Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification." The draft guidance, when finalized, will advise the dietary supplement industry of our intent to exercise enforcement discretion, for a limited time and in limited circumstances, regarding the requirement to submit a new dietary ingredient (NDI) notification prior to marketing. The purpose of the policy is to encourage manufacturers and distributors of certain NDI-containing dietary supplements to correct any past failures to submit a required NDI notification.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.