Gray area in FDA ban?

[Guest guest]

Greg

 

That's an excellent question. However I was under the assumption that the

final FDA proposed GMP rule MAY NOT have a practitioner compounding

exemption. Testimony has pleaded for this exemption, but as of my last

inspection of the rule, it still has not been codified in that form. However it

has been a few months. Do you have access to recent info to clarify this point.

I was under the impression that this rule may make it prohibitive to even

dispense raw herb teas. But even if we are allowed a compunding exception

for our private clinics, I am not sure this is a loophole vis a vis banned

herbs.

However it may be (and is a clever thought indeed). It depends on how the

dispensed substance is classified. The crux is whether raw ma huang is still

a food after you grind it and cap it in house. It can only be a food or a

dietary

supplement. What if you tinctured or otherwise extracted it in house? Would

that be manufacturing?

 

I think the position of the feds is that even wrapping up loose herbs in a

unique combination is a manufacturing process. So anything we produce in

house is manufacturing. The question is just whether we get an exemption or

not from the rules governing manufacturing. A layperson who owns an herb

shop would not get any exemption, I bet. So the question is whether the

operant definition of a dietary supplement involves manufacturing the raw

materials. Putting slippery elm in a teabag and calling it throat coat changes

the product from a food to a supplement. I would suspect that if one sells a

" manufactured " product to the public that it is indeed a dietary supplement

regardless of where it is made or sold. In fact, if the feds give us a

manufacturing exemption, it will most definitely come with strings attached,

such as not allowing us to manufacture products from banned herbs. But this

raises an interesting point. If raw ban xia is legal by itself, but constitutes

part of a manufactured product if it is wrapped with other herbs and decocted

in combination, then even raw formulas may be considered dietary

supplements under the strictest reading of the FDA GMP rule. This would

effectively ban ma huang and ban xia in raw form also.

 

, " Greg Sperber " <greg@s...>

wrote:

 

So my question is this: would the

> ban affect herbal preparations that are made in office for the use of the

> practitioner's patients only? On the one hand, I would think this would be

> considered a supplement and therefore banned. On the other hand, there is

> the exemption for raw herbs and the exemption in the GMP's for practitioner

> produced products. I guess the heart of this question is would practitioner

> produced products be considered a supplement under the FDA ban? I would

love

> to hear some thoughts and/or feedback. Thank you.

>

>

>

> Greg

[Guest guest]

The issues around importing the herbs may make all this moot. If we can't get

the

stuff we can't compound it.

doug

 

 

, " " wrote:

> Greg

>

> That's an excellent question. However I was under the assumption that the

> final FDA proposed GMP rule MAY NOT have a practitioner compounding

> exemption. Testimony has pleaded for this exemption, but as of my last

> inspection of the rule, it still has not been codified in that form. However

it

> has been a few months. Do you have access to recent info to clarify this

point.

> I was under the impression that this rule may make it prohibitive to even

> dispense raw herb teas. But even if we are allowed a compunding exception

> for our private clinics, I am not sure this is a loophole vis a vis banned

herbs.

> However it may be (and is a clever thought indeed). It depends on how the

> dispensed substance is classified. The crux is whether raw ma huang is still

> a food after you grind it and cap it in house. It can only be a food or a

dietary

> supplement.

[Guest guest]

, " " wrote:

> The issues around importing the herbs may make all this moot. If we can't

get the

> stuff we can't compound it.

> doug

 

 

suppliers may stop carrying the raw herbs for liability issues. What if we buy

them and make illegal weight loss supplements? I don't think this is

happening yet.

 

[Guest guest]

Hello all,

 

In all this discussion of the FDA ban on ephedra, there is one thing

that I haven't heard discussed. As we know ma huang and ban xia are

currently banned except for raw herbs. The FDA proposed

herb/supplement GMP's (Good Manufacturing Practices) include an

exception for products made by a practitioner for his/her patients

only. So my question is this: would the ban affect herbal

preparations that are made in office for the use of the

practitioner's patients only? On the one hand, I would think this

would be considered a supplement and therefore banned. On the other

hand, there is the exemption for raw herbs and the exemption in the

GMP's for practitioner produced products. I guess the heart of this

question is would practitioner produced products be considered a

supplement under the FDA ban? I would love to hear some thoughts

and/or feedback. Thank you.

 

Greg

 

********************************************************

Dr. Greg Sperber, BMBS (MD), MTOM, MBA, L.Ac.

Diplomate in Chinese Herbology (NCCAOM)

Diplomate in Acupuncture (NCCAOM)

Mail

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