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|Just as the Comment Period for “Natural” Ends, FDA Announces Intent to Re-Examine What It Means to Be a “Healthy” Food|
Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
June 17, 2016, previously published on May 12, 2016As any company making and selling food products knows, late last year FDA requested information and comments regarding the appropriate use of the term “natural” for food ¿ the Agency asked what types of processing make that claim misleading, or does the food have to be completely...
|LCBO Mark-Up Challenged in Court|
Brian Kells; Perley-Robertson Hill McDougall LLP/s.r.l.;
June 16, 2016, previously published on May 25, 2016In 2015, Toronto Distillery Co., a small craft distiller of spirits such as gin and whisky, launched a court challenge to Ontario’s regulatory regime for on-site sales of spirits by producers.
|6 Steps Restaurant Operators Need To Take To Prepare For the Proposed New Overtime Rules|
Scott N. Opincar; McDonald Hopkins LLC;
June 2, 2016, previously published on May 2, 2016The Department of Labor put into motion its change to the Fair Labor Standards Act Overtime Rule by submitting its final rule to the Office Management and Budget (OMB) division, which would significantly increase the income threshold for salaried employees eligible for overtime. The OMB has 30 to...
|Registration of Foreign Facilities Producing Food and Food Packaging Sold in Korea|
Yun Chen, David J. Ettinger, Wilfred Feng, Eric Gu, Mark Thompson; Keller and Heckman LLP;
May 30, 2016, previously published on April 27, 2016Only a few months remain before the August 3, 2016 deadline for Korean registration of foreign food and food packaging manufacturing facilities. Registration is required for all facilities producing food, food additives, food packaging as well as components thereof, including functional health...
|The Cole-Bishop Amendment to the Agricultural Appropriations Bill Amending the Grandfather Date for "Deemed" Tobacco Products Passes House Committee - What Next?|
Azim Chowdhury, Samantha L. Dietle; Keller and Heckman LLP;
May 26, 2016, previously published on April 29, 2016On April 19, 2016, the House Appropriations Committee voted to include a bipartisan amendment, sponsored by Rep. Tom Cole (R - OK) and Rep. Sanford Bishop (D - GA), to the 2017 fiscal year Agricultural Appropriations bill that would amend the February 15, 2007 "grandfather date" for...
|Amarin and FDA Agree to Landmark Settlement on Off-Label Promotion|
Michael A. Carvin, Toni-Ann Citera, Colleen Heisey, Karen P. Hewitt, Laura F. Laemmle-Weidenfeld; Jones Day;
April 6, 2016, previously published on March 2016On March 8, 2016, Amarin Pharma, Inc. reached a noteworthy settlement in its lawsuit against the U.S. Food and Drug Administration ("FDA") to protect its First Amendment right to promote the drug Vascepa for nonapproved, off-label uses. Amarin Pharma, Inc. v. FDA (S.D.N.Y. No. 15-cv-3588)...
|Bipartisan Bill Aims to Increase Hires at FDA and NIH|
McDonald Hopkins LLC;
March 24, 2016, previously published on March 18, 2016On Thursday, Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), the chair and ranking member respectively, of the Senate Health, Education, Labor and Pensions Committee, introduced a bill intended to make it easier for the Food and Drug Administration (FDA) and the National Institutes of...
|Trial Court Upholds NYC Regulation Mandating Chain Restaurant Menu Labeling for Excess Salt Content|
Anna M. Wiand; GrayRobinson, P.A.;
March 23, 2016, previously published on February 25, 2016On February 24, 2016, a New York state trial judge ruled that chain restaurants in New York City must warn customers about menu items containing high levels of sodium. At issue is a municipal regulation adopted by the New York City Board of Health in September of 2015 that applies to chain...
|Another California Dismissal of Proposed Class Action Regarding Disclosure of Forced Labor in the Supply Chain|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
March 22, 2016, previously published on March 7, 2016We recently blogged about a new wave of class action litigation related to California’s Transparency in Supply Chains Act. In December, Nestlé USA won the dismissal of a complaint against it alleging that the company was “obligated to inform consumers that some proportion of its...
|Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
March 21, 2016, previously published on March 11, 2016On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to treat Amarin’s proposed truthful and non-misleading off-label...