Postmarketing Surveillance of New Food Ingredients: Design and Implementation of the Program for the Fat Replacer Olestra
| Autor: | Nora L. Zorich, Candice L. Slough, Robert K. Miday, Judith K. Jones |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Quality Control
Sucrose Olestra medicine.medical_treatment Decision Making Postmarketing surveillance Toxicology Food and drug administration Product Surveillance Postmarketing Food Industry Humans Medicine Marketing Fat Substitutes Clinical Trials as Topic Brand names United States Food and Drug Administration business.industry Fat substitute Data Collection Fatty Acids Community Participation Advertising General Medicine United States Product (business) Interinstitutional Relations Medical product Food Additives Public Health business |
| Zdroj: | Regulatory Toxicology and Pharmacology. 33:218-223 |
| ISSN: | 0273-2300 |
| DOI: | 10.1006/rtph.2001.1461 |
| Popis: | Following U.S. Food and Drug Administration (FDA) approval for the use of olestra, a noncaloric fat substitute (brand name Olean) in food snacks, the manufacturer agreed to provide safety updates on market experience to the FDA. However, guidelines for food product postmarketing surveillance (PMS) are not available and those typically used with medical products were only partly applicable. In modeling the Olean program, we drew from experience with consumer products and incorporated elements typical of medical product PMS. A cooperative effort was established with Olean snack manufacturers and a two-tiered, multidisciplinary approach enlisting Consumer Relations and Medical Affairs personnel was used to maximize use of specialized skills. The result of this effort was implementation of a reliable PMS system which could handle a high volume of reports from consumers while providing pertinent data required for medical interpretation of these reports. Summaries of data for the Olean snack manufacturers and FDA were generated in timely fashion. In addition to collection of the spontaneous reports from consumers, a clinical studies program was undertaken and an independent medical advisory panel was established. Through these, we gained perspective on the spontaneous reports and additional confirmation of the safety of olestra in savory snacks. |
| Databáze: | OpenAIRE |
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