FDA Regulation of Tobacco Products: A Change in FDA’s Focus
FDA Regulation of Tobacco Products: Then The road to tobacco regulation has been a long one for FDA. Although the public health consequences of tobacco usage had been observed for several decades, FDA was not very involved in...
Quick Look on NOAA’s new Seafood Traceability Program
The National Oceanic and Atmospheric Administration (NOAA) will require a permit and additional data reporting for certain imported fish and fishery products. Starting January 1, 2018, failure to provide the appropriate permit information and/or sufficient...
The Intellectual Property Rights Challenge of Global Drug Pricing
President Trump has suggested a possible executive order to lower drug prices, which is to establish new trade policies that would strengthen intellectual property rights (IPR) in other countries markets. IPR refers to legal rights given to inventors or innovators of...
FDA Still Conducts Food Label Reviews? Oh, Yes, it does – and a Warning Letter or Recall may Result
The U.S. Food and Drug Administration has two roles related to its food jurisdiction: (1) ensure food safety and (2) protect against consumer fraud or deception. Over FDA’s 110-year history, the Agency’s focus has oscillated between these two areas. Since the early...
MELODY: Waves that Break Barriers to Improve Lives
The 21st century has brought us many new technologies that have improved lives, and now AdEchoTech has added one more innovation to the list: MELODY. 75 YEARS after the first sonography was used for medical diagnosis by neurologist Karl Dussick, AdEchoTech has...
Animal Foods: Meet the Preventive Control Regulation, but not FDA Investigators
The Food Safety Modernization Act’s (FSMA’s) staggered implementation continues with two new compliance events for the animal food industry starting yesterday, September 18, 2017. “Large” Facilities (500 or more employees) must comply with the Hazard Analysis and...
FDA Issues New Draft Guidance on Microneedling – Listen Up!
The Microneedling industry developed and flourished without any substantive guidance from FDA other than periodic whack-a-mole enforcement actions. That changed today (Sept. 14, 2017) with FDA issuing a DRAFT guidance with the captivating name: “Regulatory...
Reducing Prescription Drug Costs: The Solution Hiding in Plain Sight
The US drug approval process is long and costly, and pharmaceutical development companies pass the extensive costs of research, user fees, and monopoly rent on to American consumers. Essentially, U.S. patients have been...
Caution for Importers: US Enforcement on the Rise
We recently sat down with Customs and International Trade lawyers Jessica Rifkin and Roy León, to get their take on the current environment with respect to the White House, Customs, and inter-agency cooperation using the ACE system. Enforcement by Federal Agencies...
So it Begins: FSVP Inspections
FDA has begun inspecting U.S. food importers for their compliance with the Foreign Supplier Verification Program (FSVP). The FSVP regulation has a staggered compliance date between May 30, 2017 through July 27, 2020 (depending on the food type and the foreign...