MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

The U.S. Food and Drug Administration (FDA) issued another warning about homeopathy. Here are some of the most relevant excerpts:

… Homeopathic products … are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. FDA uses a risk-based approach to monitor these products and to evaluate reports of adverse effects.

… Homeopathic drug products are made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons. These products have the potential to cause significant and even permanent harm if they are poorly manufactured, since that could lead to contaminated products or products that have potentially toxic ingredients at higher levels than are labeled and/or safe, or if they are marketed as substitute treatments for serious or life-threatening diseases and conditions, or to vulnerable populations. In addition, some products may be labeled as homeopathic that do not conform to traditional homeopathic principles.

As the homeopathy industry continues to grow at a rapid pace, we want to clarify for both consumers and industry how we assess the potential safety risks of these products. That’s why in 2017, the FDA issued a draft guidance discussing our, risk-based enforcement approach to drug products labeled as homeopathic. Today, we are taking two new steps toward clarifying this approach.

First, we have revised the 2017 draft guidanceExternal Link Disclaimer to provide further information around our approach and are asking for public input on the revised draft. The draft guidance details a risk-based enforcement policy prioritizing certain categories of homeopathic products that could pose a higher risk to public health, including products with particular ingredients and routes of administration, products for vulnerable populations, and products with significant quality issues. We encourage the public to review this revised draft guidance and comment before it is finalized. We will consider feedback gathered through this new public comment period, the more than 4,500 comments interested stakeholders submitted on the original 2017 draft guidance, and information gleaned from a 2015 public hearing on the current use of homeopathic drug products. When finalized, this guidance will help provide transparency regarding the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach.

Second, the agency is withdrawingExternal Link Disclaimer the Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” Risk is an important driver of the FDA’s regulatory and enforcement actions for all drug products, including homeopathic drug products. Since the issuance of CPG 400.400 in 1988, the FDA has encountered multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described in CPG 400.400. However, CPG 400.400 is inconsistent with our risk-based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking. Therefore, it is appropriate to withdraw CPG 400.400 at this time.

… the FDA has issued warning letters to companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations and various other violations. So far in 2019, we’ve issued more than 10 warning letters to companies for violations concerning homeopathic products. Recently, we issued warning letters to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It Inc. and Bershtel Enterprises LLC dba WePackItAll, which had jointly manufactured and packaged eye drops produced in non-sterile conditions which could result in serious eye infections. These warning letters should alert all companies that homeopathic drug products must be manufactured and labeled in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and agency regulations…

_________________________________________________

If you ask me, ‘homeopathic drug products’ is a misleading name. A drug is defined as a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body. But highly diluted homeopathics do not contain a substance that has physiological effects.

They should be called

  • homeopathics,
  • homeopathic pseudo-drugs,
  • homeopathic placebos,
  • or fake drugs.

And their labels should make it clear that:

  • these products contain no active ingredients,
  • and have not been shown to work beyond placebo.

That would be the type of honest and transparent information which consumers deserve and have a right to.

 

6 Responses to The FDA has sent more warning letters to homeopathic manufacturers

  • It has always amazed me about the Dr’s of chiropractics, acupuncture, homeopathy, naturopathy and many more, sell natural remedies (supplements) without FDA approval. Most of their supplements are not tested by FDA, not scientifically approved or studied and definitely a 100% profit. These same practitioners will fight scientific vaccines and FDA approved medicines that are able to prolong a persons life. Science has literally brought life-span from 47 to 70’ish in one century. If one is into this crap, not scientific study, but will almost keep spending money on it and never be swayed from it.

  • Here in the Netherlands, it is illegal to sell homeopathic products with a medical indication(*), so we have the amusing(**) situation that all products have labels in more or less the following wording:
    1. What is [Homeopathic Product X] and what is it used for?
    Homeopathic medicine without specific therapeutic indication, applied in accordance with the principles of homeopathic medicine”

    When this directive was finally enacted in 2014, homeopaths and the manufacturers and suppliers of homeopathic products were furious, demanding that their products should keep their privileged status in comparison to real medicines for reasons of ‘consumer choice’ and ‘the innately harmless nature’, among other things. Which of course is ludicrous.
    In all, sales of homeopathic products dropped by some 50% after this, but have been on the rise again in recent years. This latter probably has to to with manufacturers and resellers circumventing this law, by switching to one-on-one information channels, e.g. phone numbers, chat windows on their Web sites and social media channels, so that people can get ‘personal advice’ (read: lied to) about the products offered.

    In my opinion, the sale of homeopathic products should simply be made illegal, just as it is illegal to sell other, non-health products under false pretences. If I bake loaves made from sawdust and starch and sell these as ‘bread’, I can get thrown in jail, even if my product is harmless in itself, and people swear that it is tasty and nutritious. Why are homeopaths still allowed to do basically the same?

    *: Unless there is evidence of efficacy for one or more conditions. NOT ONE manufacturer of homeopathic products has managed to supply evidence of efficacy for EVEN ONE condition.

    **: Amusing, that is, until you realize that countless people still buy these products, even if the label literally says that it isn’t good for anything. So it is more pathetic than amusing, really, and tells us once again that people want to be fooled.

  • I would propose a statement along the lines of ‘According to the FDA these products contain no active ingredients
    and have not been shown to work beyond placebo.’
    That would increase sales more than any amount of advertising.
    If only.

  • Not all American “homeopathic medicines” are highly dilute. X1 is enough to claim homeopathic status. One had enough zinc to cause anosmia. https://m.slashdot.org/story/120489

    • I know; this is why I tend to differentiate between the two.
      same in Europe.

    • I’m not sure why this one is mislabeled homeopathic but the practice is quite common.
      Arnica ointment is non-homeopathic and it’s sold alongside arnica tablets which would supposedly have the exact opposite effect.

      Which I suppose it does because the opposite of zero is zero.

      As far as the zinc the most common cause of anosmia is upper respiratory infection anyhow so this is more about a loophole for selling an untested drug.

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