Scope of the Public Hearing; Homeopathic Product Regulation

[Leilanae]

Hi all,

http://medical-dictionary.thefreedictionary.com/drug

"drug
(drug)
1. a chemical substance that affects the processes of the mind or body.
2. any chemical compound used in the diagnosis, treatment, or prevention of disease or other abnormal condition.
3. a substance used recreationally for its effects on the central nervous system, such as a narcotic.
4. to administer a drug to."
-------------------------------

http://www.fda.gov/AboutFDA/Transparenc ... 194516.htm

"What is a biological product?

Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include

vaccines
blood and blood products for transfusion and/or manufacturing into other products
allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
gene therapies
cellular therapies
tests to screen potential blood donors for infectious agents such as HIV"
---------------------------------

http://www.regulations.gov/#!documentDe ... -0540-0001

"Scope of the Public Hearing

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?"

Atb,

Leilanae

[Irene de Villiers]

We need to remember that homeopathic remedies are defined as DRUGS by USA Federal Law.
The HPUS is the official book of homeopathic DRUGS in USA.
As drugs, the homeopathic remedies do NOT fall under the protection of the health supplements act of 1974.

Under that act, health supplements (but NOT homeopathic remedies due to their classification as drugs) are protected from attack as are people recommending them, which may not be called practice of medicinel That is why your Health Food store workers can recommned supplements with zero risk of being accused of practicing medicine.

Under FEDERAL Law, the homeopathic DRUGS in the HF store, may be used as OTC drugs ONLY for self-limiting uses as described on the label. NByFederal lawm if you recommned one of those remedies for some other use then it REQUIRES a prescription from a licensed health professional, such as a MD, DVM, DO, ND depending on which state licences whom.

STATE level laws allow certain uses of OTC drugs such as "treating your own animal" and some states allow other uses of OTC drugs.

SO what we need now as "cases" is uses of the Federally allowed OTC use of homeopathic drugs.
Adding state allowed use to trerat one's own animal could be a problem to the feds, though so far this use has not been challenged in the courts.

This is the reallity within which we must work here.
Getting homeopathic remedies (=DRUGS by law) approved for off label use in chronic illness by anyone not LICENSED in a health profession would be a new use under Federal Law, and is NOT currently allowed.
It would be like a non-licenced person trying to justify recommending Aspirin for something it is not labelled or licenced to do. THAT also is practicing medicine without a license.
OTC DRUGS like homeopathic remedies and aspirin, may ONLY be used for labelled use unless you are a licenced medical professional. THAT is the current federal law.

If you want to change the law, that's a separate issue.
But right now they want to remove even this limited right to use remedies and THAT is what we need to defend now.
The HPUS homeopathic remedy drugs are NONprescription on the grounds of safety by Federal Law.
The FDA is now trying to use LACK of this safgety as an excuse to deny their use.

THIS is what we are up against.
We should not be side tracked into how WE think remedies shoud be seen currently.
Federal law defines it. We need to use the right approach to maintain it that way, for the reasons it was set up that way and we need to show those reasons STILL APPLY.

Getting a better law is not part of THIS fight.
We need to understand and work within the current law for THIS fight.

Namaste,
Irene
--
Irene de Villiers, B.Sc AASCA MCSSA D.I.Hom/D.Vet.Hom.
P.O. Box 4703 Spokane WA 99220.
www.Furryboots.info
(Info on Feline health, genetics, nutrition & homeopathy)
"Man who say it cannot be done should not interrupt one doing it."

[Roger B]

Irene,

This is all very interesting, but I think that you got lost in the details. The FDA is not into legal niceties or even constitutional niceties. Not "many is the time", but rather MOST of the time they don't give a fig about the law or even court orders, so they are aren't going to fret too much about legal details like what you describe any more than Obama worries too much about the Constitution. They will find a way to make this happen unless they think that they will take too much of a political hit for doing so.

Roger
________________________________

To: minutus@yahoogroups.com
From: minutus@yahoogroups.com
Date: Sun, 5 Apr 2015 14:37:16 -0700
Subject: Re: [Minutus] Scope of the Public Hearing; Homeopathic Product Regulation
We need to remember that homeopathic remedies are defined as DRUGS by USA Federal Law.
The HPUS is the official book of homeopathic DRUGS in USA.
As drugs, the homeopathic remedies do NOT fall under the protection of the health supplements act of 1974.

Under that act, health supplements (but NOT homeopathic remedies due to their classification as drugs) are protected from attack as are people recommending them, which may not be called practice of medicinel That is why your Health Food store workers can recommned supplements with zero risk of being accused of practicing medicine.

Under FEDERAL Law, the homeopathic DRUGS in the HF store, may be used as OTC drugs ONLY for self-limiting uses as described on the label. NByFederal lawm if you recommned one of those remedies for some other use then it REQUIRES a prescription from a licensed health professional, such as a MD, DVM, DO, ND depending on which state licences whom.

STATE level laws allow certain uses of OTC drugs such as "treating your own animal" and some states allow other uses of OTC drugs.

SO what we need now as "cases" is uses of the Federally allowed OTC use of homeopathic drugs.
Adding state allowed use to trerat one's own animal could be a problem to the feds, though so far this use has not been challenged in the courts.

This is the reallity within which we must work here.
Getting homeopathic remedies (=DRUGS by law) approved for off label use in chronic illness by anyone not LICENSED in a health profession would be a new use under Federal Law, and is NOT currently allowed.
It would be like a non-licenced person trying to justify recommending Aspirin for something it is not labelled or licenced to do. THAT also is practicing medicine without a license.
OTC DRUGS like homeopathic remedies and aspirin, may ONLY be used for labelled use unless you are a licenced medical professional. THAT is the current federal law.

If you want to change the law, that's a separate issue.
But right now they want to remove even this limited right to use remedies and THAT is what we need to defend now.
The HPUS homeopathic remedy drugs are NONprescription on the grounds of safety by Federal Law.
The FDA is now trying to use LACK of this safgety as an excuse to deny their use.

THIS is what we are up against.
We should not be side tracked into how WE think remedies shoud be seen currently.
Federal law defines it. We need to use the right approach to maintain it that way, for the reasons it was set up that way and we need to show those reasons STILL APPLY.

Getting a better law is not part of THIS fight.
We need to understand and work within the current law for THIS fight.

Namaste,
Irene

[Irene de Villiers]

They are when they can turn them against what we want and for what they want.
--
Irene de Villiers, B.Sc AASCA MCSSA D.I.Hom/D.Vet.Hom.
P.O. Box 4703 Spokane WA 99220.
www.Furryboots.info
(Info on Feline health, genetics, nutrition & homeopathy)
"Man who say it cannot be done should not interrupt one doing it."