The FDA Wants to Pry Your Dietary Supplements from Your Cold Dead Fingers

Earlier this month, the Food and Drug Administration issued for comment new guidance that aims to control customer access to dietary supplements on safety grounds. It's framed as guidance for now, but history shows that guidance all too often transmogrifies into mandatory regulations.

Currently, half of all Americans spend about $20 billion on various supplements in the hope of protecting and improving their health. Certainly there is a lot of snake oil out there, but do the safety risks justify FDA intervention?

The answer is no, if the latest Annual Report [PDF] of the American Association of Poison Control Centers' National Poison Data System is to be believed. That report finds that using dietary supplements/herbals/homeopathic remedies resulted in one reported death in 2009. The report notes that there were 24 instances in which using supplements was associated with "major" outcomes and 492 cases where supplement use resulted in "moderate" outcomes. According the same report, aspirin alone was associated with 18 deaths, and 122 and 949 major and moderate outcomes respectively. The 2008 report noted no deaths associated with supplement use that year. 

Disclosure: As far as I know, I own no stocks in any companies that sell supplements. On the other hand, I do take a variety of supplements at breakfast every morning. 

Comments

[Libertymike]

Today, you are right, Ron.

[jj]

"On the other hand, I do take a variety of supplements at breakfast every morning."

We're sure you do, Ron. We're sure you do.

[Paul]

Earlier this month, the Food and Drug Administration issued for comment new guidance that aims to control customer access to dietary supplements on safety grounds. It's framed as guidance for now, but history shows that guidance all too often transmogrifies into mandatory regulations.

Can I predict 'em or what?

[T]

But how will I turn my urine dark and expensive without dietary supplements? I can't eat that much asparagus.

[fish]

Might I suggest "Liquid Smoke".

[Res Publica Americana]

Fucking libertarians. Wake up and read the Constitution -- the authorization for creating the FDA is RIGHT there, right after that part that says "Congress shall have the power to do whatever the jack-rabbit fuck it wants, and so shall the President", and just before "the right of the state to keep and bear arms shall not be infringed".

[MiNGe]

Commerce Clause, bitchez!

[T]

My copy reads differently than yours. But I think yours is closer to reality.

[K 2 Dean]

To make sure you have a current copy, always check the First Amendment for the bit at the end that says "except for commercial speech, obscenity, and political speech in support of a candidate."

Until recently, the Second Amendment had "Kidding!" at the end. The most recent version now has "Under Construction." The "Kidding!" has been moved to the Fourth Amendment.

And, of course, the Tenth Amendment has been lined out. Stupid inkblot.

[Res Publica Americana]

Don't forget that the current version doesn't have three distinct and separate branches of government -- it's just one huge clusefuck of a mess.

[cynical]

Sorry, it's since been amended to:

"Congress the President shall have the power to do whatever the jack-rabbit fuck he wants, and so shall the President"

[Paul]

I can't wait to hear NPRs four part series describing the hidden dangers of supplements, and the stone-walling and shady practices of the [fill in dollar amount] unregulated supplement industry.

[cynical]

Well, supplements are probably mostly overpriced placebos. Still, if they aren't sold as "real medicine", and they aren't particularly medical, it isn't really the FDA's business. In fact, FDA oversight may actually lend a unwarranted veneer of legitimacy to supplement sellers by putting them in the same category as actual drug companies.

[BakedPenguin]

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

So make sure you tell the FDA to go fuck themselves before the end of September.

[Fist of Etiquette]

I just hope they don't decide to outlaw accessory spleens. Mine has been keeping me in superhuman health all my life.

[fish]

Is that the one you wear outside your body?

[Fist of Etiquette]

DON'T BE CUTE. MY ACCESSORY SPLEEN WILL CRUSH YOU.

[OO]

what? u want all those fat bitchez on speed? oh yea, good idea...

[Episiarch]

This is getting fucking ridiculous. It seems like every other day now that the FCC or the FDA or the EPA or whoever lists another fucking thing they're going to regulate. I mean, this rate is orders of magnitude greater than under any other president. This can't be a coincidence; Obama must have instructed these agencies to actively try and bring everything possible under their purview. If it were just power grabs, wouldn't it have happened under all presidents?

[Paul]

The right people are finally in charge.

[R C Dean]

Yeah, I think the Controlbots can see the end of Obama Road coming pretty quickly, and have decided to loose the hounds of law. Probably didn't even need a wink and a nod from the Oval Office. I mean, who has time, what with golfing and town halls and stuff?

[Res Publica Americana]

Time to lynch the fucker.

[cynical]

You can't say lynch about a black president, man. Try "behead", that's a noble execution.

[SIV]

TEAM BLUE really is worse when they get a hold of regulatory agencies. Progressives hate DSHEA (even though they were too scared to vote against it at the time) and continuously work to undermine the law.

[Tony]

Earlier this month, the Food and Drug Administration issued for comment new guidance that aims to control customer access to dietary supplements on safety grounds. It's framed as guidance for now, but history shows that guidance all too often transmogrifies into mandatory regulations.

How can you have freedom health if it doesn't take months to get things government approved pharmaceuticals. Waiting periods for guns waiting periods for supplements...its all part of making life better for the people.

[dunphy]

i agree on team blue being worse. there are statist assmunches like mccain who make me cringe. my favorite was his jihad against MMA, but on the whole, i think leftists are worse

[SIV]

McCain is every liberal's favorite republican

[zeroentitlement]

Speaking of "team blue," some misuse of supplements should be tolerated just because the effects are so cool. Like idiots who take too much colloidal silver, for example, and end up looking like extras in Avatar. Who wouldn't want a co-worker like that in the next cubicle?

[cynical]

ha ha, like this bozo. I wonder what crazy fringe group that dipshit belongs to.

.
.
.

Oh. Fuck.

[Robert]

DSHEA and its follow-up bill had pro-regulatory compromises that may have been necessary to get it thru, so there was plenty of "scared" all around in food & drug reform in the early to mid 1990s.

The food labeling provisions were especially poignant, making things mandatory that had been forbidden. In general they were things people wanted, so the overall effect was an improvement, but it seems you never get a simple increase in freedom.

Anyway, one of the major effects of DSHEA was to shift the ground of uncertainty from one place to another, moving the curtain towards more freedom but also fuzzing the boundary more. The definitions in state & federal food & drug law were never intended to be understood as broadly as their literal meanings, or they would convert clothing into cosmetics, art into medical devices, etc., but now on top of those there's a huge legitimately gray area in structure-function determinations.

[deified]

If they come after my fish oil and my
K2, shit's goin' down like WACO.

[OO]

u mean "they" are gonna kill everyone then burn-down ur house?

[Paul]

That's the standard government response to regulatory scofflaws.

[Nipplemancer]

all your vitamins are belong to us

[stuartl]

"...no deaths associated with supplements..."

I think the argument is that idiots are taking snake oil cures instead of getting real medicine for treatable illnesses. This does not show up in the statistics.

I don't mind letting them choose for themselves.

[dunphy]

they used some REALLY specious AER's in the congressional ephedrine scare(tm) hearings.

my favorite was the guy who died after taking ephedrine. of course he was ALSO morbidly obese, dehydrated, working out in 90+ heat, in a rubber suit, and had cocaine in his system

but it was the ephedrine's fault lol!

haven't seen anything so stupid since the anti-taser hysterics :l

[H man]

Supplements are self administered. Tasers not so much so. Although I'm sure some knuckelehead has at some point.

[dunphy]

spend some time on youtube. self-tasering is quite common

and i agree. to an extent. generally speaking, the vast majority of the time somebody is tased they have ample warning they are going to be tased if they don't knock it the fuck off, or they do something where a warning isn't given, but it clearly warranted the tase

regardless, i was commenting on the specious "medical" conclusions drawn, which are tangential to whether it was a choice or not

[H man]

Which is why I'm not arguing the relative safety of the Taser. If it was an electric chair in a holster we'd be having a different conversation. The reason why I'm bringing up the involuntary aspect of tasering is the relative part. Some people are more susceptible to heart failure due to previous health issues, drugs in the system, etc. Not sure there's an answer but just an observation.

[dunphy]

i aqree. my frequently argued point is that other methods of apprehension are ALSO stressful to the heart e.g spending 5 minutes wrestling a guy into handcuffs. ihad a guy flatline on me for that.

deaths correlated with restraint and struggle in fight or flight situations long predate tasers and imo have nothing to do with tasers qua tasers. i think the stats support this

we don't choose who fight with us. THEY choose. and a lot of these people are unhealthy, polydrug taking, dehydrated, binging (often having gone days w.o sleep), types.

the body can't take that shit

[Paul]

That's why everyone should be tasered equally.

[cynical]

I doubt that repeated self-tasering is common, if only because a successful tasering makes followup tasering difficult.

[Brett L]

Shit, in FL, we taser kids at correctional facilities on Take Your Spawn to Work Day. We definitely don't select for intelligence or decision making when hiring COs.

[dunphy]

i've had at least a couple of dozen kids (and a few adults) ask to be tased.

kids like shit like that.

it's like pop rocks to the nth degree

[fish]

we taser kids at correctional facilities on Take Your Spawn to Work Day.

Where do you think they get prison guards?

[Brett L]

Before I did contract work for FLDOC I figured they were trolling the day laborer sites and taking everyone without a record who had a state photo ID. Afterwards, I learned the truth was more depressing.

[Quetzalcoatl]

Tasering themselves is CNN's bread & butter.

[dunphy]

we have DSHEA for a reason. 90% of supplements are crap. 90% of EVERYTHING is crap. so fucking what?

DSHEA is good legislation but those assmunches still got away with (for a while) banning the SALE of ephedrine as a dietary supplement. overturned by a 9th

i support supplement freedom. fuck the FDA

[fish]

so fucking what?

So fucking 100% of what's advertised had better be in my shit. And I'm not asking some federal bucket head permission to take it. Other then that there's nothing wrong with the reg.

[Sharia Moore]

"90% of EVERYTHING is crap"

That would include cops, no doubt.

[dunphy]

only if they aren't scottish

[Brett L]

"90% of EVERYTHING is crap"

aka Sturgeon's Law

[dunphy]

there's a similar theory in employment, where about 90% of employees are basically competent, and will work only as hard as required, will get away with what they can out of laziness but are generally decent employees just putting in time and doing what's required.

5% are stellar, but often not recognized as such

5% are destructive/evil/malevolent, etc.

can apply to almost any profession

except for police of course who are all teh evul

[Jim]

I'm inclined to roughly agree with this, and I would even extend it to the police. I don't think most, or even many, are actively bad people out to do harm; only a very small minority.

Difference being, the Wells Fargo teller who is malevolent doesn't get to beat the shit out of people or shoot them if someone doesn't follow their orders, then have nothing more than an internal investigation about it.

[dunphy]

i agree with this. a bad cop can do a fuck of a lot of harm. no doubt. i loathe bad cops imo at least as much as anybody here

i just tend to respect and admire police IN GENERAL, and i don't think (for example) cops who use justified force that has bad results are bad cops

process analysis, when it comes force. ALWAYS

[Paul]

5% are destructive/evil/malevolent, etc.

I worked for a company where this 5% were all in management. It was awesome.

[dunphy]

preach on. i feel you

[Brett L]

That's the Dilbert Principle.

[Robert]

Was it NMC, Inc.?

[Res Publica Americana]

i eated them suplamints

them suplamints dont none give me none health benafits

govamint bettuh step in 'n guide me to da righteous suplamints

[jtuf]

Mint is a natural laxative, which means that, technically, I'm growing drugs behind my home.

[fish]

Mint is a natural laxative...

So are Tony and Shrikes comments. Maybe they should be regulated as well.

[cynical]

Wishful thinking. If that were the case, bullshit petty tyranny would be banned for its effect on my blood pressure.

[wingnutx]

Great, now I have to bury a 55 gallon drum of Nitro-tech to get me through the next decade.

I'm almost out of my pre-ban ephedra.

[dunphy]

ephedra/ephedrine was NEVER illegal to posses btw. regardless of the ephedrine ban (overturned by the 5th circuit iirc), you could always buy it, consume it, and possess it legally.

bronkaid is a good source for pharma grade ephedrine. pharma grade meds also have the advantage of dosing you know is precise and less change of adulterants, etc.

as a competitive athlete, i have frequently used ephedrine/caffeine in training. only banned in my org for IN COMPETITION use

and the aspirin is unecessary iow EC works just as well as ECA imo

[dunphy]

to clarify the "ban" made it illegal to sell/market AS A dietary supplement. it never affected one's ability to legally possess or consume it for those purposes

[wingnutx]

I know. I buy Bronkaid.

Some guys buy Primatene.

[dunphy]

yea. one is ephedrine chloride and the other is sulfate iirc. maybe slight different rates of absorption, but essentially the same thing

i prefer the bronkaid!

[BakedPenguin]

ephedra/ephedrine was NEVER illegal to posses btw.

Hmm. I could have sworn all the Chinese herbal places stopped selling "ma huang" at some point.

[dunphy]

i said POSSESS. and distinguished that the ban prevented the sale and marketing of it as a dietary supplement.

not the possession or consumption of same as a dietary supplement

[Robert]

The federal ban never affected the actual whole herb, only extracts thereof...I think. Then again, around the time FDA was seeking to extend their jurisdiction over tobacco products administratively, they did get a judge's ruling that a certain herb sought to be imported did not qualify as a "food" although tea was made from it. There had never AFAIK previously been a federal ruling on what counted as "food"; that judge said it had to be intended to be swallowed for its nutrition, flavor, texture, or aroma. But it was only one circuit court. We know that chewing gum and beverages are foods because the FFDCA and state laws say so.

[aldo]

The information is very interesting. It made me understand something, and it is that I never knew before.