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• W2974164022 abstract "See Related Article on p.455The dangers of patent medicines in the late 19th century were well documented, and later reforms led to entirely new government regulations that were designed to end the old concept of “caveat emptor” or “let the buyer beware.” One of the most important of these regulatory agencies was an early version of the Food and Drug Administration (FDA), created by the Pure Food and Drug Act of 1906 [[1]Barkan I.D. Industry invites regulation: The passage of the pure food and drug act of 1906.Am J Public Health. 1985; 75: 18-26Crossref PubMed Scopus (48) Google Scholar]. More than 100 years later, with extensive FDA safety hurdles in place for bringing new medications to market, it would be reasonable to think that the risky days of patent medicine were long behind us. However, new research from Or et al. [[2]Or F. Kim Y. Simms J. Austin S.B. Taking stock of dietary supplements' harmful effects on children, adolescents, and young adults.J Adolesc Health. 2019; 65: 455-461Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar] in this month's Journal of Adolescent Health shows that “caveat emptor,” at least for dietary supplements, is as important now as it was in the late 1800s. See Related Article on p.455 The legislation that created the FDA initially focused on (1) requiring that drugs met standards of strength and purity, (2) creating definitions of “adulteration” and “misbranding,” and (3) prohibiting the shipment for sale of foods, drinks, and drugs that fit these definitions of adulterated or misbranded. There was no need for manufacturers to demonstrate that their products were beneficial or even safe. After the deaths of more than 100 people from a patent medicine that intentionally included diethylene glycol as an ingredient, the federal government passed the Food, Drug, and Cosmetic Act of 1938, essentially creating the modern FDA [[3]Lipsky M.S. Sharp L.K. From idea to market: The drug approval process.J Am Board Fam Pract. 2001; 14: 362-367PubMed Google Scholar]. The Act required that manufacturers prove the safety of their products before marketing them and provide warning labels about potential side effects. Over the subsequent decades, the FDA created regulations that determined which drugs would be available on a prescription-only basis and required evidence of efficacy, resulting in the current long and complicated process of bringing new medications to market. Although the development of the regulatory infrastructure for prescription medications appears to follow a straight, if at times slow and frustrating path to drug safety and efficacy, the regulatory standards for nutritional and dietary supplements have followed a more crooked and twisting path, intertwining and often blurring the line between medication and food. The origins of this confusion date to the early discoveries of nutritional deficiencies and organic micronutrients. Carl Funk coined the term “vitamine” as a contraction of “vital amine” in 1912. It was later discovered that the micronutrients in question were not amines, but the name stuck and was eventually shortened to “vitamin” [[4]Rosenfeld L. Vitamine—vitamin. The early years of discovery.Clin Chem. 1997; 43: 680-685PubMed Google Scholar]. Soon after the usefulness of specific vitamins for the treatment and prevention of such diseases as scurvy, pellagra, and beriberi were discovered, manufacturers began marketing them as necessary supplements to ensure good health. By 1925, up to one fourth of total drug company sales and up to one third of all pharmacy sales were accounted for by vitamins [[5]Nestle M. Food politics: How the food industry influences nutrition and health. University of California Press, Berkley, CA2013: 222-246Google Scholar]. In the 1950s and 1960s, the FDA, in collaboration with the American Medical Association, attempted to reign in misleading marketing of vitamins, including hosting two joint National Congresses on Medical Quackery in 1961 and 1962 [[6]Swann J.P. The history of efforts to regulate dietary supplements in the USA.Drug Test Anal. 2016; 8: 271-282Crossref PubMed Scopus (26) Google Scholar]. In the context of this regulatory environment, a number of vitamin manufacturers joined the National Health Federation, a lobbying group formed in 1955 by the president of the Electronic Medical Foundation (who had previously been ordered by the courts to stop distributing fraudulent medical devices) [[7]Barrett S. The unhealthy alliance: Crusaders for “health freedom”.Nutr Today. 1988; 23: 26-32Crossref Scopus (1) Google Scholar]. The National Health Federation markets itself as being dedicated to promoting consumer choice and saw great success in 1976 with the passage of the Proxmire Amendment to the Food, Drug, and Cosmetics Act [[8]Proxmire Amendment, 21 USC §350 (April 22, 1976).https://history.nih.gov/research/downloads/pl94-278.pdfDate accessed: July 14, 2019Google Scholar]. This amendment prohibits the FDA from treating vitamins and other dietary supplements such as nonprescription medications and prevents any regulation unless they are inherently dangerous or are marketed with illegal claims regarding treatment or prevention of specific diseases. Although the Proxmire Amendment specifically deregulated vitamins, the antiregulatory fervor of the 1980s resulted in the 1994 Dietary Supplement Health and Education Act, which classified dietary supplements under the broad regulatory framework of food rather than drugs [[9]Dietary Supplement Health and Education Act of 1994. Pub L No. 103–417. 1994Google Scholar]. The number of dietary supplements marketed in the U.S. has increased dramatically since then, from about 4,000 before the passage of Dietary Supplement Health and Education Act to more than 90,000 in 2014, with more than 150 million people reporting use [[10]Starr R.R. Too little, too late: Ineffective regulation of dietary supplements in the United States.Am J Public Health. 2015; 105: 478-485Crossref PubMed Scopus (67) Google Scholar]. Although dietary supplements are classified as food, only 22% of users report that such products are taken to supplement their diets, whereas the majority take supplements for specific health outcomes [[11]Bailey R.L. Gahche J.J. Miller P.E. et al.Why US adults use dietary supplements.JAMA Intern Med. 2013; 173: 355-361Crossref PubMed Scopus (412) Google Scholar]. Despite the lack of regulation, a majority of consumers in the U.S. believe that the products are certified by the FDA as safe and, for weight loss supplements at least, have been tested for efficacy before being allowed on the market [[12]Dodge T. Consumers' perceptions of the dietary supplement health and education act: Implications and recommendations.Drug Test Anal. 2016; 8: 407-409Crossref PubMed Scopus (14) Google Scholar]. Physicians themselves are ill-informed about dietary supplement regulation, with about 40% of physicians believing that dietary supplements must be approved by the FDA before being sold to consumers [[13]Ashar B.H. Rice N. Sisson S.D. Physicians' understanding of the regulation of dietary supplements.Arch Intern Med. 2007; 167: 966-969Crossref PubMed Scopus (56) Google Scholar]. In this unregulated environment, identifying the health risks associated with dietary supplements can be challenging. Dietary supplements encompass an incredibly wide range of products, from the benign, such as vitamin C, to the deadly, such as ephedra, which was finally banned in 2004 after a number of high-profile deaths [[14]Food and Drug Administration, HHSFinal rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk. Final rule.Fed Regist. 2004; 69: 6787-6854PubMed Google Scholar]. It remains difficult to say what the true public health impact of such unregulated and commonly used products might be, particularly with so many consumers and health care providers believing them to be safe. Fortunately, the FDA established an Adverse Event Reporting System on food and dietary supplements, and Or et al. [[2]Or F. Kim Y. Simms J. Austin S.B. Taking stock of dietary supplements' harmful effects on children, adolescents, and young adults.J Adolesc Health. 2019; 65: 455-461Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar] have analyzed events reported between 2004 and 2015 for children, adolescents, and young adults. The results are concerning, particularly for supplements marketed for muscle building, energy, and weight loss. These findings likely represent only a small fraction of adverse events because reporting by physicians and consumers is voluntary, and only a small fraction of events are reported [[15]Pascale B. Steele C. Attipoe S. et al.Dietary supplements: Knowledge and adverse event reporting among American Medical Society for Sports Medicine Physicians.Clin J Sport Med. 2016; 26: 139-144Crossref PubMed Scopus (13) Google Scholar]. It is crucial that providers on the frontlines of patient care ask consistently about dietary supplement use and counsel about dangers of use, particularly regarding the most problematic products—caveat emptor et caveat medicus. Taking Stock of Dietary Supplements' Harmful Effects on Children, Adolescents, and Young AdultsJournal of Adolescent HealthVol. 65Issue 4PreviewThe aim of the study was to evaluate the relationship between supplement categories and adverse events in children, adolescents, and young adults. Full-Text PDF" @default.
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• W2974164022 title "Dietary Supplements: Caveat Emptor Redux" @default.
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