T Nation

New Bill to Regulate Supplement Industry

Do people have thoughts on this?

“Sen. John McCain has introduced legislation requiring manufacturers of dietary supplements to register with the Food and Drug Administration and to disclose the ingredients.”

At first blush, this sounds like a good idea. I’d be curious to hear any contrarians out there.

If you would like all supps to close up shop then support this effort
It cost millions to get thru the drug pipeline !

This is bullshit, just another reason to hate politicians more.

I would like to see the actual wording of the bill. If they want supp companies to have to apply for approval then yes, the supp industry will die. If they are only forcing companies to register and provide ingredient lists, on the surface that doesn’t sound to bad. My only reservation is that as always, once they government gets involved a little, they get involved a lot and ultimately destroy.

Sounds like this more involves cracking down on the supps that are “barely legal” with what they include in their products. How many times do people testing positive for steroids claim it was something in the supplements they were taking they didn’t know about?

Likely, the government wants accountability from the supplement industry that, until now, is able to throw anything in a bottle and sell it.

Press release from NHF
http://www.thenhf.com/press_releases/pr_04_feb_2010.html

About NHF:
http://www.thenhf.com/about_us.html


PRESS RELEASE

TAKE ACTION NOW TO PROTECT YOUR SUPPLEMENTS!

February 4, 2010

They are at it again! This time, it is Senator John McCain (R-AZ) and Senator Byron Dorgan (D-ND) who are trying to gut the Dietary Supplement Health and Education Act of 1994 by introducing a new bill (as yet unnumbered) with the misleading title of the â??Dietary Supplement Safety Act of 2010.â?? This bill has as much to do with safety as pigs with space travel.

Senator McCain just held a press conference to announce that he was co-sponsoring his Dietary Supplement Safety Act of 2010 with Senator Dorgan. The draft bill can be found on the National Health Federationâ??s website at http://www.thenhf.com/press_releases/10_0202_Dietary_Supplement_Safety_B… The bill will be introduced shortly in the Senate.

As Scott Tips, the president of the National Health Federation, stated, â??This bill strikes at the heart of the Dietary Supplement Health and Education Act (DSHEA), which was passed unanimously by the U.S. in 1994, and which took away the Food and Drug Administrationâ??s arbitrary powers over supplements. Now, this bill would create a Euro-style â??positive listâ?? of â??acceptableâ?? new dietary ingredients. And by â??acceptable,â?? the bill means acceptable to an appointed bureaucrat. This is completely unacceptable. Failure to comply would result in punitive fines upon such a company selling or distributing a product not being â??accepted.â??"

â??Just as worse,â?? Mr. Tips continued, â??would be the proposed change in the definition of an adverse event to be reported to the FDA concerning any supplement. As we first predicted when the AER bill was introduced (and unfortunately supported by too-many dietary supplement companies), this adverse event reporting bill was only to be the camelâ??s nose in the tent. More would follow, NHF predicted. And this new bill proves that we were right. McCain and Dorgan want to change the events to be reported from â??serious adverseâ?? events to any â??adverseâ?? events! This is totally unacceptable since supplements already have the safest track record of any consumable on the planet. It is just once again politicians using a special-interest group to advance their own pro-pharmaceutical agenda against natural health products.â??

Lee Bechtel, the NHF lobbyist, also said, “These two Senators want to make a law based on NFL players who took weight loss supplements. Supplements have other healthy benefits, and access of millions of consumers of dietary supplements should prevail over six highly paid football players, who cannot read the labels on supplement products.”

The reason put forth by Senator McCain for his advancing this bill was that the government needed to protect athletes who are often surprised by positive drug tests, believing that the supplements they are taking are safe, legal, and free of banned substances. He declared that all Americans have a right to know what ingredients are in the supplements they use, and that FDA should have the authority to regulate the safety of dietary supplements.

This is complete nonsense. You donâ??t take a hammer such as this and destroy a safe industry just to help a few consumers, who have clear-cut alternatives anyway. As they already do today, athletes can share information about which companies make which products that are safe for them to take so as to pass drug tests. A sane person does not destroy an entire industry for reasons such as this one.

We urge everyone to join with the National Health Federation in killing this bill before it even takes its first breath. Telephone Senators McCainâ??s and Dorganâ??s offices to tell them in no uncertain terms how strongly you are opposed to their ridiculous, power-grabbing bill. Then, send them an e-mail saying the same. Then write them a letter telling them exactly what you think of them and where they can shove this bill. Be polite, but be persistent and vocal. Be sure to write and telephone both of your Senators to register the same complaint.

This can literally ONLY be about money.

Surely there are much more pressing issues then telling us what we can/can’t put into our own bodies?

Terrorism? Rape? Murder? Child abuse? etc.

Show me the bodies. He makes it sound like they’re piling up on every street corner.

Does anyone here actually know someone who’s died from supplements?

Anyone?

Tainted multivitamin my ass, fuck that lying piece of shit Vencill. He knows goddamn well he didn’t pop positive for banned substances from a multivitamin.

Point of reference: About a hundred people die every year from Acetaminophen overdoses and thousands go to the emergency room for it.

That’s a product that’s killed thousands of people and yet ephedra was on the the chopping block for 2?

Yeah that makes sense.

Gotta love that right-wing I-know-better-than-you attitude.

[quote]Ghost22 wrote:
Gotta love that right-wing I-know-better-than-you attitude.[/quote]

You were doing well until you got to here. McCain is far, FAR from ‘right-wing’, and in fact acting as a statist like his leftist, Nannystate colleagues in this case. We can certainly take that discussion to another PWI thread if you wish.

This is not a right/left issue. “I-know-better-than-you” or “I-must-take-care-of-you-because-I-don’t-trust-YOU-to-take-care-of-YOU” attitudes are nannyish, statist, and control issues on both sides of the aisle.

Here is “Mr. RightWing, staunch libertarian, small-govt, and medical doctor” Ron Paul’s site coming out against this abortion of legislation:

http://www.dailypaul.com/node/124135

Similarly, the 2004 Anabolic Steroids Control Act, Joe Biden’s baby, was also sponsored by:

Bumblin’ Joe BIDEN (D-DEL)
Orrin HATCH (R-UT)
Chuck GRASSLEY (R-IA)
Tom HARKIN (D-IA)
Ted STEVENS (R-AK)
John MCCAIN (R-AZ)
Bill NELSON (D-FL)
Dianne FEINSTEIN (D-CA)
George ALLEN (D-VA)
Lisa MURKOWSKI (R-AK)

Not quite a ‘right-wing’ sponsor assembly there.

Signed into law by G.W. Bush ®

2004 Anabolic Steroid Control Act
http://www.theorator.com/bills108/s2195.html

Video (Biden moves forward despite medical professionals’ recommendations):
http://noolmusic.com/google_videos/senator_joseph_biden_and_steroids.php

Git your shit straight.

[quote]SteelyD wrote:
Git your shit straight.[/quote]

Sadly, people on the interweebz (and sadly in real life) are more interested in finding opportunities for making up stupid shit which to strawman and pigeonhole specific people and their (perceived or actual) political inclinations rather than in getting their shit together.

I kinda like McCain in many aspects, but this proposed bill of his takes the WTF cake.

A few thoughts:

First off, the link in SteelyD’s post was broken, and did not take me to the text of the bill. I found it at this link: http://www.ahpa.org/Portals/0/pdfs/10_0202_Dietary_Supplement_Safety_Bill.pdf

The bill does require supplement manuf’ers to register with the govt. This part doesn’t seem overly burdensome. The bill also requires manuf’ers to submit ingredient lists (along with labels, etc.) for all products. This doesn’t seem overly burdensome to me. The bill also requires that manuf’ers submit evidence of safety of any “new ingredients” when those are used. This is the part where it sounds good, but I’d like to hear testimony as to the specific effects of this step on the industry (something more than vague statements of “it’ll put them out of business! Boo!!!”). The bill also requires manuf’ers to report any evidence that the supps are not safe. The way I read it, if they have info something isn’t safe, they have to disclose it. This too seems reasonable to me.

Then you get to the cease districution and recall portion of the bill. The government has the power to order manuf’ers not to distribute supps it believes are dangerous. There will be a hearing with testimony from the manuf’er, and if the supp is considered unsafe, a recall can be ordered. A recall only affects manuf’ers - so if you, as a consumer, already own whatever has been recalled, you can keep it. However, in the case of a recall, the bill requires manuf’ers to notify, at their expense, users of the recall.

These are just the broad strokes. I do have concern about the “new ingredient” procedure. This does sound a lot more like what’s done for drugs, and it does lead to substatial expense (I admit I’m not overly familiar with the drug regulatory scheme). But the rest of the bill seems reasonable to me. Again, I could certainly be convinced otherwise if good testimony/evidence is provided.

I don’t believe this is about money. I do believe it is about safety.

Addressing Ghost22’s statements:

I think it’s pretty well established that people have died from supps. I don’t need to know them personally for that to be the case. I think it’s pretty well established that professional and amateur athletes have suffered because of unlisted ingredients. The football players in the starcaps debacle, Vencill (you say that he’s a liar, but you didn’t offer any evidence. I know he won a lawsuit against the manuf’er, so clearly he met the “more probable than not” standard in his civil action). Sure you can question how much of these negative events are tolerable. If one person dies, should you regulate? If 10,000 die, should you regulate? That’s an intelligent policy question that should be addressed.

Tylenol kills 100 people each year, so it’s regulated. I agree that there was an overreaction to ephedra. It seems to me that a supp’s utility should be measured against it’s danger to decide how to treat it. But substances that are dangerous when used incorrectly are generally the subject of regulation. You can argue the merit of the FDA if you wish.

A quick disclaimer that I do not have any specialized legal knowledge of this field, and I didn’t not to any more research than skim through the bill. Smarter and better educated minds than mine are encouraged to speak up. :slight_smile:

The more regulation there is on the supplement industry the harder it will be to have innovation. Even if it is just a broad “registration” its the first step in the move to regulate everything in the industry.

On one hand it might help you make more educated decisions when you know what is in that “proprietary” blend, but on the same level a lot of companies might not produce other innovative products when their income staples aren’t giving them the same returns because of this.

[quote]stuntmonkeys wrote:

Tylenol kills 100 people each year, so it’s regulated. I agree that there was an overreaction to ephedra. It seems to me that a supp’s utility should be measured against it’s danger to decide how to treat it. But substances that are dangerous when used incorrectly are generally the subject of regulation. You can argue the merit of the FDA if you wish.
[/quote]

???

Acetaminophen is being found to be so dangerous as far as liver damage that…you can still buy loads of it right off the shelves at Wal-Mart.

I mean, articles like this:
http://www.washingtonpost.com/wp-dyn/content/article/2007/02/23/AR2007022301114.html

get replaced ny pleasant little blurbs like:
http://www.mc.vanderbilt.edu/reporter/index.html?ID=8223

which, by the way, literally fills pages on the internet almost as if…someone paid to play down negative press.

You are one naive soul if you think this has shit to do with protecting the health of yourself or anyone else.

This is about Benjamin Franklin…and a whole host of dead prezzes.

[quote]Professor X wrote:
I mean, articles like this:
http://www.washingtonpost.com/wp-dyn/content/article/2007/02/23/AR2007022301114.html
[/quote]

 When I broke my hand 2 years ago, my doctor recommended taking OTC acetaminophen for the pain through rehab which ended up being months long.  I had wanted something stronger because 800mgs was only putting a small dent in my pain.  I remember specifically asking him if that high a dose long term was a problem.  His response?

 "People with chronic pain take that stuff for years without any kind of problems.  Just stay below 2400mg/day and you'll be fine."

 What a f'in bastard.  I am beyond pissed right now.  X, was this guy a moron?  How common are doctors like this?

[quote]Fezzik wrote:

[quote]Professor X wrote:
I mean, articles like this:
http://www.washingtonpost.com/wp-dyn/content/article/2007/02/23/AR2007022301114.html
[/quote]

 When I broke my hand 2 years ago, my doctor recommended taking OTC acetaminophen for the pain through rehab which ended up being months long.  I had wanted something stronger because 800mgs was only putting a small dent in my pain.  I remember specifically asking him if that high a dose long term was a problem.  His response?

 "People with chronic pain take that stuff for years without any kind of problems.  Just stay below 2400mg/day and you'll be fine."

 What a f'in bastard.  I am beyond pissed right now.  X, was this guy a moron?  How common are doctors like this?[/quote]

The info of how dangerous the stuff is, is just now coming to light…so your doc may not be a moron at all. He, like the rest of the population is led to believe that the dangerous drugs are “steroids, supplements, or drugs that cause so much death and despair that the damage can’t be hidden like phen-fen”. Data showing million dollar cash cow drugs to be dangerous are put on the back burner or outright hidden.

Why?

Because this is and always has been about money.

Everyone laughed when Tom Prince stated that his health conditions were brought on by the overuse of pain meds. Maybe people shouldn’t have been laughing so hard. His steroid use just may be nowhere near as potent as his overuse of OTC pain meds when it comes to his poor health.

That is why regulations like this are a complete joke and anyone who thinks this is being done for our own protection likely still believes in Santa Clause.

X, the tylenol regulation I’m speaking of is not that you need a prescription to get it. It’s that the FDA knows what’s in it, has evidence of it’s safety (just how safe is something we can discuss), and has the ability to recall it and discontinue distribution. I don’t think anyone is suggesting that our supps would require a prescription.

Also, maybe I am naive, but perhaps so are you cynical. Can you explain how it’s about money? Is it money for the gov’t in your opinion? Or money for some lobby that wants to get it’s hands in the supp industry’s pockets? Just to be clear, I’m not denigrating your argument. I’m trying to learn more.

[quote]stuntmonkeys wrote:
X, the tylenol regulation I’m speaking of is not that you need a prescription to get it. It’s that the FDA knows what’s in it, has evidence of it’s safety (just how safe is something we can discuss), and has the ability to recall it and discontinue distribution. I don’t think anyone is suggesting that our supps would require a prescription.

Also, maybe I am naive, but perhaps so are you cynical. Can you explain how it’s about money? Is it money for the gov’t in your opinion? Or money for some lobby that wants to get it’s hands in the supp industry’s pockets? Just to be clear, I’m not denigrating your argument. I’m trying to learn more.[/quote]

Supplements are big business, but pharmaceuticals are bigger. If the supplements have to play by the same rules as pharm, then pharm will crush all the little guys. It like this:

-Supplement company A says vitamin D is good for mood

-Pharm wants you to take antidepressants instead

-Pharm gets a panel of paid docs to doubt Vitamin D’s safety and then contribute to the re-election of their favorite senator, who shockingly is suddenly “concerned” that the safety of heavy Vitamin D supplementation hasn’t been proven enough.

-Gov cites the bill, makes the supplement company provide a case study and halt production until they are satisfied.

-Case study takes 4 years, and the whole time Pharm rakes in profits from lack of competition.

Replace Vitamin D with anything from thermogenics to protein, and keep in mind it is being evaluated by a group who still believes in the food pyramid and BMI.

[quote]borrek wrote:

[quote]stuntmonkeys wrote:
X, the tylenol regulation I’m speaking of is not that you need a prescription to get it. It’s that the FDA knows what’s in it, has evidence of it’s safety (just how safe is something we can discuss), and has the ability to recall it and discontinue distribution. I don’t think anyone is suggesting that our supps would require a prescription.

Also, maybe I am naive, but perhaps so are you cynical. Can you explain how it’s about money? Is it money for the gov’t in your opinion? Or money for some lobby that wants to get it’s hands in the supp industry’s pockets? Just to be clear, I’m not denigrating your argument. I’m trying to learn more.[/quote]

Supplements are big business, but pharmaceuticals are bigger. If the supplements have to play by the same rules as pharm, then pharm will crush all the little guys. It like this:

-Supplement company A says vitamin D is good for mood

-Pharm wants you to take antidepressants instead

-Pharm gets a panel of paid docs to doubt Vitamin D’s safety and then contribute to the re-election of their favorite senator, who shockingly is suddenly “concerned” that the safety of heavy Vitamin D supplementation hasn’t been proven enough.

-Gov cites the bill, makes the supplement company provide a case study and halt production until they are satisfied.

-Case study takes 4 years, and the whole time Pharm rakes in profits from lack of competition.

Replace Vitamin D with anything from thermogenics to protein, and keep in mind it is being evaluated by a group who still believes in the food pyramid and BMI. [/quote]

…and THAT, kids, is why you have politicians crying that we must SAVE THE CHILDREN from the horrors of “andro” and “ephedra” (which then get banned from use completely)…yet also why as the evidence piles about the dangers of OTC acetaminophen, there hasn’t been even ONE fucking commercial informing people not to take this drug for several months on end.

Hell, you won’t even hear about the dangers of most drugs until after litigation has been sought on a mass scale against it. However, let one athlete get popped on a drug test and blame “brand W whey protein” for it and the politicians will be tripping over each other to champion the “save the kids” cry.

No, “stuntmonkey”, if you haven’t asked yourself by now why your precious “fda regulated acetaminophen” hasn’t been REGULATED by the FDA at all…I have a whole van full of Obama Chia Pet dolls on sale for just 40 bucks a piece.

Take my word for it…these are gonna be BIG!

[quote]SteelyD wrote:

This bill has as much to do with safety as pigs with space travel.[/quote]

Sounds like a great way of shutting out small businesses and startups while leaving more elbow room for the large corporations. I though McCain was all for small business, looks like he only cares about plumbers.