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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.
References
1.
Soller RW, Bayne HJ, Shaheen C. The regulated dietary supplement industry:
myths of an unregulated industry dispelled. HerbalGram. 2012:93;42-57.
2.
Soller RW. Regulation in the herb market: the myth of the “unregulated
industry.” HerbalGram. 2000:49;64-67.
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