Insights on Cosmetics, OTC Drugs & Personal Care Products

In 2025, the retail and fashion industries are bracing for a transformative year, heavily influenced by the policies of the new Trump Administration. These policies promise rapid and significant changes, particularly in areas such as trade, tariffs, and immigration, which will profoundly affect global supply chains and labor dynamics.

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.

On December 12, the US Food and Drug Administration (FDA) announced the availability of updated final guidance on cosmetic facility registration and cosmetic product listing. If you are experiencing déjà vu, you are not alone — the FDA announced the issuance of the same final guidance almost exactly one year ago, on December 18, 2023.

Partner Emily Cowley Leongini was quoted in a recent Axios article on the Food and Drug Administration’s implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which established a July 1 deadline for companies to register their products and facilities with FDA.

As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States.

Companies subject to the requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) should take note that the deadline to register cosmetic facilities and list cosmetic products is fast approaching on July 1, 2024.

Since January 1, 2022, California’s Fragrance and Flavor Ingredients Right to Know Act of 2020 has required manufacturers of cosmetic products to disclose the following information to the California Department of Public Health (CDPH):

PFAS are a large family of synthetic organic chemicals containing carbon chains in which most or all of the hydrogen atoms have been replaced by fluorine.

Food, Drug, Medical Device & Cosmetic Associate Shoshana Golden will give a presentation on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and the intricate regulatory landscape governing cosmetics and over-the-counter (OTC) drugs at the American Conference Institute’s (ACI) Advanced Legal, Regulatory, and Compliance Forum on Over-the-Counter Drugs in New York City on January 23-24, 2024.

On December 18, the US Food and Drug Administration (FDA) announced the availability of the Cosmetics Direct electronic submission portal and publication of final guidance for industry on cosmetic facility registration and cosmetic product listing.

On December 14, the US Food and Drug Administration (FDA) issued new instructions for cosmetic companies to use when submitting mandatory serious adverse event reports to the agency.

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 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023.

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.  

The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US.

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.

The US Food and Drug Administration recently issued warning letters to four companies.