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FDA Further Extends UFI Flexibility For Food Facility Registrations

Background on Food Facility Registration The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food […]

OTC Drug Manufacturers are Required to Pay FDA Facility User Fees by May 10, 2021

Co-Authored by Denise Calle. On March 26, 2021, Food and Drug Administration (FDA) published the Federal Register Notice, “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing the OTC Monograph Drug user fee program fee rates for FY 2021. This is the first year FDA has expanded user fees […]

Breaking News – New Federal Law Expands Furniture Flammability Testing Standard

Recent Government Data Indicates that Florida Trade is Rebounding Fast Despite Pandemic Hit

Co-Authored by Sharath Patil COVID-19’s Impact on the Global Economy The COVID-19 pandemic has had systemic implications for nearly every facet of our lives and society. The world of international trade is certainly no exception. Businesses and governments alike have had to figure out how to continue import and export operations while accounting for the risks […]

Cleaning for COVID-19 – Importing Cleaning Products: Who Regulates You?

Co-Authored by Denise Calle A year into the COVID-19 pandemic, the U.S. Environmental Protection Agency (EPA) and The Food and Drug Administration (FDA) are in full enforcement mode carefully monitoring novel products claiming to treat, mitigate, or “kill” COVID-19. Compliance advisories issued at the beginning of the pandemic are now being replaced with enforcement advisories. […]

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