Natural Products Insider

JUL-AUG 2018

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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4 INSIDER July/August 2018 In the News In mid-May, the Center for Science in the Public Interest (CSPI) urged consumers to avoid Ginkgo biloba supplements due to adulteration concerns and debatable health benefi ts, and the group further requested FDA use its enforcement authority to rid the market of adulterated ginkgo products. However, botanical industry advocates argued that despite known adulteration issues with ginkgo products, the "bad apples" should not keep consumers from supporting well-invested brands and companies offering high-quality, effective ginkgo ingredients and fi nished products. In its advisory, CSPI cited 2018 tests from showed six of 10 ginkgo supplements failed the lab's quality testing and had either far less ginkgo than advertised on label or had spiked the product with cheaper material. stated one product contained no more than 3 percent of its listed ginkgo, and several other supplements appeared to have been contaminated with compounds from other plants. "The leaves of the ginkgo tree are expensive, and a large quantity of leaves is needed to produce ginkgo extracts," CSPI noted. It explained inexpensive buckwheat and other plant extracts are used to fool testing for ginkgo content, according to the American Botanical Council (ABC), a nonprofi t organization that has researched and published information on botanical adulteration, including problems with Ginkgo biloba supplements. "Economically motivated adulteration of ginkgo extracts with pure fl avonol- glycosides, fl avonols or fl avonol-rich extracts of other species is an ongoing problem in the dietary supplement industry and elsewhere," Stefan Gafner, Ph.D., ABC's chief science offi cer, concluded in a 2018 report referenced by CSPI. "While the addition of fl avonols is not considered a safety problem, the health benefi ts of substandard ginkgo extracts spiked with pure fl avonols or fl avonol-rich extracts have not been established." Gafner recommended contract manufacturers, independent analytical laboratories and manufacturers equipped with internal analytical capabilities take the lead to prevent low-cost, adulterated extracts from entering the global market. Such adulterated products, he said, appear to originate from China. However, in an email exchange with INSIDER, Gafner indicated some of the apparent discrepancies with tested ginkgo products may be due to processing variances. "In many of the research papers, the defi nition of ginkgo adulteration is that it does not correspond to a reference extract, but that this could also be due to processing differences rather than adulteration," Gafner explained, adding the published studies must be looked at carefully. "The number of products not passing muster depends on the criteria used to defi ne quality or, in some cases, adulteration. Some of the discrepancies (e.g., higher amounts of quercetin than found in ginkgo leaves) may be due to differences in the manufacturing protocol, and not necessarily represent cases of adulteration." Gafner and Mark Blumenthal, founder and executive director of ABC, agreed it is unfortunate and lamentable that there appears to be a relatively high level of adulteration in the global market for ginkgo supplements, but the bad apples should not spoil the barrel. In an emailed statement, Blumenthal said consumers can take solace in the fact that there is a high-quality, clinically-tested brand that is the pioneering ginkgo leaf standardized extract product that initially created the entire category of ginkgo standardized extract for phytomedicinal use (i.e., W. Schwabe's EGb 761 ® ginkgo extract, sold in the United States as Nature's Way's Ginkgold ® ). "Plus, there are several botanical ingredient manufacturers that are also recognized as producing high-quality ginkgo leaf extracts which have been the subject of controlled clinical trials," Blumenthal noted. "With respect to products made from this latter group of ginkgo extracts, it is much more challenging for consumers and health professionals to determine if the ginkgo extract products that they are considering purchasing are made from properly manufactured, honestly labeled extracts." He suggested one approach consumers can take is to see if the label and/or other marketing materials claim the extract has been clinically tested. On the regulatory side, CSPI sent a letter to FDA's top dietary supplement offi cial, Steven Tave, highlighting the ginkgo adulteration problems and requesting the agency ramp up enforcement. "In the specifi c case of ginkgo adulteration, the agency should act, since the evidence of intentional adulteration in U.S.-sold products is clear," Laura MacCleery, director of regulatory affairs with CSPI, wrote to Tave, director of FDA's Offi ce of Dietary Supplement Programs (ODSP). In a news release, MacCleery stated, "The FDA should take enforcement action to protect consumers from wasting their money on pills that don't do what they claim to do, and that may not even be what they claim to be." FDA has been aware of the botanical adulteration issues. "Unfortunately, the adulteration issues highlighted by CSPI are not uncommon," FDA told INSIDER, via email, noting despite many responsible manufacturers, consumers can have a hard time fi guring out which ginkgo products are high-quality. The agency assured product integrity is a top priority. "We are committed to raising the overall level of industry-wide compliance through education, inspectional activities and enforcement," FDA said. "The agency can take regulatory action as appropriate, based on public health priorities and available resources, such as by issuing a warning letter or taking enforcement action." However, the agency stopped short of warning consumers to avoid all ginkgo, instead advising them to consult with health care providers before taking a dietary supplement. "We also encourage consumers to research dietary ingredients such as ginkgo on objective government sites, such as those provided by the National Institutes of Health." Is Avoidance the Right Public Response to Ginkgo Adulteration? by Steve Myers

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