DoJ Going After Makers of Dietary Supplement (reuters.com)

schwit1 writes: Several federal agencies, including the U.S. Department of Justice, have announced criminal and civil actions related to unlawful advertising and sale of dietary supplements. "Six executives with USPlabs LLC and a related company, S.K. Laboratories, face criminal charges related to the sale of unlawful dietary supplements. Four were arrested on Tuesday and two are expected to surrender, the Justice department said. The indictment says that USPlabs used a synthetic stimulant manufactured in China to make Jack3d and OxyElite Pro but told retailers that the supplements were made from plant extracts." The FTC is working on this as well, and their press release has more details. The DoJ's case involves "more than 100 makers and marketers" of these supplements. It's about time.

Comments

Consistent

[Anonymous Coward]

You can lie all you want about what the ingredients do, but you can't get away with lying about what they are.

Re:Consistent

[techno-vampire]

Not exactly. In 1951, the FTC went against the makers of Carter's Little Liver Pills because they neither had any liver (or liver extract) in them nor worked on the liver. The company settled by agreeing to take the word "liver" out of the name.

Regulation please

[LunaticTippy]

It is mind boggling how little rules or enforcement there is in the supplement and food industries. We need a strong, well funded regulatory agency that is not beholden to the industry to protect us from the inevitable corrupt businesses who are willing to poison us in their efforts to make a buck.

Re:Regulation please

[MightyMartian]

This is America! People should be free to poison other people. Not to worry, the invisible hand of the market will fix it, or a guy with a gun.

AMERICA, FUCK YEAH!

Re:Regulation please

[Mike Van Pelt]

The reason this "supplement" law got passed was reaction to total stupidity in the other direction -- the FDA was trying to assert power to require a prescription for vitamins.

I kind of like Jerry Pournelle's proposal -- it should be perfectly legal to sell snake oil, as long as the bottle accurately describes the ingredients, and contains actual oil from actual snakes. And, under the Pournelle Rule, these bozos would be perfectly open to prosecution, since they didn't put whatever weird organic compounds some quack in China whomped up on their label.

I absolutely do not want the FDA preventing me from getting vitamin D pills with more than 400 units of D.

Re:Regulation please

[gruntled]

Uh, no. The claim is anybody was trying to force consumers to get a prescription to purchase supplements is bogus. http://www.snopes.com/politics...

Re:Regulation please

[gruntled]

To be clear: There is a lot of interest in forcing the supplement industry to document that their products are both safe and effective (like, you know, every other over the counter medication) but that's it.

Re:Regulation please

[youngone]

There was an attempt a few years ago where I live to regulate all the "Nutritional Products" and "Supplements" companies, but there was a huge backlash and it never happened.

I can't remember the arguments against proper testing and labeling but the minister involved backed down and it all went away.

Someone was even on the radio defending homeopathic remedies, and I remember her stating something along the lines that the manufacturers would go out of business if they were forced into having independent testing, and that statement went completely unchallenged. Weird.

Re: Regulation please

[bill_mcgonigle]

regulations are evil and somehow there'd magically

There's no magic involved. The FDA effectively bans the chemicals, people want them anyway, retailers find a way (these were usually kept under the checkout counter). I've tried this stuff, it did little for me and wasn't worth the price, but some people did see benefits. Everybody buying it was aware of the rouse - you can't accidentally ask for the stuff stored under the register. Nobody thought it contained flower extracts.

The ban is the entire reason for the inaccurate labels - and the high prices. There should be several brands competing for shelfspace at Walmart by vying for the best third-party certification. This is extremely simple market economics as soon as you take off your rose-colored glasses about what political edicts can achieve. In reality they cause chaos.

Re:Regulation please

[ArmoredDragon]

If that was the case, then the FDA wouldn't have announced an incoming nationwide trans fat ban.

Also if that was the case, then there would be FDA approval for certain surgical procedures that you can't get done here.

Take for example, I myself need corneal cross-linking to halt the progression keratoconus, which has been done safely in other countries for about 17 years now. A company called Avedro is lobbying really hard to get it approved so that they can start selling the equipment and drugs required to perform the procedure, but the FDA has continually denied it every year, instead opting to just wait until you go all out blind and then get a corneal transplant as their current preferred treatment option.

Re:Regulation please

[hey!]

The problem with that rule is that it presumes people are reasonable -- as in still in possession of their reason.

I have a young relative who is an anti-vaxxer. She's not stupid; she's paranoid -- about corporations and authority figures. It's the left-wing version of the right wing's hysterical climate denialism. Unfortunately she's not only nutty; she's also extremely charismatic. She's set herself up as a "certified" alternative health coach and she's recently started spreading anti-chemotherapy propaganda, although I think I've dissuaded her not to do that. She claimed she was just "sharing information", but my argument was that people are overwhelmed with contradictory data; she had to take into account that people will believe information they get from her *because* it came from her.

Now you could argue that people who buy snake oil get what they deserve -- I'd concede that point. But the people around them affected by their taking snake oil instead of medicine don't deserve what *they* get, especially if the dupe in question is a parent who is taking herbs instead of getting cancer treatment or is sending her kids to a "measles party" instead of getting them vaccinated.

I'm not sure what you're referring to about Vitamin D; the only regulation proposal I've heard is that the FDA is recommending the 400 units (the current RDA) be clearly marked on eyedroppers for liquid formulations, which seems sensible. They apparently limit vitamin D in milk to 400 units, which seems kind of low, but I think the rationale is that consumers might not be able track all the vitamin D they get from various sources. Now personally I've seen gel caps for sale offering 10,000 units, which is getting to the point where a person of normal weight could poison himself by taking four or five pills a day.

Result of the Idiots Hatch and Harkin

[gurps_npc]

All of this came from two morons that believed in Magic. Senator Hatch (R) and Harkins (D) were convinced that the FDA were holding back nutritional supplements simply because they science said they couldn't work. So they carved out an exception allowing vague health claims to be made without the FDA slamming them down.

This re-created the snake oil industry that the FDA had killed, with but minor regulations preventing extreme claims - and also made it difficult for the FDA to prosecute if the company did make those claims.

Hatch and Harkin killed more Americans than most Senators, and helped enrich a whole generation of scamsters.

Re:Result of the Idiots Hatch and Harkin

[rwyoder]

Yes, the Hatch essentially turned the regulations upside down;
Previously, you could only use ingredients that had been proven safe.
Afterward, you could use any ingredient you wanted...until it was proven dangerous.

Re:resemblance

[Earthquake Retrofit]

Can't help but to notice the resemblance between the snake oil peddlers and the politicians.

With Ben Carson you can have both.

Further Reading

[mewsenews]

I was an amateur boxer for a few years with no notable accomplishments. One thing I did notice was that supplement companies are COMPLETELY FULL OF SHIT. There is a particularly eye-opening documentary about steroids called "Bigger, Stronger, Faster" where the director creates his own supplement using unknown ingredients and gives it an obscene markup, and they don't even have to list their ingredients. https://en.wikipedia.org/wiki/...

Re:Wait...

[fuzzyfuzzyfungus]

It's actually not uncommon: The homeopathy guys are the ones who got to great lengths to avoid active ingredients; but the 'herbal supplements' industry learned some time ago that customer satisfaction is improved if the customer gets to bask in how 'natural' and 'wholistic' the remedy is(and skip tedious prescription paperwork); but it also actually does something useful because of 'impurities' that...coincidentally...tend to be dubiously sourced drugs that actually have the effect that the plant matter is supposed to have.

Regulation, but after we feel better?

[Okian Warrior]

There's nothing more squirmy than listening to a Religious Libertarian explain why medicine regulations are evil and somehow there'd magically be fewer deaths or organ damage caused if the Invisible Hand were left unhindered.

I'd like to draw a line between Religious Libertarians and smug physicians and point out that *both* ends of the line cause unnecessary medical suffering.

The themes "do no harm regardless of cost" and "federal agency takes the blame for safety, but not the costs" have driven medical research to a standstill for the last 40 years.

There can be no medicines for afflictions that affect less than a billion people, simply because it takes $1.5 billion to bring a drug to market.

We're running out of antibiotics(*), we've already got diseases which are impervious to *all* antibiotics, and there are no new ones in the horizon.

Someone here (on slashdot) put this into perspective: peanuts would not be allowed under FDA rules.

Let's take peanuts as an example for discussion. Considering that they are easy to grow, and can be nourishing, can we outline an FDA procedure that costs less than $1.5 billion, and yet addresses the issues in a sane manner?

Let's divide this by a factor of 1,000: Can we get good safety regulations for peanuts for under $1.5 million?

I think we could. I'm not a Religious Libertarian, but from a purely mathematical standpoint it's obvious that letting people die because the treatment isn't known safe (absence of evidence is evidence of absence) is less efficient than the middle ground.

Probably more - I think more people die because we don't have working antibiotics than die from complications of supplements.

(*) Note that we've run out of antibiotics *not* because we keep feeding them to livestock, but because it's too expensive to make new ones. If we had 25 separate antibiotics and used them in a staggered pattern 5 years each (5 years of use, followed by 20 years of abstinence) we would never lack for working antibiotics.

Optimum health?

[Okian Warrior]

How much benefit do you think you'll actually get by sucking down all that D in pill form? How much of that does your body actually put to use, if any? Or would you rather listen to the pill pusher's unchallenged cure-all claims and chomp on your placebo like a good consumer.

Let's take a trip down memory lane and recall how the RDA for vitamin D was established.

The FDA measured the amount of vitamin D people were getting throughout America, and then took the average value.

As anyone who isn't a physician can tell you, people living in the Northern latitudes get less vitamin D because they get less sunshine, and depending on where you live, from November through February you aren't getting any at all. And vitamin D has a half-life of about 6 weeks in the body, which is why we have a "cold and flu" season: once we stop getting sunshine, everyone's D levels drop low enough to depress our immune system.

More recently, they measured the vitamin D in a Spanish farmer working his fields w/o a shirt, and decided that he gets 50,000 IU of vitamin D each day.

So you tell me: 400 IU of vitamin D will prevent disease, but how much is the correct amount for optimum health?

Re:Optimum health?

[ArmoredDragon]

As anyone who isn't a physician can tell you, people living in the Northern latitudes get less vitamin D because they get less sunshine, and depending on where you live, from November through February you aren't getting any at all. And vitamin D has a half-life of about 6 weeks in the body, which is why we have a "cold and flu" season: once we stop getting sunshine, everyone's D levels drop low enough to depress our immune system.

Not exactly. The FDA recommendation assumes that you aren't receiving any D vitamin from sunlight at all. This assumption actually works universally because if you already have sufficient D in your blood, then it causes negative feedback so that your skin doesn't end up creating more than is necessary. So whether you get lots of sun or none, you won't overdose on D so long as you take the recommended amount.

Re:Optimum health?

[hankwang]

"... why we have a "cold and flu" season: once we stop getting sunshine, everyone's D levels drop low enough to depress our immune system."

Citation needed. At least Wikipedia states: "Beyond its use to prevent osteomalacia or rickets, the evidence for other health effects of vitamin D supplementation in the general population is inconsistent.[5][6]"

Re:They were in the wrong market sector

[Major Blud]

No one is going to take you seriously if you can't get simple facts straight.

"Take Ford. By their own admission, they have killed over 125 (or is it 150 or 200 or ???) "

It was GM, not Ford.
https://en.wikipedia.org/wiki/...

Re: resemblance

[s.t.a.l.k.e.r._loner]

Did anyone die? The answer to that is a resounding...maybe. There's no question that the active ingredient, DMAA (dimethylamylamine), is a fairly powerful stimulant. It also constricts blood vessels, thereby increasing blood pressure. Any stimulant with cardiovascular effects has the potential for adverse effects, including heart attack or stroke. In the most recent info I found with a cursory Google search, the FDA says it has received numerous reports of adverse effects, and at least five deaths which occurred with users of DMAA products. This is not proof of causation, but because it's a plausible mechanism it bears close scrutiny.