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
Top Legal Challenges for the Consumer Products Industry in 2025 -
With 2025 underway, the AFS Consumer Products team highlights some of the most pressing legal issues facing the consumer products industry this year....more
On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to...more
What Food Product Companies Need to Know About the New Proposition 65 Warning Requirements -
On December 6, 2024, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements Proposition...more
Controversial Prop 65 Warning Labels About Toxic Chemicals are Effective, Study Says -
For nearly 40 years, a controversial California law has required companies to place warning labels on their products alerting...more
Safe Harbor Warnings for Acrylamide Exposure From Food -
The Office of Environmental Health Hazard Assessment (OEHHA) has amended Title 27, California Code of Regulations 25607.2(b), to provide an additional safe harbor...more
California AG Will Not Seek Rehearing Of Bar On Prop. 65 Glyphosate Warning -
California Attorney General (AG) Rob Bonta (D) has declined to ask a federal appellate court to rehear a panel ruling that permanently blocked...more
Third Time’s A Charm: California Re-Introduces Proposed Changes to Proposition 65’s Warnings and Safe Harbor Requirements -
On October 27, the California Office of Environmental Health Hazard Assessment (OEHHA), the lead...more
California Bans Several FDA-Authorized Food Additives; New York May Soon Follow -
On October 7, California Governor Gavin Newson signed into law AB-418, the California Food Safety Act, which completely bans, on safety...more
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
10/30/2023
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Customs and Border Protection ,
DSCSA ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
MDRP ,
Medicaid ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry
CEH Takes Legal Action Against Five Metal Plating Facilities Discharging High Levels of PFAS Chemicals into the Environment in LA County -
Cision PR Newswire -
LOS ANGELES, June 12, 2023 - Nonprofit organization the...more
PFAS-Containing Consumer Products Under Attack in California -
Per- and polyfluoroalkyl substances (PFAS) are present in a variety of consumer products. PFAS have been increasingly targeted in laws and regulations and...more
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S....more
OEHHA Proposes Prop. 65 Cancer Listings For Solvent, Sealant Chemicals -
California’s health hazard office is proposing to list three chemicals as carcinogens under the state’s Proposition 65 toxic warning label law,...more
FDA joins industry groups in opposing Prop 65 cancer listing for BPA -
Chemical Watch -
The US Food and Drug Administration has joined a pair of industry trade groups in opposing the potential listing of bisphenol A as...more
Cannabis Company Shuts Down Unpermitted Diesel Generators 2 Years Later -
SFGATE -
Cannery residents paired with environmental advocacy groups Center for Environmental Health and the Environmental Democracy Project to...more
California Proposition 65: OEHHA Publishes Second Modification to Proposed Rules to Short-Form Warnings -
The National Law Review -
On April 5, 2022, the California Office of Environmental Health Hazard Assessment...more
Identifying Acrylamide Exposure Risks to Protect Residents of California -
California’s Office of Environmental Health Hazard Assessment (OEHHA) announced it proposed adding a new subsection to Article 6 of Title 27 of...more
Many of us are familiar with the triangular “chasing arrows” recycling symbol that can be found on products and packaging. Consumers may believe they are doing their part for the environment when purchasing items with the...more
Proposed Restrictions on Prop 65 Short-Form Warnings EHS Daily Advisor Changes to California’s Proposition 65 (Prop 65) short-form warning label regulations are expected soon. Once adopted, impacted industry will have one...more
Labeling Laments: Packaging and Label Regulations Are a Major Challenge to the Expanding Cannabis Industry -
East Bay Express -
When California cannabis companies prepare to go to market with a new product, they often...more
Have you shopped for jewelry, cosmetics, furniture, or exercise equipment recently? If so, you have most likely come across a Proposition 65 warning sticker. If you are unsure of whether the warning label should keep you from...more
Potential Impact of California’s Prop. 65 on Manufacturers, Distributors, and Sellers of Cannabis Products
In a Cannabis Counsel podcast, Partners Emily Leongini and Lynn Fiorentino discuss the potential impact of...more
Update to Prop 65 Concerns Related to Roasted Nuts
AGNet West -
AGNet West published an update regarding acrylamide limits for nut products under Prop 65 rules, along with an AGNET West Radio Network report. ...more
On September 30, 2020, California Governor Gavin Newsom signed two pieces of legislation that place dramatic restrictions on companies selling cosmetics and personal care products in California.
Assembly Bill 2762 -
AB...more