Natural Products Insider

APR 2012

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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AHPA Offers Star Anise Authentication The American Herbal Products Association (AHPA) added analytical identification methods for star anise fruit to its Botanical Authentication Program, making it easier for companies to distinguish between star anise fruit (Illicium verum) and its toxic cousins in the Illicium species, such as Japanese star anise (Illicium anisatum). AHPA included the star anise update in its "Guidance on Known Adulterants," in late 2011. The program also contains background information, a review of general methods for authentication and a review of specific methods. Japanese star anise contains toxic compounds, and cases of poisoning have been reported from treatment of infant colic by administration of tea made from its toxic fruit instead of from the fruit of true star anise, which is also sometimes referred to as Chinese star anise. In September 2003, FDA issued an advisory to the publ ic to not consume teas brewed from "star anise" based on illnesses associated with its consumption. FDA did not identify the species of star anise implicated, but reported Japanese star anise has long been recognized as toxic in many countries and should be used for decorative purposes only. ABC Debunks Supplement Regulation Myths A new article in the American Botanical Council (ABC) publicat ion HerbalGram details the numerous federal government regulations for dietary supplements. "The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled," which is already published online and is slated for the upcoming winter print issue, was co-written by health policy expert R. William Soller, Ph.D., who has a long history in the regulation of both dietary supplements and nonprescription medications, along with Washington-based food and drug law attorney Holly J. Bayne, Esq., who specializes in dietary supplement and botanical issues, and Christopher Shaheen, a researcher in the Center for Consumer Self Care at the UCSF School of Pharmacy, San Francisco. This new article is a follow-up to a similar article published in HerbalGram in 2000 by Soller and others. "Almost 12 years ago, when we asked Dr. Soller to write the original article, we were concerned about the lack of understanding by many people in the media, health professions, Congress and the general public regarding the regulatory authorities held by both FDA and FTC," said Mark Blumenthal, editor of HerbalGram and founder and executive director of ABC. "What's more surprising and disappointing is that an entire decade has passed since we published the initial article and 17 years since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), [yet] many people are still not clear about the extent of government regulation of herbal products and other dietary supplements." The current article revisits DSHEA and provides an in-depth review of important legislation amending the Federal Food, Drug and Cosmetic Act (FDCA) passed over the last 12 years since the publication of the previous article, including the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006), the FDA Amendments Act (2007) and the FDA Food Safety Modernization Act (2011). To help readers understand the regulatory picture, the authors included several thorough, easy- to-navigate charts summarizing key developments that build on the legal framework and core authorities of the current dietary supplement regulatory infrastructure. "FDA has used its ample authority under various laws to build a comprehensive framework of enforceable regulations and interagency collaborations to fulfill its mission to both promote and protect the public health," Soller said. "Any remnant of the myth that dietary supplements are an unregulated industry is easily dispelled by a close look at the agency's activities over the past 15 years." "It is puzzling that the myth of the unregulated dietary supplement industry has continued for so many years," Bayne added. "The passage of DSHEA clearly established a comprehensive legal framework for FDA regulation of dietary supplements. FDA has all the legal authority it needs to protect public health and safety and remove unsafe or mislabeled products from the marketplace. Dietary supplements are clearly regulated by FDA, but they are regulated differently than prescription and OTC [over-the-counter] drug products." 16 INSIDER ¥ APRIL 2012 IN THE NEWS

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