• where experts go to learn about FDA
  • Foods and Dietary Supplements

    • 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 …

    • Court Rejects FDA’s “Target Timeframes” for FSMA Regulations and Orders Publication by June 30, 2015June 30th, 2013

      By Ricardo Carvajal – A federal district court rejected FDA’s proposed “target timeframes” for issuance of regulations to implement major provisions of the Food Safety Modernization Act ("FSMA"), finding them to be “an inadequate response to the request that the parties submit a proposal regarding …

    • Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!June 25th, 2013

      By Kurt R. Karst –  It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …

    • NIH Launches Database of Dietary Supplement LabelsJune 24th, 2013

      The National Institutes of Health ("NIH") recently launched a database of labels of dietary supplements being sold in the United States.  The database includes, among other information, directions for use, ingredients, business contact information, and claims taken directly from product labels.  The database can be …

    • CFSAN Announces Science and Research Strategic Plan: Issues Range from Nanoparticles to ObesityJune 23rd, 2013

      By Etan J. Yeshua – FDA has announced several key areas on which it plans to focus its food- and cosmetic-related research and regulatory efforts.  The plan specifically names imported foods, nanoparticles in cosmetics, dietary supplement toxicology, and obesity, among others, as specific areas of …

    • FDA Sued for Failing to Confirm Product’s Medical Food StatusJune 20th, 2013

      By Riëtte van Laack – Last week, Health Science Funding, LLC filed what might be the first medical food lawsuit against FDA.  (A copy of the Complaint is available here, and a copy of the Motion for a Preliminary Injunction is available here.)  Plaintiff markets what it …

    • FDA Proposes FSMA “Schedule of Target Timeframes”; CFS DemursJune 16th, 2013

      By Ricardo Carvajal – In previous postings (see here and here),  we reported on the Center for Food Safety’s ("CFS’s") lawsuit seeking to compel FDA to accelerate its implementation of FSMA.  In April, the presiding court ruled that FDA’s delay violated the APA and ordered …

    • House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action DeadlinesJune 13th, 2013

      By Kurt R. Karst –       A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …

    • California Proposition 65 Reform Clears First HurdleJune 11th, 2013

      By Riëtte van Laack – On Friday, May 24, 2013, the California Assembly unanimously voted (72-0) for bill AB 227, amending Proposition 65 by including a new provision allowing certain small business owners 14 days to fix an alleged violation of Proposition 65’s warning requirements.  AB …

    • 2015 Dietary Guidelines Deliberations Get UnderwayJune 3rd, 2013

      By Ricardo Carvajal – DHHS and USDA announced the inaugural meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC), scheduled for June 13-14.  At the inaugural meeting, the DGAC will be provided with an orientation to the process for revising the Dietary Guidelines (revisions take place …

    • Recent Kellogg Class Action Settlement is a Reminder that Litigation Over Advertising Claims Often Comes in Several WavesMay 31st, 2013

      By JP Ellison – You may not recall our prior April 2009 blog post about the FTC’s settlement with Kellogg over its marketing campaign for Frosted Mini-Wheats.  To briefly recap, Kellogg had claimed that “its cereal was “clinically shown to improve kids’ attentiveness by nearly …