FDA’s Enforcement of FSVP: Where is Your Plan?
UPDATE 03/29/2018: FDA has committed to well over 1,000 FSVP inspections this year, so the likelihood one will be at your office has increased significantly. The reach of the Food Safety Modernization Act (FSMA)...
FDAImports.com and 3iVerify – a winning combination for FSMA compliance
FDAImports.com has signed a Strategic Partner agreement with Primority Limited and is adopting Primority’s award-winning cloud-based and account-managed compliance solution, 3iVerify, to support FDAImports.com’s regulatory services and make it even easier for their...
USDA and FDA Announce Move to Increase Cooperation
A formal agreement between the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) was announced on January 30, 2018 to increase coordination and cooperation between the two federal agencies. The agreement focuses on interagency...
FSIS DIRECTIVE WILL SUBSTANTIALLY AFFECT CATFISH TRADE IN 2018
The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture’s Directive 7120.1 will result, we expect, in a negative impact on trade at least related to the importation of catfish. FSIS’s 126-page directive is entitled the “Safe and...
VQIP Participation Delayed by FDA
UPDATE 01-31-2018 : Today FDA announced the first accredited body, ANSI-ASQ National Accreditation Board (ANAB), under the Accredited Third-Party Certification program. VQIP applications are now being accepted by the...
FSMA Enforcement Discretion Announced on Specific Provisions
FDA announced that it will exercise enforcement discretion for certain provisions of the Food Safety Modernization Act, effective January 4th, 2018, until FDA decides on further action for each of the...
The Current “State” of Drug Pricing: How States are Stepping in to Relieve Prescription Costs
Drug pricing in the United States has been a complicated issue since the regulation of food and drugs begun in 1906. Understandably, high drug prices and efforts to bring them under control are hot topics in the news; it is estimated that prescription drugs account...
Globally Sourced Ingredient Labeling and Food Allergens
Globalization has brought U.S. consumers access to foods from around the world to satisfy any need or want, and as we’ve reported, food imports continue to surge. Increasing globalization has resulted in frameshifts in food production, including a transition from food...
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...