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...
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...