(Salt Lake City, Utah / May 2, 2005) Today a major association of dietary supplement manufacturers announced that it is making a prohibition against selling products containing ephedra at any dose a condition of membership.
On April 29, 2005, members of the Utah Natural Products Alliance (UNPA) unanimously voted to make “NO SALES” of ephedra products a condition of UNPA membership. The proactive measure, the first of its kind among dietary supplement groups, comes on the heels of a recent court decision which maintained the FDA’s ban on most ephedra products but overturned the ban on low-dose (10 milligrams) ephedra products. Since FDA’s final regulation prohibiting the sale of ephedra, no UNPA member company has sold ephedra-containing products.
A recent court decision held that FDA did not have adequate scientific evidence to find that a daily dose of 10 mg or less of ephedrine alkaloids presented a significant or unreasonable risk of illness or injury. The court remanded the case back to FDA for further rule-making. This decision, which may be appealed by the FDA, has prompted renewed criticism of the Dietary Supplement Health and Education Act (DSHEA) and reopens the prospect of future sales of ephedra dietary supplement products in the U.S.
DSHEA created a statutory framework for dietary supplements, including a safety standard which is now under further review as a result of this case. UNPA’s members believe it is advisable to maintain an ephedra-free market until the judicial and regulatory processes are complete.
UNPA believes that DSHEA needs to be fully implemented and enforced by FDA as soon as possible, including prompt publication of Good Manufacturing Practices (GMPs). UNPA also supports legislation to create an adverse event reporting system for dietary supplements and will continue to actively support efforts to provide FDA the increased funding needed to fully implement and enforce DSHEA.
UNPA is hopeful that ephedra will not derail the more than ten years of efforts to implement DSHEA and believes an ephedra-free market to be a key step toward those ends.
Loren Israelsen, Executive Director, Utah Natural Products Alliance.
Phone: (801) 474-2572
Fax: (801) 474-2571
e-mail: [email protected]