MAKE A COMMENT TO THE FDA
IACH - Prof. G. Vithoulkas
MAKE A COMMENT TO THE FDA

 

Dear Homeopaths,


Below you will find our suggestions for writing comments to FDA.
Please go ahead with your own expressions

FDA Guidance on Drug Products Labeled as Homeopathic Summary of Draft

https://www.regulations.gov/docket?D=FDA-2017-D-6580  (from here you can click “Submit Comments Online” or use link below)

What it is:

 FDA revoked in October, 2019 the Compliance Policy Guide (CPG) which outlined the conditions under which “homeopathic drug products may be marketed” – this was given to allow manufacturers to avoid the expensive and time-consuming application process “new drugs” must go through.  Homeopathic remedies and products are considered “new drugs under the FD&C Act of 1938.  FDA intends more focused enforcement of products labeled homeopathic.
 

Reason:

There are drug products that are labeled homeopathic by making the ingredient sound like it is homeopathic by changing the ending;
There are bona fide homeopathic mixed Over the Counter (OTC) products that have misstated their actual concentrations causing toxicity in infants and elderly; ex: Hyland’s, a very well-known brand was reported to have toxic levels of Belladonna in their teething product;
There are drug products that contain some homeopathic drugs but the method of delivery is not sanitary or the manufacturing plant has a serious microbial problem and is not sterile;
There are drug products that are not manufactured according to HPUS guidelines;

All reports of injury involved polypharmacy/mixopathy and pretend homeopathy.
FDA website AND the Draft Guidance contain serious errors about what Homeopathy is – lack of knowledge is contributing to the proliferation of products that are either not real homeopathy or polypharmacy/mixopathy.

What we are asking you to do:

Please follow this link https://www.regulations.gov/comment?D=FDA-2017-D-6580-4828  and submit comments to the FDA before 23 January 2020 and please include the following points:

State what real homeopathy is (to correct the misinformation in their Draft) and please include this link:  https://www.vithoulkas.com/homeopathy/about-homeopathy
State that polypharmacy and mixopathy have meager and mixed results
State that manufacturers of homeopathic products have created special formulas that have turned individualized medicine into a mass medicine
As a result, homeopathy is now promoted as a medicine over the counter by both well known companies and companies purporting to be making homeopathic remedies.  A well-educated doctor does not treat chronic disease in this way but by proper case taking and prescribing the simillimum, not a mixture (mixopathy)
State that proper homeopathy is difficult to learn and could never become a mass therapy.
Please request an extension of time of an additional 180 days for allowing more comments (every organization is doing this)
We want to preserve real homeopathy and protect the right of people to have access to all the HPUS certified homeopathic single remedies.
Links to a list of articles in conventional medical journals that show the efficacy of classical homeopathy, evidence of effectiveness 1.

The Draft of the FDA Guidance document is attached.  If you prefer to mail a letter be sure to include the docket number.  The address is included on the first page.  Otherwise please submit your comments online using the above link or click the “Submit Comments Online” button on the FDA page at the top.

https://onlinelibrary.wiley.com/doi/full/10.1002/ccr3.2547?fbclid=IwAR30RisS3d8qj0TNKIy8Q00ExYayUZIyk3CNfx6sy98uMXb0v9U6J6weLY4

 https://onlinelibrary.wiley.com/doi/full/10.1002/ccr3.2197 

https://www.amjcaserep.com/abstract/index/idArt/905340 

https://journals.sagepub.com/doi/full/10.1177/2050313X18792813 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6527409/ 

https://journals.sagepub.com/doi/full/10.1177/2156587217735986?rfr_dat=cr_pub%3Dpubmed&url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org 

https://www.karger.com/Article/Abstract/481819 

https://journals.sagepub.com/doi/full/10.1177/2515690X18777995 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5467251/ 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5909950/ 

https://www.amjcaserep.com/download/index/idArt/913328 

http://www.ijrh.org/article.asp?issn=0974-7168;year=2015;volume=9;issue=2;spage=114;epage=122;aulast=Mahesh 

https://www.ncbi.nlm.nih.gov/pubmed/24779242 

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