The role of good manufacturing practices for preventing dietary supplement adulteration

Abstract

More than 50 % of US consumers use supplements and see them as a necessary dietary component, using them as a part of their healthy lifestyle. With sales reaching $30 billion in 2012, the dietary supplement industry is a vital sector of the US natural products industry that has continued to see growth despite economic woes and regulatory pressures [1]. Dietary supplements are regulated by the Federal Food, Drug, and Cosmetic Act of 1938 (FDC therefore, a dietary supplement that has not been manufactured, packaged, labeled, held, or distributed in compliance with cGMPs is adulterated by virtue of noncompliance with this section [4]. Additional provisions of the FDC unsafe pesticide residues; unsafe food or color additives; filthy, putrid, or decomposed substances; and unsanitary conditions [5]. It is vital that companies understand and comply with the laws and regulations for the products that they market. Introducing an unsafe or adulterated product into the marketplace is a prohibited act under the FD&C Act with serious legal ramifications [2, 6, 7]. The US Food and Drug Administration (FDA) has authority to enforce the statutory requirements of the FD&C Act with an arsenal of enforcement tools at its disposal, including warning letters, product recalls, product seizures, temporary restraining orders, injunctions, consent decrees, civil and criminal prosecution, and fines [2, 6, 7].