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EPIDEMIOLOGY

Across the world, there is a high prevalence of use of HDS. According to the World Health Organization, the use of HDS in the United States has increased significantly over the past two decades. Depending on the survey, more than 50% of respondents report using an HDS in the past 30 days. While used by all populations and all socioeconomic backgrounds, studies consistently show that women use HDS more than men, and family households with greater wealth also use more. Finally, older adults tend to be the highest consumers of HDS, with nearly 70% taking an HDS in the past 30 days.

REGULATORY ISSUES & QUALITY ASSURANCE

As of 2018, 124 Member States (64%) responded that they had laws or regulations on HDS. Specific to the United States, in 1994, the US Congress passed the Dietary Supplement and Health Education Act (DSHEA). This legislative act defined a dietary supplement as a product (other than tobacco) that is intended to supplement the diet; contain one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement. Under this law, supplements can be marketed without proof of safety or efficacy if no claim is made for their use in the diagnosis, treatment, cure, or prevention of disease. Manufacturers can, however, make “structure and function” claims that a product enhances a normal body function or state. For example, saw palmetto can be marketed to support urinary tract health but not to treat benign prostatic hyperplasia. In contrast to prescription medications, which must be proven safe, the US Food and Drug Administration (FDA) must first prove that an HDS is unsafe before a product is taken off the market. In 2006, the US Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which updated DSHEA so that dietary supplement producers were responsible for reporting serious adverse events related to their products. In addition, in 2007, the FDA published current good manufacturing practice guidelines, including requirements for manufacturers to test products to ensure product quality, confirm the absence of some contaminants, verify accuracy of labeling, maintain minimum standards for manufacturing and packing, monitor adverse event reports, and make all records available for FDA inspection. However, these guidelines are nonbinding on the manufacturer. Since 2007, the FDA has increased inspections of HDS manufacturers and enforcement of regulations. Other countries, including Canada, Australia, and Japan, as well as the European Union, have stricter policies on the licensure and marketing of HDS. Patients should be advised to follow certain guidelines when using HDS (Table e4–1). In 2019, the FDA reported that they will be updating the regulation of HDS to continue to promote safety, quality, and efficacy. They began to use a ...

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