NNFA sent out an email alert yesterday with updated information on ephedra. The association said that this update was prompted by recent seizures by FDA of dietary supplement products containing ephedrine alkaloids. The following Q&A was originally prompted by the decision of the federal district court in Utah invalidating the ephedra ban for supplements with 10mg or less of the supplement ingredient.

Was the ban on ephedra overturned?

No. The ban on ephedra products of more than 10 milligrams per
dose is still in effect. The ruling only invalidated the ban on
ephedra products with 10 milligrams or less of ephedrine
alkaloids and with important restrictions, as indicated below.

Can retailers and manufacturers begin selling ephedra products
again?

*The decision only applies to ephedra products with 10
milligrams or less and only within Utah’s Central Division
district court jurisdiction. FDA may challenge sales outside of
that jurisdiction.

*Only in single and daily doses of 10 milligrams or less.

*Only in states that have not prohibited or restricted sale of
ephedra.

What are the risks of selling ephedra?

*Enforcement action. Those retailers or manufacturers selling
ephedra product in any federal court district other than Utah’s
Central Division can still be subject of enforcement action by
FDA. In fact, in early December FDA seized dietary supplement
products containing ephedra in Texas and Florida. An FDA
spokesperson was quoted by the Associated Press as saying that
the agency interprets the court ruling as only applying to the
company involved in the case to sell ephedra products at the
lower dosages. To view the FDA press release, go to
www.fda.gov/bbs/topics/NEWS/2005/NEW01267.html

* Ruling reversal. FDA has appealed the ruling. Should the
ruling be overturned, the ban on all ephedra products regardless
of dosage and where they are sold or manufactured will remain in
force.

* Liability. Earlier this year NNFA understood that insurance
for ephedra products was not being underwritten. If this is
still the case, it means full exposure financially in the event
of a civil lawsuit. To date, there have been numerous lawsuits
regarding the use of ephedra products for damages in the
millions of dollars.

* Availability. While the ban on ephedra products of 10
milligrams or less sold in the US has been lifted
with important restrictions an embargo on imports remains in
effect. This means that foreign shipments of ephedra product to
the US can be turned away at the point of entry.

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.