The FDA approved olestra only on the condition that foods containing it be fortified with precise quantities of vitamins A, D, E, and K and carry a boxed warning label stating that olestra may cause abdominal cramping and loose stools and inhibits absorption of some vitamins and nutrients.
Sources
- Legal Aspects of the Food Additive Approval Process - NCBI (ncbi.nlm.nih.gov)
- https://www.federalregister.gov/documents/2003/08/05/03-19508/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-olestra (federalregister.gov)
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-172/subpart-I/section-172.867 (ecfr.gov)
- https://www.govinfo.gov/content/pkg/FR-1996-01-30/pdf/96-1584.pdf (govinfo.gov)
- https://www.jandonline.org/article/S0002-8223(98)00126-6/fulltext (jandonline.org)
- https://www.foreffectivegov.org/node/1512.html (foreffectivegov.org)