Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat...more
4/16/2025
/ Civil Monetary Penalty ,
Customs and Border Protection ,
Department of Justice (DOJ) ,
E-Cigarettes ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Intellectual Property Litigation ,
International Trade Commission (ITC) ,
Patent Infringement ,
Patents ,
SCOTUS ,
Tobacco
The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8). In May 2022, the U.S. Food and Drug...more
Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes...more
On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more
Agencies of the federal government with a consumer protection mission have always tended to work closely together and to share information, but the COVID-19 pandemic has made those cooperative efforts even more visible to the...more
Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee...more
In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19...more
Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more
12/22/2020
/ Biologics ,
CDRH ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Emergency Use Authorization (EUA) ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry
The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating...more
10/7/2020
/ Coronavirus/COVID-19 ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules
As we discussed in our last update on the Food and Drug Administration’s Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will...more
We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud. These agencies and their respective law enforcement efforts have yet to slow down and appear to have...more
Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018, the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020....more
2/5/2020
/ Biologics ,
Biosimilars ,
Competition ,
Draft Guidance ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Joint Statements ,
Pharmaceutical Industry ,
Public Health ,
Public Workshops
This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” In taking a wide-lens view of the past year,...more
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety,...more
6/4/2019
/ Cannabidiol (CBD) oil ,
Cosmetics ,
Dietary Supplements ,
FDA Warning Letters ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Marijuana ,
Marijuana Related Businesses ,
Marijuana-Infused Edibles ,
Marketing ,
Pharmaceutical Industry ,
Product Labels ,
Public Comment ,
Public Hearing ,
Regulatory Agenda ,
Regulatory Oversight
Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more
5/8/2019
/ Bad Actors ,
Distributors ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Manufacturer Liability ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda
Happy New Year! And now on to your regular Consumer Product Matters programming…
Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more
On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and...more
We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade...more
It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies. My colleague Matt Cohen recently reported on the existence of a new CPSC tool called The...more
Recently published studies are illustrating the types of issues that mobile health application, or “app,” developers will continue to face as the industry matures alongside an evolving regulatory and enforcement landscape....more
We blog frequently about new regulatory developments coming from CPSC or FDA and about enforcement actions brought by those federal agencies as well as state counterparts and private plaintiffs. But we don’t very often...more
The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more
11/5/2015
/ Anti-Competitive ,
Biologics ,
Biosimilars ,
EU ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Patient Safety ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
World Health Organization
A bluntly labeled section of the Code of Federal Regulations – “Mayonnaise” – provides a description of this particular food dressing, the food’s required ingredients, optional ingredients, and how to declare those...more