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Articles by Alexandre Gapihan
A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design | JD Supra
Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation.
A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design
Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation.
The Horse Is Out of the Barn: FDA and AAFCO Memo of Understanding on Animal Feed Ingredients to Expire | JD Supra
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 review of definitions of animal feed ingredients will not be renewed once it expires on October 1, 2024.
The Horse Is Out of the Barn: FDA and AAFCO Memo of Understanding on Animal Feed Ingredients to Expire
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 review of definitions of animal feed ingredients will not be renewed once it expires on October 1, 2024.
From Prohibition to Prescription: DEA Issues Proposed Rule to Reschedule Marijuana | JD Supra
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). This announcement comes nearly a year after the US Department of Health and Human Services (HHS) August 29, 2023 letter to the DEA recommending that marijuana be rescheduled.
From Prohibition to Prescription: DEA Issues Proposed Rule to Reschedule Marijuana
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). This announcement comes nearly a year after the US Department of Health and Human Services (HHS) August 29, 2023 letter to the DEA recommending that marijuana be rescheduled.
That’s a Wrap: FDA Announces Phase-Out of PFAS in Certain Food-Packaging Materials | JD Supra
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 packaging. PFAS consist of a large group of synthetic chemicals that have been used widely in consumer products and industrial processes since the 1950s for a broad range of uses, including to keep food from sticking to cookware or packaging, or make clothes resistant to stains.
That’s a Wrap: FDA Announces Phase-Out of PFAS in Certain Food-Packaging Materials
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 packaging. PFAS consist of a large group of synthetic chemicals that have been used widely in consumer products and industrial processes since the 1950s for a broad range of uses, including to keep food from sticking to cookware or packaging, or make clothes resistant to stains.
That’s a Wrap: FDA Announces Phase-Out of PFAS in Certain Food-Packaging Materials
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 packaging. PFAS consist of a large group of synthetic chemicals that have been used widely in consumer products and industrial processes since the 1950s for a broad range of uses, including to keep food from sticking to cookware or packaging, or make clothes resistant to stains.
From Particles to Policy: Microplastics at the Crossroads of Regulation and Litigation | JD Supra
Rising alarm over microplastics as pollutants has sparked significant attention, stirring public concern and regulatory scrutiny.
From Particles to Policy: Microplastics at the Crossroads of Regulation and Litigation
Rising alarm over microplastics as pollutants has sparked significant attention, stirring public concern and regulatory scrutiny.
Yogurt and Type Two Diabetes: FDA Serves Up New Qualified Health Claim | JD Supra
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 diabetes if the claims are not misleading and comply with other regulatory requirements. In general, a health claim describes the link between a substance and its impact on health or disease (e.g., sodium and hypertension).
Yogurt and Type Two Diabetes: FDA Serves Up New Qualified Health Claim
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 diabetes if the claims are not misleading and comply with other regulatory requirements. In general, a health claim describes the link between a substance and its impact on health or disease (e.g., sodium and hypertension).
Register, List, Report, Repeat: FDA Clarifies MOCRA Cosmetics Requirements | JD Supra
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 guidance and a newly launched registration and listing portal, provide additional clarity as to what the agency’s approach to implementing MoCRA requirements will be in 2024.
Register, List, Report, Repeat: FDA Clarifies MoCRA Requirements
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 guidance and a newly launched registration and listing portal, provide additional clarity as to what the agency’s approach to implementing MoCRA requirements will be in 2024.
Combining the ‘Ingredients’: FDA Reorganizes Human Foods Infrastructure Under a Single Leader | JD Supra
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, FDA announced the selection of James Jones, a former Environmental Protection Agency official, to serve as the first Deputy Commissioner for HFP. FDA first announced its plans to reorganize the Program on January 31, 2023.
Combining the ‘Ingredients’: FDA Reorganizes Human Foods Infrastructure Under a Single Leader
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, FDA announced the selection of James Jones, a former Environmental Protection Agency official, to serve as the first Deputy Commissioner for HFP. FDA first announced its plans to reorganize the Program on January 31, 2023.
Combining the ‘Ingredients’: FDA Reorganizes Human Foods Infrastructure Under a Single Leader
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, FDA announced the selection of James Jones, a former Environmental Protection Agency official, to serve as the first Deputy Commissioner for HFP. FDA first announced its plans to reorganize the Program on January 31, 2023.
A New Foundation: FDA Issues Draft Guidance on MoCRA Cosmetic Registration, Listing Requirements Ahead of December 29 Statutory Deadline
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 Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Every cosmetic manufacturer and private labeler will be required to make a submission regardless of prior participation in the previous voluntary registration program.
A New Foundation: FDA Issues Draft Guidance on MoCRA Cosmetic Registration, Listing Requirements Ahead of December 29 Statutory Deadline
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 Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Every cosmetic manufacturer and private labeler will be required to make a submission regardless of prior participation in the previous voluntary registration program.
Featherless Revolution: FDA and USDA's Approval of Cell-Cultivated Chicken Takes Flight | JD Supra
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.
Featherless Revolution: FDA and USDA's Approval of Cell-Cultivated Chicken Takes Flight
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.
Featherless Revolution: FDA and USDA's Approval of Cell-Cultivated Chicken Takes Flight
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.
High-Tech Revamp: FDA Announces New Measures for Clinical Trials, Invites Feedback on GCP Guidelines | JD Supra
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 the design and conduct of clinical trials, making them more agile while maintaining data integrity and participant protections.
High-Tech Revamp: FDA Announces New Measures for Clinical Trials, Invites Feedback on GCP Guidelines
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 the design and conduct of clinical trials, making them more agile while maintaining data integrity and participant protections.
Salt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in Standardized Foods | JD Supra
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 intake in Americans.
Salt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in Standardized Foods
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 intake in Americans.
Cosmetics Regulations Getting a Makeover: FDA Announces Listening Session on Cosmetic Product GMPs | JD Supra
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 added Section 606 of the Federal Food, Drug, and Cosmetic Act requiring FDA to establish GMP regulations for cosmetics.
Cosmetics Regulations Getting a Makeover: FDA Announces Listening Session on Cosmetic Product GMPs
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 added Section 606 of the Federal Food, Drug, and Cosmetic Act requiring FDA to establish GMP regulations for cosmetics.
Cosmetics Regulations Getting a Makeover: FDA Announces Listening Session on Cosmetic Product GMPs
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 added Section 606 of the Federal Food, Drug, and Cosmetic Act requiring FDA to establish GMP regulations for cosmetics.
A sweet deal: FDA allows new qualified heart-healthy claim for high flavanol cocoa powder
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 disease (CVD), provided that the qualified claim is appropriately worded so as not to mislead consumers.
FDA Issues Final Guidance on Quality Considerations for Clinical Research on Cannabis and Related Compounds in Drugs | JD Supra
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 sponsors and investigators can legally conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds such as cannabidiol (CBD).
FDA Issues Final Guidance on Quality Considerations for Clinical Research on Cannabis and Related Compounds in Drugs
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 sponsors and investigators can legally conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds such as cannabidiol (CBD).
Eat Your Greens: FDA Proposes New Definition for ‘Healthy’ Packaged Food Claims | JD Supra Original
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 nutrition labels and to make healthier purchasing decisions. Per the proposed rule, labeling is to be consistent with current nutrition science, the Food and Drug Administration’s (FDA or Agency) updated Nutrition Facts label, and the Federal Dietary Guidelines.
One License to Unite Them All: FDA Proposes National Standards for Wholesale Distributors and Third-Party Logistic Providers | JD Supra
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 under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to be licensed according to a national standard.
After a Series of False Starts, FDA Resumes Domestic Inspections | JD Supra
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 pauses, including one announced on January 19, and one announced on January 4.
FDA Grants First E‑Cigarette PMTA Authorization | JD Supra
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 time FDA authorized the marketing of such a product under the premarket tobacco product application pathway.
New US Department Of Agriculture Initiative To Combat Salmonella In Poultry
United States: New US Department Of Agriculture Initiative To Combat Salmonella In Poultry 03 November 2021 by Kathleen M. Sanzo , Maria Kalousi-Tatum and Alexandre Gapihan Morgan Lewis To print this article, all you need is to be registered or login on Mondaq.com. 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.
New US Department of Agriculture Initiative to Combat Salmonella in Poultry | JD Supra
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. In its press release, USDA explained that, although the poultry industry has managed to reduce the occurrence of Salmonella, more than 1 million Salmonella illnesses continue to occur annually, with an estimated 23% caused by consuming chicken and turkey.
USDA Bioengineered Food Disclosure Rule Goes Into Effect on January 1, 2022 | JD Supra
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, 2022, the NBFDS will require manufacturers, importers, and retailers that package or sell food in bulk to disclose the presence of bioengineered food or food ingredients on product labels intended for retail sale.
FDA Reinstates Unapproved New Drug Initiative | JD Supra
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 announcement is an abrupt—but not unexpected—reversal from a previously issued controversial decision by the Trump administration’s HHS to end the Unapproved Drugs Initiative in November 2020.
Bipartisan Group of Senators Introduces Bill to Regulate Hemp and Hemp-Derived CBD in Food | JD Supra
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 ingredients used in dietary supplements, foods, and beverages.
Heme-Burgers and Hot Dogs: Ninth Circuit Affirms FDA’s Approval of Plant Meat Color Additive | JD Supra
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, as a color additive. Ctr. for Food Safety v. U.S. Food & Drug Admin., No. 20-70747, 2021 WL 1739920 (9th Cir. May 3, 2021).
Zooming in on Inspections: FDA Issues Guidance on Remote Interactive Evaluations and Roadmap on Inspectional Oversight | JD Supra
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 continue its oversight activities. According to a recently released FDA report, while FDA conducted 218 mission critical and prioritized inspections of human drug and biologic facilities, the agency also made broad use of alternative inspection strategies.
FDA Places Mexican-Made Hand Sanitizers on Import Alert Due to Toxin Risks | JD Supra
The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. The press release notes that alcohol-based hand sanitizers from Mexico will now be subject to heightened scrutiny and potential detainment by FDA staff. Import alerts allow FDA field staff to detain without physical examination products that appear to be in violation of the law.
Burger King Has Its Way: Vegan Whopper Class Action Suit Dismissed | JD Supra
In an order issued on July 20, Judge Raag Singhal of the US District Court for the Southern District of Florida dismissed a class action lawsuit that claimed Burger King Corporation’s advertising deceived customers by making a “presumption” that its plant-based “Impossible Whopper” patties would be cooked on different grills than those used to cook meats. Williams v. Burger King Corp., Case No. 1:19-cv-24755 (S.D. Fla. July 20, 2020).
Federal Food Regulation Changes Under COVID-19 | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
FSIS, FDA Provide Flexibility with Temporary Guidance | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
FDA Issues New Temporary Policy for the Manufacture of Alcohol for Hand Sanitizer Products | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Mexico’s New Labeling Rules Will Impact Marketers and Importers of Prepackaged Foods, Nonalcoholic Drinks | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
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