Petition circulators play a crucial role in democratic processes, but managing their activities can be challenging for public entities. Balancing petitioners' rights with the need to maintain public order and access to...more
Independent laboratory Valisure filed a March 5, 2024, citizen petition (CP) asserting, based on its own testing, that a number of benzoyl peroxide products contain high levels of benzene and that benzene concentrations are...more
Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than...more
The U.S. Department of Homeland Security (DHS) recently released a notice of proposed rulemaking (NPRM) entitled, “Modernizing H-1B Requirements, Providing Flexibility in the F-1 Program, and Program Improvements Affecting...more
This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions. Make no mistake, I have an interest in this...more
On July 21, 2023, the US Food and Drug Administration (FDA) issued a letter denying a request that it reconsider its decision from May 2022 that it would not prohibit the use of eight phthalates as food-contact substances. At...more
Rarely are we able to combine the Grateful Dead and Mississippi in the same sentence, but the band once said, what a long strange trip it’s been. In November 2020, Mississippi voters overwhelmingly approved Initiative...more
The U.S. Food and Drug Administration (FDA) recently granted a citizen petition concerning the classification of acacia (gum arabic) as a dietary fiber. As a result of the petition, FDA intends to propose to include acacia,...more
Earthjustice submitted an August 24th Petition to the United States Environmental Protection Agency (“EPA”) asking that it make an endangerment finding under Section 231 of the Clean Air Act in regards to aviation gasoline...more
The Mississippi Supreme Court held on May 14, 2021 that a citizen initiative to legalize medical marijuana violated the Mississippi Constitution. The decision turned on the loss of a congressional district due to the 2000...more
Another court of appeal has held that local special taxes adopted by a citizen-sponsored initiative do not require two-thirds voter approval. City of Fresno v. Fresno Building Healthy Communities, No. F080264. (5th Dist.,...more
A Summary of Published Appellate Opinions Involving the California Environmental Quality Act - Despite relatively few published opinions this year, there were significant appellate court rulings on a range of topics,...more
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics...more
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral...more
The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than...more
The U.S. Food and Drug Administration (FDA) has released a proposed update to traceability recordkeeping requirements for foods considered “high risk” as sources of foodborne illness. The proposed rule would apply to entities...more
The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA: FDA exercise its statutory authority to establish a regulation under which...more
U.S. Citizenship and Immigration Services (USCIS) recently announced that due to the decreased amount of petitions currently being filed, it is seeking federal funding of $1.2 billion to help offset the loss of revenue it...more
Part 1: California Laws Impacting Public Agencies for 2020 - How do the laws passed last year by California lawmakers impact how public agencies do business in the new year? In this annual Legal Alert series, Best Best &...more
For years, natural sources of nitrates and nitrites have been used to cure meats as an alternative to traditional synthetic sources. The United States Department of Agriculture ("USDA") requires companies that cure meats...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
Introduction: Citizen Petitions in the News - Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more
On Friday, June 7, 2019, Gov. Ron DeSantis signed House Bill 5 into law, introducing immediate changes to the process for citizens to propose amendments to the Florida Constitution....more
The Utah Supreme Court recently decided Baker v. Carlson, 2018 UT 59, which considered a developer’s ongoing effort to build a mixed-use, part-residential and part-commercial development on the site of the long-defunct...more
LEGISLATION, REGULATIONS & STANDARDS - FDA to Hold CBD Public Hearings - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly said in a February 27, 2019, hearing before the House...more