There has been considerable confusion in the media, and even among health professionals, about the safety of the peel of bitter orange, or Seville orange (Citrus aurantium, Rutaceae). In September of last year, Consumer Reports again claimed—as it did in 2004—that bitter orange preparations can cause potentially serious adverse effects in humans. The article warned that this peel, which is the common ingredient in orange marmalade, and its extract are dietary supplement ingredients “to avoid.” Consumer Reports relied on the monograph from the Natural Medicines Comprehensive Database for the information on which it based its conclusion.
In this issue, we present an extensively peer-reviewed safety review of bitter orange, in which the authors analyze the relevant chemical, pharmacological, toxicological, and clinical trial data on the herb. These experts conclude that much of the safety information reported in the popular media and in medical journals about the potential risks of bitter orange—and one of its principle active alkaloids p-synephrine—is erroneous and not supported by scientific or clinical data. We hope this review will help to clarify the confusion about the controversial herb’s general safety as a dietary ingredient.
When I lived in the mountains of northern New Mexico in the early 1970s, I learned about an interesting, locally used medicinal plant called osha (Ligusticum porteri, Apiaceae), the root of which has found a niche in the North American herbal market among herbalists, naturopathic physicians, et al. for its reputed respiratory benefits, among others. Almost all osha is wild-harvested, and attempts to grow small or large plots for commercial markets have not been successful. We present a graphically compelling 12-page review of osha by Christina Turi and Susan Murch of the University of British Columbia Okanagan, Kelowna, British Columbia.
Except for occasional mention in HerbalGram reports on sustainability issues, and in 1 article on the ethnobotany of the American Southwest, we have not previously devoted much space in these pages to osha, for 2 basic reasons: First, there’s been no published human clinical research on osha, and second, we did not want to run the potential risk of calling undue commercial attention to this plant due to our concerns about its sustainability. However, now we believe it is time to give this respected traditional medicine its due, despite the lack of data from human clinical trials.
In the regulatory arena, one of the most important aspects of the FDA’s final rule on cGMPs (current Good Manufacturing Practices) for dietary supplement manufacturers is that since June, all manufacturers of supplements, regardless of the company’s size, must comply with the cGMP rule. One of the most important areas in this quality control pertains to the fact that all manufacturers must qualify their suppliers and their ingredients, as the suppliers themselves are not required to meet the cGMP rules for the ingredients they sell. Some industry trade organizations have proposed a mechanism to standardize information shared among suppliers and manufacturers regarding ingredient specifications, in order to make the communication of such information more streamlined. Presumably, this mechanism will eventually lower the cost of such communication (i.e., the Standardized Information on Dietary Ingredients initiative, or SIDI). Andrew Shao of the Council for Responsible Nutrition provides insights into this process.
Another of this issue’s articles concerning herb quality comes from long-time ABC Advisory Board member Dennis Awang, a respected natural product chemist and author, and a former regulator for 20 years in Canada. In his guest editorial, based on a recent speech, he calls for more focus on the identity and quality of botanical ingredients in Canada, and, by extension, also in the United States.
The issue of botanical quality of herbal dietary supplements (in the United States) and natural health products (in Canada) is of great concern. While many ethical and responsible companies take great pains to ensure the proper identity and quality of the botanical raw materials and extracts they use in their finished products, unfortunately there are still those who do not exercise adequate measures to properly qualify their raw-material suppliers, who, as noted above, are exempted from the FDA’s final rule on cGMPs. Thus, the ultimate onus of confirming proper identity and quality lies with the herbal supplement manufacturer.
In the coming year, within these pages and elsewhere, ABC will be publishing additional papers addressing herb quality as part of our contribution to community-wide efforts to ensure that consumers are able to obtain herbal products which are of acceptable and reliable quality.
–Mark Blumenthal