On November 8, 2023, FDA issued a Final Guidance entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (“FDA Guidance”) extending some upcoming deadlines set forth in the...more
On August 7, 2023, FDA issued a draft guidance document entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (“The Draft Guidance”), providing FDA’s current thoughts on the...more
On December 30th, 2022, President Biden signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), which included an Act now signed into law entitled the Modernization of Cosmetic Regulations Act of 2022...more
On May 26, Senators Murray and Burr introduced S. 4348 (pg. 97). The primary focus of the bill was to pass reauthorizations of FDA’s critical user fee programs for drugs, medical devices and biologics, which are scheduled to...more
On March 26, 2021, the FDA announced it will collect OTC user fees for Fiscal Year 2021 from owners of OTC Monograph Facilities that were in operation for the period from January 2020 through December 2020. As we previously...more
As is typical with the FDA, the Agency chose the end of the year to publish the fees it intended to collect from over-the-counter (OTC) monograph drug manufacturers under the OTC Monograph User Fee Act (OMUFA). In its...more
Last Friday, a bipartisan bill was introduced in the House of Representatives that would legalize cannabidiol (CBD) and other hemp-derived products for use in dietary supplements. The bill—H.R. 8179—was co-sponsored by Rep....more
Buried at page 415 of the Coronavirus Relief Bill is an Amendment to the Federal Food Drug and Cosmetic Act which Completely Changes How Over the Counter Drugs are Regulated by the FDA
With few exceptions for drugs like...more
The CBD industry has been looking for a resolution to the uncertainty surrounding the legal and regulatory status of CBD containing products. Yesterday (July 23, 2019), the Food and Drug Administration (“FDA” or “the agency”)...more
On May 31, 2019, FDA conducted its long awaited public hearing regarding the regulation of CBD- and THC-containing products. FDA has opened a docket for receiving additional submissions on CBD use in FDA-regulated products....more
In mid-December the United States Congress passed, and, on December 20, 2018, the President signed the 2018 Farm Bill. By far the most noteworthy aspects of the bill relate to cannabis and hemp. Under the Controlled...more
3/25/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Controlled Substances Act ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Oversight ,
USDA
On February 26, 2019, the FDA published yet another additional proposed rule in the proceedings to finalize the OTC Sunscreen Monograph.
Comments on the proposed rule may be filed with the FDA within 90 days from the...more
On September 6, 2016, the Food and Drug Administration (FDA) published a final rule on the use of certain active ingredients which were proposed for inclusion in the Over-The-Counter (OTC) Consumer antiseptic washes portion...more
On April 12th, the FTC announced proposed settlements and orders with four companies: Trans-India Products, Erickson Marketing Group, ABS Consumer Products and Beyond Coastal. The FTC issued an administrative complaint...more