The Food and Drug Administration (FDA) has taken a new and unnerving approach to directing warnings to foreign seafood processors even though the Agency has not inspected the foreign facility. Recently, FDA issued warning letters to three...
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)...
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...
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...
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...
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...
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...
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: 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...
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...
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