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Guide To Nutritional Supplements
Guide To Nutritional Supplements
As with medications and over-the-counter drugs, there are risks in taking supplements. Many supplements contain active ingredients that have strong biological effects. Depending on usage, this could make them unsafe. For example, the following actions could lead to harmful consequences:
The Food and Drug Administration (FDA) receives many questions about the labeling of dietary supplements. These questions are a consequence of the activity in this area over the past several years. Some of the important events relating to the labeling of dietary supplements include:
We have prepared this guide to help assure that the dietary supplements sold in the United Stated (U.S.) are properly labeled. This guide applies to dietary supplements produced domestically as well as those produced in foreign countries. Under our regulations, label approval is not required to import or distribute a dietary supplement.
We have included the most frequently raised questions about the labeling of dietary supplements using a "question and answer" format. If you have a question not addressed in this guide, please contact an FDA District Office (see Appendix A of this guide) or the:
Please be advised that you must comply with any requirements for dietary supplements that may publish after this booklet is issued. New regulations are published in the Federal Register prior to their effective date and are compiled annually in Title 21, Part 101 of the Code of Federal Regulations (21 CFR 101). Summaries of our new regulations (proposed regulations and final regulations) are posted on our Internet Website ( ).
You must list the specific magnesium salt in the ingredient statement below the "Supplement Facts" panel, not in the "Nutrition Facts" panel. Ingredients in dietary supplements that are not dietary ingredients, such as binders, excipients, fillers, must be included in the ingredient statement.
The % DV must be declared for all dietary ingredients for which FDA has established Daily Values, except that 1) the percent for protein may be omitted, and 2) on the labels of dietary supplements to be used by infants, children less than 4 years of age, or pregnant or lactating women, you must not list any percent for total fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, vitamin K, selenium, manganese, chromium, molybdenum, chloride, sodium, or potassium. See Appendix B for the daily values to be used for adults and children 4 or more years of age and Appendix C for the daily values to be used for infants, children less than 4 years of age, or pregnant or lactating women.
No. You are not required to place the footnote on dietary supplements that is required by 21 CFR 101.9(d)(9) on conventional foods. However, you are required to include the footnote "Percent Daily Values are based on a 2,000 calorie diet" when you declare total fat, saturated fat, total carbohydrate, dietary fiber, or protein.
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations.
Anyone participating in deceptive marketing is potentially liable under FTC law. Marketers of dietary supplements and other health-related products should ensure that anyone participating in marketing is familiar with basic FTC advertising principles. All parties who participate directly in marketing and promotion, or who have authority to control those practices, have an obligation to make sure that claims are presented truthfully and to check the adequacy of the support for those claims. The FTC has taken action not just against product marketers, but also, in appropriate circumstances, against individual owners and