The US Food and Drug Administration (FDA) has withdrawn its proposed rule on standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics, almost exactly one year after publication....more
US Congress tucked a big change into the latest government spending bill: a federal crackdown on intoxicating hemp-derived products....more
On October 13, California took a significant step toward consumer transparency with the enactment of SB 68, the Allergen Disclosure for Dining Experiences Act. This legislation makes California the first state to mandate...more
Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements....more
Last month, the US Food and Drug Administration (FDA) announced that it would begin daily publication of adverse event data for drugs and biologics via the FDA Adverse Event Reporting System (FAERS)....more
On September 8, the US Department of Justice (DOJ) announced the withdrawal of dozens of pending rulemaking actions, including two related to the cannabis industry....more
On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more
8/26/2025
/ Biotechnology ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Government Agencies ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Research and Development ,
Vaccinations
On August 6, the US Food and Drug Administration (FDA) issued an update regarding the use of per- and polyfluoroalkyl substances (PFAS), specifically fluoropolymers such as polytetrafluoroethylene (PTFE), in medical devices....more
On July 23, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a coordinated initiative to address health risks associated with so-called “ultra-processed foods.”...more
Since January, California officials have seized more than $316 million worth of illegal cannabis and $474,000 in cash through coordinated enforcement actions with state agency partners and local governments....more
Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more
It is not all doom and gloom for the cannabis industry this year; positive developments across states and the potential (albeit remote) for federal rescheduling means the cannabis industry can expect ongoing advancements....more
3/27/2025
/ Cannabis Products ,
Compliance ,
Controlled Substances Act ,
Corporate Transparency Act ,
Data Privacy ,
DEA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Marijuana ,
New Legislation ,
New York ,
Popular ,
Proposition 65 ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government
On March 3, the US Department of Health and Human Services (HHS) published a change in policy that could result in fewer opportunities for stakeholders and members of the public to weigh in on HHS regulatory action related to...more
Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more
2/27/2025
/ Compliance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Telehealth
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...more
2/20/2025
/ Americans with Disabilities Act (ADA) ,
Artificial Intelligence ,
CIPA ,
Class Action ,
Commercial Bankruptcy ,
Compliance ,
Data Privacy ,
E-Commerce ,
Environmental Social & Governance (ESG) ,
Executive Orders ,
Fashion Industry ,
Federal Trade Commission (FTC) ,
Form I-9 ,
Immigration ,
Independent Contractors ,
Influencers ,
International Trade ,
Mergers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
NAD ,
PFAS ,
Private Attorneys General Act (PAGA) ,
Public Health ,
Retailers ,
Supply Chain ,
Tariffs ,
Terms of Use ,
Tracking Systems ,
Trump Administration ,
Workplace Investigations
On January 13, the chief administrative law judge of the US Drug Enforcement Administration (DEA), John Mulrooney, postponed the highly anticipated hearing on the rescheduling of cannabis under the Controlled Substances Act...more
1/28/2025
/ Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Food and Drug Administration (FDA) ,
Internal Revenue Code (IRC) ,
IRS ,
Marijuana ,
Marijuana Related Businesses ,
Regulatory Agenda ,
Schedule I Drugs ,
Tax Credits ,
Tax Planning
Two years after the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the US Food and Drug Administration (FDA) has published the long-awaited proposed rule on talc-containing cosmetics....more
Despite growing public support, Texas continues its challenges to the legalization of recreational and medical marijuana. On December 5, Texas Lieutenant Governor Dan Patrick announced a bill that would ban all forms of...more
Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical...more
This past August, the US Drug Enforcement Administration (DEA) announced plans to hold an administrative hearing on its proposal to move “marijuana” from Schedule I of the Controlled Substances Act — the most restrictive...more
On September 30, Governor Gavin Newsom signed into law the California Assembly Bill 1775 (AB 1775). The bill amends Section 26200 of the Business and Professions Code and significantly expands the permissible activities for...more
As we discussed during our recent webinar, the administrative process associated with the US Drug Enforcement Administration’s (DEA) proposed rescheduling of “marijuana” should be expected to proceed slowly and deliberately....more
On July 16 the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) jointly issued warning letters to five companies for illegally selling “copycat” food products containing delta-8...more
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. As compliance deadlines for these new...more
6/24/2024
/ Compliance ,
Cosmetics ,
Fashion Industry ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
PFAS ,
Product Labels ,
Product Packaging ,
Product Recalls ,
Registration Requirement