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  • Foods and Dietary Supplements

    • Warning Letters Begin Addressing FSMA Reinspection FeesApril 9th, 2012

      By Ricardo Carvajal – Warning letters issued by FDA since late February provide an indication of the types of violations that could trigger reinspection fees under the authority provided by the Food Safety Modernization Act (“FSMA”).  As we noted in a prior blog posting, FSMA authorized …

    • FDA Denies NRDC’s Petition to Ban BPA in Food PackagingApril 3rd, 2012

      By Riëtte van Laack – On March 30, FDA denied a petition submitted by the Natural Resources Defense Council ("NRDC") to ban bisphenol A ("BPA") in food packaging.  As FDA explains in its 15-page response, the science NRDC presented in the petition was insufficient to support a conclusion …

    • NTP Director Turns Spotlight on Endocrine DisruptorsMarch 20th, 2012

      By Ricardo Carvajal –           Linda Birnbaum, Director of the National Institute of Environmental Health Sciences and the National Toxicology Program, published an editorial discussing the most recent evidence that certain environmental chemicals, including suspected endocrine disruptors such as BPA, “can have effects that would …

    • FDA’s Qualified Health Claim For Green Tea and Breast/Prostate Cancer Found UnconstitutionalMarch 14th, 2012

      By Ricardo Carvajal – The U.S. District Court for the Northern District of Connecticut has ruled that FDA’s qualified health claim (“QHC”) regarding the relationship between green tea and the risk of breast and prostate cancer violates the First Amendment.  In a prior posting, we commented …

    • Is Yours A High-Risk Food Facility? Now You KnowMarch 12th, 2012

      By Ricardo Carvajal – FDA published its Food Safety Modernization Act ("FSMA") Domestic Facility Risk Categorization for FY2012, which distinguishes domestic high-risk ("HR") food facilities from non-high-risk (NHR) food facilities for purposes of determining frequency of inspection.  For now, the determination of whether a facility is …

    • District Court Decides that Garden of Life’s Expert Opinion Constitutes Competent and Reliable EvidenceMarch 8th, 2012

      By Riëtte van Laack – The United States District Court for the Southern District of Florida recently denied a motion by the Federal Trade Commission (“FTC”) to hold Garden of Life and its founder, Jordan S. Rubin (collectively “GOL”) in contempt for allegedly violating a court-issued …

    • Breathable Food Draws FDA Warning LetterMarch 7th, 2012

      By Ricardo Carvajal – In a letter that includes fun facts about the function of the epiglottis, FDA has warned Breathable Foods, Inc. that its AeroShot product is misbranded.  The product’s labeling is alleged to be false and misleading because it contains contradictory statements regarding whether …

    • FTC v. POM WONDERFUL: An UpdateMarch 5th, 2012

      By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food and dietary supplements unless they are supported by two well-controlled clinical studies, the industry has been …

    • FDA Asked to Require “Added Sugars” in a Food Ingredient StatementMarch 1st, 2012

      By Riëtte van Laack –  A coalition of public health associations sent a letter to FDA encouraging the agency to amend its ingredient statement regulation to include the single food ingredient “added sugars” followed by a parenthetical listing of the specific sugars added in descending order of …

    • Engineered Nanoparticles Reported to Affect Iron AbsorptionFebruary 27th, 2012

      By Ricardo Carvajal – Researchers report that in vitro and in vivo experiments conducted with polystyrene nanoparticles indicate that nanoparticle exposure can disrupt iron transport in the gut, and may possibly disrupt absorption of other minerals, as well as vitamins.  The in vivo experiments, which were …

    • “Breathable Food” Comes Under ScrutinyFebruary 21st, 2012

      By Ricardo Carvajal – According to press reports, Senator Charles Schumer (D-NY) has prevailed on FDA to examine the regulatory status of Aeroshot, a product labeled as a dietary supplement that claims to contain “a unique blend of caffeine and B vitamins in a fine powder …

    • Quality Encompasses Safety (At Least If You’re an Almond)February 12th, 2012

      By Ricardo Carvajal – In a decision sure to bring joy to the U.S. Department of Agriculture (“USDA”), the D.C. District Court granted the government’s motion for summary judgment in a lawsuit challenging a USDA regulation that requires domestically produced almonds to be treated for Salmonella.  …

    • Supreme Court Rules Federal Meat Inspection Act Preempts California’s Ban on Slaughter of Non-Ambulatory AnimalsJanuary 26th, 2012

      By Riëtte van Laack – On Monday, January 23, 2012, the U.S. Supreme Court ruled that a California state law prohibiting the slaughter, processing, and sale of any non-ambulatory animals is preempted by the Federal Meat Inspection Act (“FMIA”). As we previously reported, under California's Downed Animal …

    • Congressional Representatives Press FDA For Action on Third-Party AuditsJanuary 23rd, 2012

      By Ricardo Carvajal – In tandem with the release of a House Energy and Commerce Committee staff report on last year’s outbreak of Listeria monocytogenes in cantaloupe, members of that committee sent Commissioner Hamburg a letter calling for reforms in the conduct and oversight of third-party audits.  …

    • National Organic Program Proposes to Change Listing of Nutrients That Can be Added to Organic FoodJanuary 16th, 2012

      By Riëtte van Laack – USDA’s National Organic Program ("NOP") published a proposed rule that would amend the listing of vitamins and minerals in the National List of Allowed and Prohibited Substances (National List).  The National List identifies non-agricultural synthetic ingredients that may be used in …