§10.4 Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS)

• Jurisdiction: United States
• Publication year: 2022

§10.4 Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS)

The ONPLDS, positioned under the Deputy Director of CFSAN, is responsible for developing policy and regulations for dietary supplements, nutrition labeling, food standards, infant formula, and medical foods. ONPLDS is comprised of seven sections.³ Pertinent to the dietary supplement regulation are the Division of Dietary Supplement Programs, the Food Labeling and Standards Staff, and the Nutrition Programs and Labeling Staff.

§10.4.1 Office of Dietary Supplement Programs

The Office of Dietary Supplement Programs is responsible for handling FDA actions relating to dietary supplements. The Office's duties include "developing and implementing policy, regulations, guidance documents, and compliance activities intended to ensure the safety and proper labeling of dietary supplements . . ."⁴

The Office is responsible for handling issues relating to pre-market notifications submitted for new dietary ingredients. The Office also provides ". . . policy review for enforcement actions taken against adulterated or mislabeled domestic and imported dietary supplements."⁵ A Regulations and Review Team, a Compliance and Enforcement Team, and a Clinical Review Team make up the Office.

§10.4.2 Food Labeling and Standards Staff

The Food Labeling and Standards Staff is responsible for, among other duties, issuing warning letters to manufacturers that have products violating statutory laws on the market, providing technical input on domestic and imported legal actions from FDA District Offices and the Office of Compliance, and participating in foreign inspections. The Staff also participates in international activities, including the Codex Alimentarius Commission Committee on Food Labeling. The Staff consists of a Regulations and Review Team, and Compliance and Enforcement Branch.⁶

§10.4.3 Nutrition Programs and Labeling Staff

The Nutrition Programs and Labeling Staff is responsible for the scientific and regulatory review of health claims and...