Dietary supplements are subject to a wide array of federal government regulations in the U.S., according to a new report published by the non-profit American Botanical Council (ABC), Austin, TX. Titled “The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled,” the article was published online and will appear in the winter issue of ABC’s quarterly, peer-reviewed journal HerbalGram. It is the second from ABC on this subject; in 2000, ABC published a seminal article titled “Regulation in the Herb Market: The Myth of the ‘Unregulated Industry’” in HerbalGram. It was written by the co-author of the present article, R. William Soller, PhD, an expert on health policy and the use of non-prescription medications for self-care who has a long history in the regulation of both dietary supplements and non-prescription medications.

Now, just more than a decade later, Dr. Soller and others have developed a greatly expanded follow-up article to clarify the breadth and depth of regulation of dietary supplements. The authors re-encapsulate the Dietary Supplement Health and Education Act of 1994 (DSHEA) and provide an in-depth review of important legislation amending the Federal Food, Drug, and Cosmetic Act (FDCA) passed over the last 12 years since the publication of the previous article. Such additional legislation includes the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006), the FDA Amendments Act (2007) and the FDA Food Safety Modernization Act (2011). To illustrate, the authors have included several thorough, easy-to-navigate charts summarizing key developments that build on the legal framework and core authorities of the current dietary supplement regulatory infrastructure.

“Today, under DSHEA and subsequent amendments to the FDCA, FDA has broad statutory authority to regulate dietary supplements appropriately and those who manufacture, distribute, and sell them, and to take enforcement action against unsafe or mislabeled products and those who sell them to fulfill the agency’s mandate to protect and promote public health and safety,” the authors wrote. “Nevertheless, critics still echo the accusation that dietary supplements are an unregulated industry. This is a myth.”

“In fact, a comprehensive review of the available evidence strongly supports the conclusion that FDA has ample authority under current law to remove unsafe dietary supplements from the marketplace and enforce the misbranding (mislabeling) provisions of the law,” they continued. 

Mark Blumenthal, editor of HerbalGram and founder and executive director of ABC, said, “Almost 12 years ago, when we asked Dr. Soller to write the original article, we were concerned about the lack of understanding by many people in the media, health professions, Congress and the general public regarding the regulatory authorities held by both the FDA and the FTC.”

“What’s more surprising, and disappointing,” he added, “is that an entire decade has passed since we published the initial article and 17 years since the passage of DSHEA, many people are still not clear about the extent of government regulation of herbal products and other dietary supplements.”