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Is Larrea safe to use?
The answer in one word is, yes. However, just like every other substance that can have an effect on the human body, it is important to apply the most current knowledge and a healthy dose of common sense to obtain the maximum benefits while eliminating the risk of any undesired effects. As you will see in the information below, there have been some questions raised about the safety of Larrea at least in a few individual cases investigated by the FDA in the early to mid-1990s. These few cases appear to be linked to preexisting liver disease and/or excessive consumption of raw, unprocessed Larrea foliage. To give the reader a balanced picture, we include a review and discussion of this data.
At least one company has taken an active stance to address the potential safety issues surrounding the medical use of
Larrea. This company has developed patented technologies to eliminate the suspected toxin from Larrea (see patents section). In independent testing at a major medical school, this patented extract of Larrea was shown to be as safe as cinnamon oil and clove oil, two natural plant oils widely used in food products. Additionally, when the extract was formulated with extra vitamin C, the same way that the company manufacturers all their dietary supplements, it was found to be much safer than either cinnamon oil or clove oil. In fact, the formulations with patented Larrea extract and vitamin C significantly extended the life of the liver cells used in this laboratory study. Over the past six years, tens of thousands of consumers and medical practitioners worldwide have used dietary supplement capsules and topical skin products containing this patented extract of Larrea with tremendous consumer acceptance and no serious adverse effects reported.
In the July 2001 issue of the Journal of Alternative and Complementary Medicine, an article entitled “The safety of low-dose Larrea tridentata (DC) Coville (creosote bush): a retrospective clinical study”, provides details about patients treated for various conditions using extracts of Larrea
tridentata. In all cases, test subjects showed no toxicity effects, as measured by blood chemistry analysis, complete blood count, and physical examination, from the use of Larrea tridentata as a natural medicine (Heron and Yarnell 2001). After a thorough search of the literature, no controlled studies in humans contradicting these published findings of safety have been found to exist.
Historical Information (1992-1996):
Dietary supplements containing Larrea tridentata, as a raw herbal ingredient, were the subject of scrutiny for a brief period in the mid-1990s. Unfortunately, while the cause of this concern was thoroughly investigated and no official regulatory action was initiated, a shadow still appears in the historical record that requires explanation. This scrutiny was initiated by a published anecdotal case of severe hepatotoxicity supposedly related to the consumption of raw larrea by an elderly patient (Gordon 1995). Although this case was published, it has been widely scrutinized as an attack against the herbal industry since major facts of the case, especially the fact that the patient had been taking many prescription drugs, including a prescription drug that was well known to cause severe liver damage, were buried without note within the report and the findings as a whole did not support the cause and effect conclusion that was being implied. During this period of investigation by the FDA, the major herbal products associations, the National Nutritional Foods Association and the American Herbal Products Association asked their members to institute a voluntary moratorium on sale of
larrea-containing products. The American Herbal Products Association also cooperated with the FDA in their investigation and commissioned an independent medical investigation into four cases of alleged hepatotoxicity that had been reported to the FDA, including the case subsequently published by Gordon in 1995. The independent investigation, headed by Dr. Clark Watts M.D., J.D., and other expert physicians in the field of liver disease, concluded that the cases most likely were associated with preexisting liver disease in the patients possibly combined with extremely rare idiosyncratic reactions to
larrea. The report went on to suggest adding informational language to product labels but no further action was recommended (Watts 1994).
Based on this independent report, in 1995, the American Herbal Products Association rescinded its voluntary moratorium on the sale of
larrea-containing products. The AHPA did however recommend that, in the interest of consumer education and well being, products for oral ingestion containing this ingredient should carry the following informational language, Seek advice from a health care practitioner before use if you have had, or may have had, liver disease. Discontinue use if nausea, fever, fatigue or jaundice (i.e. dark urine, yellow discoloration of the eyes) should occur. Consumers should not be alarmed by this informational wording but rather, should see it as a sign by the herbal products industry that at least some manufacturers are willing to take a balanced approach to consumer education and safety issues. Note: Do not use Larrea containing products that do not bear this informational wording. It is the sign of an unaware or irresponsible manufacturer not to heed the very reasonable AHPA recommendations.
Final Report on the Herb Chaparral
Abstract: September 6, 1994 report of an independent review panel of medical records provided by the FDA. Evaluation was conducted by Dr. Clark Watts, M.D., J.D. and gastroenterology/hepatitis experts, Dr. Stephen
Schenker, M.D.; Dr. Atilla Ertan, M.D. and Dr. Boris Yoffe, M.D. "In summary, this review did not reveal evidence that Chaparral is inherently
hepatotoxic." The document is in Adobe PDF format. Downloading and reprinting is permissible.
Click
here to download now.
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