Natural Products Insider

MAR-APR 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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naturalproductsinsider . com 5 In the News A new study evaluating serious adverse events (SAEs) related to supplement use found SAEs accounted for only 0.48 percent of more than 40,000 adverse events (AEs) reported to two large, U.S.-based supplement manufacturers over a period of 2.5 years. The fi ndings, published in the Journal of Dietary Supplements, supported a position asserted by representatives of the dietary supplement industry: that supplements, by and large, are safe (DOI: 10.1080/1939021 1.2018.1513109). For the study, a total of 41,121 AE reports were collected during the period starting March 1, 2014 and ending Aug. 31, 2016 via Supplement Safety Solutions' (SSS) Nutravigilance ® program, a full-service safety, product quality and AE reporting program. Of these, 203 (0.48 percent) were SAE reports, and 40,918 (99.5 percent) were nonserious AE reports. "The most important fi nding from the article is that the rate of serious adverse events is quite low, less than 0.5 percent," said Stephen Schmitz, M.D., co-founder of SSS and co-author of the study in an emailed statement. "That means that one out of every 200 reported adverse events meet seriousness criteria (e.g., hospitalization, fatal, life-threatening, etc.)." Based on the low incidence of SAEs, Schmitz concluded supplements are safe and do not pose a public health risk. "This certainly contradicts the mainstream view (not founded on data) that supplements are unsafe," he said, underlining the importance of GMPs (good manufacturing practices) and GCPs (good clinical practices) in supplement safety. "Although we did not explicitly state it, we believe that the current FDA regulation of supplements is adequate." Dietary supplements are subject to an SAE reporting law signed in 2006 by former President George W. Bush. Distributors, packers and manufacturers of dietary supplements whose name appears on the label of a product marketed in the United States must report serious adverse events to FDA. But the government's data has many limitations. For instance, adverse events potentially linked to supplements that aren't defi ned as "serious" under the law aren't subject to the mandatory reporting requirements. The 2018 study analyzed reports of AEs associated with dietary supplement use to identify characteristics of AEs, including dietary supplement type and system organ classes (SOCs). Findings revealed dietary supplements most frequently associated with SAEs included thermogenic fat burners (35.5 percent), non-thermogenic weight- loss agents (33.5 percent) and glucose control/insulin management products (19.2 percent). Additional fi ndings showed SAEs occurred most commonly in the cardiovascular, gastrointestinal (GI) and nervous system disorder SOCs. SAEs were also more common among women compared to men and those over age 60. Of the 203 SAEs reported, 144 occurred in women, (70.9 percent) compared to 59 in men (29.1 percent men). This ability to "drill down" is an important component of the study, said Duffy MacKay, N.D., co-author of the study, formerly the Council for Responsible Nutrition's (CRN) senior vice president, scientifi c and regulatory affairs, and now senior vice president of scientifi c and regulatory affairs at CV Sciences. "The key takeaway [is] that, yes, there are adverse events, which we would expect … but when you look at those adverse events, the number of serious adverse events is very low," MacKay said in a phone interview. "Then, you drill down deeper and look at, 'OK, we do have this low number of serious events; are there any patterns?' … This can be very informative for formulators and people that are just trying to improve their products and make them safer." The study is a welcome contrast to current research evaluating dietary supplement AEs, specifi cally two studies that used data from emergency room visits, published in the New England Journal of Medicine (DOI: 10.1056/NEJMsa1504267), and poison control centers, published in the Journal of Medical Toxicology (DOI: 10.1007/BF03160960), to evaluate the safety of dietary supplements—what MacKay called "bad data." "The challenge [for the supplement industry] is … people are pointing to bad data to defi ne the safety of our products," he said, "and the benefi t of this paper is it's actually looking at real adverse event data collected in methodological fashion." The study published in the New England Journal of Medicine reviewed data from 63 emergency departments obtained from 2004 through 2013 and aimed to "describe visits to U.S. emergency departments because of adverse events related to dietary supplements." Results showed an estimated 23,005 emergency department visits per year were attributed to AEs related to dietary supplements. Contrary to the latest fi ndings on SAEs, emergency visits occurred mostly in younger populations, specifi cally those ages 20 to 34 (28 percent) and "unsupervised children" (21.2 percent). However, authors did report challenges for elderly; among adults ages 65 and older, choking or pill-induced dysphagia caused 37.6 percent of all emergency department visits for supplement-related AEs. Similar to present fi ndings, herbal or complementary nutritional products for weight loss were commonly implicated (25.5 percent), along with products for energy (10 percent). Weight loss or energy products caused 71.8 percent of supplement-related AEs involving palpitations, chest pain or tachycardia. Commenting on the New England Journal of Medicine study, Duffy said, "With emergency room visits, you're just looking at records of people who went to the emergency room. And if they said 'Yes, I took some vitamin C today before I slipped on the ice and fell and broke my arm,' that vitamin C might get included and counted in one of those adverse event reports. That's just a really rough way to try to capture how safe our products are." New Study Evaluating Adverse Events Affirms Safety of Supplements by Rachel Adams

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