
Unapproved Pharmaceutical Ingredients Included in Dietary Supplements - scott_s
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496
======
learc83
The FDA needs to regulate supplements. At the very least they need more random
spot checking and stiff fines for misrepresenting ingredients.

It's absurd that you can't trust that the ingredients list on something as
mundane as a multi vitamin is accurate.

~~~
xenadu02
The FDA is prohibited by law from regulating "dietary supplements", much of
that thanks to Orin Hatch. A concerted campaign (largely effective) stripped
the FDA's ability to regulate many forms of snake oil, "alternative medicine",
and other quackery.

~~~
refurb
What do you mean prohibited from regulation?

The reason why we know these supplements have unapproved pharmaceuticals in
them is because regulations say: 1) you can't, 2) the FDA has the power to
test them, 3) the FDA has the power to force a recall.

The FDA is prohibited from banning supplements that have been in use prior to
1996 (or so). They are also allowed to restrict what can be said about the
supplements (they can't make unsupported medical claims).

I don't know about you, but unless a supplement is actually dangerous, I think
it's _good_ the FDA can't come in and tell adults what they can and can't put
in their own bodies.

~~~
scott_s
The FDA is prohibited from requiring safety and efficacy evidence before
supplements go on the market. This is unlike substances categorized as drugs,
which require both safety and efficacy evidence before going on the market. So
the FDA won't know if a supplement is actually dangerous until after it is on
the market, and then it will have to find that particular supplement among the
thousands that exist, as the onus is on the FDA to find and prove it is
dangerous.

~~~
refurb
That’s not accurate. You can’t just create a new chemical and call it a
supplement. There has to be pre-existing data indicating that a supplement has
been used in the past (prior to the legislation).

If data suggests a supplement isn’t safe, the FDA can ban it.

Plus, you’re not allowed to make specific safety or efficacy claims when
selling a supplement. You can be vague about “It’s been used for insomnia”.
But that’s about it.

~~~
scott_s
Yes, you can. You have to submit safety information, but you're not barred
from entering the market. From an article about a supplement that was
essentially an unregulated drug because it was an _unknown_ drug:

> _Under a 1994 federal law, supplement makers must submit some kind of safety
> data to the F.D.A. if they plan to introduce new ingredients to the market.
> And manufacturing-practice rules require them to make sure their products
> contain only the ingredients listed on the labels, with no hidden
> substances. But, unlike drug makers, supplement makers are not required to
> prove that their products are safe and effective on humans. Nor do they have
> to get federal approval before selling their products. That means it is up
> to the F.D.A. to identify any risky supplements from among the estimated
> 85,000 on the market, and to prove that they are adulterated or present
> health hazards._

[https://www.nytimes.com/2013/03/17/business/a-soldiers-
paren...](https://www.nytimes.com/2013/03/17/business/a-soldiers-parents-take-
aim-at-gnc-and-a-supplement-maker.html)

Again, the onus is on the FDA to _find_ supplements that are previously
unknown, regulated drugs. If we flipped the requirements, supplement makers
would be barred from selling their supplements without clearing them with the
FDA first. The active drug in that story has since been banned by the FDA:
[https://www.fda.gov/food/dietarysupplements/productsingredie...](https://www.fda.gov/food/dietarysupplements/productsingredients/ucm346576.htm)

You're not allowed to make specific _medical_ claims. But you are also not
required to show any efficacy for what you do claim, and the supplement
industry regularly gets as close as they can to "specific medial claim." And
sometimes they cross it! And, again, the onus is on the FDA to find such
cases.

~~~
refurb
We are in agreement then. My statement “you can’t just create a new
supplement” was in reference to the claim they don’t need safety information.
They do, either new data (for a new molecule) or existing data (for a
supplement with known activity).

In terms of the onus being on the FDA, that’s how it should be. A default
“it’s banned unless we say so” would limit access to supplements that have
been used for decades. They’d need to be pulled off the market. Supplement
makers are unlikely to have access to the millions of dollars it would take to
a supplement through clinical trials to prove safety and efficacy.

And as for the claims, the FDA issues warning letter by the ton when
supplement makers step over the bounds.

~~~
scott_s
We're in agreement on the facts, but not apparently on what we want to do
about them. I have no problem that this would take most supplements off the
market, as I think the current system makes companies exploiting consumers
very likely.

------
mallomarmeasle
Here is the data that the study is compiled from. The majority of the added
compounds are sildenafil (Viagra) or analogs of it. Interesting to me,
Locacerin showed up in some of the weight loss preparations.

[https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?...](https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder&displayAll=false&page=6)

~~~
wdewind
Thanks for posting the list. This is a list of dick and diet pills and Slim
Fast. Slim Fast is genuinely surprising to see on this list, especially
considering it's for an ingredient they used to have openly but was banned.
The rest of this stuff is not at all in the same category as whey, creatine
etc., and the study muddies the waters by grouping them together.

------
freeone3000
It seems like these products are mysteriously tainted with illegal active
ingredients that make them functional. It is unclear to anyone why or how this
would happen.

~~~
excalibur
Legal or not, they're filling a real niche with real demand. If you have ED
and insurance, you can go to the doctor, who will run tests to confirm that
you have a medical need before prescribing you Viagra/Cialis/whatever. If
you're uninsured, or are actually capable of getting a boner on your own, but
just want a performance boost so you can have marathon sex or crazy orgies or
something, the guy at the gas station has your back.

~~~
ensignavenger
What sort of test does a dr perform to see if you need Viagra? I thought the
doc just asked some questions and wrote the prescription if you gave the right
answers?

------
wdewind
The reality of supplements is that there is a limited number that are both
safe and have strong scientific evidence backing them. Whey protein, vitamin
D, ZMA, caffeine maybe a few others. If you buy those from any kind of
reputable brand (Optimum Nutrition is a great place to start), there is
absolutely zero risk of any of this happening. If you start taking sketchy
pre-workout that boasts ridiculous improvements, then yeah you will end up
getting a mixed bag of stuff. But the idea that this is hard to avoid is
nonsense. Same with athletes who test positive and then blame a supplement.
This problem is not at all difficult to avoid, you only find trouble if you're
looking for it.

~~~
scott_s
Forgive me if I'm reading your take wrong, but I believe your general attitude
is _buyer beware_. That is, you're assuming there are bad actors out there,
and the onus is on individuals to avoid those bad actors.

My take is that it's unreasonable to expect most of the population to be
mostly skeptical of the products they consume most of the time. I think most
people have the feeling that things they buy at the drug store or GNC will not
actively harm them; I don't think they understand that the supplement industry
is essentially unregulated. I think they have about the same level of trust in
supplements as they do in, say, buying meat from the grocery store. My
position, then, is rather than acceding to the existence of the bad actors, we
should use regulation to prevent them from existing.

An editorial from a medical researcher who thinks the FDA is under-performing
in even the light regulation they have of the supplement industry:
[https://jamanetwork.com/journals/jamanetworkopen/fullarticle...](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706489)

~~~
wdewind
No that is not my attitude. My attitude is that the only people who are
experiencing issues are shopping _way_ outside of normal channels. Nothing you
buy at GNC will be tainted with steroids.

The study takes 150 random products and finds issues with 20% of them, I
guarantee those 20% are not sold at GNC, VitaminShoppe etc.

This is just really not a big problem for normal every day people.

~~~
yayana
Every day people probably buy more vitamins by volume at supermarkets and drug
stores. But I see no reason to believe any distributor is safer across all
products sold.

[http://time.com/3741142/gnc-vitamin-shoppe-
supplements/](http://time.com/3741142/gnc-vitamin-shoppe-supplements/)

~~~
wdewind
Look at the names of the "supplements" they found issues with:

[https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?...](https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder&displayAll=false&page=1)

Literally the only surprising one on the list is Slim Fast, and it's so
surprising I'm wondering if they are using extremely old stock or something.
The rest of the "supplements" are dick pills with names like "Sexy Monkey."

It's just not even the same market as the weekend warrior crossfit bro who
takes whey protein and maybe _gasp_ creatine.

~~~
masonic
Slim Fast is _not_ on the list.

It's crap, but it's not on the list.

~~~
wdewind
[https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?...](https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=slim+fast&sortColumn=&sd=tainted_supplements_cder&page=1&displayAll=false)

It is on the list, and now that I look closer, yes the stock they are using is
from 2009 when Slim Fast openly advertised that they used sibutramine. They
have since stopped, so this list is somewhat suspect.

~~~
masonic
Sorry, I was referring to the well-known USA SlimFast retail product from
SlimFast, owned by Kainos Capital (formerly Unilever).

The "Slim Fast" that _is_ on this FDA list is a knock-off from "Universal ABC
Beauty Supply International, Inc."

~~~
wdewind
Ah, I owe you an apology then. I was super confused when I saw it on the list,
and found a bunch of stuff related to Slim Fast and sibutramine but I guess I
didn't read it close enough. Thanks for the clarification.

~~~
masonic
No problem. I missed that it was a multiple page list in the first place and
missed the "Slim Fast" name altogether.

------
mnm1
So why aren't these companies being shut down and their executives arrested
for drug trafficking? As an individual this is exactly what would happen if
say your St. John's wort also contained some prescription drug that you did
not have a prescription for and the authorities found out. Somehow it's ok for
companies to peddle this garbage to millions but not ok for the individual?

~~~
paulgrant999
#1 - Drugs aren't scheduled. #2 - They're usually dropshipped out of China.

------
jsonne
There was an NHL player who recently got suspended that made this argument. I
wonder if that was actually the case. Certainly, this evidence would help his
case or at least cast reasonable doubt.

~~~
justtopost
Many UFC Fighters have also made the claim, and were apparently vindicated by
testing at least twice I can recall.

------
394549
This is the free market at work, throwing off its chains. /s

~~~
skookumchuck
The free market proscribes fraud.

~~~
InclinedPlane
In the most abstract way possible: sure, in the real world: not so much.

~~~
skookumchuck
Misrepresenting your product is fraud and is illegal in a free market.

~~~
InclinedPlane
Misrepresentation is commonplace, even outright fraud is commonplace. Serious
fraud is a multi-billion dollar industry. "Light fraud" and gray area
misrepresentation is at least hundreds of billions of dollars a year.

~~~
skookumchuck
It's still illegal under a free market, and prosecutable.

~~~
394549
The "free market" doesn't make fraud or misrepresentation illegal, the laws
and regulations of the dreaded government do.

The worst the free market can do to a fraudster is to stop dealing with her as
knowledge of her frauds becomes widely known. That, of course, doesn't work
very well to limit fraud.

