Press Release: CRN Welcomes GMP Final Rule

Position Statement: Dietary Supplement Good Manufacturing Practices Long Overdue; Mainstream Industry Ready, Willing and Waiting for GMPs (PDF)

Press Release: CRN Celebrates Passage of AER Bill; Commends Congress on This Important Milestone for Industry, Consumers

Position Statement: Industry Should be Required to Report Serious Adverse Events (AEs) to FDA (PDF)

Click here for CRN's informational ad on AERs

NOTE: Legislation requiring the reporting of all serious adverse events was passed on Dec. 20, 2006 and will go into effect a year from that date. Click here for details on CRN/CHPA seminar on AERs, coming June 20, 2007.

DSHEA Summary & Analysis

When it enacted the Dietary Supplement Health and Education Act of 1994, Congress recognized the role supplements can play in health promotion and in the prevention of chronic diseases such as cancer, heart disease, and osteoporosis. This comprehensive piece of legislation established a new regulatory framework for supplements, ensuring continued access to safe products, made to quality standards. It also allowed for increased dissemination of information about the health benefits of these products.

In signing the Act in 1994, President Clinton stated that "After several years of intense efforts, manufacturers, experts in nutrition, and legislators-- acting in a conscientious alliance with consumers at the grassroots level-- have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law." The White House press release concluded by saying "in an era of greater consciousness among people about the impact of what they eat on how they live and how long they live, it is appropriate that we have finally reformed the way Government treats consumers and supplements in a way that encourages good health."

The legislation defined dietary supplements, created a mechanism for dealing with safety issues, regulated health claims and labeling of dietary supplements, provided for good manufacturing practices, and established new government entities to review regulations and encourage research on dietary supplements. The provisions which will aid the millions who rely on dietary supplements to improve their health are:

Definition - A dietary supplement is any product which contains one or more dietary ingredients such as vitamins, minerals, herbs or other botanicals, amino acids or other ingredients used to supplement the diet. Dietary supplement ingredients may not be regulated as food additives.

Safety- The legislation maintains FDA's authority to safeguard the public against any unsafe product. A dietary supplement can be removed from the market if FDA shows that it presents "a significant or unreasonable risk of illness or injury" or that it contains "a poisonous or deleterious substance which may render it injurious to health." FDA can act immediately against any product that presents an "imminent hazard to public health or safety."

New Products - Before marketing a new dietary ingredient, a manufacturer must supply FDA with adequate information to provide "reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury." This information must be supplied at least 75 days before marketing. A "new dietary ingredient" is one that is first marketed after October 15, 1994.

Claims - Truthful and nonmisleading claims that describe the role of a nutrient in supporting wellness will still be allowed on dietary supplement labels. (Examples: calcium builds strong bones; antioxidants protect against cell damage.) These claims are referred to as structure/function claims or nutritional support claims. Manufacturers must: a) have substantiation for these claims and b) notify FDA of the claim being made within 30 days of first marketing the supplement. In some cases, the label may have to include the following disclaimer: "This statement has not been evaluated by FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." A product making this kind of claim may not be classified as a drug solely because of the claim.

The legislation did not change the procedure for FDA approval of health claims, as established by the Nutrition Labeling and Education Act of 1990. (Example: calcium may reduce the risk of osteoporosis.) Health claims state the relationship between a nutrient and a "health-related condition." Such claims must be supported by "significant scientific agreement" and must be pre-authorized by FDA.

Publications, including articles in scientific journals, can be distributed by dietary supplement sellers as long as they are not false or misleading, do not promote a specific brand, present a balanced view of the scientific evidence, and are displayed separately from dietary supplements. If FDA asserts the material is false or misleading, the agency must prove it in court.

Labeling - A dietary supplement label must list the name and quantity of each active ingredient; identify the product as a dietary supplement; and for herbal supplements, identify the part of the plant from which it is taken. Nutrition labeling must be presented in a format appropriate to the product. If a dietary supplement claims to conform to an official standard (such as USP), it must do so.

Good Manufacturing Practices (GMP's) - Supplements must be in compliance with current good manufacturing practices. FDA is authorized to issue special regulations on GMP's for dietary supplements, modeled after food GMP's. These regulations may require expiration dating on the label.

New Government Entities - The Dietary Supplement Act established two new government bodies:

Commission on Dietary Supplement Labels - A Commission was created to conduct a study on dietary supplement label claims and "evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families." After the Commission submits a final report, FDA must implement any necessary regulatory changes, through formal rulemaking, within two years.

The Commission's seven members were appointed by the President in October of 1995. The legislation requires that the Commission's report be completed by the end of October 1996. The Commission is composed of three nutritionists, two experts on herbs, an attorney, and a specialist in government relations and public affairs. They are: Dr. Malden Nesheim of Cornell University, Chairman; Dr. Shiriki Kumanyika of the University of Illinois; Dr. Annette Dickinson of the Council for Responsible Nutrition; Dr. Norman Farnsworth of the University of Illinois; Robert McCaleb of the Herb Research Foundation in Boulder, CO; Margaret Gilhooly of Seton Hall University School of Law in Newark; and Anthony Podesta of Podesta Associates in Washington, DC. The Executive Director of the Commission is Dr. Kenneth Fisher, formerly of LSRO/FASEB (Life Sciences Research Office of the Federation of American Societies of Experimental Biology).

Office of Dietary Supplements - An office was established within the National Institutes of Health to coordinate research on dietary supplements and disease prevention, develop a database of supplement research, and advise the Secretary of Health and Human Services on supplement regulation, safety, and health claims. NIH has changed the name to "Office of Dietary Supplements Research," signaling a focus on the research-oriented aspects of the mandate. Dr. Bernadette Marriott, formerly a project director with the Food and Nutrition Board of the National Academy of Sciences, is the Executive Director.

The importance of nutrition and the benefits of dietary supplements in health promotion and disease prevention have been documented increasingly in scientific studies;

There is a link between ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;

Preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases and reduce long-term health care expenditures;

Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;

There is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;

National surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals or herbs as a means of improving their nutrition;

Legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness;

Dietary supplements are safe within a broad range of intake, and safety problems with supplements are relatively rare;

Although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;

A rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements.