Many "Grapefruit Seed Extracts" Adulterated, says Nonprofit Research Consortium

Lab Studies Show Synthetic Disinfectants Found in "Natural" Ingredient

Regulatory Action Needed, Says Group

AUSTIN, Texas, June 4, 2012 /PRNewswire-USNewswire/ -- The American Botanical Council (ABC) announces the publication of a review of scientific literature regarding "grapefruit seed extracts," raising concerns about apparent adulteration of products in the U.S. and international marketplaces. The article, titled "The Adulteration of Commercial 'Grapefruit Seed Extract' with Synthetic Antimicrobial and Disinfectant Compounds," appears in the summer issue of ABC's quarterly, peer-reviewed journal, HerbalGram.(1) The article is part of an ongoing series produced by a consortium of nonprofit groups, the American Botanical Council-American Herbal Pharmacopoeia-National Center for Natural Products Research (ABC-AHP-NCNPR) Botanical Adulterants Program.

(Logo: http://photos.prnewswire.com/prnh/20100430/DC95601LOGO )

"Grapefruit seed extract" (GFSE) has been on the natural products market for at least 30 years as an ingredient in or preservative for cosmetics and related preparations for external use, and also in dietary supplements. The ingredient is supposedly an extract of the seeds of the common grapefruit and has been touted in modern, popular literature as a natural antimicrobial agent for both topical and internal use, including, but not limited to, eczema, acne, cold sores, athlete's foot, sore throats, thrush, vaginal infections, colds, various gastrointestinal disorders and infections, allergies, and gingivitis.

The article reviews 10 published analytical studies that have determined that various synthetic disinfectant chemicals have been found in commercial ingredients and/or products labeled as "grapefruit seed extract" since 1991. The article is not based on any new chemical testing by the Botanical Adulterants Program (the Program does not analyze commercial products or raw materials), but discusses the findings of the 10 analyses published in numerous peer-reviewed scientific journals in various countries. These analytical studies performed on proprietary GFSE products have shown the presence of non-naturally occurring chemicals, including the microbicides benzalkonium chloride, benzethonium chloride, triclosan, and methyl p-hydroxybenzoate.

As noted in the HerbalGram article, contemporary research shows that "a significant amount, and possibly a majority, of ingredients, dietary supplements and/or cosmetics labeled as or containing grapefruit seed extract are adulterated, and any observed antimicrobial activity is due to synthetic additives, not the grapefruit seed extract itself."

Over time, the synthetic microbicides present in the GFSE products analyzed have changed, making a stronger case for the probability of adulteration. "The fact that the antimicrobial components found in GFSE changed from 1991 to 2008 not only argues against such in situ synthesis (i.e., occurring naturally or synthesized in the processing of grapefruit seed material itself), but is suggestive of efforts by manufacturers of these commercial materials to stay one step ahead of analytical methods to detect adulteration," writes the author, John Cardellina, PhD.

"This situation is especially curious and troubling," said ABC Founder and Executive Director Mark Blumenthal, "given the fact that there does not appear to be any historical or traditional medicinal use of grapefruit seed, or preparations made from it in any treatises or monographs in traditional literature, pharmacopeial compendia, etc.

"We do not know whether all products claiming to contain 'grapefruit seed extract' are adulterated," said Blumenthal. "But, as our article shows, there is ample evidence in the scientific literature to raise serious concerns about the probable adulteration of such products."

The United States Food and Drug Administration (FDA) has previously issued Warning Letters to several companies for illegal drug claims describing antimicrobial and antifungal effects of GFSE-containing products sold as dietary supplements and cosmetics, among other violations for those products cited by the agency. However, the FDA did not deal with the issue of adulteration.

"We believe that the FDA should immediately investigate the apparent adulteration of GFSE-containing products and take appropriate regulatory action where necessary," Blumenthal added. "This includes testing commercial GFSE-containing products, inspecting manufacturing facilities, reviewing production records, and whatever other actions are appropriate to determine if adulterated, illegal products are being sold. If such a determination is made, the FDA should immediately take appropriate enforcement action."

The article's author, John H. Cardellina II, PhD, is a natural product, organic, medicinal, and analytical chemist who has held positions in the pharmaceutical industry, academia, the National Cancer Institute, Office of Dietary Supplements at the National Institutes of Health, the US Army Research Institute of Infectious Diseases, and the Council for Responsible Nutrition. He is also past-president of the American Society of Pharmacognosy, a professional society of researchers of natural materials used for the development of medicines. Dr. Cardellina is the author or co-author of nearly 200 publications and co-inventor on numerous patents covering 13 classes of natural products and synthetic compounds.

The HerbalGram article was peer reviewed by numerous qualified experts in analytical chemistry and related disciplines, including some of the researchers whose papers are summarized and cited in the review.

Reference

(1) Cardellina JH. The Adulteration of Commercial 'Grapefruit Seed Extract' with Synthetic Antimicrobial and Disinfectant Compounds. HerbalGram. 2012;94:62-66.

About the American Botanical Council
Founded in 1988, the American Botanical Council is a leading international nonprofit organization addressing research and educational issues regarding herbs, medicinal plants, and other beneficial plant-derived materials. ABC's members include academic researchers and educators; libraries; health professionals and medical institutions; government agencies; members of the herb, dietary supplement, cosmetic, and pharmaceutical industries; journalists; consumers; and others in over 81 countries. The organization occupies a historic 2.5-acre site in Austin, Texas, where it publishes the peer-reviewed quarterly journal HerbalGram, the monthly e-publication HerbalEGram, HerbClips (summaries of scientific and clinical publications), reference books, and other educational materials. ABC also hosts HerbMedPro, a powerful herbal database, covering scientific and clinical publications on more than 240 herbs. ABC also co-produces the "Herbal Insights" segment for Healing Quest, a television series on PBS.

ABC is tax-exempt under section 501(c)(3) of the IRS Code. Information: Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900. Website: www.herbalgram.org.

About the American Herbal Pharmacopoeia (AHP)
AHP is a 501(c)(3) California-based nonprofit research organization. AHP's primary goal is to develop standards of identity, purity, quality, and testing for botanical ingredients and to provide industry with the resources needed to assure the authenticity and quality of botanical raw materials. Additionally, with most all monographs, AHP develops a Therapeutic Compendium that provides a critical review of the authoritative traditional and scientific data on herbal medicines to ensure a high level of accuracy, clinical applicability, and safety of herbal ingredients. AHP also provides industry with authenticated AHP-Verified Botanical Reference Materials for GMP compliance with identity requirements.

About the National Center for Natural Products Research
The National Center for Natural Products Research (NCNPR) at the School of Pharmacy, University of Mississippi, is a unique university-affiliated research center devoted to the study of natural products and the realization of their benefits in human health, agriculture, and other applications. The NCNPR is recognized as a Center of Excellence for botanical supplements by the FDA's Center for Food Safety and Applied Nutrition.

About the ABC-AHP-NCNPR Botanical Adulterants Program
The ABC-AHP-NCNPR Botanical Adulterants Program is a consortium of independent nonprofit organizations whose mission relates to education, scientific research, and quality of botanical dietary ingredients and related plant-derived materials. The consortium is endorsed and supported by over 70 natural product industry companies, independent analytical laboratories, law firms, trade associations, and accredited institutions of education in natural medicine involved in the production, supply, manufacture, distribution, marketing, analysis, research and education of herbal dietary ingredients and supplements.

Underwriters and Supporters of the ABC-AHP-NCNPR Botanical Adulterants Program (as of May 30, 2012)*

AdvoCare International, L.P.
Alkemists Laboratories
Amin Talati, LLC
Amway/Nutrilite Health Institute
Aveda Corporation
Bastyr University
BI Nutraceuticals
Cepham, Inc.
Chemi Nutra
Chromadex
Consumer Healthcare Products Association
Council of Colleges of Acupuncture and Oriental Medicine
Council for Responsible Nutrition
Dr. Bronner's Magic Soaps
Enzymatic Therapy, Inc.
Ethical Naturals, Inc.
Eu Yan Sang International
EuroMed
EuroMedica/EuroPharma
Flavex Naturextrakte GmbH
Flora Research Labs
Gaia Herbs
Gencor Nutrients, Inc.
GNC, Inc.
Greenberg Traurig, LLP (James Prochnow)
Helios Corp.
Herbalife International, Inc.
Horphag Research
Indena USA, Inc.
Law Office of Bayne & Associates
Markan Global Enterprises, Inc.
Martin Bauer, Inc.
Metabolic Maintenance Products
National College of Natural Medicine
Natural Factors Nutritional Products, Inc./Bioclinic Naturals
Natural Products Association
Nature's Sunshine Products
Nature's Way
Naturex, Inc.
NBTY, Inc.
New Chapter, Inc.
The New Frontier Foundation Fund of the Greater Cedar Rapids Community Foundation
New Hope Natural Media
Ningbo Greenhealth Pharmaceutical Co., Ltd.
Novel Ingredients
NOW Foods
NSF International
Nu Skin Enterprises/Pharmanex
Nutiva
Nutraceutical Corp
Nutritional Laboratories International
Pacific Nutritional Inc.
Paragon Laboratories
Perrigo Company
Pharmavite, LLC
Pure Encapsulations
Rainbow Light Nutritional Systems
RFI Ingredients, LLC
Sabinsa Corporation
Schwabe North America
Standard Process, Inc.
Thorne Research, Inc.
Traditional Medicinals, Inc.
Triarco Industries, Inc.
United Natural Products Alliance
Valensa International
V.D.F. FutureCeuticals
Verdure Sciences
Virgo Publishing
Weil Lifestyle, LLC
Whole Foods Market
ZMC-USA

*By acknowledging the generous support of these companies, organizations, and educational institutions, ABC, AHP, and NCNPR are not endorsing any ingredients, products, or services that may be produced or marketed by them.

CONTACT: Lucy Bruno, [email protected], 512-926-4900 ext 121

SOURCE American Botanical Council