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The 65-page document reviewed safety data on the botanical ingredient, and responded to a recent article on the incident.
September 23, 2022
By: Mike Montemarano
Following the death of Lori McClintock, the wife of U.S. Rep. Tom McClintock (R-CA) last year, a report from the Sacramento County Coroner’s Office obtained by Samantha Young, a reporter at Kaiser Health News, concluded that McClintock died from dehydration due to gastroenteritis that was caused by ingesting white mulberry leaf. White mulberry, a botanical ingredient that has been used for thousands of years in traditional medicine in Asia for hundreds of years, is commonly found in dietary supplement formulations due to research on its potential role in lowering blood glucose and reducing insulin response levels. According to updates from the coroner’s office through an amended death certificate, a leaf fragment which was found in McClintock’s stomach was identified, and it was unclear to the investigators whether the fragment came from fresh or dried leaves, a supplement, or a tea. “McClintock’s death underscores the risks of the vast, booming market of dietary supplements and herbal remedies, which have grown into a $54 billion industry in the U.S.—one that both lawmakers and health care experts say needs more government scrutiny,” Young wrote. Doubts Persist Among Experts In response to the coverage of the incident from Kaiser Health News, and the events that unfolded, the American Herbal Pharmacopoeia (AHP), a nonprofit educational organization known for developing monographs for the analysis of herbal products, issued a 65-page report discussing the contemporary scope of safety data and adverse events reporting involving the ingestion of white mulberry. “When such tragic events occur, it is contingent among all involved to be as conscientious as possible in determining their determinations, both to help prevent similar future events and to bring an accurate reporting of what happened to the family,” AHP said in a statement. “Because adverse effects, especially fatalities, related to botanicals are so rare, I always pay special attention when they are reported,” said Roy Upton, AHP president. “When I read about this I took particular interest as I drank copious amounts of white mulberry leaf tea when I had COVID early in 2020. I knew of an acupuncturist/herbalist friend who had given eight pounds of it to his mother-in-law for a chronic cough she had and she has been taking it for months. Just a month ago, I sent a pound of it to my sister who also had a chronic cough from COVID and my partner started drinking it for a cough she had just a few weeks ago. I needed to know right away if there was any reality that called into question the safety of mulberry leaf.” AHP said that it reached out to experts in Traditional Chinese Medicine, botanists, medical doctors, pharmacologists, and toxicologists, and reviewed as much of the national and international reporting data that was accessible on mulberry. “The consensus, with no equivocation among all experts, is that there is no way to know for certain that the fragment was white mulberry, and if it was, the combined historical and current use of white mulberry as a food and supplement, together with formal clinical trials and toxicological reviews, gives no indication that white mulberry leaf has any action that would have caused or contributed to this sad event,” AHP reported. The most glaring issue with the coroner’s reporting, according to AHP, is that it did not mention which if any method was used to determine the causality of death, i.e., whether the presence of the leaf fragment was relevant, or whether the leaf was simply present. Further, some expert botanists said that the fragment found would likely be too small to identify as white mulberry with certainty, AHP said. AHP also reached out to Young in order to “address the frequently repeated myth of an underregulated industry,” and connected her with herb and supplement experts, it said, prior to Young providing updated coverage which called into question how to coroner made the determination that the leaf fragment caused or contributed to McClintock’s death, in which she received no response from the coroner’s office and noted that a consultant to the coroner’s office described white mulberry leaf as “not toxic.” “White mulberry is not toxic,” said Alison Colwell, curator at the U.C. Davis Center for Plant Diversity, who consulted the coroner. “I compared the specimen to lethally toxic species that are known to be planted or are native in the Sacramento area and found no matches. I can provide a list of the toxic and non-toxic species I compared this specimen to and the reasons why they do not match upon request.” Technical Review In AHP’s report, the organization noted that white mulberry leaf has been used as food, animal fodder, a dietary supplement ingredient, and a traditional medicine in Asia dating as far back as 1,800 years. According to AHP, the leaf fragment found in McClintock’s stomach was estimated to be 167 mg, but clinical trials demonstrate safety of the extract when used at doses of up to 4.6 grams, with mild digestive upset being the worst adverse effect reported in trials. Further, no serious adverse events were reported in a meta-analysis of 13 studies involving 436 participants. Formal toxicological evaluations to date find that in humans, doses of white mulberry leaf extract between 3,000 and 3,600 mg daily are reported as safe and well-tolerated, and pre-clinical toxicity studies find that the extract induces no hematological, biochemical, or histopathological parameter changes at doses up to 15g/kg. Further, reviews of pharmacovigilance data internationally reveal few reports of adverse effects. When it came to the coroner’s report, AHP said that gastroenteritis was reported as the cause of death, but the autopsy revealed tissues of the gastrointestinal system were normal, and other common causes for gastroenteritis or dehydration, such as infection, dieting, or digestive disorders, were not ruled out. “There is no evidence in either the traditional or modern literature to suggest that white mulberry leaf exhibits a toxic potential to have caused or contributed to this event,” AHP concluded.
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