Dietary supplements are subject to a wide array of federal government regulations in the United States, according to a new report published by the nonprofit American Botanical Council (ABC). The article notes numerous authorities to regulate dietary supplements that are granted to the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), as well as other government agencies.
The article, titled “The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled,” has been published online and will appear in the winter issue of ABC’s quarterly, peer-reviewed journal HerbalGram.1 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.2 It was written by the co-author of the present article, R. William Soller, PhD, an expert on health policy and the use of nonprescription medications for self-care who has a long history in the regulation of both dietary supplements and nonprescription medications.
Now, just over a decade later, Dr. Soller, Holly J. Bayne, Esq.—a Washington, DC-based attorney specializing in food and drug law with a focus on dietary supplements and botanicals—and Christopher Shaheen, a researcher at the University of California – San Francisco (UCSF), have developed a greatly expanded follow-up article to clarify the breadth and depth of regulation of dietary supplements. This new article dispels the still-pervasive myth of an unregulated dietary supplement industry. 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 write. “Nevertheless, critics still echo the accusation that dietary supplements are an unregulated industry. This is a myth.”1
“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 continue.
“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,” said Mark Blumenthal, editor of HerbalGram and founder and executive director of ABC.
“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. We trust that this article, once read, will help provide more clarity to this muddled area of significant concern to many stakeholders in the areas of consumer lifestyles, nutrition, self-medication, healthcare, public policy, and related areas.”
“It is puzzling that the myth of the unregulated dietary supplement industry has continued for so many years,” said Bayne. “The passage of DSHEA clearly established a comprehensive legal framework for FDA regulation of dietary supplements. FDA has all the legal authority it needs to protect public health and safety and remove unsafe or mislabeled products from the marketplace. Dietary supplements are clearly regulated by FDA, but they are regulated differently than prescription and OTC [over-the-counter] drug products.”
“FDA has used its ample authority under various laws to build a comprehensive framework of enforceable regulations and interagency collaborations to fulfill its mission to both promote and protect the public health,” said Dr. Soller. “Any remnant of the myth that dietary supplements are an unregulated industry is easily dispelled by a close look at the agency’s activities over the past fifteen years.”
Dr. R. William Soller is the executive director of the Center for Consumer Self Care and a Health Sciences clinical professor of pharmacy in the School of Pharmacy at UCSF. Prior to joining UCSF, he was Senior Vice President of Science and Technology for the Consumer Healthcare Products Association. He is principal author of numerous drug and dietary supplement-related submissions to the FDA on a wide range of subjects related to self-medication.
Holly J. Bayne is the founder of The Law Office of Holly Bayne, P.C. She began her legal career at Hyman, Phelps & McNamara, P.C., the largest law firm in the United States exclusively devoted to the practice of food and drug law. She has extensive experience in advising companies on a wide range of regulatory issues relating to the composition, manufacture, sale, and marketing of herbal products and other dietary supplements.
Christopher Shaheen is a researcher in the Center for Consumer Self Care at the UCSF School of Pharmacy.
The article contains more than 11,000 words, including 3 tables and 79 references, and is available by clicking here.
- Soller RW, Bayne HJ, Shaheen C. The regulated dietary supplement industry: myths of an unregulated industry dispelled. HerbalGram. 2012:93;42-57.
- Soller RW. Regulation in the herb market: the myth of the “unregulated industry.” HerbalGram. 2000:49;64-67.
About the American Botanical Council
Founded in 1988, the American Botanical Council is a leading international nonprofit organization addressing research and educational issues regarding herbs and medicinal plants. ABC's members include academic researchers and educators; libraries; health professionals and medical institutions; government agencies; members of the herb, dietary supplement, cosmetic, and pharmaceutical industries; journalists; consumers; and others in over 80 countries. The organization occupies a historic 2.5-acre site in Austin, Texas, where it publishes the quarterly journal HerbalGram, the monthly e-publication HerbalEGram, HerbClips (summaries of scientific and clinical publications), reference books, and other educational materials. ABC also hosts HerbMedPro, a powerful herbal database, covering scientific and clinical publications on more than 240 herbs. ABC also co-produces the "Herbal Insights" segment for Healing Quest, a television series on PBS.
ABC is tax-exempt under section 501(c)(3) of the IRS Code. Information: Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900. Website: www.herbalgram.org.