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  • Foods and Dietary Supplements

    • A Grain of Potassium Chloride SaltMay 22nd, 2019

      On June 26, 2016, NuTek Food Science, LLC (NuTek) petitioned FDA to recognize “potassium salt” as an optional name for potassium chloride.  Petitioner claimed (and presented evidence) that consumer acceptance of potassium chloride (as alternative to salt or sodium chloride) is hindered by consumers’ association …

    • Hi-Tech Sues to Save DMHAMay 6th, 2019

      Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) and its President and Chief Operating Officer filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from continuing to seek removal of DMHA products from commerce through the issuance of warning letters and “pressure… to …

    • D.C. Superior Court Holds That Challenge to Advertising Claim for Meat Product is Preempted Because USDA Approved Same Claim on LabelApril 28th, 2019

      In 2016, the Animal League Defense Fund (ALDF) sued Hormel Foods Corporation, alleging that the company’s use of the terms “natural” and “no preservatives added” in advertising for its Natural Choice products violated the D.C. Consumer Protection Procedures Act.  Plaintiff alleged that the these claims …

    • FDA Issues Draft Guidance Regarding Labeling of Allulose (the Monosaccharide That is Not a Sugar); More Guidance on Added Sugars to FollowApril 25th, 2019

      FDA’s nutrition labeling rules have defined most nutrients based on chemical structure.  However, in light of evidence on allulose, FDA may need to reconsider that focus. Allulose is a monosaccharide, and the nutrition labeling regulation defines sugars as mono- and disaccharides.  Thus, under the regulations, allulose …

    • FSIS Proposes to Simplify Labeling Compliance by Removing the Requirement for Dual Declaration of Net ContentApril 18th, 2019

      On April 16, the Food Safety & Inspection Service (FSIS) of USDA announced the publication of a proposed rule amending the labeling regulations for net content statements on meat and poultry.  FSIS proposes to remove the requirement for dual declaration of net weight and net …

    • USDA and FDA Publish the Terms of Their Joint Regulation of Human Food, Derived from Cell Lines of USDA-Amenable SpeciesMarch 11th, 2019

      As readers of this blog may recall, the issue of the regulation of meat and poultry derived from cell lines, identified by such terms as cultured meat, clean meat, and cell-based meat, became front cover news a little more than a year ago when the …

    • FDA Announces Various Initiatives to Increase Oversight of the Dietary Supplement IndustryFebruary 15th, 2019

      On February 11, 2019, Dr. Gottlieb issued a statement that appears to build on statements from December 2018.   In December 2018, as part of remarks to the FDLI Enforcement, Litigation, and Compliance Conference, Dr. Gottlieb had alluded to FDA’s plans to step up its efforts …

    • Petition to Bar Hydroponic Operations from Organic CertificationJanuary 29th, 2019

      The question of whether hydroponic operations are eligible for organic certification in the United States has been debated since 1995.  In most countries, such as Mexico and Canada, and regions, such as the EU, organic certification cannot be extended to crops not grown in soil.  …

    • HP&M Releases 2018 Litigation BriefingJanuary 9th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …

    • AMS Issues Final Rule BE Labeling; Narrow Definition of BE and No Disclosure for Highly Refined FoodsDecember 26th, 2018

      On December 20, 2018, the Agricultural Marketing Service announced the availability of its long-awaited final rule implementing the national mandatory bioengineered (BE) food disclosure standard (NBFDS).  The history of the law and rule was discussed in our post on the proposed rule. In the proposed rule, AMS …

    • Farm Bill Resolves Issue of Added Sugar Declaration for Single Ingredient FoodsDecember 18th, 2018

      As we previously reported, one of the main components of FDA’s 2016 final rule to update the Nutrition Facts is the mandatory requirement for a declaration and a daily value (DV) for “added sugar” for both sugars added to processed foods as well as foods “packaged as …

    • Crazy Kind of ClaimsNovember 14th, 2018

      Once in a while a consumer class action catches our particular attention.  Most recently, Kind LLC was sued in the U.S. District Court for the Eastern District of New York over its advertising, labels, and ingredient statements for its “Pressed by KIND” and “KIND Fruit …

    • More Kryptonite for KratomNovember 13th, 2018

      Most people think of getting salt water taffy from resort beach town Myrtle Beach, SC. But, apparently, there is more activity going on in Myrtle Beach: a company there was supplying customers with kratom, a substance that the government contends is an illegal dietary supplement. …

    • FDA Finalizes One Guidance and Issues a Draft Guidance Related to the Amended Nutrition Labeling RegulationsNovember 12th, 2018

      Last week FDA published a final guidance and a draft guidance related to the nutrition labeling regulation amendments published in 2016. Final guidance The Guidance, titled “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of …

    • California Cuts Manufacturers Some Slack; Amends Slack Fill LawOctober 23rd, 2018

      As many of our readers know, slack fill litigation has increased within the food and beverage industry over the past several years. Approximately 300 slack fill cases were filed between 2016 and 2017, principally in California and New York. By definition, “slack fill” is the difference …