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Tracking Compliance Dates for FDA Nutrition Initiatives

The U.S. Food and Drug Administration (FDA) has received a number of questions on the timing of compliance dates for its nutrition initiatives. In response, the Agency published a reminder of those compliance dates on October 7, 2016.

  • Several of FDA’s key nutrition initiatives have compliance dates during the summer of 2018.

    • After June 18, 2016, food products may not contain partially hydrogenated oils (PHOs) for uses that have not been cleared by FDA. This is a result of a final determination by FDA that there is no longer a consensus among qualified experts that PHOs are generally recognized as safe (GRAS). 

    • On July 26, 2018, manufacturers with $10 million or more in annual food sales will need to comply with new Nutrition Facts label requirements. Final rules to implement changes to nutrition labeling requirement were issued by FDA on May 20, 2016. For background information, see FDA Final Rule Alert: Revised Nutrition Facts and RACCs.

    • On July 26, 2018, operators of vending machines with glass fronts will have to comply with all requirements of the vending machine labeling rule. The original compliance date was December 1, 2016; however, FDA delayed the compliance date to be consistent with the Nutrition Facts label requirements

  • The targets for sodium reduction that FDA is developing are voluntary, therefore, they do not have a compliance date. However, FDA published draft voluntary short-term (2 years) and long-term targets (10 years) for reducing sodium in commercially processed and prepared food. For background information, see our blog entry, FDA Draft Guidance: Scaling Back Sodium.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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