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Regulatory Affairs

More Supplement Than You Bargained For

Here’s an article right across the way here at Science on the contamination problems with dietary supplements. This industry, though, is set up perfectly for this kind of trouble under US law (see below), and it happens constantly. (The law also throws the doors wide open for scam artists of every kind, and we get them by the bushel basket as well).

But this new piece (by Jennifer Couzin-Frankel) is about the people who are actually putting active substances in their pills. That’s actually a step down from the people selling, say, mannitol that some backyard weed has been waved over, because some of these active compounds are a bit too active:

The report was unnerving: At least a dozen supplements sold in the United States for weight loss, enhanced brain function, and improved athletic performance contained a synthetic stimulant. The compound, which Cohen and his co-authors named DMBA, resembled methamphetamine in its chemical structure. It had never been tested in people, only in two animal studies from the 1940s. “Its efficacy and safety are entirely unknown,” they wrote.

There have been several other cases, which are detailed in the article. With our current regulatory environment, it’s pretty much up to the consumer to take his or her chances that what’s on the label is what’s in the pill – a situation that would get the legitimate pharmaceutical industry attached by pitchfork-wielding mobs (assuming enough pitchforks could be located in non-agricultural areas, of course). But “weight loss supplements” can have unapproved stimulants in them, or sildenafil (Viagra) or phenolphtalein or what have you – who knows? It’s been that way since 1994, thanks to the “Dietary Supplement Health Education Act”, which was brought to us by Senator Orrin Hatch and friends.

DSHEA established the first broad framework for regulating supplements. It also gave supplements a legal definition: as substances intended to “supplement the diet,” containing “dietary ingredients” such as herbs, botanicals, or vitamins.

At the same time, the law sharply curtailed FDA’s power. Companies were not required to notify FDA provided the dietary ingredient had a history of use before the law was passed. For the first time, DSHEA allowed them to make claims on the label suggesting supplements affected the structure or function of the body—for example, by boosting the immune system or protecting prostate health. And DSHEA codified a loose arrangement:  Under the law, as FDA notes on its website, “unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to ‘approve’ dietary supplements … before they reach the consumer.” The agency can act only after a supplement is on the market and evidence shows it’s unsafe.

It was called the “Snake Oil Protection Act” when it was passed, and time has validated that judgment. Tens of billions of dollars are spent every year on this stuff, which might be one reason why it’s been difficult to revisit this industry in Congress. The other reason is that if you do have the nerve to come out against the supplements industry, then you’re branded as a Tool of Big Pharma and an evil person who wants to keep safe, healthy, all-natural supplements out of the hands of the people who so desperately need them. (If you’d like to rail against the pharmaceutical industry, though, feel free – that’s a vote-getter). There are still emails being forwarded around about how “they” are about to make vitamins and supplements illegal – any day now! – with pretty much the same wording over the years. Far from it folks – you can sell damn near anything and get away with it for an extended period, as long as you’re *not* an actual drug company.

Take a look at the comments section to the article for a sample – there are already people there going on about how the whole thing is clearly a Big Pharma operation designed to discredit the wonderful dietary supplement business. And you can also see the way that many of these people think – that there are powerful, toxic “drugs” with lists of side effects as long as your leg, and then there are healthy, natural “herbs” that make people better with no possible side effects whatsoever.

Some of this is vitalism, the idea that there’s something mysteriously different about substances that come from living creatures as opposed to mere “chemicals”. If you can stand to listen to the Food Babe, you’ll find that her thinking is completely permeated with this worldview – things are full of “energy” if they’re extracted from a plant, but they’re “toxins” if they’re made in a lab. Some people will finesse this by saying that well, when you take these plant-derived compounds, you’re also getting all these other terrific phytonutrients, too – but that blurs the distinction between “this compound that comes from a plant” and “this dried plant mixture that has compounds in it”.

Beyond vitalism, there’s the attitude that natural = good and synthetic =  bad. This especially applies to things that people are willing to put in their mouths and swallow. We humans have a pretty strong “is that food or not” evaluation system, and food is stuff that was once alive. Not stuff from some sort of factory vat. The entire dietary supplement industry is a blurring of the lines between food and medicine, and a glance down the aisles of any grocery store will show that a lot of consumers and manufacturers alike are ready to assume that there are no such lines at all. But if you treat food as medicine, you’ll also wind up treating medicine as food, with all the “ick” responses that come along with that view.

But until that 1994 is revised – and I’m not hopeful – nothing is likely to change. Those of us who are actually spending our days trying to come up with drugs for cancer can confront the spectacle of people who are convinced that we’re wasting our time. This pill from Brazil, this herb from China, this tea from the wise, wise natives of New Mexico or Nauru or Nibi-Nibi – those have the real cure. Away with your toxic chemicals!

27 comments on “More Supplement Than You Bargained For”

  1. Tuck says:

    All fair comments. This corner of the marketplace is a particularly seedy one, with crooked operators on the one side and apparently willing victims on the other.

    But we already have ample law to take care of this problem. If the product doesn’t contain what it says it does, fraud is already illegal. If it makes unfounded claims, the FDA and FTC have authority.

    The problem here seems to be a problem of a lack of policing, rather than a lack of regulation or legislation.

  2. ok... says:

    I took a look in the comments section of the article, as you suggested. This one sure caught my eye:

    “99% of supplements are helping millions of people to be healthier, to cure cancer, to cure every possible decease.”

    They have supplements to bring people back from the dead?

  3. Veylon says:

    I’m all for railing at Big Pharma. There’s a lot of pressure to push pills put on doctors. But the supplement folks? They’re Big Pharma at it’s worst minus any sort of regulation or standards. For all the flaws of the Big Pharma system, their labs do actually make stuff that actually works.

    People need to eat a sane, healthy diet and not expect a wonder additive – however it describes itself – to pick up the slack. Exotic sounding stuff can’t fix a structural deficiency.

  4. a. nonymaus says:

    So, use the vitalist useful idiots against the snake oil peddlers. “These people are putting untested dangerous chemicals in your supplements!” et c.

  5. cancerdrug says:

    Oh and the people “trying to come up with drugs for cancer” are considered beyond reproach. Taking thousands from unsuspecting families only to provide a few more months of appalling quality of life. Please.

  6. b says:

    @cancerdrug, you act as if it’s the scientists that set the prices of the drugs they come up with, and that they have any control over how many more months a person gets, or their quality of life therein. Please.

  7. John Wayne says:

    Derek, can I be the first person to call you an industry shrill? If you assume that there isn’t a plant somewhere that makes Viagra, adding a known pharmaceutical compound(s) to a supplement crosses a line lots of people who believe in natural cures don’t want crossed; seems like a poor business decision. As a chemist, a snarky reply may include a statement like, “If you want your all natural cure to work, dosing it with some a compound with known properties is the way to go.” Will this bring in the FDA? Patent infringement? If not, why?

  8. Leaving Pharma for Supplements says:

    Clearly we are in the wrong business (pharma). First rule of business is to give customers what they want. And if they want to take god-knows-what, that is at best useless and at worst poisonous, but still legal and nobody complains, then so be it. Who are we to judge what others value and want to spend their money on? So I’ve had it with trying to do good in pharma, it’s back to the first rule of business for me, in supplements.

  9. Canman says:

    Please, keep reminding yourself that ‘most people are stupid’. And there’s pretty much no getting around it at this point in time.

  10. Magrinho says:


    Yes, “trying to come up with a drug for cancer” is something that anyone should be proud of.
    As for the rest of your comment, please aim it at the right target(s).

  11. pessinist says:

    I’m kinda with Canman,

    “You can fool all the people some of the time,
    some of the people all the time,
    but you cannot fool all the people all the time.”

    has always bothered me . . . I continually think something is left out:

    ‘You can fool most of the people most of the time’

  12. Mark Thorson says:

    If anybody is thinking about going over to the dark side, just ask Lane about rosemarinic acid. He’s already got the peroxynitrite spiel worked out. It’s a component of rosemary, hence automatically already GRAS. Your contribution could be making a new polymorph. Run a bunch of underpowered trials comparing your proprietary polymorph to the standard stuff, and pick the one that shows it works. Publish it in a junk journal, and use it as the basis for a patent.

  13. Sane Linoleum says:

    I’m going to start selling peroxynitwrongs to block those peroxynitrites.

  14. Dave says:

    Darwin’s Law in action? 🙁


  15. Lane Simonian says:

    In the grander scheme of things:

  16. Tanya says:


  17. Rock says:

    I would love to see the following experiment run and paid for by all the anti-pharma crowd: Pick the ten most toxic looking chemicals from strawberries or apples. Run in vitro Ames and micronucleus and in vivo carcinogenicity studies on them (highest dose possible). I would almost guarantee some of them will be carcinogenic. I can see the headlines now: “Strawberries cause cancer”.

  18. eyesoars says:


    Try your experiment with peanut butter. Aflatoxins are among the most carcinogenic compounds known, having significant effects in the few ppb range. And they’re natural (!), arriving with peanut molds.

    Or you can try your hand with some tryptophan supplements (e.g., from Showa Denko):

    Which, unfortunately, seems to be treated as a lesson on the danger of GMOs rather than the hazards of lousy production methods, quality, and regulation.

  19. tangent says:

    ‘Supplements’ deliberately spiked with under-the-table drugs has happened quite a bit — benzos, corticosteroids, and lots and lots of stimulants to feed the huge diet/energy industry. And haven’t we seen them with analogs of known compounds? Here’s a 2009, Cohen in NEJM
    mentioned fenfluramine analogs and novel “-enafils”.

    It’s not as advanced as the situation with these ‘herbal smoking blends’ that are pirate Phase 1 testing with cannabinoid receptor ligands cooked up from the literature… not yet.

    @Rock, there are lots of Causes Cancer! results on flavorings, essential oils, etc. — I’ve never read these papers but that’s not necessary to do science journalism. Plenty of results where they promote tumor growth on real whole mice, even, so we don’t have to resort to Ames.

  20. Morten G says:

    @cancerdrug the drug will go generic at some point. That might not help one person now, but it’ll help another person down the line. Dying from cancer is pretty expensive in the form of doctors, nurses, hospital beds, MRIs, CAT scans, profits for hospital pharmacies. Drugs too though but at least that cost should come down at some point.

    @John Wayne: Viagra is generic now. Dunno the cost in US but here they are about 25 / 50 cents per pill. I’m sure you could charge more for a “sexual potency” supplement.

  21. John Galt III says:

    I don’t have a big problem with the current situation, except that so many people fail to grasp that due diligence falls to them and the labels often do not accurately reflect the contents. There is a certain level of magical thinking in the supposition that natural products are invariably good, and synthetic products are bad. Let us take aflatoxin and aspirin as counterexamples. I have the same issue with the Monsanto and Kraft products that are peddled as food. The web makes it easier than ever to dredge up information and very shortly, we will have machine intelligences that can filter the information with unprecedented accuracy, turning misinformation and disinformation into actionable intelligence. Spookwerks East and Spookwerks West already have such intelligences working 24/7 to generate more money and power. Speaking of giving the customers what they want, there once was a doctor who got tired of his patients ignoring his advice to eat a healthier diet, so he opened the Heart Attack Grill to give them what they want. See, for example,

  22. steve says:

    @Rock, Bruce Ames has already done the study

  23. John Galt III says:

    I forgot to rail about synthetic endocrine disruptors being in all of the cheap plastic crap and in the foodstuffs. I mean polybrominated diphenyl ethers, bisphenols, polychlorinated biphenyls, phthalates and a host of other modern ills that seemed like good ideas. Did I say before that leaded gasoline cost the US 7 IQ points and played a role in the crime wave of the 1970’s? Antibacterial additives, pesticides and herbicides probably aren’t much better.

  24. simpl says:

    This link suggests that modinafil is helpful for cognitive improvements like executive function and decisiveness.
    Try it as a supplement in cookies at the next project milestone meeting, and please let us know the results.

  25. ZZ Tip says:

    The US military has done a shitton of research trying to find nootropics.

    They’ve located exactly one that enhances performance on mental tasks without any major side effects.

    Sadly, everyone already knows about caffeine.

  26. Pennpenn says:

    Hey, don’t get to thinking this is kind of crap is in any way limited to the US-

    Not just pharmaceuticals, but heavy metals and endangered animal DNA! Lovely…

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