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    • CFSAN Priorities for 2013-2014 Include FSMA, Food Labeling, NDIs, Energy Drinks, and Cosmetic SafetySeptember 16th, 2013

      By Etan J. Yeshua – Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic …

    • Are Foods that Contain GMOs “All Natural”? Some Courts Won’t Wait for FDA’s ViewSeptember 3rd, 2013

      By Ricardo Carvajal – In a number of recent class actions, a central allegation has been that a marketer misled consumers by labeling as “all natural” a food that contains a genetically modified organism ("GMO").  Defendants usually invoke the doctrine of primary jurisdiction in an …

    • State Actions Grounded in “Source” Claims: Preempted or Not?August 30th, 2013

      By Ricardo Carvajal – Is the word “source” (just “source” – not “good source” or “excellent source”) a nutrient content claim?  FDA seems to think so, as reflected in a paragraph in this warning letter that escaped our attention when it issued in March 2011.  FDA …

    • FSMA and Third-Party Audits: What is a “Serious Risk to the Public Health?”August 21st, 2013

      By Ricardo Carvajal – In poring over FDA’s recently issued proposed rule on Accreditation of Third Party Auditors (see our prior post here), one thing that caught our eye is FDA’s discussion of FSMA’s notification requirement for auditors.  That requirement is embedded in new § 808(c)(4) …

    • New Dietary Ingredients Revisited – Let’s Not Forget There’s a LawAugust 16th, 2013

       By Wes Siegner – In response to a history of FDA illegal restriction of the marketing of dietary supplements in the 1980s and early 1990s, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”), passing by unanimous consent the Dietary Supplement Health and Education …

    • New FDA Draft Guidance for Medical Foods Suggests that Some Common Products and Certain Label Statements Violate FDA RegulationsAugust 14th, 2013

      By Etan Yeshua – Earlier this week, FDA provided new insight into its interpretation of the definition and regulation of medical foods — a legal category established by the Orphan Drug Act of 1988, incorporated into the Federal Food, Drug, and Cosmetic Act in 1990, and …

    • FDA Sued for Failure to Ban Partially Hydrogenated OilsAugust 13th, 2013

      By Ricardo Carvajal – Fred Kummerow, a Professor Emeritus at University of Illinois, sued FDA for failing to respond to his citizen petition (Docket No. FDA-2009-P-0382) asking the agency to ban partially hydrogenated oils containing artificial trans fat.  The citizen petition was submitted in August …

    • USDA OIG Reviews Implementation of Access to Pasture and Related Rules for Organic Dairy CattleAugust 6th, 2013

      By Riëtte van Laack – The Organic Foods Production Act requires that the U.S. Department of Agriculture (“USDA”) establish national standards for the production and handling of organic products to assure that agricultural products marketed as organic meet consistent uniform standards.  USDA established the National Organic …

    • Whew! “Gluten-Free” Claim Threshold Remains 20 ppmAugust 4th, 2013

      By Ricardo Carvajal – FDA published a final rule implementing the directive in the Food Allergen Labeling and Consumer Protection Act ("FALCPA") to define the term “gluten-free” (and other terms that FDA regards as equivalent, namely “no gluten,” “free of gluten,” and “without gluten”).  The threshold …

    • FDA Announces Fiscal Year 2014 User Fee Rates; They’re Movin’ On Up!August 1st, 2013

      By Kurt R. Karst –   Now that we've put the theme from The Jeffersons in your head . . . . On August 2, 2013, FDA will officially announce in a series of Federal Register notices the Fiscal Year 2014 (“FY 2014”) user fee rates under …

    • Another Lawsuit Alleges That Stevia Sweetener Is Not NaturalJuly 31st, 2013

      By Riëtte van Laack – In March 2012, in a consumer action against Jamba Juice, filed in California, plaintiffs asserted, among other things, that steviol glycosides should not be considered natural because of the “chemical processing” used to extract them.  Earlier this month, another lawsuit concerning …

    • Might You Be An “Importer” for Purposes of FSMA’s FSVP Requirement? Now You Know.July 30th, 2013

      By Ricardo Carvajal – Last Friday, FDA released two additional proposed rules that are fundamental to the agency’s implementation of the Food Safety Modernization Act (FSMA): Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule) and Accreditation of Third-Party Auditors/ …

    • Amended COOL Regulations Constitutionally UncoolJuly 22nd, 2013

      By Riëtte van Laack – In a lawsuit filed in federal court, meat industry representatives have challenged the constitutionality of Country of Origin Labeling (“COOL”) regulations as amended by USDA’s Agricultural Marketing Service (“AMS”) in May of 2013.  To understand the origin of the lawsuit, it …

    • FDA SOS: New Bill Would Exempt FDA User Fees From the Ravages of SequestrationJuly 18th, 2013

      By Kurt R. Karst –       “… — …” – That’s the international Morse code distress signal commonly shown as SOS.  SOS is also in the title of the acronymized “FDA SOS Act,” or the “FDA Safety Over Sequestration Act,” which a bipartisan group of members …

    • Companies Seek Expansion of Soluble Fiber-Coronary Heart Disease Health ClaimJuly 10th, 2013

      Two companies, DKSH Italia Srl and Polycell Technologies LLC, have filed a citizen petition with FDA asking that it expand the health claim on soluble fiber and coronary heart disease to include their product, Glucagel.  The petition describes Glucagel as a “barley beta-glucan fiber that …