Keller Heckman (LexBlog United States)

2201 results for Keller Heckman (LexBlog United States)

  • FTC Requests Comments on Proposed Changes to Endorsement Guides and .com Disclosures Guidance

    The Federal Trade Commission (FTC or Commission) has issued several new proposals or policy statements affecting advertisers recently, including resurrection of its Penalty Offense Authority and an Enforcement Policy Statement Regarding Negative Option Marketing (which we previously reported on here). The FTC is now seeking public feedback on a proposal to enhance and strengthen the...

  • Senate Committee Passes the FDA Safety and Landmark Advancements Act

    On June 14, 2022, the Senate Health, Education, Labor, and Pensions (HELP) Committee passed the FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348) which proposes various changes to the regulation of dietary supplements and cosmetics. The legislation was originally introduced by Sen. Patty Murray (D-WA) on May 26, 2022 and would amend Chapter IV...

  • JANAAC Recognized as an Accreditation Body Under FDA’s Accredited Third Party Certification Program

     The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, also referred to as the Third-Party Program (TPP).  The voluntary TPP allows accreditation bodies (ABs) to apply for recognition by FDA. Recognized ABs have the authority to accredit certification bodies (CBs), otherwise known as third-party auditors. In turn, the CBs (1) conduct consultative...

  • FDA Denies Authorization to Market JUUL ENDS Products; Company Intends to Seek Stay of the Marketing Denial Orders

    On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs)[1] to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years ago,...

  • U.S. Government Files Amicus Brief in Prop 12 Case

    As previously reported,  on March 28, 2022, the U.S. Supreme court granted a Writ of Certiorari petition submitted by the National Pork Producers Council (NPPC) and the American Farm Bureau Federation (AFBF) in National Pork Producers Council v. Karen Ross. The petitioners argue that California’s Proposition 12 places excessive burdens on interstate commerce in violation...

  • Senate Confirms Mary Boyle as 5th CPSC Commissioner

    Nearly a year after she was first nominated, Mary Boyle was confirmed Wednesday to be a Commissioner of the U.S. Consumer Product Safety Commission (CPSC). When she takes office for a term that will run through October 2025, Boyle will bring the Commission to its full five-member strength for the first time since 2019. Boyle...

  • FDA Provides Updates on Closer to Zero Plan

    As we have previously blogged, FDA announced a three-phase “Closer to Zero” plan in 2021 to reduce the levels of arsenic, lead, cadmium, and mercury that babies and young children are exposed to. In regard to arsenic and cadmium, the plan requires FDA to: (1) develop an interim reference level (IRL) for arsenic in phase...

  • HELP Committee Approves Bill to Address Infant Formula Shortage

    The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the FDA Safety and Landmark Advancements Act of 2022 (FDASLA) to introduce policies in response to the infant formula crisis. Sen. Patty Murray (D-WA), who chairs the HELP committee, introduced the bill in May. The HELP Committee added sections 909 and 910 to address...

  • FDA Responds to Severe Weather Incidents

    On June, 6 2022, FDA released an online resource page for human and animal food producers who may be affected by flooding and severe weather incidents.  It identifies federal and state resources available to those who may be harvesting, mixing, storing, or distributing grains and other foods. For example, FDA highlights that crops harvested from...

  • Beyond Meat Sued Over Protein Content Claims

    A proposed consumer class action lawsuit was filed against Beyond Meat, Inc. on June 10, alleging that the plant-based meat manufacturer embellished the amount of protein contained in its line of plant-based sausages, breakfast patties, meatballs, ground beef, and chicken products. [Subscription to Law360 required]. In the complaint, plaintiff Mary Yoon alleges that Beyond Meat...

  • Counsel Daniel McGee to Present at Next Generation Nicotine Delivery USA 2022 Conference

    Keller and Heckman Counsel Daniel McGee will present, “Navigating Evolving Vaping Laws Around the Country – State Law Update,” at the Next Generation Nicotine Delivery USA 2022 event, June 22-23, 2022, in Miami, Florida. This event will bring together business leaders from the ENDS and tobacco industry together with other experts in the field for...

  • Class Action Lawsuits Follow in Wake of JIF Recall

     As many of our readers (and fellow peanut butter consumers) are likely aware, on May 20th J.M. Smucker Co. issued a voluntary recall of its JIF peanut butter products due to potential Salmonella contamination linked to a manufacturing facility in Lexington, Kentucky. Class-action lawyers wasted no time in holding J.M. Smucker accountable and at least...

  • DC Circuit Upholds FDA Ban on Raw Butter

     Mark McAfee, a dairy farmer who wishes to sell raw, unpasteurized butter beyond his home state of California, and a co-plaintiff, the Farm-to-Consumer Legal Defense Fund, appealed FDA’s February 27, 2020 denial of McAfee’s 2016 citizen petition for a rulemaking by FDA to exclude butter from the requirement under 21 CFR 1240.61 that “milk products”...

  • Class Action Complaint filed in Eastern District of New York challenging “Natural” Dietary Supplements

    The United States District Court of the Eastern District of New York received a class action complaint on May 31, 2022 regarding the usage of the term “natural” in Nordic Naturals’ dietary supplement products. Plaintiffs allege that use of “natural” for said products constitutes false advertising as the products contain synthetic ingredients, including but not...

  • Prop 65 Short-Form Warning Rulemaking to Expire

    As previously reported, in January 2021 California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed limits on the use of the Proposition 65 short-form version of the safe harbor warning. The short-form warning became an option in 2016 and does not require manufacturers to disclose the chemical name(s) in the warning. OEHHA sought to limit...

  • Lawmakers Press White House on FDA’s Draft Guidance for Plant-Based Dairy Alternatives

    The White House Office of Management and Budget (OMB) received FDA’s proposed guidance on “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements” on March 31, 2022. The draft guidance, which has not been publicly released, comes several years after the FDA requested comments from the public regarding the labeling of plant-based dairy alternatives and...

  • “Fudge” Pop-Tarts Claims Dismissed

     Kellogg Escapes Class Action Over Fudge Ingredients (Law360 Subscription Required) We reported on three substantively identical class action lawsuits filed in district courts in Illinois that allege products containing vegetable oils in place of dairy fats (i.e., butter and/or milk) are falsely and misleadingly described as “fudge.”  The lawsuits, which are all filed by Sheehan...

  • False Advertising Suit Over “Smoked” Gouda Continues

    On May 27th, the United States District Court for the Northern District of Illinois Eastern Division granted in part and denied in part, Defendant’s motion to dismiss a false advertising class action lawsuit which alleged that The Kroger Co. misled consumers by implying that its “Smoked Gouda” sliced cheese was cheese smoked over hardwood. The...

  • USDA Responds to Avian Flu Outbreak

    On May 27, 2022, the U.S. Department of Agriculture (USDA) reported that Agriculture Secretary Tom Vilsack had approved funds to support USDA’s Animal and Plant Health Inspection Service (APHIS) in its response efforts to the outbreak of highly pathogenic avian influenza (HPAI) in the United States. HPAI requires a rapid response because it is highly...

  • Senate Bill to Revise and Reassess GRAS Program

    On May 27, Senator Edward J. Markey (D-Mass.), alongside Senators Richard Blumenthal (D-Conn.) and Elizabeth Warren (D-Mass)., introduced the Ensuring Safe and Toxic-Free Foods Act, which is described as “comprehensive legislation that ensures the Department of Health and Human Services (HHS) fulfills its responsibility to promote the health and well-being of American families by directing...

  • The Who, What, When, and Where of the FCC’s New Broadband Data Collection

    As discussed in our initial post in this series, the FCC is about to launch its new Broadband Data Collection (“BDC”) program. Starting this summer, all facilities-based providers of fixed and mobile broadband Internet access services will be required to submit broadband data on a biannual basis. In this post, we delve into the who,...

  • SUNSET Rule Withdrawn

    On May 27, 2022, the U.S. Department of Health and Human Services (HHS) issued a final rule withdrawing the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule, which had been promulgated in the waning days of the Trump administration and would have required most rules administered by HHS to be reviewed within 5 years...

  • FDA Issues Warning Letters to Four Companies Selling Unapproved CBD Products for Food-Producing Animals

    On May 26, 2022, FDA issued warning letters to Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD, and Kingdom Harvest, alleging, among other things, that the companies were illegally selling unapproved animal drugs with cannabidiol (CBD) intended to be used in food-producing animals. While some of the companies claim that...

  • FDA Webinar on Action Levels for Lead in Juice

    FDA will hold a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to provide an overview of the recent draft guidance that the Agency issued on action levels for lead in juice. As previously reported, the guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” set action levels of 10...

  • Pop-Tarts False Ad Lawsuit Permanently Dismissed

    On May 24, an Illinois federal judge permanently dismissed a proposed class action that alleged Kellogg misled consumers to believe its Frosted Strawberry Pop-Tarts contained more strawberries than actually present in the product (subscription to Law360 required). The plaintiff argued that strawberries are the pastries’ characterizing ingredient and their amount has a material bearing on...

  • The State of U.S. State Privacy Laws: A Comparison

    In the continuing absence of Congressional action on a comprehensive U.S. federal privacy law, five states have now enacted their own laws. We previously provided a summary of the California, Virginia, and Colorado laws (available here), and Connecticut and Utah have since enacted new privacy laws. The Connecticut Act Concerning Personal Data Privacy and Online Monitoring (CTDPA) was...

  • FDA Denies Request to Exempt D-Tagatose from Added Sugar Labeling

    In a letter dated May 18, 2022, FDA denied a citizen petition from Bonumose LLC which requested that the Agency (1) exempt D-tagatose from classification as an “Added Sugar” and (2) allow for the voluntary labeling of D-tagatose as a separate declaration under “Total Carbohydrates,” similar to the approach taken for sugar alcohols. By way...

  • New Draft Guidance on FDA Enforcement Discretion for Past-Due NDI Notifications

     The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or a dietary supplement that contains the NDI, to notify the FDA at...

  • FDA Updates Agricultural Water Protocol

    As previously reported, on July 30, 2020, FDA worked with EPA to release a protocol to evaluate the efficacy of antimicrobial pesticides in agricultural water. The protocol established an agricultural water panel assay that companies could use to test the capability of their water treatment processes to combat strains of Listeria, Salmonella and E. coli...

  • House Bill To Give FDA More Funding to Address Formula Shortage

    On May 17, House Appropriations Committee Chair Rosa DeLauro (D-CT) introduced H.R. 7790, a supplemental appropriations bill to provide $28 million in emergency funding to address the shortage of infant formula in the US for the fiscal year ending September 30, 2022. The bill is intended to provide the FDA with needed resources to address...

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