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
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...more
In an industry known for its fast-paced changes, 2024 will be no different for cannabis. For all those with an eye on the industry, the number one question remains, is this the year for rescheduling? The answer is, maybe. And...more
4/19/2024
/ Artificial Intelligence ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Capital Raising ,
DEA ,
Decriminalization of Marijuana ,
FDIC ,
Hemp ,
Intellectual Property Protection ,
Machine Learning ,
Marijuana ,
Marijuana Related Businesses ,
Political Parties ,
Popular ,
Regulatory Agenda ,
Regulatory Requirements ,
State and Local Government ,
State Legislatures ,
Taxation ,
Trademarks
New York Supreme Court Justice Kevin Bryant recently ruled that all New York State cannabis regulations are unconstitutional and therefore, null and void. In an opinion issued on April 3, Justice Bryant explained that the...more
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...more
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.
As we reported last year, the...more
On November 8, the US Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing.
On November 8, the US Food and...more
Last Friday, the US Food and Drug Administration (FDA) announced its newly developed draft electronic submission portal — Cosmetics Direct — to facilitate submissions of cosmetic product facility registrations and product...more
For better or worse, generative artificial intelligence (AI) is already transforming the way we live and work. Within two months of its initial release to the public, ChatGPT reached 100 million monthly active users, making...more
8/28/2023
/ Artificial Intelligence ,
Cannabis Products ,
Confidential Information ,
Data Security ,
Enforcement ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Intellectual Property Protection ,
Licensing Rules ,
Machine Learning ,
Medical Marijuana ,
Producers ,
Reliability Standards ,
Retailers ,
Startups ,
Strict Product Liability ,
Training
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,” which clarifies the agency’s expectations regarding the...more
As those in the reproductive health space scramble to keep up with the ever-changing landscape of mifepristone (Mifeprex) access, it seems that every party must have their say.
The last three months have seen updates from...more
In January, the United States Court of Appeals for the Tenth Circuit issued a published opinion in Serna v. Denver Police Department, No. 21-1446 (10th Cir. Jan. 24, 2023), upholding the dismissal of a hemp farmer’s lawsuit...more