Why Won't FDA Test Herbs and Stuff?

[TokyoBayer]

@running_coach

Supplements are exempt.
Thank Orrin Hatch.

From the same article.

Nice, to the tune of $13 billion a year in sales. And here in Utah, which is to the dietary supplement business what Northern California is to marijuana, a huge industry has taken hold, complete with a network of doctors making unproven claims, well-connected lobbyists and entrenched politicians who keep regulators at bay.

Utah county where Brigham Young University is located, is home to Nu Skin and numerous other MLM companies.

Chances are, if you have lived in Utah County, you have been to a party where friends encourage you to buy scrapbook supplies, oils or the latest natural supplement or health drink. Utah County is home to dozens of multi-level marketing companies, selling a wide variety of products.

Sometimes called direct sales companies, these businesses rely on independent distributors to sell their products, typically through word of mouth, parties or website sites.

Here are 15 successful MLMs headquartered in Utah County.

Utah has one of the highest rates of participation in MLM’s. There is a number of reasons for that, one is that women are encouraged to stay home and not work, so working for a MLM is an attractive option. Most of the men have had sales experience as missionaries, and have learned how to put on a happy face even when people are rejecting your product. And from here.

Utah is famous for many things: world-class ski resorts, the Church of Jesus Christ of Latter-day Saints and, most recently, Trump-hating Republicans who may vote Democrat for the first time since 1964.

Beyond that, however, Utah has a lesser-known claim to fame: It is the unofficial world capital of multi-level marketing and direct sales companies.

There are at least 15 major MLMs in Utah County alone, generating billions in annual revenue and making direct sales the second-biggest industry in Utah behind tourism, according to Loren Israelsen, executive director of the Utah-based United Natural Products Alliance.

Per capita, Utah has more MLMs than any other state.

“It must have something to do with the way LDS culture works in the valley,” said Ann Dalton, CEO of the beauty product direct-seller Perfectly Posh, from her Salt Lake City office.

Connections fostered in LDS communities, said Dalton, create a hotbed for businesses with a social sharing model. The prevalence of national and international missions by young men and women for the LDS church, she speculates, plays a huge role.

“You get a lot of return missionaries who speak every language on the planet, then all of a sudden you have a sales force that’s very well connected," she said. "They’re connecting with their friends, they know the languages, they’re tech savvy. That’s my untested theory.”

(shortened)

For Alyx Garner, Lipsense lipstick consultant and mother of two, the prevalence of MLMs in Utah is about more than an educated Mormon sales force.

“There’s so much pressure in LDS culture to be a stay-at-home mom,” said Garner, a devout Mormon who took up direct sales while raising her children.

The numbers back up Garner’s claim: Utah has one of the highest concentration of stay-at-home mothers in the country, according to a national study by the New York Times, which estimates 46 percent of prime-age women in Provo are not working, while 8 percent of men are not.

“Heavily Mormon areas are a throwback,” wrote the Times. “The male-dominated nature of Mormon culture has kept non-employment rates for prime-age women extremely high – as high, in some areas, as they were for American women in the 1950s.”

Garner estimates about 75 percent of Utah women she knows are involved in direct sales, some because they want to stay in the workforce and others because they want to contribute to household income.

My bolding.

So for Hatch, it was a simple matter of following the money.

[Bill_Door]

Under the Unapproved Drugs Initiative started in 2006 the FDA encouraged drug manufacturers to test older drugs which had never been properly tested for safety and efficacy under FDA protocols. One of these drugs, colchicine, was derived from the mountain saffron plant, which had been used to treat inflammation since 1500 B.C. and had been isolated since 1820.

Testing a drug like this is expensive, and in order to incentivize drug companies to run the tests the FDA allowed them a three year exclusive market in the drug. Overnight a drug which had cost literally pennies per pill went up to $5.00 a pill. Many patients on long term prophylaxis regimes saw their annual costs go from less than $10.00 a year to $3,600.00 per year.

Sorry, too late to make a long story short. Anyway, this points out the problem with herbal treatments. Who is going to pay for testing? Suppose cinnamon does improve blood sugar regulation in diabetics? I don’t need FDA approval to buy cinnamon, I can get a big bottle of it a Costco for a few dollars. There’s no incentive for people to test these herbs because there’s not a captive market. If it did work, and the FDA did give someone exclusive market rights, how am I going to make my Snickerdoodles?

[boffking]

@lazybratsche

If you like your horror served with spasms of rage, consider this case of a Hyland’s homoepathic “teething remedy” which contained deadly nightshade in decidedly non-homoepathic quantities.

Ten children died, and hundreds more were hospitalized because of the negligence of a company that sold magic poison water.

Ten children died because the Hatch Act prevented the FDA from making sure the magic poison water was made correctly in the first place.

Ten children died because the Hatch Act prevented the FDA from doing proper safety testing on magic poison water.

Ten children died because the Hatch Act prevented the FDA from recalling deadly magic poison water in a timely manner.

Countless people have died and suffered because the Hatch Act forces the FDA to allow the sale of magic poison water.

And now I have to have a stiff drink, because I’m too enraged to go to sleep after re-reading this case.

IANAL, but what does the Hatch Act have to do with any of this? I thought that was the law regarding federal employees and their influence on elections.

[lazybratsche]

@boffking

IANAL, but what does the Hatch Act have to do with any of this? I thought that was the law regarding federal employees and their influence on elections.

My mistake, I was referring to the Dietary Supplement Health and Education Act of 1994, and all subsequent laws and regulations. For which we have Orrin Hatch to blame, though you’re right that it’s not colloquially referred to as “the Hatch Act”.

[Chronos]

A long-serving, influential senator will doubtless have multiple bills for which he was the prime mover. There’s more than one “Hatch act”.

[Jackmannii]

@naita

Ethical medical scientists would maybe love it, but Big Pharma and Big Alt med are to a large degree the same companies. This way they get to make money from both.

I think this is an overstatement. Big Pharma traditionally has been involved in making vitamins, and only recently has started buying up some supplement companies. A huge chunk of the $37 billion-a-year U.S. supplement industry still comprises “independent” companies, from small to mega-players like Herbalife and Shaklee. Multi-level marketing [del]scams[/del] firms remain powerful players.

A reminder that lots of these products are manufactured overseas in places like China and India which are not noted for superb quality control, so we wind up inferior and adulterated supplements (not that the “quality” ones actually work).

And the recalls keep on coming.

[Der_Trihs]

@Jinx

In this era where Congress celebrates the killing off of Americans in need of their expensive medications, treatments, etc…why won’t the FDA start testing natural remedies?

It’s been tried; pretty much none of it works.

Ten years ago the government set out to test herbal and other alternative health remedies to find the ones that work. After spending $2.5 billion, the disappointing answer seems to be that almost none of them do.

Once you spend s few billion dollars for essentially no return, it’s questionable if you should spend more digging the same dry hole.

As said, the “natural remedies” that actually worked are conventional medicine now; a famous example being penicillin, derived from a mold. What’s left is the stuff that doesn’t work.

[Jackmannii]

Added note: It is not the job of the FDA to test drugs - manufacturers are responsible for getting them tested, and then FDA expert reviewers go over the evidence in deciding whether they should be approved.

As noted, the DSHEA (spearheaded by the likes of Orrin Hatch and Tom Harkin) has short-circuited this process for supplements, to the glee of supplement companies.

[JcWoman]

@smithsb

Unless you die or are seriously injured, why or how could you sue? You have to prove it was the supplement. These companies have lawyers, lots of them, deep pockets too. And legislators, don’t forget them. Didn’t get the proper effect? Prove you followed direction precisely, with data, blood/tissue samples, witnesses, etc… [ironic that the companies themselves aren’t proving it either]. Don’t forget to read all the fine print on the labels or in the ads or on the web site. Good luck without a law degree.

Actually, this is a problem with FDA-approved medications as well. I used to know a lady who had a stroke in her early twenties. She was sure that it was birth control pills that caused it, and if you look at the information sheet that comes with any BCP, you’ll see stroke listed as one of the possible serious “side effects”. She was facing daily migraines of varying intensity for the rest of her life as a result. Despite taking her off The Pill and prescribing migraine cocktails, none of her doctors would agree that it was the pill that caused it. They suggested that perhaps she had a pre-existing, undiagnosed vascular defect in her brain. There was no way to prove it or prove the opposite.

I think the only way to get something taken off the market is if LOTS of people die or are harmed, and the entire population of harmed/killed people can be somehow proven to be the result of the drug in question.

[TriPolar]

The FDA shouldn’t regulate herbs as drugs, they should be regulated as herbs, like the oregano or paprika in your spice cabinet. This is more of an issue for the FTC or Dept. or Agriculture. What has to be done is some oversight to ensure these herbs contain what they say they do, and they shouldn’t be advertised as having medical benefits. If you want to treat cancer with Old Bay Seasoning and dried parsley flakes go ahead the government shouldn’t stop you.

[Dewey_Finn]

What amuses me is that the advertisements for these herbal supplements have a statement (apparently required by the FDA) that says, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” And then the ads go on to make what sound very much like claims that the herbal supplement can treat, cure or prevent some disease.

[Really_Not_All_That_Bright]

Bill Door, thank you for that view of the other side of the issue.

@Chronos

A long-serving, influential senator will doubtless have multiple bills for which he was the prime mover. There’s more than one “Hatch act”.

No. There is more than one act for which Orrin Hatch was the primary sponsor, but there are only two Hatch Acts, neither of which has anything to do with him. One dates from 1939 and was sponsored by Carl Hatch - no relation - and prohibits federal employees from engaging in certain political activity. The other is from 1887 and funded agricultural research. Nobody has ever called the DSHEA “the Hatch Act,” or even an “Hatch Act.”

[shiftless]

Wasn’t Virginia’s ex-governor Bob McDonnell tried for taking bribes from at least two supplement companies? Turns out that taking such payments isn’t quite illegal in Virginia but still, the fact there is more than one supplement business paying off politicians should sound some alarms.

[Derleth]

@snfaulkner

Oooo, I like being horrified! Are you able to divulge any details?

Here’s a long article on the subject. Some excerpts:

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.

[snip]

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.

John Adams, of Chipley, Fla., was one of the victims. His silver hair — which had earned him the nickname “Silvertop” at work — began falling out in clumps. His fingernails and toenails became discolored, peeled off, regrew and peeled off again. He had a hard time remembering how to do his job as a telephone repairman. He became so weak it was hard to get in and out of his work truck, and eventually he was forced to retire.

Adams and his wife, who also experienced problems, sued along with dozens of others. This year, the couple received a settlement. Adams, now 65, said he is still weak on his left side, has ruined fingernails and toenails that do not grow and struggles with memory problems.

So what was the excuse given by Total Body Essential Nutrition, the distributor of the supplements that caused the mass poisoning? A lawyer for the company blamed a contractor for incorrectly interpreting the formula, incorrectly formulating it, or both. I kid you not. Amusingly (from a schadenfreude standpoint, not from the standpoint of any injury to any person), it’s not just Total Body Essential Nutrition who’s produced a dangerous batch of supplements and tried to blame it on a contractor’s screw-up. In fact, two years ago Gary Null, conspiracy theorist and quack supreme, suffered a similar fate to that of John Adams, but he was poisoned by one of his own products. Specifically, what happened was that Null overdosed on vitamin D consuming Gary Null’s Ultimate Power Meals. As a result, he suffered from “excruciating fatigue along with bodily pain,” and “began to suffer from extreme cracks and bleeding from within his feet.” The reason? There was 1,000 times as much vitamin D in his power meal than what the label listed. That meant that instead of ingesting 2,000 IU of Vitamin D daily, Null was ingesting 2 million IU. The usual recommended daily intake is 600 IU per day.

That’s a long quote from a much longer post, which contains plenty of citations. Orac is nothing if not thorough.

[Jackmannii]

@Dewey_Finn

What amuses me is that the advertisements for these herbal supplements have a statement (apparently required by the FDA) that says, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

This Quack Miranda Warning only is required if the manufacturer “claims, explicitly or implicitly, that the product… has an effect on a specific disease or class of diseases.”

[Tranquilis]

@Jackmannii

I think this is an overstatement. Big Pharma traditionally has been involved in making vitamins, and only recently has started buying up some supplement companies. A huge chunk of the $37 billion-a-year U.S. supplement industry still comprises “independent” companies, from small to mega-players like Herbalife and Shaklee. Multi-level marketing [del]scams[/del] firms remain powerful players.

This. ^^

Yes, some pharmas do own supplement companies - and you’ll find that those supplement companies are among the best-behaved in their industry - Centrum, One-A-Day, etc. Partly, because their parent company actually does real science, and partly because their parent company doesn’t want a festering sore of a lawsuit-target attached to their bottom line. This is not to say that there’s not a lot of hucksterism going on, because there is, but do try to place the blame where it belongs.

[Shodan]

@Mangetout

Weasel words “May be effective against…”; “Believed to be beneficial to…”

Also one I heard last Friday - “has been clinically studied in the treatment of (I think) male testosterone deficiency”. Oddly enough, they didn’t mention the results of the clinical studies.

Regards,
Shodan

[Tranquilis]

@Shodan

Also one I heard last Friday - “has been clinically studied in the treatment of (I think) male testosterone deficiency”. Oddly enough, they didn’t mention the results of the clinical studies.

Regards,
Shodan

These words have very specific, legal meaning. The fact that they can also be used as weasel words isn’t an accident.

[Musicat]

@Der_Trihs

As said, the “natural remedies” that actually worked are conventional medicine now; a famous example being penicillin, derived from a mold. What’s left is the stuff that doesn’t work.

Don’t you find it interesting, in light of this statement, that penicillin was discovered by Fleming in the lab? It did not result from testing some witch doctor’s folk remedies.

@Jackmannii

As noted, the DSHEA (spearheaded by the likes of Orrin Hatch and Tom Harkin) has short-circuited this process for supplements, to the glee[sup]*[/sup] of supplement companies.

• Translation of “glee”: Unabashed reverence for humongous pocketbook enhancement at the expense of people who are wishful, trusting, and sick.

[Jackmannii]

@Mangetout

Weasel words “May be effective against…”; “Believed to be beneficial to…”

And also “FDA-approved”, which typically means “Thanks to Congress mandating pitifully inadequate supplement regulation, the FDA can’t touch us!”.