Recently we informed members of a district judge’s ruling that partially lifted the Food and Drug Administration’s (FDA) ban on the dietary supplement ephedra. As a result, NNFA has been fielding many questions from its retail and manufacturer members about what the decision means for the industry in both the long and short term. For instance, NNFA has learned that retailers are now being approached by ephedra manufacturers or their representatives about putting ephedra products back on store shelves. Although the court decision leaves room for interpretation and an appeal by the FDA is anticipated, following is some clarification and guidance in complying with the court decision.
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?
- Liability. NNFA understands that no insurance companies are currently underwriting coverage for either manufacturers or retailers who sell ephedra. This 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.
- Enforcement action. Those retailers or manufacturers selling ephedra product in any federal court district other than Utah’s Central Division can still be sued by the FDA.
- Ruling reversal. If the FDA appeals the ruling, and indications are it will, there is no guarantee the recent Utah decision will be upheld. 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.
- Availability. While the ban on ephedra products of 10 milligrams or less sold in the United States has been lifted – with important restrictions – an embargo on imports remains in effect. This means that foreign shipments of ephedra product to the United States can be turned away at the point of entry.
As further events develop, NNFA will continue to inform its members about the effects of this important court ruling.