If Nelsons goods are banned from being imported into the US…

…guess which US homeopathy advocate is still flogging one of their products on his website?

UK based manufacturer of homeopathic remedies Nelsons have been severely reprimanded by the US FDA for a slew of manufacturing cock-ups. [ Quackometer | FDA letter to Nelsons]

Cock-ups include:

  • “glass fragments present during the manufacture” and ” in the Clikpak Assembly”
  • “one out of every six bottles did not receive the dose of active homeopathic drug solution due to the wobbling and vibration of the bottle assembly during filling of the active ingredient. The active ingredient was instead seen dripping down the outside of the vial assembly. Your firm lacked controls to ensure that the active ingredient is delivered to every bottle.”
  • “The dosing process has not been validated appropriately. Specifically, your surrogate validation study, “Medication of un-medicated pillules with (b)(4),” visually demonstrates the variability of the amount of (b)(4) for the pillules in one vial. Your firm lacks control of the variation for the amount of the active ingredient in the pillules.”
  • “Your firm does not have an established written program to calibrate/qualify the Perkin Elmer Clarus gas chromatograph (GC) at suitable intervals.”
  • ” Your firm did not calibrate and qualify the Jasco high performance liquid chromatography (HPLC) instrumentation adequately, in that there is no periodic qualification or evaluation of the pump, oven, injector, or detector. The “Use and Calibration of HPLC” procedure does not include criteria to define adequate calibration of the instrument.”

Basically – they don’t manufacture their remedies in a controlled and consistent manner, and they cannot monitor this because it’s homeopathy, there’s nothing to monitor they don’t maintain the equipment for doing so in the correct and proper fashion.

If this was a real drug company, the implications could be disastrous. If one in six packs of antibiotics was duff, you can bet that we’d hear about that and there would be huge fines levied all round.

One wonders if users of the duff batches of remedies noticed the lack of “powerful gentle natural effective” homeopathic active ingredient, and promptly complained to Nelsons about this?

This failure to adhere to best practice has landed Nelsons on the FDA red list [Link – scroll down to United Kingdom] – “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs” – it seems (from my reading of this notice) that Nelsons cannot export their goods to the US, and if US customers officials discover people bringing Nelsons products into the US they are to confiscate the goods. This will clearly have a negative impact on their US exports, and Nelsons are clearly rather proud of their export success [Link].

NB. Nelsons also make the Prince Charles’ Duchy Orignal line of herbal remedies [Link – Warning – Daily Mail].

So, can Nelsons products be sold in the US?

I don’t know about the legal ramification about being on the red list, but I cannot find mention of a US based manufacturing facility. Indeed, the Nelsons website states that

Our range of products meet the appropriate UK and global regulatory and licensing requirements, and are made in our Wimbledon manufacturing facility which operates to Good Manufacturing Practice (GMP) and rigorous procedures. [Link]

Clearly the FDA might have something to say about the “Good Manufacturing Practice (GMP) and rigorous procedures”.

However, as Nelsons homeopathic products are manufactured in Wimbledon, UK, it follows that any Nelsons products sold in the US must have been imported. I don’t imagine that the FDA red notice acts retrospectively, but obviously, as we are repeatedly told that “homeopathy is exceedingly popular and therefore it must work” 🙂 – one imagines that US stocks of Nelsons goods will soon run dry. I invite you to keep your eye on this page [link – warning – may cause nausea and temporary blindness ;)] to see when then this occurs.

Obviously, such a high profile and conscientious homeopath will ensure that the information on his website will remain up-to-date and entirely responsible. Moreover, given the concerns about the quality of Nelsons goods, one wonders if said homeopath will stop supplying them, to avoid the stigma of being tainted by Nelsons new-earned reputation for poor quality goods.

9 Responses to If Nelsons goods are banned from being imported into the US…

  1. Slipp_Digby says:

    I bet Mr. Najib Fayad needs some Kali Phos 30C himself after that letter.

    Not from batch #36659 though 🙂

  2. […] the Quackometer and Anomalous Distraction have already pointed out its a bollocking from the U.S Food and Drug Administration (FDA) detailed […]

  3. […] US authorities have placed Nelsons products on their ‘red list’which means they will be siezed if […]

  4. Neuroskeptic says:

    You may have to change that 10^23 logo that appears in the top left. “Homeopathy: There’s Nothing In It Except Maybe Shards of Glass”

  5. magufo says:

    “Really” arguments, and example of pseudoskeptik ad-hominem:

    “link – warning – may cause nausea and temporary blindness “

    • xtaldave says:

      Ah, Magufo, you’re back. I note you dodge the serious issue of non-existent QC on homeopathic remedies and shards of glass contaminating production lines, and treat the obvious joke (clearly marked as such by a 😉 ) as if it were some heinous crime of logic.

      A piece of rhetorical legerdemain worthy of Ullman himself.

      • Magufo says:

        There is lack of quality in Nelsons and say that for that reason no active ingredient, is like saying that an industry farmacéutcia X or Y (Call it whatever you want) there are no controls and therefore all conventional medicine is flawed.

        The rhetoric is very well used by Steven Novella, where extracted such news.

        Therefore I see no problems that can warn Nelsons. I do not defend Nelsons. But you like the skeptics are entertained otors fighting quality or assembly lines, but the legal aspect, the studies actually fight.

        You can comparame with Ullman or whoever.

      • xtaldave says:

        “There is lack of quality in Nelsons and say that for that reason no active ingredient, is like saying that an industry farmacéutcia X or Y (Call it whatever you want) there are no controls and therefore all conventional medicine is flawed”

        That’s not what I’m saying. There is no active ingredient in KaliPhos 30C because it has been diluted away.

        The lack of QC (in terms of glass in the line) and production controls (no control of the amount remedy in the remedy) is something that real pharma would get seriously reprimanded over. The same should apply to Nelsons.

        One can take a table of paracetamol after production, and determine how much active ingredient is in it, and how pure it is. One cannot do the same for most homeopathy remedies, because there is no ingredient to assay.

  6. xtaldave says:

    Just in case anyone is interested – user Magufo has been placed in the moderation queue and will remain there until such time that he/she stops making the same zombie arguments – to whit –

    “Mr. PostDoctor, understand that even 6D dilution is active or not you took basic chemistry?” and variations thereof.

    Yes. I have answered this on countless occasions, in direct response to Magufo.

    At the risk of repeating myself – remedies where active ingredients remain are plausible, but still need proper testing for efficacy.

    Magufo is also questioning my academic record (even though I seem to recall it was them who asked how I was qualified to comment on homeopathy) and seems to believe that because I haven’t published anything on homeopathy, I cannot comment.
    I haven’t been shot in the face either, but I am sure that it is extremely painful.
    I am not an artist, yet I can appreciate art. You get the gist.

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