Homeopathic remedies in the USA are coming under attack!
We hope our global homeopathic family will speak out:

Here’s what you need to know:

Last year, the Citizen’s Petition to the U.S. Food and Drug Administration (FDA), created by Americans For Homeopathy Choice (AFHC), attempted to turn FDA Compliance Policy Guide (CPG) 400.400 into a regulation. A CPG is subject to change, but a regulation cannot be easily altered.

However, the FDA has recently determined that it will completely throw out CPG 400.400, erroneously suggesting that homeopathic remedies are not well-regulated by this tried-and-true, 30-year old document.

Since 1988, CPG 400.400 has been in place as a guiding document for the FDA, keeping homeopathic remedies under the Agency’s oversight. It is a comprehensive document with an excellent track record that clearly:

  • Establishes conditions under which homeopathic drugs may be marketed.
  • Dictates the manufacturing standards under which homeopathic remedies are made. [Homeopathic remedies must be rigorously tested under the direction of the Homeopathic Pharmacopoeia Convention.]
  • Outlines how the strength or “potencies” of homeopathic remedies are specified in terms of dilution; they must only contain diluents commonly used in homeopathic remedies.

The FDA has issued a Notice Document to replace CPG 400.400, “Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry.”

 

Here are the most disturbing points of this document:

 

  1. Homeopathic remedies will be treated like every other substance the FDA monitors, even though it was established in the 1930s by the Federal Food, Drug & Cosmetic Act that homeopathic remedies are in a category by themselves and under the jurisdiction of the Homœopathic Pharmacopœia of the U.S.
  2. Homeopathic remedies will fall under the category of “new drugs” because they have not undergone the same testing process that the FDA puts conventional drugs through. As “new drugs,” they can be deemed unsafe and withdrawn if they have not gone through the rigorous and expensive conventional testing process.
  3. The FDA has claimed that many remedies will be left alone, but there is no guarantee. They state they will prioritize their enforcement actions, targeting specific remedies—those that are made from:
  • Infectious agents (i.e. – nosode remedies, such as Syphilinum)
  • Controlled substances (i.e. – remedies made from drugs, such as Opium)
  • Combinations (i.e. – OTC homeopathic remedies, such as those made for bedwetting, sinusitis, etc.)

Or remedies that have:

  • “Potential toxic effects” (Particularly targeting the lower potencies, 1x, 2x, 1c, etc.)
  • Caused users to “delay or discontinue medical treatments [using pharmaceuticals] that have been found safe and effective.”
  • Been produced for “vulnerable” populations (i.e. – old, young, pregnant and/or immunocompromised people).
  • Been adulterated or have compromised safety.

Several obvious points jump out:

  • CPG 400.400 already regulates the production of the remedies, and the safety record of homeopathic remedies in the USA is unblemished, thanks in large part to the long-standing regulations put in place by the CPG.
  • The FDA made this decision to move away from the CPG without first consulting both professionals and consumers who are knowledgeable about homeopathy. Homeopathic professionals should be consulted regarding enforcement, policy and legislative direction of the FDA regarding homeopathy. Additionally, representation from the consumers who use homeopathy should be a necessary component of the committee.
  • Additionally, such shortsightedness does not recognize either the respectability of homeopathic principle or the growing need for alternative medical approaches to negate the effects of the opioid addiction, antibiotic resistance, and sky-rocketing healthcare costs. Homeopathic remedies withdrawn by the FDA will not return until they first undergo the agency’s New Drug Application (NDA) process, a costly business designed to weigh the risks and benefits of chemical drugs which may have toxic effects. The public is best served by crafting regulations that are respectful to homeopathy as a unique system of medicine; the public is not well served when homeopathy is forced to conform to the standards set in place for conventional drugs. The safeguards for chemical drugs simply do not apply to homeopathy and FDA resources should not be so diverted.
Submit your comments to the FDA

Please share this information with all your friends and relatives who have benefited from homeopathy. It does not matter what part of the world you live in. Please let the FDA know that they are misguided in their attempts to limit homeopathy in the USA.

New deadline to respond is March 23, 2020
11:59 PM ET