• As previously discussed in this blog, in November 2013, FDA announced its tentative conclusion that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS).  In June  2015 FDA issued a final determination the PHOs are not GRAS and must be regulated as food additives – which require FDA approval prior to use in food.  As we blogged about further, subsequent to FDA’s determination that PHOs are not GRAS, a leading food industry trade association, the Grocery Manufacturers Association (GMA) filed a food additive petition for certain PHOs present in low levels in foods when used as carriers for color additives and flavoring agents, pan release agents for baked goods, and as processing aids.
  • Today FDA announced that foods manufactured using PHOs before June 18, 2018 may remain on the market until January 1, 2020 to accommodate the shelf life of the products.
  • FDA’s announcement also indicated that it is denying the GMA petition “because the petitioners did not provide sufficient evidence that the requested uses are safe.”  FDA did acknowledge that industry may need additional time to find replacements for the PHOs that were the subject of the petition, so the PHOs that were the subject of the petition have until June 18, 2019 to be removed from manufactured food and foods manufactured before this date have until January 1, 2021 to remain on the market.
  • FDA’s tables summarizing the extended compliance dates is reproduced below:

 

Non-Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with non-petitioned uses of PHOs June 18, 2018 Not extended
Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 June 18, 2018 January 1, 2020
Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with the petitioned uses of PHOs June 18, 2018 June 18, 2019
Foods manufactured with the petitioned uses of PHOs before June 18, 2019 June 18, 2018 January 1, 2021