Joel Rothman is an attorney with the Florida law firm Rutherford Mulhall, P.A. where he practices intellectual property and business litigation. Joel maintains The Nutritional and Dietary Supplement Law Blog, a legal weblog on nutritional and dietary supplement regulation and litigation.
- I. DSHEA A. NDI’s
B. Banned substances II. Supplement Labeling and Advertising; Organic Designation
A. FDA Label Claims
B. FTC Advertising Claims
C. Organic Products Regulation
D. Controlled Substances III. International Regulation
IV. Secondary Resources and Bibliographic Information
V. Industry Associations
Nutritional and dietary supplements are a multi-billion dollar business in the United States. Nutritional supplements such as vitamins, minerals, herbs, botanicals, amino acids, and other substances derived from fruits, vegetables or animals play an important role in many peoples health regimens.
The supplement industry is regulated by several different agencies. This makes researching laws and information regarding supplements somewhat difficult. This non-exhaustive guide to resources is provided to assist those who are researching this field.
Nutritional supplements are regulated differently from pharmaceuticals in the United States. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the Federal Food, Drug and Cosmetics Act, substances that are “dietary supplements” or contain a “dietary ingredient” are considered safe and may be sold unless such supplement or ingredient is shown to present “a significant or unreasonable risk of illness or injury.” Therefore, unlike drugs, supplements may be sold without prior approval from the Food and Drug Administration.
The FDA has published a document entitled Overview of Dietary Supplements, dated January 3, 2001. This document is an excellent introduction to dietary and nutritional supplements and should be read first by anyone interested in researching the laws concerning this particular industry.
The US regulatory structure for dietary and nutritional supplements is confusing to say the least. At the FDA, the Office of Nutritional Products, Labeling, and Dietary Supplements, part of the Center for Food Safety and Applied Nutrition, develops policy and regulations for dietary supplements, nutrition labeling and food standards. In addition, DSHEA established the Office of Dietary Supplements of the National Institutes of Health which has an education and scientific research role relating to dietary supplements.
Under DSHEA there are two kinds of supplements or supplement ingredients: “new dietary ingredients” (NDI) which are substances that were not marketed in the United States prior to October 15, 1994, the date DSHEA became law, and dietary ingredients that had already been in the food supply prior to DSHEA. If a dietary ingredient was already in the food supply before DSHEA was enacted no special steps are required in order to sell such a supplement.
However, if a supplement maker wishes to market a supplement containing an NDI, before doing so it must file with the FDA a new dietary ingredient notification that provides information to FDA about the safety of the NDI 75 days in advance of marketing. The specific regulations for NDI’s are at 21 CFR 190.6. The NDI notification must include information that is the basis for the company’s conclusion that the dietary supplement will “reasonably be expected to be safe.”
The FDA collects and posts 75-Day Premarket Notifications for New Dietary Ingredients. To make access to and understanding of NDI’s easier, the American Herbal Products Association in conjunction with NDI Center created a database of new dietary ingredient notifications that can be accessed for a fee. There is also an excellent article on NDI’s available online that contains an extensive analysis of notifications submitted to the FDA over a ten-year period. McGuffin, M. and AL Young. 2004. Premarket notifications of new dietary ingredients – a ten-year review. FDLJ 59(2):229-244
Very few substances have been banned by the FDA since the passage of DSHEA. Most recently, Ephedra, a compound derived from herbs that was used widely in diet pills, was banned because the FDA claimed that it raised blood pressure and heart rate and, as a result, could cause heart problems including ST-Elevation Myocardial Infarction (STEMI) and Non-ST Segment Myocardial Infarction (NSTEMI). Documents concerning the FDA ban on Ephedra are collected here.
Within this regulatory environment, advertising and labeling issues are by far the most common among legal issues facing supplement makers. The FDA has jurisdiction over claims made by nutritional supplement manufacturers on their supplement labels, while the Federal Trade Commission has jurisdiction over advertising claims made for supplements. Since the passage of DSHEA, the FDA and FTC have aggressively gone after supplement makers who exaggerate label and advertising claims and fail to provide scientific support for their claims.
The FDA has published non-binding guidance documents that reflect the agency’s views concerning what may or may not be claimed in supplement labeling. The FDA Dietary Supplement Labeling Guide is a good starting point. The FDA also maintains an extensive web site containing resources on Label Claims.
There are several types of claims. An authorized health claim is an “explicit or implied characterization of a relationship between a substance and a disease or a health-related condition.” According to the FDA, a health claim “describes the effect a substance has on reducing the risk of or preventing a disease, e.g., ‘calcium may reduce the risk of osteoporosis.'” This type of claim requires significant scientific agreement and must be authorized by FDA. The FDA maintains a list of authorized health claims here.
A qualified health claim is supported by less scientific evidence than an authorized health claim. FDA requires that qualified claims be accompanied by a disclaimer that explains the level of the scientific evidence supporting the relationship. The FDA maintains a list of authorized qualified health claims here.
A structure/function claim describes the role of a substance intended to maintain the structure or function of the body. Structure/function claims do not require preapproval by FDA. Structure/function claims are permitted with have substantiation that such statement is truthful and not misleading; include a required disclaimer; and the marketer notifies FDA of the claim no later than 30 days after the first marketing of the product.
When the FDA learns of a supplement claim it believes violates the provisions of the Food, Drug and Cosmetic Act or regulations promulgated thereunder, it sends a letter to the supplement manufacturer or marketer advising them of the questionable claims, the potential violations raised by those claims, and a request that the claims be withdrawn. The FDA posts these letters in a database on the internet that is searchable by date, month and type of violation. Responses to these letters are also posted when received.
Unfair or deceptive acts or practices in or affecting commerce are illegal under Section 5 of the Federal Trade Commission Act. Such acts or practices include advertising for nutritional or dietary supplements. The Federal Trade Commission enforces the FTC Act and a variety of other laws that protect consumers from unfair, deceptive or fraudulent practices, including deceptive and unsubstantiated advertising.
FTC maintains a guide for nutritional supplement advertising called FTC Dietary Supplements: An Advertising Guide for the Industry. Investigations and cases brought by the Federal Trade Commission against nutritional supplement manufacturers for deceptive advertising have been collected at FTC.gov here.
The USDA also maintains a site containing information on dietary supplements and herbal products at the USDA Food and Nutrition Information Center. The United States Department of Agriculture also regulates the use of the designation “organic” for consumer products including nutritional supplements through the National Organic Program.
Nutritional and Dietary Supplements cannot legally be sold if they contain controlled substances. While it is unusual for the Drug Enforcement Administration, the agency that regulates and prosecutes controlled substance law, to become involved with supplements, there have been occasions, most notably supplements that contain steroids and issues relating to hemp.
The World Health Organization has published the International Digest of Health Legislation that collects information on international regulation of foods, drugs and supplements. International standards for dietary supplements and ingredients are created and published by the Codex Alimentarius Commission which is part of the FAO/WHO Food Standards Program. The WHO also publishes Nutrition labels and health claims: the global regulatory environment, a comprehensive publication on international nutritional labeling regulations. A British supplement industry organization, the Alliance for Natural Health, has assembled an archive of documents including links to EU supplement regulations.
The FDA maintains a page entitled Information Materials for the Food and Cosmetics Industries that contains a catalog of publications and other materials available from non-government sources as well as FDA and other agencies, many of which deal with nutritional substances. The American Society of Nutrition archives The Journal of Nutrition in full text format on its site at http://www.nutrition.org. The Food and Drug Law Institute, publishers of the Food and Drug Law Journal, maintains a database of abstracts online, but you must join the institute, or subscribe to the journal, to get full text access.
The National Academies Press has published Proposed Framework for Evaluating the Safety of Dietary Supplements which is available for free browsing and pdf download in full text format on the internet.
The websites belonging to the various nutritional and dietary supplement industry groups contain a wealth of information. The American Herbal Products Association maintains several resources for researchers. In addition to the NDI database mentioned above, AHPA also provides direct access to HerbMed, an interactive, electronic herbal database that provides hyperlinked access to the scientific data underlying the use of herbs for health. This public site provides free access to 45 herbs (top 40 + controversial herbs), but to access information regarding the remainder of the herbs a subscription is required. The American Herbal Pharmacopoeia publishes information about herbal products and helps develop botanical reference standards for the industry, all of which are available for purchase on its site. Similarly, the American Botanical Council publishes a wealth of information on herbs and botanicals, including HerbalGram, a quarterly journal available by subscription.
The National Nutritional Foods Association is one of the oldest and largest industry groups supporting the nutritional and dietary supplement industry. The NNFA maintains a large number of publications including scientific backgrounders on different dietary ingredients and studies and surveys regarding supplement use. The American Society for Nutrition publishes The Journal of Nutrition, and articles are searchable on its site but only abstracts can be accessed for free.
Several webblogs collect information on different aspects of health law that may be relevant to those researching the law relating to nutritional and dietary supplements. Medlogs.com is a comprehensive news and weblog aggregator for medical related information. HealthLawProf Blog is contains expert commentary on health law issues of all kinds by S. Elizabeth Malloy, Professor of Law & Director, Weaver Institute of Law & Psychiatry, Univ. of Cincinnati College of Law, and Thomas W. Mayo, Associate Professor of Law, SMU School of Law and Adjunct Associate Professor, Univ. of Texas, Southwestern Medical School (Dallas).
Of course, I must mention my own blog, the Nutritional and Dietary Supplement Law Blog. In addition to the resources mentioned above, nutrisuplaw.com also contains an extensive list of links to the large number of associations, trade organizations and lobbying groups that serve various aspects of the nutritional supplement industry.