The US Food and Drug Administration found “significant violations of Current Good Manufacturing Practice” in a 2011 inspection of the A Nelson & Co facility in London which produces homeopathic products. The Quackometer blog has the scoop.
Nelsons, UK manufacturers of such products as Bach Rescue Remedies, and a range of Homeopathic sugar pills, such as Teetha, have been inspected by the US authority the FDA as their products are exported to the US.
The FDA reports many concerns about their manufacturing processes in London and have ordered them to report how they are going to remediate their concerns.[…] Nelsons appear to go through the magic rituals of homeopathic preparation, including the impossible dilutions and magic shaking. Therein lies their problem.
Tip: @lecanardnoir on Twitter
The FDA notice outlines the findings that show the products are not manufactured in a controlled and consistent manner. Glass fragments were present in the process, “wobbling and vibration of the bottle assembly during filling of the active ingredient” caused one out of every six bottles to not receive the dose of active homeopathic drug solution, it was seen dripping down the outside of the vial assembly, and there were also equipment calibration problems.
This piece by Anomalous Distractions notes:
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.[…] as Nelsons homeopathic products are manufactured in Wimbledon, UK, it follows that any Nelsons products sold in the US must have been imported.
Indeed. It’s a bit odd to talk about “active ingredient” when we are speaking of homeopathic products that are diluted to the point where there is NO active ingredient. But, this warning notice by the FDA shows that the products are problematic. But to wipe all this away as pretty meaningless, these products have never been demonstrated to be effective beyond that of a placebo. Why use them? Why does the U.S. import them?