FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF FOODS AND VETERINARY MEDICINE
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
OFFICE OF NUTRITION, LABELING AND DIETARY SUPPLEMENTS
DIVISION OF DIETARY SUPPLEMENT PROGRAMS
Effective Date: October 1, 2012
1. DIVISION OF DIETARY SUPPLEMENT PROGRAMS (DJJHKA).
A. Primary Center responsibility for policy development and strategic management of the dietary supplement program, which includes safety assessments and compliance strategy for the New Dietary Ingredient Notification Program, implementation and execution of Dietary Supplement Good Manufacturing Practices, structure-function notifications, Certificates of Export, safety assessments for dietary supplement policy, responses to petitions and industry-related notifications, post-market adverse event evaluations, and issues related to dietary supplement safety and nutrition.
B. Enforcement of the dietary supplement requirements of the DSHEA Act of 1994 and other relevant statutes to ensure the safe and truthful labeling of dietary supplements.
C. Provides expert advice for officials and other agency units on good manufacturing practices (GMP), field programs, compliance and enforcement issues and related activities, and provides assistance to Federal and State agencies and industry concerning regulatory requirements and compliance policies.
D. Provides guidance to the Field in cooperation with agency units in handling regulatory actions and assistance in the development, management, and coordination of enforcement/compliance cases.
E. Evaluates adverse events and other sources of signals related to the safety of dietary supplements.
F. Provides clinical/scientific/regulatory expertise in the assessment of risk of dietary supplements for related compliance activities, clinical responses to petitions, and in the evaluation of safety information provided in New Dietary Ingredient Notifications.
G. Provides guidance to agency scientific units and affiliated scientific units on activities related to compliance and regulatory activities and strategies.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of Health and Human Services effective October 1, 2012.