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

    • 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 …

    • Senators Hatch and Harkin Request that FDA Withdraw Draft NDI GuidanceJanuary 10th, 2012

      By Riëtte van Laack – In a strongly worded letter to FDA Commissioner Hamburg dated December 22, 2011, the principal authors of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), requested that FDA immediately withdraw the …

    • USP Proposes Standards for Probiotic Food IngredientsJanuary 9th, 2012

      By Riëtte van Laack – On January 3, 2012, the U.S. Pharmacopeial Convention (“USP”), a scientific organization that publishes the Food Chemical Codex (“FCC”), an international compendium of quality specifications for food ingredients, announced proposed standards for probiotic food ingredients. The proposed standards will be included …

    • HP&M Director to Present at FDLI Food Week 2012January 3rd, 2012

      The Food and Drug Law Institute’s (“FLDI”) annual Food Week Conference is being held in Washington, DC on January 23-26, 2012.  FDLI Food Week features a two-day introduction to food law and regulation, as well as three days of advanced programming on advertising and labeling, …