Dietary supplements (21 CFR 190.6)

604 21 CFR Ch. I (4–1–16 Edition) Pt. 190 Information received by the Food and Drug Administration establishes that the use of such a capsule on wine bot tles may reasonably be expected to re sult in lead becoming a component of the wine. (b) The capping of any bottles of wine after February 8, 1996, with a tin-coat ed lead foil capsule renders the wine adulterated and in violation of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act because lead from the capsule, which is an unsafe food ad ditive within the meaning of section 409 of the act, may reasonably be ex pected to become a component of the wine. [61 FR 4820, Feb. 8, 1996] PART 190—DIETARY SUPPLEMENTS Subpart A [Reserved] Subpart B—New Dietary Ingredient Notification Sec. 190.6 Requirement for premarket notifica tion. AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 350b, 371). SOURCE: 62 FR 49891, Sept. 23, 1997, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 190 appear at 66 FR 56035, Nov. 6, 2001. Subpart A [Reserved] Subpart B—New Dietary Ingredient Notification § 190.6 Requirement for premarket no tification. (a) At least 75 days before intro ducing or delivering for introduction into interstate commerce a dietary supplement that contains a new die tary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer or distributor of that supplement, or of the new dietary in gredient, shall submit to the Office of Nutritional Products, Labeling and Di etary Supplements (HFS–820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, information including any cita tion to published articles that is the basis on which the manufacturer or distributor has concluded that a die tary supplement containing such die tary ingredient will reasonably be ex pected to be safe. An original and two copies of this notification shall be sub mitted. (b) The notification required by para graph (a) of this section shall include: (1) The name and complete address of the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient; (2) The name of the new dietary in gredient that is the subject of the pre market notification, including the Latin binomial name (including the au thor) of any herb or other botanical; (3) A description of the dietary sup plement or dietary supplements that contain the new dietary ingredient in cluding: (i) The level of the new dietary ingre dient in the dietary supplement; and (ii) The conditions of use rec ommended or suggested in the labeling of the dietary supplement, or if no con ditions of use are recommended or sug gested in the labeling of the dietary supplement, the ordinary conditions of use of the supplement; (4) The history of use or other evi dence of safety establishing that the dietary ingredient, when used under the conditions recommended or sug gested in the labeling of the dietary supplement, will reasonably be ex pected to be safe, including any cita tion to published articles or other evi dence that is the basis on which the distributor or manufacturer of the die tary supplement that contains the new dietary ingredient has concluded that the new dietary supplement will rea sonably be expected to be safe. Any ref erence to published information offered in support of the notification shall be accompanied by reprints or photostatic copies of such references. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00614 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 605 Food and Drug Administration, HHS § 190.6 (5) The signature of the person des ignated by the manufacturer or dis tributor of the dietary supplement that contains a new dietary ingredient. (c) FDA will acknowledge its receipt of a notification made under section 413 of the Federal Food, Drug, and Cos metic Act (the act) and will notify the submitter of the date of receipt of such a notification. The date that the agen cy receives the notification submitted under paragraph (a) of this section is the filing date for the notification. For 75 days after the filing date, the manu facturer or distributor of a dietary sup plement that contains a new dietary ingredient shall not introduce, or de liver for introduction, into interstate commerce the dietary supplement that contains the new dietary ingredient. (d) If the manufacturer or distributor of a dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient, provides additional information in support of the new die tary ingredient notification, the agen cy will review all submissions per taining to that notification, including responses made to inquiries from the agency, to determine whether they are substantive and whether they require that the 75-day period be reset. If the agency determines that the new sub mission is a substantive amendment, FDA will assign a new filing date. FDA will acknowledge receipt of the addi tional information and, when applica ble, notify the manufacturer of the new filing date, which is the date of receipt by FDA of the information that con stitutes the substantive amendment. (e) FDA will not disclose the exist ence of, or the information contained in, the new dietary ingredient notifica tion for 90 days after the filing date of the notification. After the 90th day, all information in the notification will be placed on public display, except for any information that is trade secret or oth erwise confidential commercial infor mation. (f) Failure of the agency to respond to a notification does not constitute a finding by the agency that the new die tary ingredient or the dietary supple ment that contains the new dietary in gredient is safe or is not adulterated under section 402 of the act. [62 FR 49891, Sept. 23, 1997, as amended at 66 FR 17359, Mar. 30, 2001] PARTS 191–199 [RESERVED] VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00615 Fmt 8010 Sfmt 8006 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R