Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA

Laws Regulating Dietary Supplements Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Food, Drug, and Cosmetic Act (FD&C Act)  Defined the term dietary supplement  Included dietary supplements under the FD&C Act’s adulteration provisions  Established requirements for new dietary ingredients

Definition of Dietary Supplement Product (other than tobacco) that is intended to supplement the diet Contains one or more of the following dietary ingredients:  Vitamin  Mineral  Herb or other botanical  Amino acid

Definition of Dietary Supplement Dietary ingredients (continued):  Other dietary substance used by man to supplement the diet by increasing total dietary intake (e.g., glandulars, organ tissues & enzymes)  A concentrate, metabolite, constitute, extract, or combination of any of the above dietary ingredients

Dietary Supplement Forms Tablet Capsule Liquid Powder Softgel Gelcap

Other Requirements for Dietary Supplements Cannot be represented as a:  Conventional food  Sole item of a meal Must be intended for ingestion Must be labeled as a dietary supplement

Excluded As Dietary Supplements Articles approved or authorized for investigation as a new drug, antibiotic, or biologic that were not first marketed as a dietary supplement or as a food

Structure-Function Claims 21 CFR May make claims about:  Nutritional deficiency disease  Structure/function  Mechanism of effect on structure/function  General Well Being

Requirements to make claims Must be an allowed claim Must have substantiation it is truthful and not misleading May not claim to treat/cure/prevent disease Must use mandatory disclaimer Must notify FDA

NOTIFICATION REQUIREMENTS: Ingredients: New Dietary Ingredients (NDIs) NDI: Those ingredients that were not marketed in the U.S. prior to October 15, 1994  Note : There is no authoritative list of dietary ingredients that were marketed before October 15, 1994

NDI Premarket Notifications Manufacturers or distributors must submit a notification to FDA 75 days before a new dietary ingredient is marketed or introduced for marketing in the U.S. This notification must meet the requirements of 21 CFR § (

NDI Premarket Notifications Safety standard is history of use or other evidence of safety establishing that the NDI, when used under the conditions recommended or suggested in the labeling, is reasonably expected to be safe. Notification must set forth manufacturer’s basis upon which they have concluded they have met standard.

NDI Notification Process For 75 days after the “filing” date, the manufacturer or distributor is not permitted to introduce or deliver for introduction into interstate commerce the dietary supplement(s) containing the NDI.

NDI Notification Process For 90 days after the “filing” date, FDA will not disclose the existence of, or information contained in, the NDI notification. Afterwards, the NDI notification will be placed on public display at FDA’s Documents Management Branch in Docket number 95S-0316.

NDI Notification Process New dietary ingredients reviewed by FDA are not “approved” or “authorized” by FDA. If a manufacturer or distributor does not hear from FDA by 75 days after the “filing” date of its notification, it may legally market in the U.S.

Safety Responsibilities The manufacturer of a dietary supplement is responsible for ensuring that it is safe before it is marketed in the U.S. FDA is responsible for taking action against any unsafe dietary supplements after they are marketed in the U.S.

Adulteration of Dietary Supplements A dietary supplement is adulterated if it:  Poses a significant or unreasonable risk of illness or injury when it is used as directed on the label  Poses an imminent hazard to public health or safety  Contains a poisonous or harmful substance  Contains an NDI unless: There is history of use as a food in the U.S. in a form not chemically altered, or There is evidence of safety and the NDI has been reviewed by FDA through the 75-day premarket notification process

Product quality: At present, the manufacturer is responsible for establishing its own guidelines to ensure that the dietary supplements and dietary ingredients it produces are safe and contain the ingredients declared on the label.

CONTACTS for dietary supplement information   Click dietary supplements in middle of page  General Questions  Bradford Williams (301)  Notifications  new dietary ingredients(75 DAY): Ms. Victoria Lutwak  Claims(30 day): Dr. Robert Moore,