ABC Article Outlines Supplement Regulation Myths

AUSTIN ,TexasA new article in the American Botanical Council (ABC) publication HerbalGram details the numerous federal government regulations for dietary supplements. The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled, which is already published online and is slated for the upcoming winter print issue, was co-written by health policy expert R. William Soller, PhD, who has a long history in the regulation of both dietary supplements and nonprescription medications, along with Washington-based food and drug law attorney Holly J. Bayne, Esq.,  who specializes in dietary supplement and botanicals issues, and Christopher Shaheen, a researcher in the Center for Consumer Self Care at the UCSF School of Pharmacy, San Francisco.

This new article is a follow-up to a similar article published in HerbalGram in 2000 by Soller and others. 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. Whats more surprising, and disappointing is that an entire decade has passed since we published the initial article and 17 years since the passage of DSHEA, [yet] many people are still not clear about the extent of government regulation of herbal products and other dietary supplements."

 The current article revisits the Dietary Supplement Health and Education Act of 1994 (DSHEA) and provides 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, including the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006), the FDA Amendments Act (2007), and the FDA Food Safety Modernization Act (2011). To help readers understand the regulatory picture, the authors 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.

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, Soller said. Any remnant of the myth that dietary supplements are an unregulated industry is easily dispelled by a close look at the agencys activities over the past fifteen years.

 It is puzzling that the myth of the unregulated dietary supplement industry has continued for so many years, Bayne added. 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.