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EPIDEMIOLOGY

Across the world, there is a high prevalence of HDS use. According to the World Health Organization (WHO), HDS use in the United States has increased significantly over the past two decades. Depending on the survey, over 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 HDS used is higher in women than men and in family households with greater wealth. Finally, older adults tend to be the highest consumers of HDSs, with nearly 70% taking an HDS in the past 30 days.

REGULATORY ISSUES & QUALITY ASSURANCE

As of 2018, 124 Member States (64%) of the WHO responded that they had laws or regulations on HDSs. in 1994, the US Congress passed the Dietary Supplement and Health Education Act (DSHEA). This 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 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 FDA must first prove that an HDS is unsafe before a product is taken off the market. Dietary supplement producers are responsible for reporting serious adverse events related to their products; in addition, they must abide by 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 provide all records for FDA inspection. Although these guidelines are nonbinding on the manufacturer, the FDA has increased inspections of HDS manufacturers and enforcement of regulations. Other countries, including Canada, Australia, and Japan, and the European Union, have stricter policies on the licensure and marketing of HDSs. Patients should be advised to follow certain guidelines when using an HDS (Table e4–1). In 2019, the FDA reported that they will update the regulation of HDSs to continue to promote safety, quality, and efficacy. They used a different electronic submission system for notification of new dietary ingredients and structure/function claims.

Table e4–1.Advice to patients using herbal and dietary supplements (HDS).

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