On March 5, FDA published its long-awaited Final Guidance on New Dietary Ingredient Notification (NDIN) Procedures and Timeframes (Final Guidance). This new guidance updates and finalizes Section V of FDA’s revised 2016 Draft Guidance. More specifically, it explains who should submit the NDIN, the information it should and should not contain, and addresses the option to meet with FDA to ask questions and obtain preliminary and nonbinding feedback from the agency regarding planned or potential NDINs, among other topics.What Are New Dietary Ingredient Notifications?Manufacturers must submit an NDIN to FDA 75 days before marketing a new dietary ingredient (NDI). See Federal Food, Drug, and Cosmetic Act (FD&C Act) § 413(a)(2) (codified at 21 U.S.C. §350b(a)(2)). Under the FD&C Act, NDIs are dietary ingredients (i.e., vitamins, minerals, botanicals, amino acids, and substances used to supplement the diet) that were not marketed in the United States before October 15, 1994. 21 U.S.C. 350b(d)).Key Aspects of the Final GuidanceWho must submit? FDA explains that either the manufacturer or distributor of the NDI must submit an NDIN. FDA also clarifies that, in its view, manufacturers or distributors of dietary supplements containing an NDI must submit an NDIN unless the NDI manufacturer’s NDIN included information about the dietary supplement at issue. In particular, FDA requires the NDI manufacturer’s NDIN to include a description of the dietary supplement together with the history of use or other evidence of safety that formed the basis of the conclusion that the dietary supplement would reasonably be expected to be safe under its labeled conditions of use.What information should and should not be in an NDIN? The submission should only contain

11See generally U.S. Food & Drug Admin., Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (Aug. 2016). This draft guidance pertains to implementation of the premarket safety notifications required under current section 413 of the FD&C Act (21 U.S.C. § 350b).12See generally U.S. Food & Drug Admin., Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (Aug. 2016). This draft guidance pertains to implementation of the premarket safety notifications required under current section 413 of the FD&C Act (21 U.S.C. § 350b).

But unfortunately, until Congress enacts a bill, this profitable market will likely remain in an uncertain position.1There are three main types of CBD. CBD isolate is the pure form of CBD, while full-spectrum CBD is an extract containing other compounds of the cannabis plant, such as terpenes and other cannabinoids. The third type is broad-spectrum CBD, which contains many cannabis plant compounds.2https://www.prnewswire.com/news-releases/global-13-4-billion-cannabidiol-market-to-2028---increasing-awareness-cbd-health-benefits-changing-consumer-opinion-and-attitude-toward-cbd-products-301254807.html3See 21 U.S.C. § 350b(a).4See FDA, New Dietary Ingredients (NDI) Notification Process (updated Dec. 16, 2019), https://www.fda.gov/food/dietary-supplements/new-dietary-ingredients-ndi-notification-process.5See 21 U.S.C. § 350b(a)(2).6See id. § 342(f)(1)(B).7See id. § 321(ff)(3)(B).8See id. § 321(ff)(3)(B).

By Wes Siegner –In response to a history of FDA illegal restriction of the marketing of dietary supplements in the 1980s and early 1990s, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”), passing by unanimous consent the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). In simple terms, DSHEA clarified that FDA does not have premarket approval authority over dietary supplements or the dietary ingredients in such products, put the onus for the safety of such products on industry, and established a new dietary ingredient (“NDI”) notification process in section 413 of the FDC Act, 21 U.S.C. § 350b, for certain ingredients that had not been marketed in the United States prior to 1994 to provide notice to FDA of the basis for safety of new ingredients. In July 2011, FDA published a controversial draft guidance that attempted to return the industry to pre-DSHEA restrictions by narrowly interpreting the NDI notification provision of the FDC Act.

I(c)(17) (placing tetrahydrocannabinols—except those in “hemp”—on Schedule I of the CSA).6See,supra, FDA, Cannabis FAQs, A.2.7See,supra, FDA, Cannabis FAQs, A.8.8See 21 U.S.C. § 321(ff)(3)(B).9See, supra, FDA, Cannabis FAQs, A.11.10See, supra, FDA, Cannabis FAQs, A.9.11See id.12See 21 U.S.C. § 350b(d).13See, supra, FDA, Cannabis FAQs, A.9.14See id.15See, supra, FDA, Cannabis FAQs, A.10.16See 21 U.S.C. §§ 321(s) and 348.17See, supra, FDA, Cannabis FAQs, A.10, 12.18See, supra, FDA, Cannabis FAQs, A.14.19See id.20FDA, Warning Letters and Test Results for Cannabidiol-Related Products, available at: https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products.21See id.22See, e.g., Cannafyl Warning Letter, No. 611957 (Mar. 1, 2021), available at: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cannafyl-611957-03012021.

[10] Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020, H.R. 8179, 116th Cong. (2020).[11] FDCA § 413 (21 U.S.C. § 350b).[12] U.S. Food & Drug Admin., Letter from Office of Dietary Supplement Programs to Charlotte’s Web, Inc. (Jul. 23, 2021), Docket No. FDA-2021-S-0023, https://www.regulations.gov/document/FDA-2021-S-0023-0053.