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    • POM’s Lanham Act Claims Against Coca-Cola are Not Precluded by the FDC ActJune 12th, 2014

      By Jennifer M. Thomas – In another confirmation of the Lanham Act’s reach following on the heels of the Lexmark decision, the U.S. Supreme Court ruled today that POM Wonderful LLC’s (“POM’s”) Lanham Act suit against Coca-Cola Co. (“Coke”) over juice product labeling is not precluded …

    • California Supreme Court to Review Whether the Organic Food Production Act of 1990 Preempts State Consumer Lawsuits Regarding Organic MislabelingJune 9th, 2014

      By Riëtte van Laack – In Quesada v. Herb Thyme Farms, Inc., Plaintiff Quesada alleged that Herb Thyme Farms, Inc. (Herb Thyme) lied about the nature of its “Fresh Organic” line of herbs.  According to Plaintiff, Herb Thyme misrepresented its “Fresh Organic” products as 100% percent …

    • As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List GrowsMay 29th, 2014

      By Kurt R. Karst –       On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …

    • FDA Seeks to Mow Down Lawsuit Over GRASMay 27th, 2014

      By Ricardo Carvajal – FDA filed a motion to dismiss the lawsuit brought by the Center for Food Safety challenging the legality of FDA’s GRAS notification program (for background information on the lawsuit, see our prior posting here).  In its supporting memorandum, FDA argues that plaintiff …

    • FDA’s Proposal on Nutrition Labeling and FiberMay 20th, 2014

      By Riëtte van Laack – FDA’s proposed rule regarding nutrition labeling (see our previous post here) will have far-reaching consequences that may not be obvious.  For example, FDA intends to make major changes in its approach to defining and measuring dietary fiber – changes that could …

    • NOP Issues Final Guidance Concerning “Made with Organic” ClaimsMay 15th, 2014

      By Riëtte van Laack – In 2011, the National Organic Program (“NOP”) of the USDA announced the availability of a draft guidance for “Made with Organic” claims.  Of the four categories of organic claims (“100% organic,” “organic,” “made with organic,” “x% organic”), this category of organic …

    • FDA Issues Draft Guidance Regarding Food Allergen Labeling Exemption Petitions and NotificationsMay 12th, 2014

      By Ricardo Carvajal – FDA issued a draft guidance for industry that sets out the agency’s expectations for the content of petitions and notifications for exemption from food allergen labeling requirements.  To date, such petitions and notifications have met with very limited success – a situation …

    • Race to Market: Drugs vs. Dietary Supplements; FDA Plants a LandmineMay 11th, 2014

      By Riëtte van Laack – The FDC Act, as amended by the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, excludes from the definition of dietary supplement any article that is approved as a new drug and any article “authorized for investigation as a new …

    • FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims for Omega-3 Fatty AcidsApril 28th, 2014

      By Ricardo Carvajal – FDA issued a final rule that prohibits nutrient content claims for the omega-3 fatty acids DHA and EPA, as well as certain nutrient content claims for ALA.  The final rule carries through on the proposed rule issued in November 2007 with no …

    • Proposed GMO Labeling Bill Would Block State LawsApril 16th, 2014

      By Riëtte van Laack – Legislation that would require labeling of genetically engineered or bioengineered foods (generally referred to as “GMOs”) has been proposed in various states.  If enacted, these state laws may expose companies to a patchwork of different GMO labeling requirements.  On April, 10, 2014, …

    • Setting the Record Straight on GRAS: Part 1April 15th, 2014

      By Ricardo Carvajal & Diane B. McColl – When GAO issued its 2010 report criticizing FDA’s oversight of the GRAS exception, we were motivated to respond first in short form in a blog post, and then in long form through a Washington Legal Foundation Legal Backgrounder.  …

    • When is a Thick Sweet Syrupy Substance Properly Labeled as Honey?April 13th, 2014

      By Riëtte van Laack – In 2006, the American Beekeeping Federation and honey industry groups petitioned FDA (Docket No. FDA-2006-P-0207) to adopt a standard of identity for honey.  In 2011, FDA denied this petition because it concluded that no standard of identity was needed.  FDA asserted …

    • D.C. Circuit to Hear COOL Case En BancApril 8th, 2014

      By Riëtte van Laack – Does the same standard that applies when regulators require label statements that “correct a deception,” such as false advertising, also apply when they require label statements for other purposes based on the interests of the government?  This issue will be before …

    • HP&M Comments on IND Guidance; Says FDA Lacks Authority to Impose Requirements on Non-drug StudiesApril 8th, 2014

      By Jennifer M. Thomas & James P. Ellison – Hyman, Phelps & McNamara, P.C. (HP&M) filed comments on April 7 concerning FDA’s Guidance document, Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND (the “Guidance”).  HP&M has previously blogged …

    • Registration Opens for ABA’s Fourth Annual Food and Supplements WorkshopApril 7th, 2014

      The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) just announced its Fourth Annual Food & Supplements Workshop, scheduled for June 5 in the Minneapolis area.  Among the topics to be addressed: Emerging Issues: Surveying the Regulatory …