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  • Foods and Dietary Supplements

    • 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 …

    • Citing Delaney Clause, FDA Revokes Food Additive Approval of Six Artificial Flavoring SubstancesOctober 14th, 2018

      As we previously speculated might come to pass, FDA announced that it is amending the food additive regulation for synthetic flavoring substances and adjuvants (21 C.F.R. § 172.515) to remove six substances found to induce cancer in animals, namely benzophenone, ethyl acrylate, eugenyl methyl ether …

    • ITIF Petitions FDA to Ban “Non-GMO” on Consumer Foods and GoodsOctober 3rd, 2018

      On September 24, the Information Technology and Innovation Foundation (ITIF) petitioned FDA to prohibit the use of the term “Non-GMO” on consumer foods and goods because according to ITIF the claim is misleading. Although the Petition focuses on the Non-GMO Project Verified “butterfly” logo, it asks …

    • FDA Seeks Information on Labeling and Consumer Use of Certain Plant-Based ProductsSeptember 28th, 2018

      FDA published a notice requesting information on how consumers use plant-based products whose names include terms such as “milk,” “yogurt,” and “cheese,” and how consumers understand those terms when used in such product names.  The notice seeks data and evidence in five major areas, namely: (A) the …

    • FDA Adopts New Policy on Release of Retailer Lists During Human and Animal Food RecallsSeptember 27th, 2018

      FDA announced the establishment of a new policy that provides for the release of lists of retailers that may have received a food subject to a recall.  Historically, FDA has not released such information because it is considered confidential commercial information.  FDA now has concluded that …