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  1. Services
  2. Cosmetics, OTC Drugs & Personal Care Products

Perspectives on Cosmetics, OTC Drugs & Personal Care Products

21 total results. Page 1 of 1.

Alerts
Modernization of Cosmetics Regulation Act of 2022
February 14, 2023
Brian P. Waldman, Shoshana Golden
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023.
Alerts
Consolidated Appropriations Act, 2023 Contains Significant Provisions for Cosmetic Products
December 28, 2022
Emily M. Leongini, Shoshana Golden
On December 20, 2022, the US Senate unveiled the long-awaited Consolidated Appropriations Act, 2023. The US House of Representatives passed the bill three days later, and it is now awaiting President Biden’s signature.
Alerts
FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs
April 7, 2021
Emily M. Leongini
As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in the United States.
Alerts
USDA and FDA Address Equipment Shortages to Protect Nation’s Food Supply
May 26, 2020
Wayne H. Matelski
On Friday, May 22, 2020, the USDA and FDA jointly released recommendations to address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industries.
Alerts
Congress Enacts Sweeping Reforms to Over-the-Counter Drug Regulation as Part of COVID-19 Response Bill
April 22, 2020
Brian P. Waldman, Emily M. Leongini
For years, regulators, industry, and lawmakers alike have sought to modernize the regulatory framework under which most over-the-counter (OTC) drugs are marketed in the US. With the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) on March 27, 2020.
Alerts
FDA Temporarily Relaxes Requirements For Alcohol Used in Hand Sanitizers
March 26, 2020
Emily M. Leongini
As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the production of alcohol-based hand sanitizer.
Alerts
Update: The Latest Science on COVID-19
March 25, 2020
Robert G. Edwards, Ph.D., Deborah M. Shelton, Brian P. Waldman
Arent Fox continues to monitor the latest scientific reports on COVID-19 and the novel coronavirus for issues that may be of general concern to our clients.  
Alerts
FDA, TTB Announce Emergency Policies to Increase the Domestic Supply of Hand Sanitizer
March 25, 2020
Michael T. Kelly, Emily M. Leongini, Dan Jasnow
The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US.
Alerts
Delay in Reporting Adverse Event Reports for FDA-Regulated Products During the Pandemic
March 25, 2020
Wayne H. Matelski
FDA has just published a new Guidance that will allow for the suspension of reporting of certain adverse event reports while the COVID-19 pandemic continues.
The Fine Print
Legislation Introduced to Define the Term ‘Natural’ for Personal Care Products
December 11, 2019
Anthony V. Lupo, Matthew R. Mills, Emily M. Leongini
Last month, Representatives Sean Patrick Maloney (NY-18) and Grace Meng (NY-6) introduced the Natural Cosmetics Act that would define the term “natural” as it relates to personal care products and give the US Food and Drug Administration (FDA) authority to enforce the new requirements. 
Events
3rd Annual Dietary Supplement Regulatory Strategy Conference
December 3, 2018
Karen Ellis Carr, Emily M. Leongini
Partner Karen Carr and Associate Emily Leongini will participate as speakers at the 3rd Annual Dietary Supplement Regulatory Strategy Conference in December 2018.
Events
New York State Bar Association Food, Drug & Cosmetic Law Section Annual Meeting and Reception
January 25, 2018
Karen Ellis Carr
Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.
Alerts
Companies Marketing CBD Products Be Warned: FDA Is Watching
November 20, 2017
Emily M. Leongini
The US Food and Drug Administration recently issued warning letters to four companies.
Alerts
FDA to Begin Posting Adverse Event Report Data for Foods and Cosmetics
December 8, 2016
Brian P. Waldman
On December 7, 2016, FDA published a Notice in the Federal Register announcing that its Center for Food Safety and Applied Nutrition will begin publishing data extracted from adverse event reports the Agency has received for conventional foods, dietary supplements, and cosmetics.
Alerts
FDA Enforcement Against Cosmetics Continues at Record Pace in 2016
September 14, 2016
Brian P. Waldman
FDA continues to maintain an aggressive enforcement stance against cosmetics/personal care product companies and has already issued a record 19 Warning Letters to such companies so far in 2016.
Alerts
FDA Issues Final Rule on Consumer-Use Antimicrobial Washes
September 7, 2016
Brian P. Waldman
The US Food and Drug Administration published a Final Rule in the Federal Register on September 6, 2016, which establishes that Over-the-Counter consumer antiseptic wash products containing one of 19 specific active ingredients (listed below) can no longer be marketed.
Alerts
Congress Considering Legislation Giving FDA Additional Regulatory Authority Over Cosmetics and Personal Care Products
September 6, 2016
As Congress returns from its summer recess and begins wrapping up its work for the remainder of 2016, one of the many outstanding issues is FDA regulation of cosmetics and personal care products.
Alerts
State AG’s Action Another Reminder of the Risks of Minimum Resale Price Policies
June 23, 2016
Brian D. Schneider
Manufacturers were reminded recently why resale price maintenance policies can be risky.
Alerts
FDA Issues Warning Letter to L’Oreal for Skin Pigmentation Claims
March 3, 2015
Wayne H. Matelski, Brian P. Waldman
Recently, the US Food and Drug Administration issued a Warning Letter to L’Oreal USA for marketing its cosmetic products, “Rosalic AR Intense” and “Mela-D Pigment Control,” with claims deemed by FDA to be drug claims.
Alerts
The FDA Publishes Draft Guidance on CGMPs for Combination Products
January 27, 2015
Brian P. Waldman, Wayne H. Matelski
The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.
Alerts
FDA Issues Inspection Guidance
December 17, 2014
Brian P. Waldman, Wayne H. Matelski
The Food and Drug Administration (FDA) recently issued Guidance that describes circumstances that could occur during a drug facility inspection that might be deemed to constitute a “delay,” “denial,” “limitation,” or “refusal” of an inspection.

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