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|FDA Holds Back-to-Back Workshops on Next-Generation Sequencing Diagnostic Tests|
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Cristiana Spontoni; Jones Day;
November 27, 2015, previously published on November 2015Last week, FDA held two workshops to gather information on developing a flexible approach for the regulation of next generation sequencing ("NGS") in vitro diagnostic tests. NGS tests facilitate the rapid sequencing and analysis of segments of DNA, yielding information that can be used to...
|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 to Accept Comments on “Natural” in Food Labelling|
Loeb Loeb LLP;
November 27, 2015, previously published on November 17, 2015In a surprising shift, the Food and Drug Administration has announced that it is soliciting public comments concerning how the term “natural” may be used in food labeling. As we reported in a January 2014 alert, three federal judges had previously requested clarification from the FDA as...
|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...
|While Marijuana Makes Headlines, Industrial Hemp Quietly Grows Legal|
Richard M. Blau; GrayRobinson, P.A.;
November 27, 2015, previously published on November 17, 2015Thanks to changes legislated in the U.S. Farm Bill of 2013, numerous land grant universities across America currently sponsor and conduct research into agricultural and industrial hemp. The legality of such research depends on whether the state in which the university resides has formally approved...
|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 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...
|Information exchange between competitors in the light of Bulgarian competition law practice. By object and by effect restrictions following Dole|
Zoya Todorova, Radina Tomanova; Dimitrov, Petrov & Co.;
November 26, 2015, previously published on Autumn 2015Under the present-day economic conditions the information exchange between market participants is a prerequisite for more efficient market operation of each of them. The access to up-to-date market information provides the companies with an opportunity for effective performance of their activity...
|What You Need to Know About Hong Kong Competition Law (Part 3) - The Second Conduct Rule|
Simon H. Berry, Alec J. Burnside, Michael Liu, Jane Ng, Charles F. (Rick) Rule; Cadwalader, Wickersham & Taft LLP;
November 20, 2015, previously published on November 4, 2015The implementation of the new Competition Ordinance (Chapter 619 of the Laws of Hong Kong) (the Competition Ordinance) on 14 December 2015 will mark the first time that Hong Kong has a general and crosssector competition law.
|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...