

Dietary supplements: Scary substances manufactured under scary conditions - derleth
http://scienceblogs.com/insolence/2012/07/02/dietary-supplements-scary-substances-manufactured-under-scary-conditions/

======
Lazare
Interesting article...mostly because it is written, throughout, with the
assumption that it would be wonderful if the FDA could prevent people from
selling harmless food items. This is masked, but consider these quotes:

"the FDA can’t do anything about a harmful supplement until after it has been
on the market and caused harm" and "...legislators [...] pounce, doing their
best to kill or water down any legislation that strengthens the FDA’s hand in
removing potentially dangerous supplements."

In other words, the FDA needs to do something about dangerous supplements
before it has caused any harm. But not just _actually_ dangerous supplements,
but _potentially_ dangerous supplements too. Well, anything new is
_potentially_ dangerous. How would you prove something isn't actually
dangerous? A clinic trial, one supposes, at a cost of hundreds millions of
dollars? This would effectively outlaw the sale dietary supplements, none of
which are profitable enough to make such a trial worthwhile.

So, the author wants to shift dietary supplements from "food" to "drugs",
thereby destroying the industry. But why? What's so bad about the status quo,
anyhow? The author gives a few examples, but almost without exception they are
issues which are already solved. That scary story about the NJ factory? Yeah,
that's actually ALREADY ILLEGAL. The owners WENT TO JAIL. After being
discovered by FDA inspectors, who ALREADY have the power to inspect factories.

So, uh...we have an example of something admittedly bad, which is already a
crime, and which is already being monitored by the relevant government
department, and the owners already went to jail over it, and this is a reason
why we need a law change...why?

Next example, same deal. An incorrectly made product poisoned hundreds of
people. If that's a reason to effectively destroy the industry, then god only
knows what we should do poultry farmers after the various salmonella outbreaks
over the years. Shoot them, I guess?

And finally, to cap the entire piece...the author complains about the FDA not
doing a good job of enforcing existing regulations. Which is...an argument for
giving them more regulations to enforce. Uh....what?

It's like a politician running for election with the slogan "hey, our team may
have completely screwed up the economy, but that just means we know more about
to fix it!" Where I come from, serious failure on someone's part is not a good
argument for increasing their role and responsibilities.

~~~
derleth
> if the FDA could prevent people from selling harmless food items

No. Supplements are not food, legalistic tricks notwithstanding.

> But not just actually dangerous supplements, but potentially dangerous
> supplements too.

Well, yes. Or else you're fraudulently using your customers as test subjects.
People get angry enough when video game companies do that.

> This would effectively outlaw the sale dietary supplements

Why would this be a bad thing?

> What's so bad about the status quo, anyhow?

Massive amounts of fraud.

> The author gives a few examples, but almost without exception they are
> issues which are already solved. That scary story about the NJ factory?
> Yeah, that's actually ALREADY ILLEGAL. The owners WENT TO JAIL. After being
> discovered by FDA inspectors, who ALREADY have the power to inspect
> factories.

Interesting how nobody's found half a rat in a factory that makes actual
drugs, as opposed to "officially-not-a-drug" supplements.

We need to raise the standards to make the bad things less common. Getting
supplement makers up to the standards drug makers are would be good.

> If that's a reason to effectively destroy the industry, then god only knows
> what we should do poultry farmers after the various salmonella outbreaks
> over the years. Shoot them, I guess?

No, just raise the bar. Same as here.

> And finally, to cap the entire piece...the author complains about the FDA
> not doing a good job of enforcing existing regulations. Which is...an
> argument for giving them more regulations to enforce. Uh....what?

More and better regulations and more funding, yes.

> Where I come from, serious failure on someone's part is not a good argument
> for increasing their role and responsibilities.

So, given the failures of the free market to put fraudulent supplement makers
out of business, why would we trust it to do so in the future?

~~~
Gormo
> > This would effectively outlaw the sale dietary supplements

> Why would this be a bad thing?

Because people who wish to consume dietary supplements would only be able to
obtain them via black markets which would likely expose them to more, not
less, potential danger.

~~~
derleth
But fewer people total would consume them, leading to less damage being done
overall.

~~~
Gormo
The 'damage' described in the article is the result of mis-labeled products
being sold to unwary consumers, not of properly-informed consumers
experiencing negative consequences of risk judgments that they've
intentionally chosen to make. This kind of damage is more likely to occur in a
black market setting, in which the protections of law are unavailable, than it
is to occur in an open and above-board market, in which participants have
recourse against such fraud.

Consider also that suppressing supplements entirely also equally suppresses
the _benefit_ that consumers may enjoy from their use, and it's entirely
plausible that the 'overall' reduction in benefit may exceed the 'overall'
reduction in harm, so even if we were to use your purely utilitarian criterion
as our only decision-making guide, such a policy might still be unjustified.

~~~
derleth
> This kind of damage is more likely to occur in a black market setting

But less of it, since making it illegal would greatly reduce demand. Unless
you can come up with a reason why supplements are similar enough to illegal
drugs it wouldn't.

> Consider also that suppressing supplements entirely also equally suppresses
> the benefit that consumers may enjoy from their use

Empirically, that is a very minor concern, if it is one at all.

~~~
Gormo
> But less of it, since making it illegal would greatly reduce demand

It would reduce the _expression_ of demand, certainly, but not the actual
desires of individuals that produced that expression; or to put it another
way, will reduce the fulfillment of demand while the underlying unfulfilled
demand still exists. This yields a net reduction in total happiness, which is
counter to your apparent utilitarian ethos.

> Empirically, that is a very minor concern, if it is one at all.

Empirically? What does assessment of subjective value have to do with
empirical data, apart from recognizing that individuals' subjective value
empirically exists and is the source of demand?

Apart from that, apart from your apparent utilitarianism - the criteria of
which remain yet unsatisfied in this discussion - what's the moral basis your
assertion that forcibly denying the extant happiness of many is justifiable in
order to reduce the potential unhappiness of few, especially considering that
the former is not strictly necessary in order to achieve the latter, and that
forcing a single uniform policy indiscriminately upon all is merely a
contrivance of convenience?

~~~
derleth
My moral basis is preventing fraud and punishing people who commit fraud.

> forcing a single uniform policy indiscriminately upon all is merely a
> contrivance of convenience

No. If you want to claim to promote health, your products need to be shown to
promote health. Supplement makers have been able to get around that very basic
moral law using loopholes and bought-off politicians. I want an end to that.

~~~
Gormo
> My moral basis is preventing fraud and punishing people who commit fraud.

You appear to be going far beyond dealing with fraud, and instead wish to
suppress activity that's being undertaken _without_ any deceit.

> If you want to claim to promote health, your products need to be shown to
> promote health.

That's fine. Note, of course, that the vast majority of supplement products
contain explicit disclaimers on their labels (e.g. "These statements have not
been evaluated by the FDA" and "This product is not intended to diagnose,
treat, cure, or prevent any disease") that make allegations of actual _fraud_
quite spurious. And, of course, actual fraud of the kind described in the
article - e.g. selling a bottle labeled "Vitamin C" that contains no actual
vitamin C - is entirely illegal with or without FDA intervention.

However, if I want to purchase a bottle of _foo_ , honestly labeled as "foo"
without making any unsustainable promises, and use the contents of that bottle
based upon my own understanding of the properties of "foo", that's entirely my
prerogative, and it's entirely my right to assume whatever risks the use of
_foo_ entails.

(Of course, there _is_ the issue of defining exactly what it actually means to
"promote health".)

~~~
derleth
> You appear to be going far beyond dealing with fraud, and instead wish to
> suppress activity that's being undertaken without any deceit.

'Deceit' does not start and end with the technical definition of fraud.

> Note, of course, that the vast majority of supplement products contain
> explicit disclaimers on their labels

They shout their ads and whisper their disclaimers. Why should we ignore their
shouting?

> However, if I want to purchase a bottle of foo, honestly labeled as "foo"
> without making any unsustainable promises, and use the contents of that
> bottle based upon my own understanding of the properties of "foo", that's
> entirely my prerogative, and it's entirely my right to assume whatever risks
> the use of foo entails.

Why should you be able to sell something that you lead others to believe is
good for them when it isn't?

Selling dandelions by marketing them as pretty flowers is fine. Selling them
by marketing them as wine making material is also fine, as you can, in fact,
make wine out of dandelions. Selling them by claiming dandelion wine is good
for what ails you is lying. Can you honestly not see that last step?

~~~
Gormo
> 'Deceit' does not start and end with the technical definition of fraud.

No, but fraud does start and end within the definition of 'deceit'.

> They shout their ads and whisper their disclaimers. Why should we ignore
> their shouting?

I've not personally seen ads for supplements of the kind you're describing,
but if they* were* advertising features that weren't actually available in the
products, that is, at minimum, a bait-and-switch ad, which is already a
fraudulent practice.

> Why should you be able to sell something that you lead others to believe is
> good for them when it isn't?

Whether it is or isn't "good for them" is, of course, determined by _them_ \-
we're in the realm of value judgments here - and while it's entirely unethical
and already illegal to sell someone a product on the basis of fraudulent
information, selling a product with an explicit disclaimer that states that
the product has _not_ been empirically proven to fulfill any health claims
made about it is perfectly legitimate.

Selling dandelions in a box marked "dandelions" without making any unprovable
claims is _always_ perfectly OK; selling dandelions as a cure for cancer is
_already_ a fraudulent activity punishable by law.

------
Empact
There's a misleading conflation of at least 2 issues here:

If manufacturers are releasing product with substantially different contents
than the label, then they are guilty of defrauding their customers. This is a
crime which should be expensive for the guilty company.

But giving the FDA control over what supplements are allowed in the market is
a travesty waiting to happen. The FDA works dramatically slower than
decentralized market action, and works under incentives favoring control over
free choice. Sites like <http://examine.com/> are working to bring science and
facts to the supplement market, and I expect a lot more progress in this area
over the next few years.

~~~
derleth
> If manufacturers are releasing product with substantially different contents
> than the label, then they are guilty of defrauding their customers. This is
> a crime which should be expensive for the guilty company.

I think it should result in prison terms for the principles, but massive fines
and punitive damages are a start, at least.

> But giving the FDA control over what supplements are allowed in the market
> is a travesty waiting to happen.

How? What can be worse than pills being sold with the wrong things in them,
with unknown trash in them, and pills being made in conditions that would get
a McDonald's shut down? It's like going back to the pre-FDA era of snake oil.

> The FDA works dramatically slower than decentralized market action, and
> works under incentives favoring control over free choice.

Free choice only works if everyone knows what's on offer. That means people
would somehow have to know what manufacturers are trustworthy. We've seen from
the evidence at hand, both in this century, the previous one, and the ones
prior to that, that _this does not work in reality. It is utopian. It is a
fantasy._

You cannot expect people to out-FDA the FDA. _Theory must give way to
evidence, and we have evidence in this matter._

~~~
ars
> How? What can be worse than pills being sold with the wrong things in them,
> with unknown trash in them, and pills being made in conditions that would
> get a McDonald's shut down?

What does that have to do with pills? If people are making any kind of food at
all that is filled with trash then the FDA should stop them, but it has
nothing at all to do with them being supplements.

~~~
derleth
> What does that have to do with pills?

We're discussing supplements, which are usually sold in pill form.

> If people are making any kind of food at all that is filled with trash then
> the FDA should stop them, but it has nothing at all to do with them being
> supplements.

 _Should_ , yes. However, if you read the article, you'll see a very bad law
that prevents the FDA from doing so in the case of supplements.

> Snake oil at least was (usually) what it said on the bottle.

Really? I don't know one way or the other for sure about _historical_ snake
oil: My usage there was 'snake oil' as a synonym for 'an untested product
guaranteed to cure anything and everything, sold by a con artist'.

~~~
ars
> However, if you read the article, you'll see a very bad law that prevents
> the FDA from doing so in the case of supplements.

I did read the article, and that isn't true. If the pill does not have what it
says on the bottle then they can easily shut them down.

> Really? I don't know one way or the other for sure about historical snake
> oil: My usage there was 'snake oil' as a synonym for 'an untested product
> guaranteed to cure anything and everything, sold by a con artist'.

I realized that right after I said it, so I edited out that sentence. But to
reply to you: If the product has what it says it has, then the FDA has no
business regulating it. They should regulate fraud - a product that does not
have the listed ingredients for example. Or a false claim. But they have no
business telling people that they can not buy/eat this or that plant.

~~~
derleth
> But they have no business telling people that they can not buy/eat this or
> that plant.

Yes, they do, because part of the FDA's job is looking after idiots. That's
because looking after idiots is part of society's job. It's why highways have
guard rails: You can't expect everyone to be perfect all the time.

------
Zak
I happen to like the fact that I can get hormones like melatonin and drugs
like piracetam as dietary supplements without having to go through a doctor or
have them approved by the government to treat a specific disease. I don't have
insomnia, but sometimes I want to go to sleep at a specific time and melatonin
enables me to do it. I don't suffer from any diseases causing cognitive
impairment, but sometimes piracetam helps me think more clearly. I strongly
oppose any legislative efforts to make it more difficult for me to obtain
these substances.

That said, some companies in the supplement industry have, without a doubt
behaved badly. It seems to me that there are three issues to consider.

* Advertising - making false claims in product marketing is already illegal.

* Purity - making false claims about what's in a product or selling a contaminated product is already illegal.

* Safety - if a substance can cause dangerous effects, the packaging should say so.

The first two are already the law. If there are loopholes or unreasonable
barriers to enforcement, they should be patched. This doesn't require any
major changes in policy - just fine-tuning to make sure existing policy can be
enforced.

The last one is a bit more problematic under current policy. It's my
impression that dangerous supplements can be sold with no labeling even when
the dangers are fairly well known. The FDA's only recourse is to remove them
from the market if they're found dangerous. I think mandatory warnings on
packaging when there's significant evidence a supplement _may_ be dangerous,
similar to the black-box warnings on prescription drugs would be a good middle
ground.

~~~
ZoFreX
> I strongly oppose any legislative efforts to make it more difficult for me
> to obtain these substances.

The way I took the article was that, if some sane rules were applied and
enforced, it would actually be _easier_ for you to obtain them - because right
now you could be knocking back selenium and rat urine for all you know.

~~~
Zak
What I took from the article is that its author would like supplements with
drug-like effects regulated as drugs. That generally means they'd need
clinical trials demonstrating that they're safe and effective for treating a
specific disease, with extra-strong requirements to be sold without a
prescription. I don't want that.

In his conclusion, he advocates milder measures for enforcement of purity and
policing dubious advertising claims, but his use of "at least" implies he
wants more rules.

------
praptak
Unproven health claims are not only confined to dietary supplements. Dannon
(Danone) has a track record of trying to sneak cure-all yogurt claims into
their marketeering: [http://www.weightymatters.ca/2009/10/european-union-
doesnt-b...](http://www.weightymatters.ca/2009/10/european-union-doesnt-
believe-in-magic.html)

------
narrator
Every year there is a regulate supplements as drugs bill in congress. Every
year it fails. Mainly because their is a lot of grass roots support for
keeping supplements legal and the industry has developed to a point where it
can effectively lobby.

The constatnt onslaught of anti-supplement bills almost reminds me of the
RIAAs continuous lobbying onslaught of draconian copyright bills (sopa, pipa,
protectip, etc). Just like too many people are using the internet for the most
disturbing copyright bills to pass, there are too many people taking
nutritional supplements for the pharma industry "we're all going to die" anti-
supplement fud to be effective. Interestingly enough, given all the anti-
supplement fud going around in articles like these, prescription drug
overdoses now kill more people now than car crashes
(<http://www.voanews.com/content/article/171721.html>).

~~~
dalke
I have tried to track down information about the statement "prescription drug
overdoses now kill more people now than car crashes." What I found was "In
2007, approximately 27,000 unintentional drug overdose deaths occurred in the
United States" from <http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm> .

I then found "According to the National Highway Traffic Safety
Administration's (NHTSA) early projections, the number of traffic fatalities
fell three percent between 2009 and 2010, from 33,808 to 32,788."
<http://www.nhtsa.gov/PR/NHTSA-05-11> .

Which means about 20% more people die from car crashes than from overdoses.
The most common overdose was painkillers. "Overdoses of prescription
painkillers have more than tripled in the past 20 years, leading to 14,800
deaths in the United States in 2008" says
<http://www.cdc.gov/injury/about/focus-rx.html>. Which means 1/2 of the
prescription drug overdoses is from pain killers.

Moreover, "Almost one-third of prescription painkiller overdose deaths involve
methadone. Six times as many people died of methadone overdoses in 2009 than a
decade before." from
[http://www.cdc.gov/Features/VitalSigns/MethadoneOverdoses/in...](http://www.cdc.gov/Features/VitalSigns/MethadoneOverdoses/index.html)
. The problem, of course, is that there are benefits to methadone, so it's not
as simple as banning methadone.

BTW, acetaminophen is a relatively dangerous drug. It causes "450 deaths and
56,000 emergency-room visits a year" says
[http://online.wsj.com/article/SB1000142405297020357730457427...](http://online.wsj.com/article/SB10001424052970203577304574272292331942618.html)
. While reading
[http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a....](http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.html)
the estimate is about 650.

Anyway, you say "The constant onslaught of anti-supplement bills almost
reminds me of the RIAAs continuous lobbying onslaught of draconian copyright
bills" and I say the defense of supplements almost reminds me of the tobacco
industry's defense of selling and promoting tobacco.

------
raverbashing
In the movie "Bigger Stronger Faster" they have a section on supplements, and
this comes as no surprise

"Supplements" are a very broad term, and a lot of things are sold under this
banner:

\- "True" Nutritional supplements, offering a dietary value, like
carbohydrates, proteins

\- Supplements of a specific nature like mineral supplements, creatine, other
amminoacids or peptides.

\- Stimulants, some mild, some very heavy and with controversial substances

\- "Pre-hormones" which are usually actually more damaging than most of the
common steroids

\- Other things, usually useless

I guess 80%/90% of all the products are BS, real products usually go straight
to the point in their advertisement, and don't try to pass for a miracle or
for something they are not.

------
asithinketh
Selling supplements online. The secret of the Tim Ferris "4 hour work week".
;)

------
Evbn
There was a fantastic Reddit comment last year where someone did some basic
controlled chemical analysis of a very popular cheap protein supplement, and
found it had no protein in it.

~~~
Scaevolus
Here's the post:
[http://www.reddit.com/r/Fitness/comments/uva9t/big_reddit_pr...](http://www.reddit.com/r/Fitness/comments/uva9t/big_reddit_protein_powder_measurement_results/)

Someone offered to test samples of various protein supplements for various
metrics (protein %, solubility, etc.), and discovered that American Pure Whey
contained .5% protein.

------
derleth
Quotes from the article, this batch from FDA inspections of supplement
factories:

> Some firms don’t even have recipes, known as master manufacturing records,
> for their products.

> Others make their supplements in unsanitary factories. New Jersey-based
> Quality Formulation Laboratories produced protein powder mixes and other
> supplements in a facility infested with rodents, rodent feces and urine,
> according to government records. FDA inspectors found a rodent apparently
> cut in half next to a scoop, according to a 2008 inspection report.

And this shoddiness has a grave impact on real people:

> In 2008 more than 200 people — including a 4-year-old — were poisoned by
> selenium after taking liquid multivitamin dietary supplements that were sold
> in health stores and by chiropractors, according to a medical paper
> published on the mass poisoning. The products, called Total Body Formula and
> Total Body Mega Formula, contained an average of 40,800 micrograms of
> selenium per serving instead of 200, according to the paper.

~~~
anigbrowl
Clearly we need less regulation and government interference, and these
problems will magically take care of themselves.

~~~
Evbn
Yes, evolution will clear the gene pool of chiropractor and GNC customers.

