A virtual barrage of U.S. Food and Drug Administration (FDA) activity in the area of herbs and dietary supplements (DS) has kept both agency and industry extremely busy in the past six months.
In December 2002 the FDA announced a new "Consumer Health Information Initiative" to implement regulations on claims for supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a move almost universally welcomed. FDA’s new commissioner, Mark McClellan, M.D., Ph.D., a physician and economist, appears to be guiding the agency to work more effectively. Since January, the FDA has launched a trio of major initiatives: implementation of the Bioterrorism Act, new label warnings for ephedra products, and proposed Good Manufacturing Practices.
The Bioterrorism Act and its FDA rules are part of the Bush Administration’s War on Terror. The Bioterrorism Act impacts all foodstuffs imported into the United States, including herbal materials for teas and dietary supplements. In this issue, Washington regulatory attorney Paul Rubin provides an in-depth look at the ramifications on the industry and, eventually, the consumer.
In February, about three weeks after the death of Baltimore Orioles pitcher Steve Bechler from an ephedra-related case of heatstroke, FDA proposed warnings for supplements that contain ephedra. Stern "black box" warnings are intended for the front panel of all ephedra supplement labels. At the same time FDA released the long-awaited report from the RAND Corporation on the safety and efficacy of ephedra in weight loss and athletic performance products. We publish an article that details the findings.
Then, FDA finally published proposed Good Manufacturing Practices (GMPs) for DS! Industry organizations that have been pleading for their publication for the past 4—5 years initially hailed them as a positive step. However, closer examination of the 550-page document raised serious concerns among some technical experts in the industry. We explore this key topic in this issue as well.
The Chinese I Ching defines "crisis" as "dangerous opportunity." With the herb industry in crisis, and DSHEA under attack in Congress and elsewhere, industry leaders Loren Israelsen and Tom Aarts provide compelling advice in this issue for industry members, presenting a perspective beyond the provisions of DSHEA and the emergent realities of a post-DSHEA world.
This issue also features a brief account of the ceremonial use of peyote in Mexican Indian rituals. In indigenous cultures whose transmission of knowledge is based on oral traditions, anthropologists and ethno-botanists have few means to date the earliest use of a particular food, or medicinal or ritual plant. Peter De Smet and Jan Bruhn provide hard data on what is possibly the new benchmark date for the Huichol’s ritual use of this fascinating plant.
We also feature the remarkable photography of Steven Foster, displaying some common backyard ornamental plants that are traditional Chinese medicines.
And the debate in the herbalist community continues over whether and how to step into some type of certification process. This issue includes another side to the discussion by herbal philosopher Stephen Harrod Buhner.
Finally, we welcome supplement industry veteran Anthony Almada, who now contributes a regular column on herb patents. It has been some time since our last Plant Patents column by Karen Dean, who is busy editing Alternative and Complementary Therapies. Unlike Karen’s column reporting on patents issued on various herbal preparations (i.e., after the formal review and approval process), Anthony’s column covers patents applied for, thereby providing information on patent activity much earlier in the process.