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|Three More FSMA Rules Finalized As the Year Comes to a Close|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
December 21, 2015, previously published on November 16, 2015Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the Act). The Final Rules on Foreign Supplier Verification Programs,...
|Nicholas Nanovic Program Expert at Wills for Heroes|
Harold N. Iselin, Joshua L. Oppenheimer, Francis J. Serbaroli; Greenberg Traurig, LLP;
December 16, 2015, previously published on December 1, 2015On Nov. 13, 2015, the Albany County Supreme Court upheld New York Governor Cuomo’s Executive Order regarding executive compensation and administrative expenses of certain service providers (EO 38), as well as several aspects of the EO 38 regulations promulgated by the New York State...
|FDA Publishes Draft Guidance Documents on Compounding Using Bulk Drug Substances|
Duane Morris LLP;
November 30, 2015, previously published on November 3, 2015On October 27, 2015, the U.S. Food and Drug Administration (FDA) published notice of two draft guidance documents in the Federal Register: “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act” and “Interim...
|FDA Explores Use of Term "Natural" on Human Food Labeling|
Edgar J. Asebey, Jonathan Berman, Colleen Heisey, Katherine M. Llewellyn, Cristiana Spontoni; Jones Day;
November 27, 2015, previously published on November 13, 2015FDA is requesting public comments on (i) whether it is appropriate to define the term "natural" and, if so (ii) how the agency should define "natural," and (iii) whether it should determine appropriate use of the term on food labels. FDA considers a human food to be...
|Food-Contact Substances Subject to Final FSMA Foreign Supplier Verification Rule|
Keller Heckman LLP;
November 27, 2015, previously published on November 17, 2015 The U.S. Food and Drug Administration (FDA) made available on Friday, November 13, 2015, the pre-publication version of a final rule implementing the Foreign Supplier Verification Programs [FSVP] for Importers of Food for Humans and Animals provision of the FDA Food Safety Modernization Act (FSMA)....
|FDA Publishes Three Major FSMA Final Rules|
Edgar J. Asebey, Jonathan Berman, Colleen Heisey; Jones Day;
November 27, 2015, previously published on November 2015On November 13, 2015, the U.S. Food and Drug Administration ("FDA") published the three major rules affecting the food industry that it will adopt in 2015. These include final rules on Foreign Supplier Verification Programs ("FSVP"), Accredited Third-Party Certification, and...
|FDA Issues Three New Food Safety Rules|
Anna M. Wiand; GrayRobinson, P.A.;
November 27, 2015, previously published on November 16, 2015The U.S. Food and Drug Administration (FDA) finalized three new food safety regulations for produce farms and imported foods. The new rules are a major component of the Agency’s efforts to reduce the risks of foodborne illnesses, and implement the bipartisan Food Safety Modernization Act of...
|FDA Seeks Comments on the Meaning of "Natural"|
Melvin S. Drozen, Alissa D. Jijon, Evangelia C. Pelonis; Keller and Heckman LLP;
November 20, 2015, previously published on November 11, 2015 As food industry stakeholders are well aware, the use of the term “natural” in food labeling and advertising is fraught with ambiguity and risk of challenge. FDA’s informal policy is that “natural” means nothing artificial or synthetic (including all color additives...
|FDA Requests Input on Use of the Term “Natural” for Foods|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
November 18, 2015, previously published on November 11, 2015On November 12, 2015, FDA is scheduled to publish a notice in the Federal Register announcing a request for public comments on the use of the term “natural” in food labeling. As the Agency points out, it has been under pressure in recent years from many stakeholders to develop a...
|FDA Releases Draft ICH Guidance with Aim to Improve Pharmaceutical Benefit-Risk Assessments|
Scott S. Liebman; Loeb & Loeb LLP;
November 10, 2015, previously published on Ocotber 2015The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory submissions. The guidance doesn’t call for a particular approach, but specifies what elements should be included in submissions.