FDA to regulate CAM more in USA?

[ysabella]

The FDA is gearing up to more closely regulate CAM products!

PDF file of docket, although it's not the smoothest read ever.

Page where you can comment on the docket (until April 30th).

Seen via a dieting site, which referenced this Newstarget.com article (outraged, of course).

I'm still reading the document, so I'm not sure if all of the NewsTarget claims are true ("They'll regulate massage rocks as medical devices!" etc.). But I'm posting some of you have time to read it too and we can discuss.

 

[noryl]

A lot of complaining on that dieting site...typical of people to not understand what something is saying and to be caught up in the hype of some conspiracy theorist.

I support the FDA regulation of anything that is sold to be put into our body to improve our health. We need an independant organization to decide if something is safe. Yeah they don't get every decision right but its something we need.

You can't trust any company out there to put their customer's health first. That includes big pharm and the little health food store.
There's plenth of "supplements" out there to cure this and that and its BUNK. I welcome the FDA to demand labeling changes so the consumer knows its not guaranteed to cure something or make you healthier.

Anyway the document in question isn't anything binding, its giving the FDA's opinion on how CAM products should be governed.
People act as if this is said and done and these CAM products will just disappear. No, thats not the case.
If you are providing fruit juice in some therapy that you say cures cancer, then you are selling a drug. A drug is a product that cure's a disease. Cancer is a disease. There's nothing saying you can't sell your product but if you want to use the lingo that it cures cancer, then you'd better be able to prove it. Of course, if you market it differently, then you can sell it.

 

[noryl]

It seems there are a lot of people out there who have a strong distrust of the pharm companies. At least the products they sell have been through a lot of tests. I'm sure someone is going to bring up corruption and bribery and such to get some pill approved...

However, i'd trust the FDA approved drug before i'd trust some guy selling the latest diet pill. You read the ingredients and its vitamins and caffeine. And there is so much of that junk out there. I'd like to see the FDA crack down on junk products like that.

 

[casebro]

Last time they did 'regulated' cam, they made it easier for the nutracueticals to do business. What makes anybody think the richer, more powerful industry won't 'buy' the regulations this time, even more so?

 

[Eos of the Eons]

With the insurmountable mountain of junk out there, the CAM purveyors are going to start crapping their undies if they actually have to prove that their "products" contain something other than cigarette ashes. Awwww, muffins!

First you have to start shoveling some of that mountain of doo doo off somewhere. I don't know how, since it is sooo out of hand at the moment. I think that is why they are starting to think about regulations again though.

What makes anybody think the richer, more powerful industry won't 'buy' the regulations this time, even more so

Ohhhh wah, they can actually afford to quality check and put real ingredients in their products. Can't say I'm sorry about that! If the small players can't put their money back into ensuring quality and efficacy (if they make claims about having effects), then I hope they do go out of business! They make a 500% profit on their useless junk as it is! The supplement and alternative industry makes billions of dollars by stuffing whatever they feel like into capsules.

Just look at "high quality" supplements the bigger fish put out, like Cold FX. It's gingseng carbs stuffed into a pill. Sure, they make sure nothing weird, like arsenic, gets into it, but it's not expensive to extract starch from gingseng and stuff it into pill form. They can even afford to pay celebrities to say it works.

With regulations the Cold FX makers will survive fine, since they at least make sure ginseng sugar/polysaccharide is in the pills (and not just outsides of stalks), and the same amount every time. It's the back door supplement makers that stuff generic weeds into their capsules that will complain the loudest. THEY will have to figure out how to get some "active" ingredients in their pills, or they will go out of business. Boo hoo.

A study of the “Top 10” brands of the joint supplement Glucosamine and Chondroitin sulfate showed that only two or three brands actually contained what they claimed on the label. Most brands have much less than claimed and a few, in beautiful packages, had absolutely no active ingredient! Another study revealed that 84 percent of brands did not meet label claims in terms of ingredients.

http://www.drnick.com/your_kneerx/supplements/supps_details.asp

They still won't have to prove their "food" will do anything beneficial to you. But making sure the products contain what they say they do would be a darn fine huge step in the right direction, finally.

 

[blutoski]

If you are providing fruit juice in some therapy that you say cures cancer, then you are selling a drug. A drug is a product that cure's a disease. Cancer is a disease. There's nothing saying you can't sell your product but if you want to use the lingo that it cures cancer, then you'd better be able to prove it. Of course, if you market it differently, then you can sell it.

I think you've captured a legitemate concern with that last sentence. Marketing is responding to two entities: customer and regulator.

I watch some of these ads, and their claims are largely implied rather than explicit. For example: "Has been used for centuries to treat cancer." This is not a claim that it actually works.

Another approach is to make no actual claims, but to march out a series of anecdotes: "I took X and now my cancer is gone." The company is making no claim at all, just repeating customer experiences with the product.

Will a judge see through this? Sure. There's a "reasonable person" clause in fraud suits. However, my experience is that a lot of the little operators are morons, and they will see regulations as something to work around to shift to a position of liable impunity, even though they're wrong about this interpretation.

I'll give you an example of a guy who was pushing his health herbs on Wreck Beach a few years ago, interrupting my tanning session. In Vancouver, you're not allowed to sell food on public property without a licence.

He produced his 'licence' to sell food on the beach. It was a hand-made document, written in crayon. He said that nowhere was it actually written that he had to get a licence from some official - just that he needed one. So, in his mind, he was in compliance.

If it came down to it, a judge would toss this guy out on his ass, but in the meantime, he seems to believe that he has beaten the system.

 

[ysabella]

I finally took the time to really read this document, and all it is doing is outlining how they apply their mandate lately. No new law, no new domain, no changes, nothing binding. It is just an attempt to clarify policy so that industry can be sure they are complying.

So it's kind of funny how alt-med sites everywhere are all up in arms about "Big Brother" and FDA "fascism" and so on (and yes, those are actual quotes).