U.S. Food and Drug Administration

 FDA Talk Paper,   Mar 31, 2000

FDA ANNOUNCES THE AVAILABILITY OF NEW EPHEDRINE
AND "STREET DRUG ALTERNATIVE" DOCUMENTS

The Food and Drug Administration (FDA) today announced the public display of three Federal Register documents involving dietary supplements containing ephedrine alkaloids, and issued a new guidance to curb the use of alternatives to illicit street drugs. A Federal Register notice announcing the availability of this new guidance also went on public display today.

The Federal Register documents involving dietary supplements containing ephedrine alkaloids address issues arising out of the Agency's proposal of June 4, 1997 (the ephedrine alkaloids proposal) to establish a finding that a dietary supplement is adulterated if it contains 8 milligrams or more of ephedrine alkaloids per serving within a 6-hour period, or a total daily intake of 24 mg or more of the substance. The proposal, which was developed after FDA received more than 800 adverse events reports (AERs) associated with ephedrine alkaloids, also called for certain warnings on the label of such products, including a statement that they are not to be used for more than 7 days.

During the comment period on the ephedrine alkaloids proposal, FDA received approximately 14,775 comments, mostly from individual users and distributors of dietary supplements containing ephedrine alkaloids. The proposal was also examined by the Government Accounting Office (GAO), which last August concluded that FDA was justified in determining that the number of events related to dietary supplements containing ephedrine alkaloids warranted the Agency's attention and consideration of steps to address safety, but called for additional evidence to support the proposed limits on the dosing level and duration of use.

In light of GAO's conclusions, comments from others on the ephedrine alkaloids proposal, and having considered issues related to the proposed dietary ingredient level and the duration of use limit, FDA has determined that these aspects of its proposed approach to regulating these products should be reassessed. Accordingly, one of the Federal Register documents withdraws the provisions of the ephedrine alkaloids proposal relating to the dietary ingredient level and duration of use limit for these products. A second Federal Register document released today announces the availability of additional information concerning 17 ephedrine alkaloids-associated AERs received in 1997, that were not part of the basis for FDA's June 4, 1997 ephedrine alkaloids proposal because they were received after the Agency began its analysis for the proposal.

A third Federal Register document announces a new public docket (Docket No. 00N-1200) that makes available new adverse event reports and related information, the vast majority of which was received after the publication of FDA's June 1997 ephedrine alkaloids proposal. It also announces FDA's intent to participate in a public forum to address the new information. This public meeting will be sponsored by the Public Health Service and will be designed to share information and seek opinion on the safety of dietary supplements containing ephedrine alkaloids in the Agency's ongoing effort to assess the safety of these products. More details will be provided concerning the public meeting by May 1, 2000, including the name of a contact person.

One hundred forty of the adverse reports (New Case Series) being made available have received an in-depth clinical review by FDA and by certain outside consultants whose findings are included in the new public docket. This New Case Series constitutes all AER's on dietary supplements containing ephedrine alkaloids reported to FDA from June 1, 1997 to March 31, 1999. For completeness, FDA has also included in the new docket all AER's on dietary supplements containing ephedrine alkaloids that fall outside these dates, up to December 31, 1999, with any additional follow-up information received by February 15, 2000. The total number of AER's in this new docket is 273.

FDA welcomes any additional new data from interested parties and encourages such information to be submitted to the docket within 45 days.

In addition to these three actions, FDA today issued a Federal Register notice announcing the availability of a guidance for industry entitled "Street Drug Alternatives" that outlines FDA's response to the proliferation of various products promoted as alternatives to illicit street drugs. These products, which are intended to affect psychological states, are generally labeled as containing botanicals, and some are alleged to include vitamins, minerals, or amino acids.

FDA does not consider street drug alternatives to be dietary supplements because they are intended for recreational purposes to affect psychological states (e.g., to get high) and are not intended to supplement the diet. The guidance, which is being implemented immediately without prior public comment, states that street drug alternatives are unapproved and misbranded drugs that can be subject to regulatory action, including seizure and injunction.

All of these Federal Register documents will be made available on the Internet at FDA's dockets Website: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm Copies of the adverse events of the New Case Series will also be made available on this Website no later than Friday, April 7.

The text in this article was prepared by the FDA Office of Public Affairs.