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U.S. Department of Health and Human Services

Food

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An Algorithm for the Decision Tree to Determine When a Dietary Ingredient Requires a New Dietary Ingredient Notification Before Marketing

(Return to main Guidance document)

  1. Was the dietary ingredient marketed in the U.S. before October 15, 1994? (See IV.A.5 and IV.A.8.). If yes, Go to 2. If no, go to 7.
  2. Have there been any proposed or implemented changes to the manufacturing process for the dietary ingredient? If yes, Go to 3. If no, go to 5.
  3. Does the new manufacturing process change the identity of the ingredient (e.g., different chemical structure or composition, use of extraction, use of a different starting material, such as a different part of a botanical)? (See IV.A.11.) If yes, Go to 4. If no, go to 5.
  4. Was the dietary ingredient, in its revised form, marketed as a dietary ingredient in the U.S.A. before October 15, 1994? If yes, Go to 5. If not sure, go to , If no, go to 7.
  5. Pre-DSHEA Dietary Ingredient. No NDI notification required.
  6. The manufacturing change may have created an NDI. NDI notification may be required. Consult with FDA.
  7. New Dietary Ingredient (NDI). Has the NDI been present in the food supply as an article used for food? (See section IV.B.) If yes, Go to11. If no, go to 8.
  8. Has the notifier submitted a notification to FDA for a product containing the same NDI with the same or lower NDI intake level, same composition, and same or narrower conditions of use? (See IV.B.1.) If yes, Go to 9. If no, go to 15.
  9. Will the manufacturing process for the new product change the identity of the NDI (e.g., different chemical structure or composition, use of extraction, use of a different starting material, such as a different part of a botanical)? (See IV.B.4.) If yes, Go to15. If no, go to 10
  10. NDI adulteration standard (21 USC 324(f)(1)(B)) applies. No NDI notification required.
  11. Has the NDI been chemically altered from its conventional food form*?
    *Examples of processes that do not chemically alter an ingredient are minor loss of volatile components, dehydration, lyophilization, milling, or formation of tincture, aqueous solution, slurry, powder, or solid in suspension. See IV.B.3. Examples of changes that chemically alter an ingredient (see IV.B.4 for more details and additional examples):
    1. 11. A. New process makes or breaks chemical bonds. If yes to 11 A,B, C, D or E, Go to 12. If no to 11 A,B, C, D and E, go to 13.
    2. 11. B. New solvents (except tincture or water) or post- extraction processing that changes chemical composition of mixture. If yes to 11 A,B, C, D or E, Go to 12. If no to 11 A,B, C, D and E, go to 13.
    3. 11. C. New manufacturing method (e.g., new agricultural or fermentation conditions) that significantly change chemical composition If yes to 11 A,B, C, D or E, Go to 12. If no to 11 A,B, C, D and E, go to 13.
    4. 11. D. Changes in particle size that also alter chemical properties If yes to 11 A,B, C, D or E, Go to 12. If no to 11 A,B, C, D and E, go to 13.
    5. 11. E. New starting materials (e.g., different part of a plant).   If yes to 11 A,B, C, D or E, Go to 12. If no to 11 A,B, C, D and E, go to 13.
  12. The NDI may have been chemically altered. If so, NDI notification will be required. Consult with FDA.
  13. Is NDI the intake level under the intended conditions of use, the same as, or lower than the intake from conventional food use of the NDI? (See IV.B.2.). If yes, Go to 14. If no, go to 15
  14. Regulatory status of the NDI is unchanged. NDI adulteration standard (21 USC 342(f)(1)(B)) applies.
  15. NDI adulteration standard. (21 USC 342(f)(1)(B)) applies. NDI notification not required, but recommended.