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Dietary Supplements

Under Dietary Supplement Health and Education Act (DSHEA) of 1994, a dietary supplement company is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

FDA regulations require that certain information appear on dietary supplement labels. Information the must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product. In addition, each dietary supplement (except some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a "Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

Our Dietary Supplements Practice includes:

  • labeling advice and opinions

  • establishment registration and reporting

  • advising device manufacturers regarding compliance with FDA regulations

  • inspections and recalls

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