FDA renews attack on homeopathy

The agency is doubling down on a bad guidance that endangers access to important medicines. Action Alert!

Recently, the FDA announced the withdrawal of Compliance Policy Guide 400.400, a document that had been in place since 1988 and which established the agency’s enforcement policies regarding homeopathic medicines. In its place, the FDA has issued a revised draft guidance declaring all homeopathic drugs are being marketed illegally.

We must fight back against this attack on homeopathic medicine.

As we’ve reported previously, the FDA’s guidance says:

  1. Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
  2. FDA has not determined that any homeopathic drugs are GRAS/E;
  3. A new drug cannot be marketed unless it goes through the FDA’s approval process;
  4. No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.

This means, according to the FDA, all homeopathic medicines are being marketed illegally. The FDA explains that it will focus enforcement actions against specific categories of medicines with safety concerns: products with dangerous ingredients, products intended for vulnerable populations, etc. However, the FDA does reserve the right to take action against any homeopathic product: “This guidance is intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time.”

There is not much new in the revised guidance. The FDA does provide a definition of “homeopathic drug,” which was notably absent from the initial guidance, much to the confusion of the homeopathic industry and other stakeholders.

It is somewhat encouraging that the agency did not issue a final guidance, but rather another draft. This is an indication that our voices are being heard and the FDA is engaging with the natural health community.

There seems to be a lot of confusion about homeopathy. While opponents often say that there is not any evidence that homeopathy works, in fact several major meta-analyses have found homeopathic medicines to have an effect greater than placebo. We address these and some other common misconceptions here.

Unfortunately, it’s likely that the FDA’s antipathy towards homeopathy is fueled more by a desire to protect drug industry profits than ignorance about the data. The FDA continues to cite homeopathic teething tablets with belladonna as one of the concerns that prompted the agency to tighten control over homeopathic medicines. Specifically, the agency states that 99 adverse events were “possibly related” to homeopathic teething products. Yet, while the agency did find variable amounts of belladonna in some products, these amounts were well within safe limits, even if an infant swallowed an entire bottle.

The FDA will not stop this attack on homeopathy unless it is forced to do so by engaged citizens. We must issue a strong response to the FDA and Congress, telling the government that these actions threaten the future of homeopathic medicine.

Action Alert! Write to the FDA and Congress, telling them to protect consumer access to homeopathic medicines. Please send your message immediately.

Read the full article at ANH-USA.org.

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By ANH-USA

What We Believe and What We Do

The Alliance for Natural Health USA (ANH-USA) is committed to sustainable health, the recognition that true health requires a proactive and preventive approach that focuses on a nutrient-rich diet, proper supplementation, and limiting our exposure to toxic substances. A system that is single-mindedly focused on “treating” sick people with expensive drugs, rather than maintaining healthy people, is neither practical nor economically sustainable.

ANH-USA is part of an international organization dedicated to promoting natural and sustainable health—and, in particular, consumer freedom of choice in healthcare—through good science and good law:

  • Since our founding in 1992, we have worked to shift the conventional medical paradigm from an exclusive focus on surgery, drugs, and other conventional techniques to an integrative approach incorporating functional foods, dietary supplements, and lifestyle changes. We believe this is the way to improve health and extend lives while reducing the costs of healthcare back to a sustainable level.
  • Sustainable health also applies the environmental ethic of conservation to our bodies. It urges us to live as nature intended us to live. Diet, nutritional supplements, exercise, and the avoidance of toxins are especially important tools in building and maintaining health.
  • Sustainable health is also about financial sustainability. Ever higher healthcare costs lead directly to higher unemployment and lower standards of living, both of which lead to more illness.
  • Today, preventive medicine is too often defined as taking more and more drugs at an earlier and earlier age, even in childhood. The concept of sustainable health is real preventive medicine and will dramatically reduce healthcare costs.

To this end, ANH-USA actively engages in legal initiatives, standing against forces that would limit your access to safe and effective dietary supplements, complementary therapies, and integrative medicines. We lobby Congress and state legislatures, act as a government watchdog, file comments on proposed rulemakings, and educate the public, the media, and other decision-makers.

Our most important tools:

  • A strong grassroots member base that is ready to act on a minute’s notice. ANH-USA is fortunate to have a dynamic, fast growing member base that collectively presents a unified front and demands their collective voice be heard. Thank you, members!
  • Effective lobbying. ANH-USA monitors legislation and regulatory activity on the state, federal, and international levels daily. Staying apprised of the domestic and global pulse on integrative medicine assists greatly in developing policy to advance integrative medicine.
  • Litigation. The court system has a role in protecting integrative medicine and a consumers’ right to choose. When it is required, ANH intervenes, through legal action, to protect the rights of the public.
  • Strategic coalitions. Collaboration is the most effective means to further a cause. ANH-USA has been highly effective in building long-term relationships with outside groups, members on the Hill, medical societies, and consumers from all walks of life.
  • Timely education campaigns. The timely launch of public educational campaigns is key to increasing support and recognition of key issues while furthering our overall cause.

Working closely with the media. Media can be a friend or a foe and whichever it may be, media is imperative to quickly disseminate a message. ANH-USA works collaboratively with the media to increase coverage of important natural health-related issues.

(Source: healthimpactnews.com; November 8, 2019; https://tinyurl.com/v285jmv)
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