USP/NF  - A National Formulary (NF) monograph is in the United States Pharmacopeia / National Formulary (USP/NF) version USP 40 – NF 35. Vitamin E TPGS USP Monograph.

DMF Status - Antares Vitamin E TPGS, NF Grade has an Active Type IV Drug Master File, #28188. 

GRAS Status - Vitamin E TPGS has a self-affirmed GRAS (Generally Recognized As Safe) status when used as an oral dietary supplement of vitamin E.

United States Food and Drug Administration (FDA) - The FDA has not challenged a self affirmed status GRAS (Generally Recognized As Safe) status and approved products containing Vitamin E TPGS. The FDA includes Vitamin E TPGS in the list of inactive ingredients.

Clean Label - Tocopherol Polyethylene Glycol Succinate (TPGS) is considered equivalent to Vitamin E and can be labeled as such.

Canada - Approved as a form of vitamin E.

European Community - Meets IPEC-PQG GMP guidelines. Approved as an API (Active Pharmaceutical Ingredient). On July 24, 2009, the European Medicines Agency granted marketing authorization for Vitamin E TPGS (brand name Vedrop® of Orphan Europe S.A.R.L.) for the treatment of vitamin E deficiency due to digestive malabsorption in pediatric patients suffering from congenital chronic choleostasis or hereditary chronic choleostasis.

EFSA - The European Food Safety Authority (EFSA) Panel on Food Additives and Flavourings, in response to a petition supported by Antares, evaluated the safety of Vitamin E TPGS as a new food additive to be used in several food categories as emulsifier. In its report published in 2025, the EFSA panel concluded that the use of Vitamin E TPGS as a new food additive does not raise a safety concern at the proposed use and use levels. EFSA’s official action is expected soon.

EFSA - The EFSA Panel on Food Additives and Flavourings in its report on April 17, 2007 approved TPGS for use in Foods for Special Medical Purposes (FSMP).

Japan - Approved as of September 2005 as a pharmaceutical excipient for oral drug formulations.