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Regulatory Affairs

The FDA and the Dietary Supplements

I’ve been complaining for years on this blog about the “dietary supplement” industry, which exists in its present form thanks to Sen. Orrin Hatch. That’s the 1994 “Dietary Supplement Health and Education Act”, which like many a federal bill has a name that is somewhat detached from reality. I would suggest the “Sell Any Damn Pill You Want Act” , with the proviso that you include words “dietary supplement” in 8-point font on the label, and have someone quickly mutter “These statements have not been evaluated by the FDA” at the end of your TV ads. Then you can sell any damn pill you want, apparently. When someone takes the time to analyze many of these preparations, all too often the herbal goodies turn out to be weeds and unknown material, although there are times when active ingredients get thrown in there, too – just not the ones on the label.

I’m glad to report that the FDA seems to be devoting more scrutiny to this issue. To be fair, the agency doesn’t have much freedom to operate thanks to that 1994 law, but they’re trying to implement an NDI framework (New Dietary Ingredient) that manufacturers would need to comply with, and trying to communicate potential problems with marketed supplements much more quickly. The announcement coincides with letters to 17 companies pointing out that their dietary supplement are not, in fact, therapies for Alzheimer’s disease, no matter what their ads say. Here’s an example of such a letter – the medical claims go all the way down the page. Known to treat this, clinically proven for that, counteracts the symptoms of the other, safe and highly effective, prevents Alzheimer’s, prevents cancer, prevents Parkinson’s, prevents diabetes, on and on and on. This is crap, of course.

The US supplement industry has grown at least tenfold since the 1994 legislation, and why wouldn’t it? While there are legitimate things one can add to one’s diet, the big problem is that the law as written is an invitation to sell snake oil. Find something that no one knows how to treat and tell people that you can treat it; it’s not a difficult business model to understand, and the money most certainly does roll in. The sorts of claims made above are a disgrace, and should in fact be a crime, but they’re very profitable indeed. If the FDA can turn a hose on this sort of thing, then good for them. Let’s see what happens. . .

83 comments on “The FDA and the Dietary Supplements”

  1. Emjeff says:

    “To be fair, the agency doesn’t have much freedom to operate thanks to that 1994 law…”

    I’m not sure that is completely true. If companies make medical claims in their ads, then the drug is, by definition, mis-branded. Nothing in DSHEA precludes them from then going after these companies on that basis. I suspect the reason they don’t is simply resources.

    I agree that the FDA needs to act and DSHEA is disgraceful, but the real problem here is the American people, who can look at me and say “You work for Pharma and get paid to sell drugs so we don’t believe you”, while at the same time looking at the shills on Dr. Oz’ show and say ” look, it’s natural”, conveniently forgetting that those people, too, are charging for their “drugs”.

    1. Mike D. says:

      At least the FDA doesn’t have to worry as much about the Congressional Review Act nullifying its rules as of last month.

    2. b says:

      I’ve always found the cognitive dissonance quite astounding. Don’t trust Pharma because they’re in it for the money… but the snake oil salesmen are in it for the good of their hearts? I guess they pay their mortgage with good vibes. Throw some cheap weeds in a bottle, say it’s good for something and sell it to the fools- that doesn’t sound cynical at all.
      In the end, all these recent debates about drug pricing lead to one important point. The drugs actually work. If they didn’t, nobody would really care how much they cost and we’d all be chomping down weeds.

    3. Porgy says:

      Because of DSHEA, the US is the world’s cesspool of dietary supplements. Anyone from anywhere can dump their misbranded and/or adulterated dietary supplements onto the US market. Products appear at the border with one name then after getting due process by being cleared by CBP, they change their identity and are sold to unsuspected Amaricans.

  2. Billy says:

    Hang on Derek. Are you telling me the prevagen I just ordered isn’t going to help my brain?

    1. Derek Lowe says:

      You’re getting smarter already, and it hasn’t even arrived!

      1. John Wayne says:

        This does bring up an interesting ethical question: is it okay to charge people good money for something that is a placebo? One one hand, placebo effects are real so the product technically works. On the other hand, if you have good control groups it doesn’t work so that is bad. I can argue this one either way.

        Amusingly, charging people more money will make the placebo effect stronger and deliver even more benefits. To quote Derek, I bet McKinsey has a slide on this. We are in the wrong business.

        1. A Nonny Mouse says:

          Not quite true.

          Placebos can continue to work even when you know that they are placebos; this is well documented.

          1. John Wayne says:

            Really? Wow. Do you have any references?

          2. Nesprin says:

            “Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome” comes to mind

          3. zero says:

            One wonders if that’s a consequence of the patient choosing to do something to treat their symptoms, regardless of whether that ‘something’ makes sense. In that context, prayer and meditation count as ‘something’. They may not cost money, but they do cost time and mental energy.

          4. An Old Chemist says:

            ‘The New York Times’ published this long article on ‘placebo effect’ a few months ago:


          5. Derek Freyberg says:

            The study referred to by Nesprin came in for some serious criticism of the validity of its claimed results on the Science-Based Medicine back in 2010: see; and it also has some fairly skeptical comment on the New York Times article mentioned by An Old Chemist: see

          6. There’s an argument that most of what gets called “the placebo effect” is really regression to the mean:


            Indeed, with diseases where there is no regression to the mean (in cancer, people regress to the grave), one doesn’t hear much about the placebo effect working. And it’s only of interest anyway if it involves objectively measurable results: with something like pain, you’re largely testing how much you can bias the patient’s reporting.

        2. Anonymous says:

          There’s another consideration which the FDA is considering. When a treatment shown to be efficacious exists what’s the risk patients will take inactive dietary supplements rather than proven treatment?

        3. A Nonny Mouse says:

          It is, apparently, well documented with pain.

      2. Terry says:

        I did my bachelor’s thesis in the lab that discovered aequorin (Prevagen claims to be apoaequorin), which was used in monitoring nerve flux in squid axons since it is a photoprotein activated by Ca++. We were all puzzled by this blue light from aequorin, since the jellyfish fluoresce green. It wasn’t until the FRET partner was found by a “research professor” in the lab (Frank H Johnson was the PI) named Osamu Shimomura. Today, the FRET partner is known as GFP. Every time I see that ad for Prevagen, my blood pressure rises a bit, but when I remind myself that I was present across the bench for a Nobel-winning discovery, it eases a bit

    2. oldnuke says:

      The jellyfish next door won a chess tournament just the other day. Saw it on TV. Right after the miracle water commercial.

    3. AcademicMedChem says:

      Too many (older/non-scientist) people I know have jumped on the prevagen train… I try to graciously explain the state of supplement claims and evidence, but don’t have the boldness required to tell them it is 100% BS and their money was completely wasted. Makes me angry to see that commercial every few min.

      1. Design Monkey says:

        Yea. It’s kind of dualistic feeling , when you have relatives, otherwise normal and adquate in life, and then, oops, they buy and use oscillococc-blahblah homeopathic crap. Probably was peddled to them by totally rotten so called “pharmacist”.

    4. Porgy says:

      If you purchase the “Extra Strength” Prevagen, you may have a misbranding claim. The term “extra strength” is a nutrient content claim per NLEA. Since there is no RDV or DV, can’t make that claim. In addition, each company must petition the FDA to use this nutrient content claim.

  3. Lane Simonian says:

    I agree that Prevagen is the poster child for misleading supplement claims. In an ischemic stroke study apoaequorin (if that is the main ingredient in Prevagen) was directly injected into the brains of mice. Apoaequorin may not even cross the blood-brain barrier.

    The use of supplements raises all sorts of questions: is it poorly absorbed, is it rapidly metabolized, is it rapidly excreted, has it been adulterated, have transport systems been altered that prevent its uptake, does it again cross the blood-brain barrier, just for a few.

    From my perspective, though, the greatest problem is that no one seems to want to determine what is effective and what is not. It is easier for a supplement company to suggest that their product may have some health benefit rather than to test it to find out (for one thing, they are afraid to find out that the supplement is ineffective). For those who believe all supplements are junk it is more convenient to use words like snake oil, woo, and pseudoscience, then to take the risk to find out that some natural product may be helpful for some conditions. There is too much money involved on all sides to make a good faith effort to get at the health effects and side effects of all treatments.

    1. MTK says:


      The channel for funding the type of testing you allude to is NCCAM which has now changed its name to National Center for Complementary and Integrative Medicine. A really complete waste of NIH resources that was set up by Tom Harkin who believed in that stuff. Now I saw its a waste because basically they’ve been accused of supporting some pretty shoddy science.

      It really came to a head when after some years in existence and numerous studies funded by NCCAM that came back negative for various supplements that Harkin famously said in a Senate hearing “One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. I think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.”

      So it’s not that we don’t have a center to test supplement effectiveness, but rather that the center was set up with the expectation that it would prove they work, not find out if they work. Now one can imagine the quality (cough, cough) of some of the studies that have followed when the center’s prime patron Senator (now retired) expresses disappointment in their funded findings.

      1. Chris Phoenix says:

        If NCCAM was intended to test the supplements most likely to work – and actually, instead, focused on the supplements thought to do the most harm – then Harkin’s quote would be a reasonable and well-deserved complaint. Not because of the negative results, but because of running tests on the wrong set of things.

        Of course if NCCAM actually tested the ones thought likely to work, and got negative results, then Harkin would be way wrong. But this description doesn’t say that.

    2. AVS-600 says:

      “For those who believe all supplements are junk it is more convenient to use words like snake oil, woo, and pseudoscience, then to take the risk to find out that some natural product may be helpful for some conditions.”

      The pharmaceutical industry isn’t afraid to use natural products and natural-product-derived treatments; they’ve been doing it as far back as aspirin and penicillin, and have kept doing up into paclitaxel and arteminisin. The reason that no one wants to run a trial to find out whether most supplement claims actually stand up to rigor is:

      – Those who are actually interested in whether the treatments are effective don’t have compelling pre-clinical evidence that there’s anything worth investigating in trials
      – Those who are currently selling the supplements can already sell them without having to deal with the expense and trouble of clinical trials (not to mention what happens when most of the products end up being useless), so why would they bother?

  4. luysii says:

    Some history might help. The 1994 bill authored by Senator Hatch of Utah reflects the Mormon experience of being forced to flee the settled USA after Joseph Smith was LYNCHED in 1844 not in the deep south but in Illinois. They took with them what they could on the trek to Utah, and used what herbs they could find there as medicines (something that has a long US history — visit the herbal gardens on Martha’s Vineyard), so they have a long history of dietary supplementation and treatments from natural products.

    Living in Montana from in the 70s and 80s, Mormons were a large enough group to be perceived as such (around 5%) and discriminated against. I thought of them as the Jews of Montana. I am not a Mormon.

    1. MTK says:

      Yeah, I’m not sure I buy the Mormon angle completely. As you mention, luysii, we (meaning the entire human population) all have a long history of herbal based medicines. I will say this much, however, Utah does have a very large supplement industry and is home to some of the biggest supplement manufacturers thanks to Hatch. Now the roots of that may be from Mormonism, but I don’t really know.

      1. cancer_man says:

        “From my perspective, though, the greatest problem is that no one seems to want to determine what is effective and what is not.”

        Elysium has run trials of its Basis (NR + pterosilbine) on 120 healthy, non-obese adults aged 50 to 79 and found that the group taking a double dose (500 mg of NR and 100 mg of pterostlbne) performed almost 8% better on a balancing test and walked almost 8% farther on a 6 minute walking test after taking the supplements for eight weeks.

        A recent publication showed that ALS patients who took Basis at 1,200 mg of NR + pterosilbine a day saw some improvement after 4 months whereas the conduction of the placebo group continued to decline. Moreover, Elysium’s Basis also outperformed the latest drug approved for ALS, Radicava.

        Are those trials junk science?

        1. MTK says:

          EH301 was given orphan drug designation by the FDA. Now I’m not sure what the origin of it is, but it really doesn’t matter. The point is that they are going through the regulatory process which will allow them to get approval based on clinical trials that are reviewed for safety and efficacy, manufacturing processes that are controlled, inspected, and approved, and labeling that has been supported by actual evidence.

          Supplement makers skirt all of that thanks to DSHEA. No one is saying these supplements have no place or that they are actually all shams. As noted by others natural products have played a major role in many therapies. The problem is selling of these things without good clinical evidence in terms dosing, safety, or efficacy or even quality assurances that if they do work they actually get what you’re paying for.

          1. Kevin says:

            Exactly. There is a specific term for “complementary and alternative medicine” that is shown to be effective–we call it “medicine.”

          2. cancer_man says:

            “Supplement makers skirt all of that thanks to DSHEA.”

            But Elysium is a supplement maker that has shown results. Leonard Guarante, who co-founded Elysium, is one of the authors of the recent ALS paper. Chromadex, which has a patent on the NR making process, says the publication of its 140 person trial of healthy non-obese people age 40 o 79 will be out soon. So there is a second supplement company demonstrating the efficacy of its product in controlled trials.

          3. cancer_man says:

            Could you expand upon “*sigh*”?

        2. David Young MD says:

          Just 8 percent better? There sense of balance is 8 percent better and you find that to be significant. What about the other 5 studies that did not show this and the 2 other studies that showed worsening which they did not publish (I hypothesize) so we do not know that they exist. No, I am not impressed.

          1. cancer_man says:

            The ALS study recently published that showed better efficacy with the NR/pterostilbine supplements than the best drug isn’t at least an interesting starting point? Granted, that was a very small pilot trial.

            Which drug could you give someone, besides maybe a steroid, that would improve walking and balance by 8 percent? I’ll wait for the studies that show no efficacy at 500 mg of NR.

      2. Yes but, they were very big on supplements in the 70s and 80s long before Hatch’s bill

      3. Speaking as a Mormon, I’m not sure they’re a Mormon thing, either. It’s probably more a local-industry thing. I prefer my medicine scientific.

        My control group is the highly-educated, science-oriented, mostly-non-Mormon community I live and work in. There are folks in my congregation that are in to the medical woo. There’s also an physician’s assistant and an emergency physician that are decidedly not. I can say pretty much the same for the non-Mormons in the wider community.

    2. JustHatched says:

      Hatch is old but Smith was long dead when Hatch was born, although this needs checked. Nutraceuticals are big among the Mormons as they strive for perfection and physical and spiritual beauty. What else is big in Utah is rampant prescription drug and antidepressant use, teen suicide, domestic abuse and divorce. But they sure look good in a downward spiral!

      1. Don’t care much for Mormons?

        1. luysii says:

          Pay no attention Kent. He must be from Montana. I saw a fair amount of this sort of thing when I was there.

        2. JustHatched says:

          No -just snake oil salesmen at all levels.

    3. metaphysician says:

      So? The Mormons could have suffered however much historical repression you wish. They could still be repressed, if you wished. Its not going to make a damn bit of difference to the question “Do these herbs actually work?”

  5. loupgarous says:

    Late last year, FDA sent a warning letter to folks just down I-10 from where I live who sold a “dietary supplement” with an interesting secret ingredienttianeptine, which is approved for use as an atypical antidepressant – just not here in the US.

    Kudos to Commissioner Gottlieb for mucking out the health supplement stables.

  6. Anonymous says:

    I’m enjoying some of the links to older Pipeline posts and other articles and side links to Food Babe and SciBabe.

    About Prevagen and its claims to benefit memory and brain health: jellyfish do not have brains. I’m googling for articles, but I don’t find any evidence that jellyfish even have memory or that aequorin enhances it. (Cf., goldfish can retain memories up to around 3-months. Link in handle. Note to self: Start company to sell nutraceutical goldfish extract.)

  7. An Old Chemist says:

    Below are a few interesting excerpts from the long New York Times article on placebo effect, entitled “What if the placebo Effect is not a trick.” The URL of which I just posted in my previous message.
    *** ** *
    *Surprise: The placebo effect seems to be getting stronger as time goes on, especially in the US, thus making approval of new pain drugs much harder. Why? One theory is that the US allows drug ads, so Americans have been conditioned to expect greater benefits from drugs.

    * The roots of placebo effect may lie more in the nature of the doctor-patient interactions than in the treatment itself (thus possibly explaining why some alternative treatments work so well).

    * The placebo effect is a result of the complex conscious and non-conscious processes embedded in the practitioner-patient relationship. The rituals embedded in the doctor-patient encounter are fundamental to the placebo effect, and that he believes embody an aspect of medicine. “Medical care is a moral act”, in which a suffering person puts his or her fate in the hands of a trusted healer.

    *Some researchers have found a new molecule (an enzyme called COMT) that is correlated with the placebo effect (PE). This may explain an erstwhile psychological phenomenon in terms of a biochemical process, thereby making it more credible and comprehensible to mainstream medicine.

    *Give people a sugar pill, they have shown, and those patients — especially if they have one of the chronic, stress-related conditions that register the strongest placebo effects and if the treatment is delivered by someone in whom they have confidence — will improve. Tell someone a normal milkshake is a diet beverage, and his gut will respond as if the drink were low fat. Take athletes to the top of the Alps, put them on exercise machines and hook them to an oxygen tank, and they will perform better than when they are breathing room air — even if room air is all that’s in the tank. Wake a patient from surgery and tell him you’ve done an arthroscopic repair, and his knee gets better even if all you did was knock him out and put a couple of incisions in his skin. Give a drug a fancy name, and it works better than if you don’t.

    *You don’t even have to deceive the patients. You can hand a patient with irritable bowel syndrome a sugar pill, identify it as such and tell her that sugar pills are known to be effective when used as placebos, and she will get better, especially if you take the time to deliver that message with warmth and close attention. Depression, back pain, chemotherapy-related malaise, migraine, post-traumatic stress disorder: The list of conditions that respond to placebos — as well as they do to drugs, with some patients — is long and growing.

    x). these psychologists and neuroscientists and physicians and anthropologists and philosophers had come to his city to talk about — the placebo effect, the phenomenon whereby suffering people get better from treatments that have no discernible reason to work — to call it “fake medicine,” and to add that it probably works because “people like to be cheated.”

    * Placebo effect works better in some people than in others because of the levels of the enzyme COMT in their brains. COMT affects the production of catecholamines which are connected to dopamine and epinephrine, which, in turn, are known to be ‘feel-good hormone’, and so this connection gives a scientific connection to the psychological effect of the centuries old placebo effect. If this COMT-placebo effect connection can be confirmed by other researchers that would change the practice of clinical trials, and may lead to a new drug that modulates COMT levels.

    * Will this research change anything in health care? Not likely. Mainstream medicine will continue to treat placebo effect as a nuisance or a hurdle (that needs to be overcome in drug trials). There is no money in placebos–they can’t be patented and they can’t be sold very profitably. For this reason, further research into PE is unlikely to receive much funding.

    * If you wish to avail of the placebo effect, find a doctor who listens to you and is easy to work with. Ask him if doing nothing is a good/safe option in your case. If so, try doing nothing for some time and watch your symptoms. I have had a lot of success with this method:-)

    * Traditional drug trials are required to demonstrate the efficacy of a drug by showing its superiority over a placebo. For example, if 50% of patients in the drug group and 30% in the placebo group get better, then the drug is assumed to have a net efficacy of 50-30 or 20%. However, according to this article, placebo effect and drug effect may not always be additive. In fact, the placebo pathway and the drug pathway (both being biochemical pathways now) may interfere in some cases. This raises some fundamental questions about the validity of the double-blind, placebo-controlled trials (the gold standard for drug testing and approval).

    1. Anonymous says:

      Also from that NYT article, “A 2015 study published in the journal Pain analyzed 84 clinical trials of pain medication conducted between 1990 and 2013 and found that in some cases the efficacy of placebo had grown sharply, narrowing the gap with the drugs’ effect from 27 percent on average to just 9 percent.” Maybe I’m being cynical, but could improved oversight of some clinical trials account for the trend? Back in 1990, an ambitious analyst might have tossed out placebo responders for various reasons (skipped a dose – withdrawn from study; severe hangnail – withdrawn; etc.). Under more recent guidelines and supervision, it might be harder to trim the placebo responders.

      1. NJBiologist says:

        IIRC, that overlaps well with industry’s uptake of certain enhanced enrollment strategies for clinical trials–particularly selecting the highest pain scores. This had the goal of optimizing treatment effects, and the effect of optimizing regression to the mean.

    2. This.

      Physicians can learn an important lesson from quacks: Bedside manner is still very, very important.

  8. shanedorf says:

    With new drug development, they find out fairly early on which cyp enzymes are involved in metabolism and that makes it fairly straightforward to do drug-drug interaction studies. It also allows physicians to make informed choices for their patients. What’s the current state of affairs for supplements ? Are the cyp enzymes known for many of these or are people playing Russian roulette in terms of what other meds they may be taking ?

  9. dearieme says:

    I ask from ignorance: are there US laws that govern the claims that may be made for cosmetics?

    1. Thoryke says:

      When a product claims to do more than decorate or clean the body, that product may be crossing the line into “drug” territory. See the FDA page linked to this reply for more specifics.

  10. steve says:

    Surprised no one has mentioned homeopathy. Imagine if things really worked that way – you could dilute your Starbuck’s coffee in the local reservoir and everyone in the city would get a buzz every time they drank the tap water. You could take a gallon of gasoline and dilute it enough to run your car the rest of your life. That one expensive bottle of Laphroaig single malt would be enough to keep all your friends, family and business associates happily imbibing for decades if not centuries. If only Avogadro hadn’t been such a killjoy.

    1. x says:

      Ah, no. You see, you are ignorant of the SCIENCE of homeopathy.

      It is not enough to simply dilute an ingredient to unleash its potency; there is a special technique that involves making the dilution in a certain vessel, and then whacking the vessel on a table covered with a special leather pad. That’s what transfers the vibrational frequency of the active ingredient to the water’s memory.

      By the way, I’m sure all the industrial homeopathic manufacturers are following this very crucial step and not just throwing a dustpan full of factory floor sweepings into a big vat with a mechanical mixing paddle.

      1. loupgarous says: shows in great detail just how little of the “active ingredient” remains at various homeopathic “potency scales”.

        Good point about the assumption that everyone selling homeopathic remedies is following the recommended procedure instead of letting what remains of their common sense guide them and selling objectively more potent solutions of, say, arsenicum album – or as we, the ignorant call it, arsenic trioxide.

        I wouldn’t bet against some homeopathic arsenicum album on the market containing toxic or at least carcinogenic quantities of arsenic trioxide. It depends on which school of thought the homeopath doing the dilution belongs to. Some early homeopaths were diluting no more than 3x (or 1:1000, which would make a solution of arsenic trioxide potentially carcinogenic, wouldn’t it?).

        1. steve says:

          Oh nonsensical crap. You shake it up a bit. Big deal. Still violates every law of chemistry and physics known to man. “Vibrational frequency” “water memory” and other phrases are just pseudoscientific hogwash. Shake your Starbucks coffee all you want as you dilute it until there’s not a single molecule of the original solution left and then tell me it still wakes you up in the morning. For goodness sakes it’s amazing what people will believe.

    2. Design MOnkey says:

      There is yet another bullshit of homeopathy. Hahneman out of his ass proposed not only the dilution and shaking crap, but also “like cures like” crap. Thus, if normal coffee induces excitement, awareness and the like, then homeopathically diluted coffee should magically “cure” all that, therefore it should act as sedative. If one wants a homeopathically caused buzz, then he has to shake/dilute, I dunno, probably chloral, according to homeopthic principles.

      1. Isidore says:

        Actually homeopathy works with coffee. If you dilute it, say, thousand-fold, even hundred-fold, the effects of your morning coffee in inducing excitement and waking you up are negated, as the homeopathic coffee does nothing of the sort. Ergo “like cures like”.

      2. sgcox says:

        Decaf does exactly that.
        At least according to Dilbert

  11. James says:

    On a completely different front for supplement makers, Google has made a new commitment to punish search engine rankings for websites that fail to demonstrate “expertise, authority, and trust” in areas where health may be at stake. Websites that promote alternative medicine, including supplements, have been hit hard by a significant Google search algorithm change (the “Medic” update) around August 1, 2018. “Natural health solution provider” Dr. Axe one business particularly hammered by this change, as was dietdoctor and prevention. Organic search engine traffic down 80%.

  12. Jim Mowreader says:

    I’ve been mildly following the “X2Zero” case for a few years.

    X2Zero was a supplements store in Corpus Christi, TX, that was selling “herbal weight loss products” and “herbal Viagra.” You know the spiel…causes weight loss, improves your love life, all that good stuff. The FDA analyzed their wares. The various supplements sold at their store contained sibutramine, phenolphthalein (used in laxatives until they figured out it mutates your DNA and gives you cancer) and sildenafil.

    The fun part about this case is their reaction after the FDA sent them a C&D letter: instead of complying with it, they hired sovereign citizen guru Karl Lentz. All their court filings are in Lentz’ bizarre “i, man” style. It didn’t work; both were convicted. The husband got twelve months in federal prison, and the wife was found mentally incompetent to stand trial and hospitalized.

  13. loupgarous says:

    FDA sent a Warning Letter out to a “nutraceutical” outfit near here (MS Gulf Coast) which hit on a new twist – add a working API to make sure the customer feels better. An API that got marketing approval in a bunch of places, just not in the US. An atypical antidepressant.

    The atypical antidepressant they went with, tianeptine isn’t Generally Recognized as Safe as a food additive under the Food and Drug Act, hence the Warning Letter.

    1. loupgarous says:

      Want some scary bedtime reading? I read the FDA’s Warning Letter to the guy selling tianeptine as a “supplement” and found this footnote describing “other exemptions from the food additive definition” (which can legally appear in food and dietary supplements” here in the US:

      ” Under section 201(s) of the FD&C Act [21 U.S.C. § 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement.”

      I’m hoping the rest of the Food, Drug and Cosmetic Act prevents sale and marketing of food and dietary supplements fortified with non-residue quantities of, say, paraquat.

      1. NJBiologist says:

        Loupgarous, EPA has extensive regulations on paraquat applications, and I believe they include minimum intervals between application and harvest.

        1. loupgarous says:

          My fault, I wasn’t clear about the clause I was talking about, “pesticide chemicals”, not “pesticide chemical residues in or on a raw agricultural commodity or processed food”, which would be addressed by intervals after application.

          I was wondering about the exemption from the Act for “pesticide chemicals” in general, and not specifically paraquat (which is why I said “(say)” before “paraquat”).

          Looking up the “definitions” section of the Food, Drug and Cosmetic Act (q)

          (A) Except as provided in clause (B), the term “pesticide chemical” means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.], including all active and inert ingredients of such pesticide. Notwithstanding any other provision of law, the term “pesticide” within such meaning includes ethylene oxide and propylene oxide when such substances are applied on food.

          1. NJBiologist says:

            Disclaimer: IANAL, and I haven’t given any of those statutes a thorough read in a good long while. With that said… I remember thinking that they were written with a pretty good transfer of authority (EPA vs. FDA) and a pretty solid-looking foundation. We do have laws that are likely to cause problems, but I’ve never looked at pesticide regulation as a particularly bad source.

  14. Fluorine Chemist says:

    Maybe slightly off-topic, but under Snake Oil: the other day, I (accidentally!) clicked on a link for “hydrogenated” water, Mercola’s site. What I saw there really surprised / shocked / astounded… me – almost had a fit! He claims that when water is subjected to electrolysis, you get two fractions, one which is hydrogenated and the other which is not (or something to that effect)… Was at a total loss for words, still shocked…

  15. Stanislav Radl says:

    Addition of sildenafil and other approved drugs to herbal products for the erectile dysfunction is not so bad. However, when these products started to be checked for the drugs content, producers of these “herbal” product started to add some analogs of the approved drugs which have never been approved and probably even tested for their safety…
    There are many examples published, e.g. J Toxicol Environ Health A. 2006 Nov;69(21):1951-8; Food Addit Contam. 2004 Aug;21(8):737-48; J Pharm Biomed Anal. 2008 Mar 13;46(4):814-7.

    1. loupgarous says:

      Sildenafil’s side effect profile is, by itself, bad enough that you want it sold by prescription and used under medical supervision. It’s the most toxic of the PDE5 inhibitors approved by FDA for sale here. Tadalafil wouldn’t be so bad, if you could count on the stuff offered on the Web for sale to actually be tadalafil.

      But if a company breaks one law (offering legend drugs for sale without a prescription), they won’t quibble about breaking laws that are harder to follow, like “not selling adulterated drugs”.

      I’m assuming these guys are ordering bulk quantities of stuff labeled as sildenafin, tadalafil, et cetera from China and reselling them along with God knows what as excipients and other additives. China being the place where folks put melamine in baby formula and pet food to make it seem more full of protein than it really was, and wound up killing kids and pets.

      1. PSimpson says:

        This is what I’m most worried about. Companies buying ingredients from China, India, and other countries with (how shall I put this) “flexible” quality control. The “flexing” comes when the bottom line for the month is too light, or the price of a key ingredient goes up. In that case, the rate of return is the primary driver and who knows or cares what goes out in those drums, as long as the paperwork is right.

        On this side of the ocean, the anonymous companies who compound and package supplements and multivitamins for CVS, WalMart, Target and the like, carefully mix the ingredients, package and sell pallets of the stuff. Not a lot of responsibility there, either, because the packaging says “Distributed by CVS”, or Target, or whoever, but no indication at all as to who made the stuff or where the ingredients came from.

        You’ll excuse me if I’m somewhat hesitant to buy any of this anonymous, unregulated junk.

  16. SteveM says:

    From a Libertarian perspective, it seems to me that the logic of compassionate use and supplement use should be essentially the same. I.e. maximize personal autonomy as much as possible.

    Near everybody has access to the internet. They can research the different supplements and then decide for themselves whether to try them.

    If someone can buy alcohol and marijuana, they should also be able to buy supplements if they so choose. It’s their mind / body, so it’s their business, not the government’s.

    1. loupgarous says:

      As a registered Libertarian, I agree – to a point.

      I accept government as a necessary evil. One of those necessary evils is protecting the public from predatory marketing – that’s an acceptable use of the “police power” in the Constitution.

      Things sold on the Internet as, say, sildenafil or tadalafil aren’t necessarily either pure enough to ingest by the standards of drug companies (the standard the “reasonable man” accepts) or even what they’re advertised to be. The Internet’s not curated, nor do I wish it to be – but I also don’t want people hurt or killed by toxic chemicals in fraudulently advertised food and drugs. Government, even by libertarian standards, has the duty to stop that from happening.

      The “it’s their mind/body, so it’s their business, not the government’s” argument is a counsel of perfection. It assumes an electorate full of libertarians with enough integrity to accept harms they willingly undertake (such as consumption of recreational drugs) and to, say, not drive or take care of their children under the influence of those drugs.

      Reality intrudes daily with reports of people cooking meth in apartments and hotel rooms in the presence of their young children. That’s not the worst extreme I can imagine of drug abuse but it’s close enough that my libertarianism takes a back seat to my common sense and I quietly call the cops when I see it happening.

      I think cannabis ought to be legal – it’s less toxic than ethanol. But I think there ought to be strict rules about what you can do under its influence – like take care of your kids. Any definition of “libertarian” which encompasses a highly intoxicated parent caring for small children (regardless of the intoxicant) with no legal consequences differs from definition, which is tied to the social contract.

      1. Isidore says:

        The devil is, as always, in the details. Who and how defines what a “highly intoxicated” parent is, other than some government entity. And what prevents said government entity to apply such standard not only to intoxication brought about by chemicals (ethanol, THC) but also by “mind intoxicants” such as undesirable political or religious views, for instance. It really is a slippery slope.
        I am playing devil’s advocate here to some extend, since I also believe that if someone wants to smoke cigarettes or pot or drink to excess it really is none of my business, unless this person is in the wheel of a car driving on the wrong side of the road while I am trying to get home.

        1. loupgarous says:

          The good side of a balanced Supreme Court (some statists, some libertarians, some strict constructionists, some believers in a “living Constitution) is that some of the slppery slopes are beginning to be marked “CLOSED” to Congress.

          Eventually, the states and the Federal government are going to have to take the wrangle over who gets to legislate access to drugs before the Supreme Court. Sessions tried to re-assert the Federal government’s authority, and did succeed in shutting down some foreign racketeers who were playing in California’s cannabis market.

          I want to know where the Congressional delegations of the states that have legalized cannabis are on this. Defying the Federal government on cannabis strikes me as a slippery slope that needs shutting down. If nothing else, Congress’ authority under the supremacy clause seems to be in trouble here (but IANAL, either). If Congress won’t defend that clause of the Constitution, perhaps it needs to be abolished (although nothing fills me wirh fear and trembling as much as a Constitutional Convention just now).

  17. Different system here in Europe, with supplement-related health claims (whether functional, relating to risk reduction, or child development) subject to scientific evaluation and risk assessment by the European Food Safety Agency. Prospective label claims are given a pretty rigorous kicking.

    With respect to cognition for example, the Agency has to date only agreed that iodine, iron, zinc and water have verifiable effects.

  18. debunker says:

    It’s not just the supplement area that’s rife with misinformation and fraud, it goes on in the so called legitimate pharma’s all the time too, just take a look at Entresto…..

    1. cancer_man says:

      How is Entresto part of misinformation or fraud?

      The one negative thing that I read two years ago is that the drug wasn’t tested against a normal strong regimen of an ace inhibitor for heart failure so that it got over an easier bar than it should have.

  19. steve says:

    I was traveling so I only just now answered the nonsense about homeopathy in the earlier thread above but I must say that I’m rather disappointed that a discussion dominated by chemists let those claims slip by without anyone else chiming in. The response shouldn’t be left up to an immunologist. Guess the posters have never heard of vibrational spectrometry, IR spectrometry, Raman spectrometry, NMR or any other methods that could assess the mystical “vibrational memory” of water after you shake it up. Good grief.

  20. Matt says:

    apparently immunologists are remarkably bad at detecting sarcasm.

  21. Ralph says:

    The USA loves its snake oil salesfolk, just watch a tv show where you get blasted by big pharma ads for this monoclonal antibody therapy, that small molecule chemo, this health system, that health system, many of which make claims almost as nutty as the snake oil folk, as far as I am concerned, the place for the FDA to start to clean up this mess is shut down advertising for all remedies, FDA approved or not

  22. CG says:

    I still think you SHOULD be allowed to sell any damn pill you want. People have a right to put what they want in their own body.

  23. Alex Kravch says:
    Article about Alpha Brain vs. Prevagen vs. OptiMind: Review, Side Effects, Ingredients

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