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|Food Menu Labeling Requirements Are In Effect. Enforcement Expected May 2017|
Bose McKinney Evans LLP;
January 18, 2017, previously published on January 6, 2017The new FDA food menu labeling rules, which were originally to be effective as of December 1, 2015, are now in effect as of December 1, 2016. While the FDA has stated it will not enforce the rules until May 5, 2017, covered establishments should be in compliance.
|Dismissal of Movie Candy Slack-Fill Case Leaves Sour Aftertaste: Federal Court Rejects Labeling Disclosure Defense|
Douglas J. Behr, Arthur S. Garrett, Eric P. Gotting, Robert S. Niemann, Manesh K. Rath, Christopher G. Van Gundy; Keller and Heckman LLP;
January 12, 2017, previously published on January 5, 2017"Slack-fill" cases are on the rise across the country. Consumers have filed suits alleging that non-transparent packaging - involving everything from household cleaning and personal care products to food and pharmaceuticals - consists of extra space that serves no functional purpose and...
|FDA Issues Final Guidance on Quality Agreements in Arrangements for Contract Manufacturing of Drugs|
Frederick R. Ball, Neelaabh Shankar; Duane Morris LLP;
January 12, 2017, previously published on January 3, 2017FDA recommends that owners and contract manufacturers implement written quality agreements to define each party’s manufacturing activities/roles to ensure compliance with current good manufacturing practices.
|FDA Form 483 Inspectional Observations Are Not Findings of Wrongdoing|
Duane Morris LLP;
December 9, 2016, previously published on October 24, 2016Since shortly after the U.S. Food and Drug Administration (“FDA”) began publishing FDA Form 483 inspectional observations of Section 503B outsourcing facilities, many State Boards of Pharmacy have inappropriately relied upon the FDA’s findings as a basis to pursue outsourcing...
|FDA Updates Guidance Related to Food Facility Registration|
Colleen M. Heisey, Laura E. Koman, Francoise S. Labrousse, Katherine M. Llewellyn, Cristiana Spontoni; Jones Day;
December 6, 2016, previously published on November 2016This month, in the middle of the renewal period for registration of food facilities, FDA has published the seventh edition of its draft guidance "Questions and Answers Regarding Food Facility Registration," which clarifies the Amendments to the Registration of Food Facilities final rule...
|All Wrapped Up: China Finalizes Long-Awaited Standards for Food Packaging|
David J. Ettinger, Chen Hu, Mark Thompson; Keller and Heckman LLP;
November 28, 2016, previously published on November 18, 2016On November 18, 2016, China's National Health and Family Planning Commission (NHFPC) finalized the following Standards applicable to food-contact materials marketed in the People's Republic of China in its announcement No. 15/2016:
|FDA No Longer Releasing Final Guidance on Laboratory Developed Tests|
Emily A. Johnson; McDonald Hopkins LLC;
November 28, 2016, previously published on November 22, 2016The U.S. Food and Drug Administration (FDA) announced last Friday that it will not release much anticipated final guidance on the regulation of laboratory developed tests (LDTs). Instead, the FDA indicated that it will continue to work with the new administration, Congress, and key stakeholders to...
|Last Chance to Comment on China's Implementing Regulation of the Food Safety Law|
Yun Chen, David J. Ettinger, Eric Gu, Mark Thompson; Keller and Heckman LLP;
November 14, 2016, previously published on October 28, 2016 On October 19, 2016, the Legislative Affairs Office of the State Council of P.R. China published the Regulation on the Implementation of the Food Safety Law (Draft for Approval) (hereinafter "Regulation") for public comment. This draft is an update on the version released in December...
|New York City Council Passes Retention Bill for Cafeteria Workers|
Jonathan L. Bing, Javier A. Lacayo; Jackson Lewis P.C.;
October 20, 2016, previously published on October 18, 2016The New York City Council has overwhelmingly passed a bill that mandates a 90-day transition period for displaced food service workers when a new owner or operator takes over a city building.
|Ninth Circuit Reverses Summary Judgment Regarding Dole's "All-Natural Fruit" Labeling but Affirms Decertification of the Damages Class|
Edgar Asebey, Jonathan Berman, Colleen M. Heisey, Francoise S. Labrousse, Cristiana Spontoni; Jones Day;
October 11, 2016, previously published on October 2016On September 12, 2016, in an unpublished disposition, the Ninth Circuit reversed in part a district court's ruling that "All Natural Fruit" labeling on Dole Food Co. products was unlikely to deceive consumers. The plaintiff, Chad Brazil, who sought to represent a class of consumers,...