Minutus

re labeling of single Homeopathic Remedies:

from the Great Late Julian Winston:
Labeling
The homeopathic community attempted to regulate themselves back in 1988. It failed-- because of the FDA.

Until that point, all single homeopathic remedies had on them “to be used according to homeopathic indications.” The single remedies were, generally, NOT on the shelf. You had to ask for them. It was assumed if you did ask for them that you KNEW what you asking for and why.

In 1988 the FDA developed (with the homeopathic pharmaceutical industry) the new guidelines. The FDA has TWO classes of medicines:

OTC and RX.

For a medicine to be OTC is MUST have an indication on the label, sand the indication MUST be for a self-limiting condition. The Industry fought this move because of the complete idiocy of it. How do you put indications on a bottle of Lachesis? Menopausal hot flushes? Left sides sore throats? Extreme jealousy? Aggravations from tight collars? Wakes into the aggravation?

The industry tried to get it to back to where it was: stuff on the shelf has indications (usually combos), stuff without is available OTC but only when asked for.

The FDA was adamant. The proposal created a third class of drug. Either the industry puts an indication on all OTC remedies, or all homeopathic remedies become Rx only.

So the industry said, OK.

And one pharmacy labels Lachesis for hot flushes, and another for the sore-throat. And so far, the FDA has not complained. There is a story that one pharmacy labels *every remedy* as “headache”-- since that is a common symptom to almost all....

We know that Digitalis is a remedy for heart stuff-- but THAT is not legal to label, since it is not “self-limiting.” But to label it as “headache” is OK.

I know a lot of this because I was on the HPCUS at the time, was working on one of the panels with the FDA, and was working to develop OTC indications on the top 150 remedies that B&T sold.

If people use them according to the indications, and find it doesn’t work, then it is the fault of the FDA for asking to industry to comply with such foolishness.
JW
Best,
Lynn
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Imagine Peace
http://www.homeopathicsolutions.blogspot.com/

thanks for that Lynn - I didn't have that in my JW files - glad to have it.
I miss him!
We talked a lot by email but by the time I could get to NZ he had left this plane
Sheri

At 09:01 AM 4/13/2013, you wrote:
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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath
http://homeopathycures.wordpress.com/ & http://vaccinationdangers.wordpress.com/
ONLINE/Email classes in Homeopathy; Vaccine Dangers; Childhood Diseases
Next classes start April 9, 14, & 15

They could just dispense remedies in very little vials with package insert to circumnavigate the rule “imposed” on them. Here is an excerpt from FDA Compliance Policy Guides: CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed:

"Container Size - Labeling Exemption: For those products packaged in containers too small to accommodate a label bearing the required information, the labeling requirements provided under Section 502 of the Act and 21 CFR 201 may be met by placing information on the carton or outer container, or in a leaflet with the package, as designated in 21 CFR 201.10(i) for OTC drugs and in 21 CFR 201.100(b)(7) for prescription drugs. However, as a minimum, each product must also bear a label containing a statement of identity and potency, and the name and place of business of the manufacturer, packer, or distributor".

V
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Similar with the expiration dates that appear (per FDA) on every bottle. Homeopathic remedies do not *expire* (assuming proper storage), and a few people are using kits that were made back in Hahnemann's day, and they work perfectly. But the FDA says…

Shannon
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