As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in a continuing series of posts diving into each...more
As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a...more
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in our continuing series of posts diving into...more
8/24/2023
/ Cosmetics ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Marketing ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Labels ,
Reasonable Certainty Standard ,
Responsible Party ,
Safety Standards ,
Testing Requirements ,
Toxic Chemicals
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more
7/3/2023
/ Clinical Trials ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Foods ,
Medical Research ,
Pharmaceutical Industry ,
Plant Based Products ,
Popular ,
Prescription Drugs
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each...more
Facility Registration: What Is a Facility and Who Has to Register?
Section 607 of MoCRA requires the registration of facilities that manufacture or process cosmetics for distribution in the United States. While this...more
Am I making a “cosmetic product”?
If you are a manufacturer, packer, importer, or distributor, the first question you should be asking is whether your product falls under the definition of a “cosmetic product,” which...more
The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law on December 29, 2022. MoCRA expands the authority of the U.S. Food and Drug Administration (“FDA”) to regulate cosmetics and serves as the...more
On April 19, 2021, the U.S. Postal Service issued a notice regarding the upcoming changes to Publication 52, which is titled “Hazardous, Restricted, and Perishable Mail.” Postal Service, “Treatment of E-Cigarettes in the...more
The U.S. Food and Drug Administration (FDA) issued Warning Letters this month to two companies concerning the marketing and sale of over-the-counter (OTC) drug products containing cannabidiol (CBD) as an inactive ingredient....more
3/24/2021
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Marketing ,
Misleading Impressions ,
Misleading Statements ,
Over The Counter Drugs (OTC) ,
Warning Letters
Companies that import, market and distribute vaping products will see significant changes to their businesses due to a major modification in the scope of products subject to the Prevent All Cigarette Trafficking (PACT) Act....more
On January 21, 2021 at 3:00 PM in Eastern Time, the Centers for Disease Control and Prevention (CDC) will host a joint webinar to provide updates on COVID-19 vaccine implementation for food and agriculture essential workers....more
On December 16, 2020, the U.S. Food and Drug Administration (“FDA”) issued a corporate Warning Letter to Whole Foods Market (“Whole Foods”) following 32 recalls Whole Foods conducted over an approximate one year period for...more
On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program. That user fee program was an addition...more
On August 20, 2020, the Drug Enforcement Administration (“DEA”) published an Interim Final Rule on industrial hemp and hemp derivatives (the “Interim Rule”), which immediately went into effect, to conform DEA regulations with...more
The U.S. Food and Drug Administration issued a final rule, effective October 13, 2020, to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and...more
The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) has proposed to amend the organic regulations to strengthen oversight and enforcement of the production, handling, and sale of organic...more
On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend the Proposition 65 regulations. Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986,...more
Recently, the Centers for Disease Control (CDC) and Occupational Safety and Health Administration (OSHA) jointly issued an interim guidance to meat and poultry processing companies to facilitate continued operations and...more
The U.S. Food and Drug Administration (FDA) announced updated plans for conducting routine inspections of domestic and foreign inspections during the COVID-19 public health emergency. In March, FDA announced that it was...more
The U.S. Food and Drug Administration (FDA) has announced it will begin conducting remote inspections of importers under the Foreign Supplier Verification Program (FSVP) during the COVID-19 Public Health Emergency. FSVP...more
The U.S. Food and Drug Administration (FDA) and Alcohol and Tobacco Tax and Trade Bureau (TTB) have issued new and updated guidance documents in addition to those previously published in order to address the decreased market...more
Over the last several days, the U.S. Food and Drug Administration (FDA) has updated its recommendations for food manufacturers and food retailers during the COVID-19 public health emergency. While FDA continues to underscore...more
The U.S. Food and Drug Food and Drug Administration (FDA) has issued two guidance documents intended to assist restaurants and other retail food establishments during the COVID-19 public health emergency....more
The U.S. Food and Drug Administration (FDA) announced a new policy to provide flexibility for restaurants and food manufacturers that have products on hand that are not labeled for retail sale (i.e. labeled for foodservice)....more