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Author Topic: Grapefruit Seed Extract Warning  (Read 4047 times)

Offline jodi f.

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Grapefruit Seed Extract Warning
« on: June 11, 2012, 06:42:07 AM »
While not exactly "news," since this information has been around for some time now, it's noteworthy that it's now reaching a wider audience. If you're not already aware of the problems with GSE, you'll want to read this.

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) 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 US 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.

"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.

Offline MaureenM

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Re: Grapefruit Seed Extract Warning
« Reply #1 on: August 21, 2013, 01:19:48 PM »
Hi Jodi,

I just saw this article for the first time. And, it is the first that I have heard any negative news about GSE. Does it pertain to all GSE or just certain products that contain GSE along with other ingredients? I have always used Nutribiotic GSE when traveling abroad and always felt like it has worked well in preventing parasites and other digestive problems. And, have recommended it to others. But, this is all new news to me, and it doesn't sound like anything I should take or recommend to others. Do you have any other references about this? I just want to delve a little deeper. 

Thank you for the continuous education you offer.

Sincerely,
Maureen

Offline jodi f.

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Re: Grapefruit Seed Extract Warning
« Reply #2 on: August 22, 2013, 10:46:43 AM »
Here's the actual HerbalGram article: http://cms.herbalgram.org/herbalgram/issue94/QUALCONTROL_gfse.html?ts=1377192798&signature=14e193652c83b5188bfc5d83f16379e0


I suggest you read the entire thing, as it's quite enlightening. The conclusion is pasted, below. Also, I read an interview with a manufacturer of GFSE, and it's very clear that this is in no way an extract as most of us have learned about them. No manufacturer will reveal the actual process, but it's a much more involved process than merely extracting the flavonoids, and involves an ammoniation process, among other things. In other words, regardless of contamination, this is not as natural a product as we've been led to believe (gives you some idea of the value of "natural").


BTW, it behooves us to read, read, and read some more. This information has been circulating since at least the mid-2000s. And don't feel bad, I just found out about it recently, too.


Conclusion[/b]
A significant amount, and possibly a majority, of ingredients, dietary supplements and/or cosmetics labeled as or containing grapefruit seed extract (GFSE) is adulterated, and any observed antimicrobial activity is due to synthetic additives, not the grapefruit seed extract itself. Tests conducted in multiple laboratories over almost 20 years indicated that all commercial GFSE preparations that exhibited antimicrobial activity contained one or more synthetic microbicides/disinfectants, while freshly-prepared extracts of grapefruit seeds made with a variety of extraction solvents neither exhibited antimicrobial activity nor contained the antimicrobial synthetic compounds found in the commercial ingredient materials. Furthermore, over the course of the 18 years covered by the various analyses, the actual antimicrobial compounds found in the putative grapefruit seed extracts changed from triclosan and methyl p-hydroxybenzoate in early samples to benzethonium chloride in the middle years to mixtures of benzalkonium and/or alkonium chlorides in more recent years. The suggestion on a commercial website4 that these antimicrobial compounds are formed from the phenolic compounds naturally occurring in grapefruit seed and pulp by heating them with water, ammonium chloride, and hydrochloric acid is not supported by chemical evidence, or any known organic chemistry pathway. None of these compounds could be formed from flavonoids like naringenin, the most abundant flavonoid in grapefruit seeds, pulp, and peel, or other grapefruit seed constituents (e.g., limonoids) and ammonium chloride; the alkyl chains and substituent arrays found in the antimicrobial adulterants are not naturally present in grapefruit seed and cannot be prepared from those materials. The fact that the antimicrobial components found in GFSE changed from 1991 to 2008 not only argues against such in situsynthesis (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.

 


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