The production and distribution of dietary supplements is an industry that has grown steadily. Yet, the oversight has remained almost the same since 1994. With the authority of the FDA limited by statute to removing supplements from the market only after reports of adverse effects, the role of pharmacists to intervene and assist patients with optimal product selection is vital.
The principal legislation covering products in this classification is the Dietary Supplement Health and Education Act of 1994 (DSHEA), which defined what constitutes a dietary supplement and outlines the limited role of the FDA in the oversight of the industry. Any dietary supplement ingredients marketed before 1994 are not required to have FDA clearance before marketing in interstate commerce.1 As a result, manufacturers are responsible for ensuring that products are neither adulterated nor misbranded and comply with the Current Good Manufacturing Practices (CGMP).2 The FDA’s authority is limited to surveillance and acting after defective products reach the market. An improvement to the legislation, the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, was passed 12 years ago, mandating that manufacturers report adverse effects within 15 days after they are received.3
Although the DSHEA has been around for more than 20 years, the public has misconceptions about what it entails. This has a lot to do with the growth and prevalence of the supplement industry, which is projected to grow from $100 billion in 2013 to more than $260 billion by 2024.4 The appearance of supplement packaging and “dosage forms” frequently resemble those of the medications that have been proved effective and safe. Additionally, the supplements are located near these medications in stores, which may contribute to assumptions and misunderstandings about their quality. Many consumers do not know that a way to ensure that a product contains what it says and nothing more is to look for a verification seal from a quality assurance program, such as consumerlab.com, the National Sanitation Foundation International, and the US Pharmacopeial Dietary Supplement Verification Program. Products with these seals should be recommended to patients.