The U.S. Food and Drug Administration (FDA) will be continuing its enforcement discretion policy for compliance with certain FDA Food Safety Modernization Act (FSMA) supply chain program requirements applicable to receiving facilities that are co-manufacturers.

Three of the rules created to implement FSMA—Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs—require co-manufacturers that are receiving facilities and/or importers that produce food for the brand owners to approve suppliers and conduct certain supplier verification activities. These requirements are designed to ensure suppliers are addressing hazards requiring a supply-chain-applied control.

Previously, industry expressed concerns that in some situations the supply chain requirements could conflict with existing contracts between brand owners and the firms the brand owners select to supply their co-manufacturers. To comply with the supply chain program requirements, co-manufacturers often need detailed information about suppliers that only the brand owner has, and that can’t be shared because of confidentiality clauses in the contracts between brand owners and the co-manufacturers’ suppliers.

In November 2017, the FDA announced an enforcement discretion policy until Nov. 6, 2019, for compliance with certain supply chain program requirements related to supplier approval and supplier verification. The enforcement discretion was intended to give brand owners more time to work with suppliers to adjust contracts so that supply chain related information could be shared with co-manufacturers.

Since that time, the FDA has learned of additional challenges industry is facing in trying to meet the supply chain requirements. The FDA will continue its enforcement discretion policy while advancing its work with stakeholders to better understand these challenges and to consider possible solutions to address these situations. The agency intends to announce the extension in a forthcoming notice in the Federal Register.

Press release

More News right arrow

FDA releases the third installment of the intentional adulteration guidance

The U.S. Food and Drug Administration (FDA) has released supplemental draft guidance designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA).

Chile’s labeling law may be working to reduce sugared beverage purchases

A study published in PLOS Medicine suggests that there has been a significant reduction in household purchases of sugar-laden beverages in Chile since the country implemented its Law of Food Labeling and Advertising in 2016.

PepsiCo’s takeover of Pioneer Food Group receives conditional approval

According to Reuters, South Africa’s Competition Commission has conditionally approved PepsiCo’s $1.7 billion acquisition of food and drinks producer Pioneer Food Group, saying it is unlikely to lessen competition in relevant markets.

FDA opens Voluntary Qualified Importer Program application portal

The U.S. Food and Drug Administration (FDA) opened the Voluntary Qualified Importer Program (VQIP) application portal on Jan. 1, 2020, for the benefit period between Oct. 1, 2020, and Sept. 30, 2021.

FDA releases guide to help small food manufacturers meet nutrition labeling standards

The U.S. Food and Drug Administration (FDA) has announced the availability of a Small Entity Compliance Guide (SECG) to help packaged food manufacturers meet federal standards in the final rule “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.”

IFT Weekly Newsletter

Rich in industry news and highlights, the Weekly Newsletter delivers the goods in to your inbox every Wednesday.

Subscribe for free