alone for your Vit E isn't effective (it's not by the research I have read)? Should a Vit E be sold that is 100% Alpha-tocopherol? Many are. And how do you know that you are getting what it says you're getting on the label? Consumer Reports did a study and they conclusively said you don't. <br/><br/>Jimmy, the hype and paranoia about this is the junction of soon-to-be-regulated scam artists and anti-government libertarians. Ask your local libertarian who is going to guarantee your quality on something you can't monitor for yourself. So, here are your choices:
1- An unregulated market (current state)
2- A market with regulation similar to pharmaceuticals (proposed state)

I will take choice #2. Why?
1- Statements. There is currently no regulatory body watching the claims made by the vitamin and supplement community to make sure they actually do what they claim to. I would greatly prefer a world with a third party lab test for efficacy required before statements are made.
2- Quality. Currently, there is no way for you to know if you are getting what you are paying for when you buy a supplement. You don’t know about concentration, quality, etc.

Jimmy, I think you are giving in to some fear mongering from the CORPORATE ENTITIES who produce vitamins and minerals. Key line: “With one out of every three Americans using nondrug treatments for their health at an estimated cost of $5 billion annually…” This is a BIG Business that is:
a) Involved in people’s health
b) completely unregulated as to quality
c) completely unregulated as to claims
d) currently due to b&c possessed of a huge competitive advantage over the traditional medical produce establishment.

As to your fear mongering:
“Do you own a home gym for medical purposes? It would need FDA approval for use or commerce. How about heading down to your local drugstore to find your favorite vitamins? Good luck because the FDA would need to give their go-ahead. In fact, any store caught selling vitamins without the FDA’s magic stamp could be prosecuted for ‘practicing medicine.’”

#1 – gym equipment (ie weights) are outside the purview of the FDA, even with this proposed change in the law.
#2 – Use is not personal use. The phrase ‘use & commerce’ means trade. If you don’t sell admissions to your home gym, there is no ‘use and commerce’.
#3 – As to Vitamins, why shouldn’t someone regulate the claims and quality of them? What if taking alpha-tocopherol alone for your Vit E isn’t effective (it’s not by the research I have read)? Should a Vit E be sold that is 100% Alpha-tocopherol? Many are. And how do you know that you are getting what it says you’re getting on the label? Consumer Reports did a study and they conclusively said you don’t.

Jimmy, the hype and paranoia about this is the junction of soon-to-be-regulated scam artists and anti-government libertarians. Ask your local libertarian who is going to guarantee your quality on something you can’t monitor for yourself.

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