Silver Spring, MD—The American Herbal Products Association (AHPA) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion. (Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.) While expressing support for FDA’s proposal to offer a period of enforcement discretion for the...
Washington, D.C.—The Council for Responsible Nutrition (CRN) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion. (Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.) As CRN noted, the NDI filing and enforcement discretion paradox has been a hot-button issue affecting the...
On May 19, the U.S. Food and Drug Administration has released a draft guidance outlining a proposed policy to give companies an opportunity to submit late new dietary ingredient (NDI) notifications. If finalized, the draft guidance will "advise the dietary supplement industry that FDA intends to exercise enforcement discretion, for a limited time...
Washington, D.C.—In comments made to the FDA, the Natural Products Association (NPA) questioned why the Agency's draft guidance for food labeling serving sizes does not provide examples for dietary supplements, according to a press release. The NPA took issue with the fact that no examples were provided for dietary supplements carrying Supplement Facts...
New York, NY — At the American Conference Institute’s 5th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements, in partnership with the Council for Responsible Nutrition (CRN), Cara Welch, Ph.D., senior advisor for the Center for Food Safety and Applied Nutrition, Office of Dietary Supplement Programs, U.S. Food and...
The U.S. Food and Drug Administration (FDA) issued a final rule on August 24th that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules for the Food Safety Modernization Act (FSMA). The changes, which will include “providing more time for manufacturers to meet...
Washington, D.C.—On Thursday, the Natural Products Association (NPA) submitted a request to the U.S. Food and Drug Administration (FDA) for an extension of the comment period on the newly revised guidance re-draft for New Dietary Ingredient (NDI) Notifications. The draft guidance, which was released on August 11, currently has a...
FDA Releases Draft Guidance for NDI Notification The U.S. Food and Drug Administration issued a long-awaited revised draft guidance on Aug. 11 seeking to clarify new dietary ingredient (NDI) notifications for industry. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, manufacturers and distributors must notify FDA at...
