Leading insight on legal developments in the healthcare and life sciences industries.
The “Open Payments” database of transactions reported under the Physician Payments Sunshine Act has launched on its scheduled release date of September 30 and is now available for public review.
Pharmaceutical and medical-device manufacturers reported information about their financial relationships…
On September 19th, a federal jury in Albany, GA found three former Peanut Company of America (“PCA”) executives guilty of felony charges related to food safety violations.
Stewart Parnell, the former owner of PCA; Mary Wilkerson, the former quality control…
Pharmaceutical manufacturers have primary responsibility for ensuring that Medicare Part D members do not redeem copay coupons that could trigger federal inducement prohibitions, according to a report and Special Advisory Bulletin released on September 19 by the Office of Inspector…
Health Canada recently published a proposal to extend Canada’s Lists of Permitted Food Additives to permit the use of tripotassium phosphate, potassium tripolyphosphate, sodium potassium tripolyphosphate and sodium potassium hexametaphospahte in certain standardized and unstandardized foods sold in Canada.
The…
The Food and Drug Administration (“FDA”) issues Warning Letters to provide individuals and companies with an opportunity to take voluntary and prompt corrective actions for violations of regulatory significance that may otherwise lead to enforcement.
A Warning Letter is the…
Applied Food Sciences (“AFS”), a company that offers a green coffee ingredient used in dietary supplements and foods, agreed to settle with the FTC to pay a US $3.5 million fine for “pushing” its product based on a “seriously flawed” …
The Food and Drug Administration (“FDA”) recently released results from exposure assessments it conducted, which indicated that most American children are exposed to dyes in food. Although the full results have not yet been published, the FDA presented these…
A scandal involving the production of food using oil recycled from restaurant waste and slaughterhouse byproducts is currently unfolding in Taiwan and is raising new concerns about food safety enforcement in China. Chang Guann Co., a Taiwanese company, is accused…
Four food safety rules under the Food Safety Modernization Act (“FSMA”) regarding produce safety, Foreign Supplier Verification Program (“FSVP”) and preventive controls are still under review at the Office of Management and Budget (“OMB”) despite the looming deadlines. Specifically, the …
On August 25, 2014, US Magistrate Judge Barry Kurren ruled in favor of several companies seeking to stop the October rollout of Kauai’s local law requiring that food labels denote the presence of genetically modified organisms (“GMOs”) and of pesticides.…
