Robert Durkin on Manufacturers

Magic’s in the Makeup: FDA Modernizes Cosmetic Product Labeling Requirements

“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent...more

6/17/2024 / Cosmetics , Disclosure Requirements , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health and Safety , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , Personal Care Products , Product Labels

FDA Announces End of Sales of PFAS Used in U.S. Food Packaging

The U.S. Food and Drug Administration (“FDA”) recently announced that grease-proofing substances containing per and poly-fluoroalkyl substances (“PFAS”) are no longer being sold by manufacturers for food contact use in the...more

4/25/2024 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Manufacturers , PFAS , Product Packaging , Toxic Chemicals

Not Just for Looks: FDA Publishes Guidance Regarding New Registration and Listing Requirements for Cosmetics

Registration and listing requirements are old news for many FDA-regulated products, but FDA did not have authority to require cosmetic product listings or facility registrations until just recently. FDA had a voluntary...more

8/30/2023 / Consumer Product Companies , Cosmetics , Draft Guidance , Food and Drug Administration (FDA) , Listing Rules , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , Personal Care Products , Registration Requirement

Honesty is Hardly Ever Heard, And Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting With FDA

From the 1978 52nd Street album, Billy Joel sings, “Honesty is such a lonely word, everyone is so untrue; honesty is hardly ever heard, and mostly what I need from you.” While we don’t want to start out this Bulletin on such...more

11/23/2021 / Food and Drug Administration (FDA) , Manufacturers , Regulatory Oversight , Risk Mitigation

There’s No Reply At All: It’s Never a Good Idea To Ignore FDA During an Inspection (and, in Fact, It’s Illegal)

Rule Number One: If a facility is regulated by the Food and Drug Administration, the agency may inspect it (although there are some boundaries, not discussed here)....more

10/29/2021 / Food and Drug Administration (FDA) , Inspections , Manufacturers , Warning Letters

AGG Food & Drug Newsletter - October 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

10/28/2021 / Clinical Trials , Cyber Attacks , Department of Justice (DOJ) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Inspections , Insurance Industry , Manufacturers , Pharmaceutical Industry

Be Careful to Not Beat Yourself in the Race To Market and Wind Up Excluding Your Own Ingredient From Being Allowed in Food or...

We are often approached by clients interested in conducting studies relating to an article that qualifies as a dietary substance or ingredient. Some of these clients are interested in studies intended to provide insight into...more

11/20/2020 / Animal Food , Biotechnology , Dietary Supplements , Food and Drug Administration (FDA) , Manufacturers , Product Labels

AGG Food & Drug Newsletter - October 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

10/30/2020 / Dietary Supplements , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Food Labeling , Imports , Manufacturers , Medical Devices , Nutrition Facts Labels , Pharmaceutical Industry , Prescription Drugs

Required Revisions to Nutrition and Supplement Facts Labels are to be Fully Implemented by January 1, 2021

The Food and Drug Administration issued new regulations requiring changes to the nutrition and supplements facts labels of conventional food and dietary supplements, respectively, on May 27, 2016....more

10/29/2020 / Dietary Supplements , Food and Drug Administration (FDA) , Food Labeling , Manufacturers , Nutrition Facts Labels , Nutritional Supplements , Product Labels

AGG Food & Drug Newsletter - September 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

10/2/2020 / Advertising , Drug Pricing , Food and Drug Administration (FDA) , Inspections , Manufacturers , OPDP , Pharmaceutical Industry

FDA Issues Proposed Rule Seeking to Clarify Evidence Relevant to Its Intended Use Determinations of FDA-Regulated Products

On September 23, 2020, the U.S. Food and Drug Administration (FDA) published in the Federal Register a proposed rule titled, “Regulations Regarding ‘Intended Uses.’”...more

10/1/2020 / Food and Drug Administration (FDA) , Intended Use , Manufacturers , Medical Devices , Product Labels , Regulatory Requirements

FSVP: Basics for Importers of Dietary Supplements and Their Components

Importing dietary supplements and dietary supplement components can present many challenges. Not the least of which are those required to stay in compliance with aspects of the Food Safety and Modernization Act (FSMA)....more

6/29/2020 / Dietary Supplements , Food and Drug Administration (FDA) , Food Safety , Foreign Suppliers , FSMA , FSVP , Imports , Manufacturers

AGG Food & Drug Newsletter - November 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

11/27/2019 / Centers for Medicare & Medicaid Services (CMS) , CGMP , Food and Drug Administration (FDA) , Manufacturers , OPDP , Open Payments , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Warning Letters

Robert Durkin

Arnall Golden Gregory LLP

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