Comparison of Pharmaceutical Excipients and Food Ingredient Requirements

• Published in: Pharmaceutical Technology 2020-04, Vol.44 (4), p.54-60
• Main Authors: Grocholi, Luke, Zawislak, Priscilla, Moreton, R Christian, Ulman, Katherine L
• Format: Article
• Language: English
• Subjects: Dietary supplements; Good Manufacturing Practice; Manufacturing; Suppliers
• ISSN: 1543-2521; 2150-7376

[...]it is also incorrect to assume that product approved for use as a pharmaceutical excipient will automatically comply with food or dietary supplement requirements. 5 FDA's food additive definition (1) does not include generally recognized as safe (GRAS) substances; however, all food ingredients (including food additives, GRAS substances, and non-dietary ingredients for dietary supplements) are held to the same good manufacturing practice (GMP) requirements. Finished dietary supplements are subject to Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements (3) dietary supplement GMP requirements; non-dietary ingredients are subject to 21 Code of Federal Regulations (CFR) 117 Part B (2) like all food ingredients. Other regulatory requirements In addition to GMPs, food ingredients and excipients are subject to other regulatory requirements including the following: * California Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly called Prop 65) for the reporting of known carcinogens * Pesticides and potential pesticide residue * World Anti-Doping Agency * Bovine spongiform encephalopathy/Transmissible spongiform encephalopathy (6) reporting requirements * Applicable USP general chapters (for excipients) * Applicable FCC general chapters (for food additives). Material origin considerations Because ingredients used in any of these markets could be derived from raw materials of natural origin, additional restrictions to prevent exploitation of endangered species (12,13) need to be considered.