Health Law Daily Compliance dates for certain uses of partially hydrogenated oils extended, FAP denied
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Monday, May 21, 2018

Compliance dates for certain uses of partially hydrogenated oils extended, FAP denied

By Harold Bishop, J.D.

The FDA is extending the compliance dates for certain uses of partially hydrogenated oils (PHOs) in human food. For most uses of PHOs, June 18, 2018 will remain the date after which manufacturers cannot add PHOs to human foods. However, to allow for products manufactured before June 18, 2018 to work their way through the marketplace, the FDA is extending the compliance date for these foods to January 1, 2020 (Notice, 83 FR 23358, May 21, 2018).

Contemporaneous with this extension of compliance dates, the FDA is denying a food additive petition (FAP 5A4811) from the Grocery Manufacturers Association (GMA) requesting approval for certain limited uses of PHOs. To allow the food industry time to reformulate the petitioned uses, the FDA is extending until June 18, 2019 the compliance date to stop manufacturing foods with the specific, limited petitioned uses of PHOs. In addition, for food manufactured with the petitioned uses before June 18, 2018, the FDA is extending the compliance date until January 1, 2021 (Notice, 83 FR 23382, May 21, 2018).

2015 determination. On June 17, 2015 (80 FR 34650), the FDA published a final determination that there is no longer a consensus among qualified experts that PHOs are Generally Recognized as Safe (GRAS) for any use in human food. Because PHOs are the primary dietary source of industrially produced trans fatty acids (IP-TFA), the FDA’s evaluation of the GRAS status of PHOs centered on the trans fatty acid component of these fats and oils. The FDA’s determination identified significant human health risks, namely an increased risk of coronary heart disease (CHD), associated with the consumption of trans fat (see The national diet, FDA cuts trans fats, June 17, 2015).

The FDA’s final determination established a three-year compliance date, to June 18, 2018, to allow time for food manufacturers using PHOs to identify suitable replacement ingredients for PHOs and to reformulate and modify labeling of affected products. The three-year compliance date was also intended to allow time for submission and review and, if applicable requirements were met, approval of FAPs for uses of PHOs for which industry or other interested individuals believe that safe conditions of use may be prescribed. The compliance date was also intended to give manufacturers time to exhaust existing inventories and give distributors and retailers time to distribute products with PHOs.

GMA FAP. Following the FDA’s June 17, 2015 final determination, on October 28, 2015 (80 FR 65978), the FDA announced that it had filed a FAP submitted by the GMA seeking approval for certain uses of PHOs in or on select foods. GMA subsequently amended their FAP petition, and it was re-filed on March 7, 2017.

The FAP requested approval for the limited use of PHOs as: (1) carriers for color additives and flavoring agents; (2) pan release agents for baked goods; and (3) processing aids. The FDA refers to these specified uses of PHOs in GMA's FAP as the "petitioned uses" and all other uses of PHOs not authorized by FDA as "non-petitioned uses." The FDA ultimately denied the FAP because the GMA did not provide sufficient evidence that the requested uses are safe.

Extended compliance dates. The extended compliance dates for non-petitioned uses can be summarized as follows:

  • Manufacturing of food with non-petitioned uses of PHOs – June 18, 2018.
  • Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 – January 1, 2020.

The extended compliance dates for petitioned uses can be summarized as follows:

  • Manufacturing of food with the petitioned uses of PHOs – June 18, 2019.
  • Foods manufactured with the petitioned uses of PHOs before June 18, 2019 – January 1, 2021.

Foods manufactured after the compliance dates may be subject to FDA enforcement actions.

Objections and hearing requests. The denial of the FAP is applicable May 21, 2018. Written objections and requests for a hearing on the denial must be submitted by June 20, 2018. Late objections will not be considered by the FDA.

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