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CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements
November 2004; Updated January 2006
The Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) is responsible for developing policy and regulations for dietary supplements, nutrition labeling and food standards, infant formula and medical foods as well as for scientific evaluation to support such regulations and related policy development. ONPLDS staff also support compliance/enforcement actions and is responsible for the clinical review, data summaries, and, as appropriate, follow-up and research related to adverse events associated with dietary supplements and infant formula.
ONPLDS, which was realigned in February 2003, is organized by product categories and features separate units for dietary supplements, nutrition labeling and program activities, infant formula and medical food, foods standards and labeling, and analytical and database research.
CFSAN/ONPLDS Organizational Chart
ONPLDS is currently headed by Dr. Barbara Schneeman, Director, with Ms. Camille Brewer as Associate Director. Housed within the Office of the Director are several Special Assistants.
The Division of Dietary Supplement Programs, headed by Dr. Susan Walker, is responsible for agency activities concerning dietary supplements. The Division has primary responsibility for developing and implementing policy, regulations, guidance documents, and compliance activities intended to ensure the safety and proper labeling of dietary supplements and works closely with other units in FDA to accomplish these tasks. The Division reviews safety information in 75-day premarket notifications for new dietary ingredients to ensure that such products are reasonably expected to be safe. The Division provides policy review for enforcement actions taken against adulterated or mislabeled domestic and imported dietary supplements. It also works with other CFSAN offices, FDA field organizations, and the regulated industry to ensure that products comply with applicable labeling and safety standards. The Division also works with other Federal scientific agencies to identify dietary supplement research topics to be undertaken. The Division consists of a Regulations and Review Team, a Compliance and Enforcement Team, and a Clinical Review Team.
More information about dietary supplements.
The Food Labeling and Standards Staff, headed by Ms. Felicia Billingslea, The Food Labeling and Standards Staff is responsible for developing policy, regulations, guidance documents, and enforcement strategies governing all aspects of food labeling, including warning statements and safe handling practices, and food standards. The Staff works closely with other enforcement arms in FDA and FDA District Offices to ensure enforcement of FDA regulations on conventional foods, infant formula and medical foods. The Staff issues warning letters to firms that have violative products on the market, issues special field assignments, reviews and provides technical input on domestic and imported legal actions from FDA District Offices and the Office of Compliance, and participates in foreign inspections. The Staff also participates in international activities such as the Codex Committee on Food Labeling and the U.S./Canada/Mexico Trilateral Technical Working Group on Food Labeling, Packaging and Standards. This staff consists of a Regulations and Review Team and a Compliance and Enforcement Branch.
More information about food labeling and nutrition.
The Nutrition Programs and Labeling Staff, headed by Dr. Kathleen Ellwood, is responsible for scientific and regulatory review of nutrition labeling issues, such as health claims and nutrient content claims; and changes to the Nutrition Facts Panel (e.g., trans fatty acid). Moreover, this Staff develops guidance documents, promulgates and administers regulations, and sets policy related to nutrition labeling. This Staff is comprised of a Regulations and Review Team and a Nutrition Science Evaluation Team.
More information about nutrition labeling.
The Division of Research and Applied Technology, headed by Dr. Jeanne Rader, provides expert advice to CFSAN and agency components on matters within the scope of responsibility of the Division. The Division serves as the principle Agency liaison on methods for assuring dietary exposure to substances in food and for evaluating the validity of dietary exposure estimates. The Division consists of a Database Management and Evaluation Team and a Methods Development and Application Team.
The Infant Formula and Medical Foods Staff, headed by Dr. Benson Silverman, deals with infant formula issues, regulation and policy development. Infant Formula and Medical Foods Team responds to data and notifications from manufacturers of all new or modified infant formulas and medical foods, and provides counsel and review in the areas of nutritional science and medical science.
More information about infant formulas.
Office of the Director (HFS-800) | |
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Director, Dr. Barbara Schneeman | 301-436-2373 |
Associate Director, Ms. Camille Brewer | 301-436-2373 |
Secretary, Ms. Brenda Adams
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301-436-2373 |
Division of Dietary Supplement Programs (HFS 810) | |
Division Director, Dr. Susan Walker | 301-436-2375 |
Secretary, Ms. Lisa Barr-Thompkins | 301-436-2334 |
Regulation and Review Team | |
Dr. Linda Pellicore, Team Leader | 301-436-1448 |
Compliance and Enforcement Team | |
Dr. Robert Moore, Team Leader | 301-436-1441 |
Clinical Evaluation Team | |
Dr. Jason Woo, Team Leader | 301-436-1680
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Food Labeling and Standards Staff (HFS-820) | |
Staff Director, Ms. Felicia Billinglsea | 301-436-2371 |
Secretary, Lynise Fox, Acting | 301-436-2371 |
Regulations and Review Team | |
Ms. Geraldine June | 301-436-2371 |
Compliance and Enforcement Team | |
Vacant | 301-436-2371
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Acting Team Leaders Nutrition Program and Labeling Staff (HFS-830) |
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Staff Director, Dr. Kathy Ellwood | 301-436-1450 |
Secretary, Ms. Lynise Fox | 301-436-1450 |
Regulations and Review Team, | |
Vacant, Team Leader | 301-436-1450 |
Nutrition Science Evaluation Team | |
Dr. Paula Trumbo, Team Leader | 301-436-2579
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Division of Research and Applied Technology (HFS-840) | |
Division Director, Dr. Jeanne Rader | 301-436-1786 |
Secretary, Ms. Brenda Adams | 301-436-2373 |
Database Management and Evaluation Team | |
Dr. Mary Brandt, Team Leader | 301-436-1788 |
Methods Development and Application Team | |
Vacant, Team Leader | 301-436-1789
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Infant Formula and Medical Foods Staff (HFS-850) | |
Director, Dr. Benson Silverman | 301-436-2375 |
Secretary, Ms. Lynise Fox | 301-436-1450 |
Regulations and Review Team | |
Dr. Sue Anderson, Team Leader | 301-436-1453 |
Clinical Evaluation | |
Dr. Benson Silverman | 301-436-1450 |