Homeopathy Tips for 4/14/15 Urgent!! FDA to Further Regulate Homeopathy

There has been a sudden concern by the FDA about the manufacture and safety of over the counter homeopathic medications. Safety alerts have been issued and there will be a public hearing about the issue in one week on April 20 and 21, 2015.

This hearing comes only 3 weeks after the bulletin announcing safety concerns with homeopathic medications. It seems as if this sudden concern is an attack to further regulate homeopathy and make it harder for clients as well as practitioners to access homeopathic medications.

Homeopathic medicines have been accepted and regulated in the Homeopathic Pharmacopeia of the United States (HPUS) and regulated under a document called CPG Sec. 400.400, Conditions Under Which Homeopathic Drugs May be Marketed. This has been in place for 40 years.

Homeopathic medicine is the safest form of medicine on the planet. Being energetic in nature it is virtually impossible for homeopathic remedies to do significant harm, especially when prescribed and managed by a professional homeopath.

Now there is a sudden push to label them as dangerous and to further control homeopathic medications. The time is NOW!!! to come to the defense of Homeopathy. Oral comments will be accepted at the hearing on April 20 and 21. Written comments will be accepted until June 22, 2015. The FDA needs to hear from you.

Here is the link to the Federal Register, more information and how to file a comment. https://www.federalregister.gov/articles/2015/03/27/2015-07018/homeopathic-product-regulation-evaluating-the-food-and-drug-administrations-regulatory-framework

There are over 3,500 subscribers to this FREE newsletter. If everyone of you sent a comment and short story of support for homeopathy, that would make a significant impact on future decisions the FDA may make. They need to hear from all of us.

After 40 years there is a sudden push for change. This is in the face of thousands of FDA approved drugs that have significant direct adverse effects on peoples health. Homeopathic medicine is safe and needs to remain available.

5 comments so far

  1. Michelle Lucafo on

    Good work
    Thanks

  2. Sarah on

    I am interested in responding but if I tell of my success, I am not sure if it helps in this case. It looks like they had reports of chemical poisoning related to Homeopathy, and that is why they are pursuing an investigation. My understanding has always been that when homeopathics are made they are so diluted, that only essentially the energy of the base is left. Do you have any idea of how these people would have been considered poisoned by homeopathics in the first place? And are they trying to determine if the manufacturers are making them properly? Any insights will be helpful before I can respond to the FDA. Thanks for sharing the article!

    Sarah

  3. ellen kire on

    Below are the issues that one can comment on regarding homeopathic products which is under review by the FDA. There is a green tab in the upper right corner- Submit a Formal Comment- by email.

    In the following section regarding safety, homeopathic products are equated with other drugs and therefore said to have the potential to cause drug interactions- as well as other negative effects. The FDA claims there have been thousands of reports of poisoning in 2012 from homeopathic drug products! So perhaps this, as well as the increased sale of homeopathic products is raising red flags and part of the reason for this public hearing?

    -ellen

    E. Safety of Drug Products Labeled as Homeopathic

    Drugs products labeled as homeopathic can contain a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals (either as active or inactive ingredients). As with ingredients in other drug and biological products, homeopathic ingredients, even if highly diluted, can cause side effects, drug interactions, and allergic or other adverse reactions. Negative health effects from drug products labeled as homeopathic have been reported through the FDA’s Adverse Event Reporting System and the National Poison Data System (NPDS), which is maintained by the American Association of Poison Control Centers and tracks human poison exposure cases. Data in the NPDS pertaining to homeopathic drug products is tracked under the category “Homeopathic Agents.” The 2012 American Association of Poison Control Center Annual Report indicated that there were 10,311 reported poison exposure cases related to “Homeopathic Agents,” with 8,788 of those reported cases attributed to children 5 years of age and younger (Ref. 3). Of the 10,311 reported cases, 697 required treatment in a health care facility (Id.).

    II. Scope of the Public Hearing
    Back to Top

    FDA is seeking broad public input on the current enforcement policies related to drug products labeled as homeopathic in an effort to better promote and protect the public health. FDA has developed a list of questions to facilitate a more productive discussion at the public hearing. This list is not intended to be exclusive, and FDA encourages comments on other matters related to the development and regulation of drug and biological products labeled as homeopathic. Issues that are of specific interest to the Agency include the following:

    What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?

    What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?

    Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in thehomeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.
    Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.

    Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?

    A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?

    Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?

    Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?

  4. Jennie Richardson on

    I wanted to leave a comment but can’t see which category number it comes under. Can anyone help?

    • ellen kire on

      Jennie,

      I think perhaps you are asking about which category to choose in the drop down box below your name and personal info? So pick which one applies to you- could be as a consumer, health practitioner, or an organization you are representing, etc. If I am reading this correctly!


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: