ABC continues its rollout of strategic educational projects. In our last issue, we introduced the publication of ABC Clinical Guide to Herbs, our new book for health professionals. We now introduce our new Safety Labeling Program (SLP), intended for consumers and healthcare professionals alike. SLP was initiated with the help of Pharmavite Corporation for its new expanded labels on its Nature’s Resource® line of herbs. The labels contain a 4-page "brochure" that peels back from the front panel of a bottle, offering guidelines for responsible use by consumers. The label text is based on ABC’s comprehensive peer-reviewed assessments of the safety literature. These new labels will be on 4 million bottles within a year on 21 Nature’s Resource products. SLP labeling is available to other qualified manufacturers. This nonprofit/industry initiative is particularly significant since there are few FDA label guidelines regarding the safety of herb products.
FDA’s proposed good manufacturing practices (GMPs) for dietary supplements are causing considerable concern among many industry groups. FDA has based the GMPs upon those for drugs, despite Congressional guidance that they be modeled on food GMPs. The differences are significant in the amount of testing required for ingredients and finished products – the testing is expected to be so prohibitively expensive that even FDA spokespersons are said to have acknowledged that if the proposal is finalized in its present form, several hundred small companies could be forced out of business. Although some industry groups are filing critical comments with constructive suggestions to FDA, industry leaders are careful not to appear to be against the GMPs in general, so as not to appear in the media as "anti-quality," an epithet that no one can afford at a time of continuing negative media articles and mounting Congressional pressure on the industry.
Along these lines, U.S. Senator Richard Durbin (D-IL) has introduced the Dietary Supplement Safety Act of 2003 (S. 722), a bill that, if passed with any of its current provisions, would substantially alter the way the dietary supplement industry conducts business, in addition to the changes required by the Bioterrorism Act (see last issue) and the proposed new GMPs. Sen. Durbin has held several hearings on the safety of ephedra, the new bill being a direct result of his and others’ mounting concerns over its safety. S. 722 would require companies to submit reports of all serious adverse event reports (AERs) to the FDA within 15 days, file an annual report of all AERs, obtain FDA approval for the safety of many ingredients, and would require FDA approval of all supplements intended as "stimulants" (except coffee and caffeine). In this sense, the bill takes an interesting strategic step: instead of going after specific individual ingredients used for stimulation or weight loss, the bill targets the entire category. The recent National Nutritional Foods Association convention in Las Vegas was buzzing about this bill, and NNFA has begun to arm retailers with instore promotion packets to elicit consumer opposition of the bill.
In this issue, we also highlight rooibos, the South African herb with a delightful flavor and a relatively high antioxidant effect. Rooibos was first introduced into the U.S. market in the early 1980s by herbal tea leader Celestial Seasonings, but the product was avoided by many human rights-conscious health food consumers who did not want to support a product from the then-apartheid South Africa. Ironically, sales of rooibos would have benefited the very African people whom the consumers would have wanted to support. Rooibos is back, with numerous companies beginning to market the product as a tea or dietary supplement.
We also offer some new insight into the current kava controversy. Ethnobotanist Paul Cox and colleagues provide a survey of traditional native healers and biomedically trained healthcare professionals in Samoa. Despite concerns by some public health officials of the alleged hepatotoxicity of kava, the traditional and Western healers surveyed have not observed liver disease among native kava users.
And, finally, a mea culpa. HerbalGram 55 included an article on an herbalist’s quest to determine the botanical contents of the Patterson Bundle, an Indian medicine bag found in Utah. The author felt it important to determine the identity of the herbs, and their known medicinal and/or sacerdotal properties. One of our loyal readers, herbalist Cindy Bloom, herself half Native American, was horrified to see what she considered the defiling of a sacred site and its contents. She contacted us, we invited to share her concerns with us, and we now print her letter in its entirety. We sincerely apologize for any insensitivity we may have exhibited in this matter.