Frequently Asked Questions (FAQ)
The Food and Drug Administration (FDA) defines a dietary supplement to be a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combination of these ingredients.
The Food and Drug Administration (FDA) regulates dietary supplements. While dietary supplement manufacturers are responsible for the safety of their products, they do not need to get government approval before producing or selling their products. FDA is not responsible for determining the efficacy of dietary supplements. The law specifies certain conditions under which FDA can take action to remove a dietary supplement from the market based on evidence that it presents a significant or unreasonable risk or is otherwise adulterated. The advertising of dietary supplements is regulated by the Federal Trade Commission (FTC).
NLM® did not select the products for the database. Products were selected by our Database Providers based on market shares of supplement categories and products within those categories found at retail outlets such as drugstores, supermarkets and vitamin stores.
We do not have information on all products sold by a manufacturer but strive to obtain information on each manufacturer’s most popular products. We will continue to add products as we obtain product data.
We do not test or in any way evaluate the products in the database. However, results of product evaluations by non-governmental test laboratories are provided when available.
The Government does not validate the manufacturers' claims. The responsibility for ensuring the validity of the product claims rests solely with the manufacturer.
The FDA does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label.
Manufacturers of dietary supplement products are required to use "Good Manufacturing Practices" (GMPs). GMPs frequently include quality and purity testing. Consumers can address questions about the quality and purity of a specific product to the manufacturer or distributor using contact information noted on the product label. A few commercial organizations have been testing the potency and purity of supplements. Some provide approval seals that may be displayed on products that have passed laboratory tests for potency and contaminants. The approval seal is intended to provide assurance to consumers that the product contains the ingredients listed on the label and that it does not contain harmful levels of measured contaminants. However, these approval seals do not mean that the product is safe or effective. Test results, when available, for supplements in this database are displayed with all products tested.
The following is a list of several organizations that test dietary supplements:
- ConsumerLab.com approved quality product seal: http://www.consumerlab.com/seal.asp
- NSF International dietary supplement certification: http://www.nsf.org/business/dietary_supplements/index.asp?program=DietarySups
- U.S. Pharmacopeia dietary supplement verification program: http://www.usp.org/USPVerified/dietarySupplements/
NLM® does not stock or sell any products in the database. The mention of specific products, or usage does not constitute or imply a recommendation or endorsement by NLM. Addresses and telephone numbers are provided so that you may contact manufacturers for further information.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), this disclaimer must be displayed on the product label because current laws do not require the Food and Drug Administration (FDA) to evaluate the efficacy of specific dietary supplements.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. FDA does receive notification prior to marketing for some dietary supplement ingredients and reviews the safety of these ingredients. Portions of those notifications and the FDA evaluations are available for review on the FDA website http://www.fda.gov/ohrms/dockets/dockets/95s0316/95s0316.htm
If you think you have suffered a serious harmful effect or illness from a dietary supplement, the first thing you should do is contact or see your healthcare provider immediately. Then, you and your health care provider are encouraged to report this problem to FDA at 1-800-FDA-1088
Natural is not necessarily safe. For example, the “natural” herb comfrey contains certain alkaloids that, when ingested, have been linked to serious, even fatal, liver damage. Even certain vitamins can be toxic at high doses. And certain supplements have been found to interact with other medications in ways that could cause injury.
This database has been designed to help you review studies of the effectiveness of specific ingredients of supplements. After entering an ingredient in the Ingredients Search Box you will be presented with a variety of information sources.
The National Library of Medicine® does not test, analyze or rate dietary supplements, nor can we recommend certain products. You may wish to ask your health care provider to make a recommendation. If you have questions about a specific product of dietary supplements, you can contact the manufacturer for more information. Ask to speak to someone who can address your questions, some of which may include:
- What information does the firm have to substantiate the claims made for the product? Demand documented peer-reviewed proof of their claims of safety and effectiveness of the ingredients in the product. Do not rely solely on undocumented reports from satisfied customers.
- Does the firm follow good manufacturing practices and have a quality control system in place to determine if the product actually contains what is stated on the label and is free of contaminants? Do they have the results of tests of purity, contamination and safety of the product by third-party laboratories? Has the firm received any adverse events reports from consumers using their products?
The FDA requires manufacturers of dietary supplements to provide the following information on product labels:
- Product Name including the word "supplement" or a statement that the product is a supplement, net quantity of contents, directions for use and name and address of manufacturer/distributor
- Supplement Facts panel with serving size and list of dietary ingredients with amount per serving size and percent of Daily Value, if established. If the dietary ingredient is a botanical, the name and part of the plant used If the plant is a proprietary blend (i.e., a blend exclusive to the manufacturer), the total weight of the blend and the components of the blend in order of predominance by weight
- Other ingredients such as fillers, artificial colors, sweeteners, flavors, or binders listed by weight in descending order of predominance and by common name or proprietary blend
- The label of the supplement may contain a cautionary statement but the lack of a cautionary statement does not mean that no adverse effects are associated with the product. A label for a fictitious dietary supplement product may be found here.
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