The Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA) announced on August 2, 2024 that their long-standing Memorandum of Understanding (MOU) governing the development and...more
On May 21, 2024, The Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA)....more
The US Food and Drug Administration (FDA) recently announced that manufacturers have completed the voluntarily phase-out of the use of certain per- and polyfluoroalkyl substances (PFAS) in grease-proofing agents for food...more
Rising alarm over microplastics as pollutants has sparked significant attention, stirring public concern and regulatory scrutiny. While there is both a lack of standardized methods for measuring microplastics and no...more
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final...more
In a sizable step toward reorganizing the Human Foods Program (HFP or Program) to rehaul the US Food and Drug Administration’s (FDA’s) current food infrastructure to better coordinate the agency’s regulation of food products,...more
The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the...more
In a historic decision, the United States Department of Agriculture (USDA) has approved two companies, Upside Foods and GOOD Meat, to market lab-grown chicken in the United States....more
FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize...more
FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...more
FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which...more
FDA recently announced it does not object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular...more
The US Food and Drug Administration (FDA) recently issued a final guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” The guidance finalizes a 2020 draft guidance outlining how...more
The US Food and Drug Administration issued a proposed rule on September 29 setting forth new criteria for the labeling of food products with the nutrient content claim “healthy” intended to help consumers more easily navigate...more
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations...more
FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more
The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first...more
The US Department of Agriculture (USDA) recently announced a new initiative that its Food Safety and Inspection Service (FSIS) plans to put in place to limit Salmonella in poultry plants to help reduce related illnesses....more
The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on December 21, 2018, implementing the National Bioengineered Food Disclosure Standard (NBFDS). Beginning on January 1,...more
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more
9/21/2021
/ Coronavirus/COVID-19 ,
Drug Distribution ,
DSCSA ,
Food and Drug Administration (FDA) ,
Manufacturers ,
New Guidance ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Wholesale
In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The...more
US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other...more
6/2/2021
/ Beverage Manufacturers ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Health and Safety ,
Legislative Agendas ,
Marijuana ,
Plant Based Products ,
Regulatory Agenda ,
Regulatory Oversight
A US Court of Appeals for the Ninth Circuit panel recently affirmed a decision by the US Food and Drug Administration (FDA) approving soy leghemoglobin (also known as “heme”), a soy protein ...more
Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to...more