Earlier this week, the US Food and Drug Administration (FDA) issued draft Q&A guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products.”
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.
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.
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.
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.
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.
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.
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.
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.
Partner Karen Carr and Associate Emily Leongini will participate as speakers at the 3rd Annual Dietary Supplement Regulatory Strategy Conference in December 2018.
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.
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.
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.
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.
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.
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.
The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.
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.