Dietary Supplements and Functional Foods: A Practical Guide to FDA Regulation, by Stuart M. Pape, Danial A. Kracov, Paul D. Rubin. Thompson Publishing Group: Tampa, FL; 2001. 394 pp., including nine appendices, plus index, softcover. $307 ISBN 1-930872-02-X.
Comprehensive is the signal word that describes Dietary Supplements and Functional Foods: A Practical Guide to FDA Regulation. Authored by three seasoned and experienced food and drug lawyers, the book tracks the history of dietary supplement law and regulation, and the political basis for the stunning passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). All of the relevant Federal regulatory authorities and their jurisdictions are described. The role of the States is also briefly discussed. Most importantly, this book, in detail and with substantial citation to the law and to FDA's regulations, puts the lie to the national press mantra that dietary supplements are not regulated.
The authors organize this book into relevant subject areas that correspond to the areas of most interest to product developers and manufacturers, with chapters that include history, safety, good manufacturing practices, labels, claims, advertising, inspections and enforcement, and an overview of international regulations. They address in detail the most popular relevant product categories: conventional foods, so-called functional foods and dietary supplements, and medical foods. The regulatory framework for dietary supplements is described, as are the interaction of the food, drug, homeopathic drug and dietary supplement definitions. Against this framework, there is a discussion of the present state of law enforcement. Importantly, there is a substantial discussion of the complex regulatory scheme for the ingredients used in foods and dietary supplements.
There is a good and understandable explanation of DSHEA's new dietary ingredient notification provision, the gatekeeper provision that applies to dietary ingredients that were not on the market in dietary supplements at the time DSHEA was enacted in October of 1994. This provision and this discussion is important because this is the provision that allows the Food and Drug Administration (FDA) to look at, evaluate, and provide its views on new ingredients that are intended for use in dietary supplements. The book is instructive with respect to the do's and don'ts of notifications under this provision and provides a listing of "allowed" and "rejected" new dietary ingredient notifications. It is interesting to note that the listing of allowed new dietary ingredient filings shows that important new dietary ingredients have met the requirements of the act (e.g., huperzine, SAM-e, astaxanthin, plant stanol fatty esters, vinpocetine, 7-keto DHEA, and stevia). This demonstrates that the dietary supplement industry is being attentive to the requirements of law.
Since this book was only recently published, it does not discuss the newly proposed dietary supplement current Good Manufacturing Practices (cGMPs) that were published by FDA in early March 2003. This does not detract from the value of the book to the industry because it will take FDA some time to sort out the many comments it will receive on its proposal and to put together final cGMP regulations. It took FDA almost eight years to evolve from the industry's draft cGMPs to a Federal Register proposal. Moreover, the publisher provides an on-line service that provides more current materials. The on-line service is helpful, but attention to FDA's and FTC's websites and their reports on current matters can be used to keep current.
As Casey Stengel used to say, "You can look it up." This book puts FDA enforcement powers and actions near the end of the text, appropriately enough. Enforcement has, so far, been at the end of FDA's list of priorities, and you can look it up on FDA's website for Warning Letters to dietary supplement marketers and for seizures, injunctions, and criminal prosecutions in the dietary supplement industry. This lack of enforcement led the trade associations of the dietary supplement industry to ask Congress to earmark funding for FDA to enforce DSHEA. In contrast, the book places dietary supplement and functional food advertising ahead of FDA enforcement and describes the controlling principles for advertising, including the competent and reliable scientific evidence standard that controls with respect to substantiation of advertising claims under the Federal Trade Commission (FTC) Act. The FTC is where much of the action is, insofar as enforcement is concerned. In contrast to the FDA, where there has been institutional gridlock with respect to enforcement, the FTC has demonstrated that it can, and will, bring actions against those companies that do not observe the requirements of law. Only in the first half of 2003 has FDA shown a similar resolve.
Most regulatory texts include relevant agency policy and regulations as appendices and this book is no different. It contains FTC's dietary supplement advertising guide, FDA's structure/function claim regulation and new dietary ingredient notification regulation. All of these are valuable and important to anyone in this business. Indeed, these are regulations and guidance that no executive in the dietary supplement industry should fail to read. And this Practical Guide to FDA Regulation of Dietary Supplements and Functional Foods is a good accompaniment to those documents. Think about it. You invest personal and/or stockholder funds in a line of commerce. If it's important enough to invest in, is it not important enough to spend the time necessary to read and to learn the regulatory system under which this business will be operated? If they don't teach that in business success school, they should. This book is a great vehicle to learn about that system, and even though it's priced at just over $300, it's certainly less expensive than one hour of time from any of the lawyers who wrote it.
Hopefully, this book will not become yet another unregarded primer on regulatory compliance and lawful business practices in an industry so blinded by non-enforcement and indifference that it has a very difficult time staying on the right side of the road. This book should be read and followed - and copies should be provided by the industry to the press so that they can heft the weight of regulation on this industry.
- Anthony L. Young
Kleinfeld, Kaplan & Becker, LLP