FDA Seizes Ephedra Supplements

[Guest guest]

, " mischievous00 "

<mischievous00> wrote:

 

> The complaint noted despite the product's labeling denoting it as

> a " traditional Asian herbal formulation, " it is considered a dietary

> supplement because the labeling includes a " Supplement Facts " panel

> and the dietary supplement disclaimer.

 

This is bizarre. It is illegal to produce and sell such a product in

the US without this disclaimer. All legal authroties agree that that

the FDA ephedra rule did not exempt patents from this rule and also

did NOT create a exempt class of Traditional Asian medicines. The

AHPA keeps pushing this line becasue they are a lobby for the

interests of manufacturers, NOT consumers and NOT practitioners. Why

would their interests be any different than any other corporate

lobbyist. Since their position conflicts with independent legal

opinions, I tend to dismiss all quotes from this org as self-serving

corporate propaganda. In fact, the FDA has also quietly blocked the

import of both ban and ephedra containing products for a number of

companies selling chinese herbs for traditional uses.

 

 

Also, claims on the Web site

> for VITERA-XT, including using the product to treat allergies,

> angina and flu, make the product an unapproved and misbranded drug.

 

 

this is a serious matter and was probably the main reason for the

action. but what follows below is just outrageous. Did mcguffin even

read the complaint against this company. They were NOT making weight

loss claims. They were selling is as a traditional asian remedy and

they complied with the actual law regarding supplement labeling. Many

companies that you do business with are also guilty of thes exact same

things. Look on your shelves. Do you have recently purchased chinese

herbal products that have supplement labeling and disclaimers on them

- beware if you don't, you are not protected against liability related

to your prescription of such products. In addition, do any of these

products have information on their manufacturer's websites that

discuss the use of these products for western named diseases or

symptoms. finally, regardless of the manufacturer's intent, is it a

simple matter for a layperson to obtain such products.

 

I think you will find the answer to all three questions is yes. I

think if you give it any thought, you will also realize there is no

way to enforce any of these things with the ubiquity of the internet.

So if the issue is public safety, the ONLY way to prevent the public

from getting their hands on such products is to ban them outright.

Now that the election is over and their is no fear of offending

interest groups (such as asian importers, who are overwhelmingly

republican), I bet we will see stepped up enforcement. Its no surpise

this happened just 3 weeks after elction day. Keep in mind I am not

advocating such a ban. I just think you all are dead wrong and

sticking our heads in the sand for the past year on this matter is now

biting us in the butts. We need to lobby for a real exemption, not

one that has no legal standing, but is rather enforced at the whims of

politics and favoritism.

 

>

 

At the time, Michael McGuffin,

> president of the American Herbal Products Association (AHPA),

called the move both " timely and

> appropriate. " " FDA made clear in its final rule on ephedrine

> alkaloids that 'traditional Asian medicines' containing ephedrine

> alkaloids would not be covered by the rule, " he said. " In

> conversations with AHPA and its Chinese Herbal Products Committee,

> FDA has made clear to traditional practitioners and manufacturers of

> these traditional products that the rule would be enforced against

> anyone marketing such products for weight loss. Thus, FDA's action

> comes as no surprise to AHPA, and legitimate manufacturers of

> traditional Asian medicines have nothing to fear from this action.

> Indeed, FDA's action protects the integrity of those who manufacture

> and prescribe products that are truly traditional. "

 

 

[Guest guest]

Talked to a Chinese inmporter of powdered Chinese medicinal extracts

recently. Asked him how he was. First thing he said that he was having

real problems with Customs not releasing his formulas. His packaging

is not FDA compliant in terms of DSHEA. In other words, he's not

selling his formulas (which are all traditional standards) as dietary

supplements. He only sells to practitioners and does not have a

Website. Yet his goods are still being embargoed. The idea that there

is any loop-hole for traditional ready-made Chinese medicines is

simply not true, as Todd has pointed out. If such a loop-hole exists,

it's only for bulk-dispensed Chinese meds, but no ready-made meds,

including powdered extracts without a supplement information panel.

 

Bob

[Guest guest]

FDA Seizes Ephedra Supplements

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Posted on: 11/24/2004

 

 

 

HOUSTON--At the behest of the Food and Drug Administration (FDA),

the Texas Department of State Health Services embargoed more than

2.1 million tablets of an ephedra-containing dietary supplement from

a company based here. A complaint filed by the U.S. Attorney for the

Southern District of Texas in U.S. District Court charged Asia

MedLabs Inc. with marketing VITERA-XT™ in violation of the federal

ban on ephedra-containing dietary supplements, as well as making

claims positioning the product as an unapproved or misbranded drug.

 

In a statement, Tommy G. Thompson, secretary of the U.S. Department

of Health and Human Services, said the government would not tolerate

marketing of such dietary supplements. Added Lester Crawford, Ph.D.,

FDA's acting commissioner, " We've issued a rule banning ephedra-

containing products and we're sparing no effort to stop their

manufacture and distribution. If any of these dietary supplements

are still on the store shelves, I urge the retailers to stop selling

them immediately. "

 

The complaint noted despite the product's labeling denoting it as

a " traditional Asian herbal formulation, " it is considered a dietary

supplement because the labeling includes a " Supplement Facts " panel

and the dietary supplement disclaimer. Also, claims on the Web site

for VITERA-XT, including using the product to treat allergies,

angina and flu, make the product an unapproved and misbranded drug.

 

On its Web site (www.asiamedlabs.com), Asia MedLabs posted

information on FDA's ephedra ban, noting " FDA exempted Traditional

Asian medicines containing ephedrine alkaloids. … Comments also

asserted that Ephedra in Traditional Asian formulae is usually

combined with other botanicals that typically modify Ephedra's

inherent stimulant effects. (So very true!) VITERA-XT contains

Aimisu Grass, the best buffer available! " It also calls the product

a " remarkable blend of natural herbs " that has been used by Chinese

herbalists for " generations. " At press time, Asia MedLabs had not

responded to INSIDER's request for comment on the situation.

 

When the ephedra ban was implemented in April, 2004, FDA

(www.fda.gov) did include language exempting preparations based on

Traditional s (TCMs), as the products are intended

for episodic rather than chronic use. At the time, Michael McGuffin,

president of the American Herbal Products Association (AHPA), noted

this could represent a potential " loophole " in the regulatory

system, provided marketers are selling products as TCMs and not

dietary supplements. When contacted for comment on FDA's action

against Asia MedLabs, he called the move both " timely and

appropriate. " " FDA made clear in its final rule on ephedrine

alkaloids that 'traditional Asian medicines' containing ephedrine

alkaloids would not be covered by the rule, " he said. " In

conversations with AHPA and its Chinese Herbal Products Committee,

FDA has made clear to traditional practitioners and manufacturers of

these traditional products that the rule would be enforced against

anyone marketing such products for weight loss. Thus, FDA's action

comes as no surprise to AHPA, and legitimate manufacturers of

traditional Asian medicines have nothing to fear from this action.

Indeed, FDA's action protects the integrity of those who manufacture

and prescribe products that are truly traditional. "