Understanding the Regulations Governing Dietary Supplements

The dietary supplement industry is subject to extensive regulations issued and enforced by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), as well as government agencies from each of the 50 states. Companies are responsible for having proof that their dietary supplements are safe and for ensuring that product labels are accurate and not misleading. The FTC regulates the advertising of dietary supplements as it does with all consumer products through the application of truthful advertising laws and applies the same standards in all forms of advertising, whether in newspapers, magazines, on the Internet, in the mail or on billboards and buses.

In addition

, Council for Responsible Nutrition (CRN) member companies adopt self-regulatory practices and adhere to a strict code of ethics and dosage recommendations, as well as voluntary guidelines and best practices.

The Dietary Supplements Health and Education Act (DSHEA) established the regulatory framework for dietary supplements as foods through the FDA. The DSHEA described the legal definition, labeling requirements, and the process for reporting adverse events of dietary supplements. The FDA also published formal guidance on current good manufacturing practices to ensure that processes for preparing, packaging, labeling and storing supplements and ingredients are documented and meet specifications to ensure purity, composition and concentration. Despite regulations to improve the market, many challenges persist; as a result, the quality and safety of the products available can vary widely, especially in the case of botanical and herbal products.

The ability of regulators to carry out their mission successfully is hampered by the large number of products and manufacturing facilities and the lack of analytical methods for all ingredients and products on the market, which is especially difficult in the case of herbal and botanical dietary supplements. Safety problems, such as adulteration and contamination, continue to exist, especially with specific types of products (i.e. botanical supplements). Therefore, there is still a need for further efforts and improvement of techniques for evaluating the quality of dietary supplements, especially with regard to purity, bioavailability and safety. The main challenge when it comes to regulating dietary supplements is the lack of international consensus on how this category of products is defined; standards that guarantee quality and integrity do not exist in the global context (Dwyer, Coates & Smith 201).

This review will highlight the regulatory framework for dietary supplements, focusing primarily on the regulatory landscape in the U. S. UU. However, there are many similar problems on the world stage (Dwyer, Coates & Smith 201).

The advances are described, as well as some of the regulatory obstacles that still exist, to ensure that all dietary supplements available on the market are safe. The FDA has long worked together with the FTC to regulate advertising claims related to dietary supplements (Federal Trade Commission Consumer Protection Office 200). The FTC Advertising Act is designed to “prohibit unfair or deceptive acts or practices in commerce” and “prohibits false advertisements” (section 1), including but not limited to dietary supplements. The FTC has published guidance for the supplement industry to clarify its enforcement policies and practices related to dietary supplements (Federal Trade Commission Consumer Protection Office 200). Under FTC law, manufacturers are responsible for the accuracy of statements expressed, suggested or implied. Given the financial incentives and competing interests of the dietary supplement industry and regulatory bodies, there are quite diverging views on how to address existing barriers to the regulation of dietary supplements (Dwyer, Coates & Smith 201).

Since dietary supplements are considered a subset of foods under DSHEA regulations are largely based on a post-marketing approach (Dwyer, Coates & Smith 201). In other words supplement manufacturers don't have document quality and safety in same way that pharmaceutical products do (Table 1 box). Some exceptions include that manufacturers must notify FDA of products containing a new dietary ingredient before placing them on market. Within framework of DSHEA FDA conducts on-site post-marketing audits to ensure that manufacturers comply with Good Manufacturing Practices (GMP), which are discussed in detail below. The following sections will describe federal & non-federal resources available to support efforts to ensure quality of dietary supplements.

The quality of a dietary supplement generally refers to its purity & safety (i.e. absence of contaminants) while efficacy an equally important dimension is briefly discussed in later sections. It is important for consumers to be aware that despite regulations governing dietary supplements there is still a need for further efforts & improvement of techniques for evaluating quality & safety. Consumers should be aware that not all products available on market may be safe & effective & should always consult their healthcare provider before taking any supplement.

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