FDA Seizes Ephedra Supplements

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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. "