Dosing with Kan - the need for UNAMBIGUOUS labelling on herbal ingredients

[Guest guest]

Phil,

 

In the U.S., CM herbal products are sold legally under DSHEA (Dietary

Supplement Health Education Act). Therefore, there must be a single

stated serving size as if these meds were a vitamin pill with a

vitamenin or mineral having an RDA. Please know that this is a legal

convention. Manufacturers are not allowed to give a dose range

because these are not " doses. " Doses imply medicines and these are

not legally recognized as medicines. As part of DSHEA, the labels on

these products are standardized. The FDA tells you exactly what

information you can put where (e.g. right panel, left panel, above,

below, etc.) and even specify the point size of the print for various

statements. So all this is a highly standardized convention that was

not intended for our CM products.

 

However, as you say, manufacturers are free to include information

allowing practitioners to make conversions from amounts of

ingredients to what that means in terms of water-decocted, bulk-

dispensed meds. For instance, Blue Poppy does this on all our

internal med labels. Unfortunately, we find that most practitioners

are clueless as to do the simple math for figuring out true dosage

amounts. This still seems to be an area of much confusion and

ignorance.

 

Realistically, I think manufacturers " low-ball " not to prevent

sticker shock but to prevent adverse reactions from uninformed users

and the legal suits which might stem from those adverse reactions.

Because we are working outside the law in a very litigious society

(i.e., working under a law not actually intended or appropriate for

us), I think there is a great deal of risk involved in being in this

industry. Those of us in the industry (which requires huge capital

expenditures, as in typically tens of thousands of dollars to bring a

single new formula on-line), know that we can be put out of business

in a heart beat. Look what happened to all our formulas that

contained ephedra. Therefore, I think we tend to be very conservative

in how we deal with the public and hence the low-ball " doses. " One

suit could wipe out an entire career and a lifetime's earnings.

Remember that FDA enforcement is complaint driven. So we all minimize

everything we can that might leave us open to adverse reactions

leading to complaints.

 

Just my 2 cents.

 

Bob

[Guest guest]

Hi Dave & All,

 

Dave wrote:

> Hi All, I am trying to figure out how to calculate the dose of raw

> herbs when prescribing a Kan tincture

 

Relative to the dose that practitioners wish to use, manufacturers

often UNDERSTATE the dose greatly. They do this in order to keep the

" cost per dose " at a level that does not frighten off consumers.

 

The best way to expose these companies is to demand that they list

the equivalent RAW (DRIED) HERB amounts in THEIR recommended daily

dose, or per unit mass or volume of their product.

 

Labelling / data sheet on some (many) herbal products leave much to

be desired. Practitioners should not have to " guess " what is in these

products, whether they be tinctures, granules, concentrated extracts,

powders, pills, etc!

 

The labelling / data sheet should state UNAMBIGUOUSLY the recommended

dose rate and the amount of each herb (or its concentrated extract, &

the ratio of raw herb : extract) in the product.

 

If those data are AMBIGUOUS, we should ask the manufacturer for a

written statement to allow us to check the MANUFACTURER'S recommended

dose with the dose that WE would like to use from our experience, or

that of others.

 

Best regards,

 

[Guest guest]

Great information and perspective, Bob. More than .02 cents worth

definitely.

I would like to plug Al Stone who has a 5 unit California CEU class on

gancao.net which explains the Dietary Supplement and Health Education

Act requirements for claims and labeling. I found it very helpful.

Doug

 

 

 

, " Bob Flaws "

<pemachophel2001 wrote:

>

> Phil,

>

> In the U.S., CM herbal products are sold legally under DSHEA (Dietary

> Supplement Health Education Act). Therefore, there must be a single

> stated serving size as if these meds were a vitamin pill with a

> vitamenin or mineral having an RDA. Please know that this is a legal

> convention. Manufacturers are not allowed to give a dose range

> because these are not " doses. " Doses imply medicines and these are

> not legally recognized as medicines. As part of DSHEA, the labels on

> these products are standardized. The FDA tells you exactly what

> information you can put where (e.g. right panel, left panel, above,

> below, etc.) and even specify the point size of the print for various

> statements. So all this is a highly standardized convention that was

> not intended for our CM products.

> -------------------------

 

 

> Just my 2 cents.

>

> Bob

>