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Herbalist & Alchemist Responds to Consumer Report Article

Washington, NJ (April 9, 2004) Herbalist & Alchemist, Inc., one of America’s premier herbal extract companies for over 22 years, is deeply concerned about a recent article, “Dangerous Supplements: Still at Large” published in Consumer Reports. While the text of the article contains some important information highlighting the importance of working with quality herbal products companies, as well as some inaccuracies about the legal framework regulating Dietary Supplements, our main concern is with a chart of supplements, “Twelve Supplements You Should Avoid.” We contacted Consumer Reports for their research sources used for this article. Katherine Breglio, Customer Relations Representative for Consumer Reports responded: “the main sources of our data were the Natural Medicines Comprehensive Database 2004 and Consumers Union's medical and research consultants.” We have requested their information on certain herbs discussed in the article from the Database cited. A review of the authors of the private, fee-for-purchase database shows that they do not have any prominently known practicing, clinical herbalists on their editorial staff or review boards. While awaiting the data to review, we wanted to send out our analysis of the information contained in the article. The following was written by David Winston, Herbalist AHG, President and Founder of Herbalist & Alchemist, Inc.

Consumer Reports
12 Dietary Supplements Too Dangerous For Marketplace
April 2004

David Winston, AHG*

 Distributed by Herbalist & Alchemist, Inc.

 

Consumer Reports’ recent article, “Dangerous supplements: Still at large” citing “Twelve supplements you should avoid” unfortunately confuses consumers more than helps them. Their article contains:

¨      Some good information

¨      Some partially accurate information, taken out of context or no longer current

¨      Some outright inaccurate data

 

Having followed all of these issues and their investigation for years, here’s our Product – by –Product analysis of what they derisively call the “Dirty Dozen”:

 

Aristolochic Acid (AA) –Aristolochic Acid is not a supplement. It is a phytochemical found in several genera and species of plants. Consumer Reports is correct in stating that plants containing Aristolochic Acid should be avoided for internal use, as it has been implicated in kidney failure and renal cancer.[1] It is unclear if one of the plants mentioned, Asarum canadense, actually contains Aristolochic Acid[2]. Herbalist & Alchemist does not sell any products containing Aristolochic acid.

 

Comfrey-Comfrey contains unsaturated Pyrrolizidine Alkaloids (“PAs"), which are hepatotoxic and cause a liver disease known as veno-oclusive disease (VOD). How dangerous PAs in comfrey are, is somewhat controversial. The article states that comfrey causes deaths, but in all of the literature, there are only 6 cases of liver damage reported (millions of people have used comfrey as a tea, in capsules or in tinctures over the last 40 years) suggesting the concerns are real, but wildly overblown in this highly sensationalized article. PA-free extracts of comfrey are also available, but are not mentioned in this article.

 

Androstenedione – is not an herb-it is a synthetic hormone.  I agree with Consumer Reports-it has no place in the over-the counter marketplace.

 

Chaparral - The FDA and other researchers could not find any hepatotoxic compounds in this herb. The final results of studies suggested that the liver damage (which occurred in only a few people) was probably an idiosyncratic reaction. This type of reaction can occur in anyone, ingesting almost any substance. The very intense taste and effects of Chaparral indicate it is best used in small quantities and for limited periods of time. Herbalist & Alchemist does not produce Chaparral extract. However, this herb is used by practitioners and there are no reports of adverse effects when it is used in formulas or for short periods of time[3].

 

Germander -Germander (Teucrium chamaedrys) is hepatotoxic and should not be ingested. Herbalist & Alchemist does not produce this product.

 

Kava –(our March 2002 press release-updated) The FDA as well as the American Herb Products Association (AHPA) and the German Health Authority (BFARM) issued health warnings or news releases concerning the use of Kava (Piper methysticum) in 2002.

 

In Germany & Switzerland there were approximately 30 cases of moderate to serious liver damage associated with Kava use.  In 3 cases there was complete liver failure including 1 death.  In most, if not all, of these cases, Kava was utilized daily for 4-12 months, and in 27 of 30 cases the people were using other medications or had a history of alcoholism which may have contributed to the liver toxicity. 

 

AHPA commissioned Dr. Donald Waller, a pharmacologist and toxicologist, to scientifically review and evaluate all of the kava AERs. Dr. Waller concluded that there is "no clear evidence that the liver damage reported in the USA and Europe was caused by the consumption of kava." The report states:

".... kava when taken in appropriate doses for reasonable periods of time has no scientifically established potential for causing liver damage. However, as with any pharmacologically active agent, there is always the possibility of drug interactions, preexisting disease conditions and idiosyncratic or hypersensitivity reactions, which can exacerbate the toxicity of such an agent."

AHPA met and worked with the FDA on the safety of kava products. The FDA has evaluated the kava AERs but has not declared kava products unsafe nor taken any actions against them. At this point kava products continue to be legally sold in the USA.

The German Federal Institute for Drugs and Medical Devices (BfArM)
revoked the license of medicines containing extracts of the kava in 2002. However, the German Commission E, a special herb expert committee commissioned by BfArM, issued the following statement critical of BfArM's conclusions and actions:

"When one examines the reactions in detail, it appears that the BfArM’s classification of causality linked to kava, is, to a large extent, incomprehensible, and arbitrary. Moreover, in its evaluation of cases, the BfArM had not taken into consideration various existing pieces of information, for example those with regard to other possible causes. One extreme example may be concerning the aforementioned lethal case: in this instance, it was known to the Institute that the cause of liver failure was several years of alcohol abuse, and that kava was not involved in the genesis of the liver symptoms. The autopsy had shown that the cirrhotic process had already started long before the administration of kava began."

 

Is Kava Hepatotoxic? - Kava (also known as Kava-Kava, Awa, Ava) has been used as a ceremonial, social, and medicinal beverage in Polynesia for thousands of years.  In the form of a water emulsion, Kava has been regularly used with little history of side effects.  Kava abuse (it has been reported that "Kava-heads" in the South Pacific may consume 10-40 coconut shells of Kava per day every day, for years on end) has been linked to impaired cognitive function and Kava Dermopathy (patchy skin discoloration).

 

Ethanol tinctures of Kava have been used since the 1850's in England and were a popular Eclectic medicine from the 1880's through the 1930's.  Articles extolling the health benefits of Kava start appearing in the British Medical/ Pharmaceutical literature in 1844.  Eclectic physicians including F. Ellingwood, N.D., H. Webster, M.D., and H.W. Felter, M.D., all utilized Kava tinctures and were unaware of any liver toxicity associated with Kava use in their patients.

 

The "active" constituents are known as Kava lactones, but it may be an alkaloid, Pipermethystine[4], that researchers believe is more problematic. Most of the cases of liver damage are associated with the utilization of acetone or ethanol extracts that have enhanced levels of Kava lactones (30-80%).  These dry-powdered extracts have been substantially altered from the raw herb or crude tincture and should be classified as phytopharmaceuticals. The dose of Kava lactones in a tea or tincture is relatively low (3-10%). Some Hawaiian researchers believe that some European companies used cheap stem peelings, not the traditionally used root to make their “standardized” kava extracts. The stem peelings contain a possibly hepatoxic chemical found only in trace amounts4,[5] in the root.

 

Herbalist & Alchemist, Inc. has sold Kava tincture and formulas with Kava in them for over 20 years.  We have had no adverse reaction reports for these product, nor reports of hepatotoxicity.  We share a concern about the safety of Kava but it is important not to place all products in the same category.  In an attempt to understand the safety or lack thereof for our product we submitted our Kava to a laboratory for hepatotoxicity testing; results were negative. 

 

Until further information is available, we took the following actions. In 2002 we removed Kava from all of our formulas, selling it only as a simple extract. AHPA has issued a statement regarding Kava use.We amended our Kava label to reflect the following:

·        An association between the chronic use of Kava and serious liver disease has been reported.

·        Do not use if you have any liver problems, are taking any drug products (or without consulting or under the supervision of a health care professional), or are a regular consumer of alcohol.  Do not take on a daily basis for more than 4 weeks.

·        Discontinue use if symptoms of jaundice (e.g., dark urine, yellowing of the eyes) occur.

 

Bitter Orange (Citrus aurantium) – Orange peel is a safe, edible spice and herb.  The peel and extract are commonly used as digestive herbs, flavorings, and in orange marmalade. There are no reported problems associated with the use of Orange peel or Orange peel tincture.  Synephrine is a naturally occurring chemical found in bitter Orange peel, and concentrated extracts of it are being promoted as weight loss aids.  This product is very different than the dried peel or crude extracts of Orange peel.  Synephrine is chemically similar to the now banned Ephedra alkaloids, but unlike Ephedrine it does not produce significant central nervous system effects.  In the Consumer Reports article, it is mentioned that bitter Orange may have caused a seizure in a young woman.  The same product contained Theophylline (also found in tea and chocolate), which is also noted in their article as causing seizures.  It is more likely the causative agent.

 

Organ/glandular extracts – Are not herbal products.  Manufacturers of this type of product should test products to make sure they are Prion-free.

 

Lobelia -There are no confirmed deaths or serious adverse events associated with Lobelia[6]. In overdose it can cause nausea, vomiting and respiratory distress, but the effects are transient. Lobelia is a strong herb, best used with a practitioner’s guidance. In normal doses, it is safe and a useful medicinal herb. Traditionally it is used in Native American medicine and was popular with Eclectic and Physio-medical physicians. This herb is always used in small amounts or as a minor ingredient in formulas.

 

Pennyroyal oil – Essential oil vs. herb or extract—The essential oil of Pennyroyal is extremely toxic and should not be used orally or topically. The herb, which contains small amounts of essential oil, has never been implicated in human health risks. Herbalist & Alchemist sold Pennyroyal extract for many years without any adverse events. Due to low sales volume, we discontinued production of this extract.

 

Skullcap – No reports of botanically vouchered skullcap causing any illness exist. In the late 1980’s and early 1990’s much of the skullcap on the American and European market was adulterated with Germander, which is hepatotoxic[7]. Now most if not all skullcap is really Scutellaria lateriflora and there have been no additional cases of hepatotoxicity. Responsible and knowledgeable herb companies have always been able to botanically ID their herbs and prevent adulteration. These herbs are easily differentiated when received as whole plants. Herbalist & Alchemist only uses fresh or freshly dried whole skullcap in making its products.

 

Yohimbe – A very powerful herb, best used under professional guidance. Herbalist & Alchemist does not sell any products containing this herb.

 

____________________________________________________________________________

*David Winston, Herbalist AHG has been a practicing herbalist and educator for 35 years. A founding member of the American Herbalists Guild, he is trained in Cherokee, Western and Chinese herbal medicine and an author of several books on herbal medicine. He is President and Founder of Herbalist & Alchemist, Inc., a traditional style botanical products company that is celebrating its 22nd year in business.

 



[1] Nortier, J.L., et al, Urothelial Carcinoma Associated With the Use of a Chinese Herb (Aristolochia Fangchi), New England Jrl. Medicine, 23, 200: 1686-1692.

[2] Hashimoto, K., et al, Quantitative Analysis of Aristolochic Acids, Toxic Compounds, Contained in Some Medicinal Plants, Jrl. Ethnopharmacology 64, 1999:185-189.

[3] Heron, S, Yarnell, E., The Safety of Low-Dose Larrea tridentata (DC) Coville (Creosote Bush or Chaparral): A Retrospective Study, Jrl. Altern. Complement Med, 7(2), 2001:175-85.

[4] Dragull, K., Yoshida W.Y., Piperidine Alkaloids From Piper methystine, Phytochemistry, 63(2) 2003: 193-198

[5] Nerarkar, P.V., Dragull, K., In Vitro Toxicity of Kava Alkaloid, Piper methystine, in HepG2 cells as compared to Kavalactones, Toxicol Sci, 21, 2004

[6] Bergner, P., Is Lobelia Toxic?, Medical Herbalism, 10(102), 1998, 1,15-17, 20-36

[7] De Smet, PAGM, Adverse Effects of Herbal Drugs, Vol. 2 – Springer-Verlag, 1993, pp. 289-296