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FDA & NDA Multivitamin Requirements

Multivitamins contain both vitamins and minerals with a classification as a dietary supplement; because of this classification, the U.S. Food and Drug Administration, known as the FDA, does not require a New Drug Application, or NDA. However, a multivitamin that contains high doses of one or several vitamins may require a prescription and any new dietary ingredient requires a pre-market notification.

  1. NDA & FDA process

    • The NDA is the primary vehicle for drug manufacturers to propose that a new drug be approved by the FDA for sale and marketing in the United States. NDA documentation of a drug states the clinical results, information from animal studies, the drug's performance in the body, the ingredients and the production and packing of the drug. The FDA's role after the NDA gathers adequate information is for a reviewer to determine if the drug is safe and effective and if the benefits outweigh any risks, if the packaging is appropriate and contains the right information and that the drug's quality upholds against FDA standards.

    Regulation

    • In 1994, President Clinton signed into law the Dietary Supplement Health and Education Act, known as DSHEA. This law requires drug manufacturers to be responsible for determining that its products are safe, its labeling is not misleading, and that any claims about a product's intended purpose(s) are proven by ample evidence. Basically, the new law means that drug manufacturers are no longer required to seek FDA approval for dietary supplements unless the product is a new dietary ingredient or exceeds recommended dietary allowance know as the RDA.

    New Dietary Ingredient Notification

    • If the ingredient, which include a vitamin, mineral, herb or other botanical or amino acid, was not available in the United States before 1994, the FDA considers it a new dietary ingredient. Distributors and manufacturers who are interested in marketing a new dietary ingredient or a supplement that contains a new dietary ingredient must submit a pre-market notification. If manufacturers market the new dietary ingredient without notification, the FDA adulterates the ingredient and it becomes subject to the law. The notification must contain information about the history of the ingredient if it has not been used in the food supply and the assurance that consumption of the new dietary ingredient is "reasonably expected to be safe" according to any claims made on its label. Also, the pre-market notification should include a description of the product, conditions of use for the new dietary ingredient, how much of the ingredient is in the product and any reference materials.

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