Joi Jackson

John Block: NAFTA

By former USDA Secretary John R. Block Today, let’s talk about trade and tax reform. President Trump wants to improve the North American Free Trade Agreement (NAFTA), and the Congress is presenting a tax reform package. NAFTA is in the spotlight right now. The whole farm and food industry is worried that President Trump could formally

John Block: NAFTA Read More »

Patient – Consumer – Industry Coalition Suggests Reducing Government Barriers to Medication Non-Adherence

In an October 2017 White Paper, Prescriptions for a Healthy America (P4HA), a broad-based group that includes representatives of the pharmaceutical and pharmacy industries, as well as consumer- and patient-based groups, called for a new anti-kickback regulatory safe harbor.  The new safe harbor would reduce regulatory uncertainty and expressly permit business entities in the healthcare

Patient – Consumer – Industry Coalition Suggests Reducing Government Barriers to Medication Non-Adherence Read More »

FSMA Update: FDA Releases FSMA Compliance Deadlines Guide

FDA has released a helpful and user friendly Food Safety Modernization Act (FSMA) compliance date webpage to assist farmers, manufacturers of food and food products, and other stakeholders.[1]  The webpage includes deadlines for the following rules: Produce Safety (21 C.F.R. Part 112), Preventive Controls for Human Food (21 C.F.R. Part 117), Preventive Controls for Animal

FSMA Update: FDA Releases FSMA Compliance Deadlines Guide Read More »

SNAP Retailers Beware: FNS Wants to Take Away Your SNAP Authorization

Virtually all grocery stores, convenience stores, and supermarkets sell hot foods.  Nearly all sell cold prepared foods as well.  Most of the more than 260,000 retail food stores authorized by USDA’s Food and Nutrition Service (“FNS”) to accept Supplemental Nutrition Assistance Program (“SNAP”) benefits sell some hot foods and cold prepared foods.  But the SNAP

SNAP Retailers Beware: FNS Wants to Take Away Your SNAP Authorization Read More »

John Block Reports: The Opioid Crisis – Stop Pointing Fingers

On October 26, 2017, OFW Law founding principal Richard L. Frank filled in for former USDA Secretary John R. Block on his weekly radio broadcast. The opioid epidemic is a national crisis. Drug overdoses are killing 64,000 Americans each year. It is the leading cause of death for individuals under 50. It requires urgent action and solutions from across our

John Block Reports: The Opioid Crisis – Stop Pointing Fingers Read More »

Kristen O’Brien Joins OFW Law as Counsel in the Health Industry Policy and Regulatory Practice

Kristen O’Brien serves as Counsel in OFW Law’s Health Industry Policy and Regulatory Practice, which represents clients in the health care delivery system and innovative life sciences areas. She is principally responsible for the group’s work with health care delivery system clients, including large physician groups, integrated health systems and other provider organizations. She also

Kristen O’Brien Joins OFW Law as Counsel in the Health Industry Policy and Regulatory Practice Read More »

FDA Inspector General Report on Progress of FSMA Inspections

On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on the agency’s domestic food facility inspections: Challenges Remain in FDA’s Inspections of Domestic Food Facilities (the Report).  The Report concluded that FDA is on track to meet the initial domestic food facility inspection timeframes

FDA Inspector General Report on Progress of FSMA Inspections Read More »

Extension of Compliance Date for Revised Nutrition Labeling of Foods and Supplements

While generally expected for months (e.g., since the menu labeling compliance date extension) and recently the subject of a “tweet” from FDA Commissioner Gottlieb, the agency now officially has proposed to extend by about 1.5 years the compliance date for the final rules that will provide updated nutrition information on the labels of most conventional

Extension of Compliance Date for Revised Nutrition Labeling of Foods and Supplements Read More »

Open Date Labeling Revisions for Food Appear To Be on the Horizon

Over 30 years ago, the National Conference on Weights and Measures (NCWM) collaborated with the Association of Food and Drug Officials to establish an initial open dating regulation.  This regulation — now the Uniform Open Dating Regulation (UODR), published by the National Institute of Standards and Technology within the U.S. Department of Commerce — is

Open Date Labeling Revisions for Food Appear To Be on the Horizon Read More »

Nutrition Facts Update: Compliance Date Expected to be Delayed 18 Months

Last Thursday, at the Politico Policy Summit, Commissioner Scott Gottlieb announced that the new Nutrition Facts requirements compliance date will be pushed back one-year and, subsequently, announced via Twitter that the compliance date extension will be “closer to 18 months.”  As described in our last blog on this topic, industry groups met with the Trump

Nutrition Facts Update: Compliance Date Expected to be Delayed 18 Months Read More »

To Fix FEMA’s National Flood Insurance, Take a Page From USDA’s Federal Crop Insurance (Part 1 of a 2 Part Series)

It will take months to calculate the damage Hurricanes Harvey and Irma unleashed on Texas, Louisiana, Florida, and other states this summer: lives lost, homes destroyed, businesses wrecked, property damage in the tens of billions of dollars.  But beyond everything else, these storms and their massive devastation have exposed deep problems in the Federal government’s

To Fix FEMA’s National Flood Insurance, Take a Page From USDA’s Federal Crop Insurance (Part 1 of a 2 Part Series) Read More »

Will the Trump Administration Align Compliance Dates for Nutrition Facts Update, GMO Labeling?

Several food industry groups hope so. The responsibility for implementing two major changes to food labeling requirements has fallen on the Trump Administration: Nutrition Facts Panel – On May 27, 2016, FDA published a final rule that will overhaul the Nutrition Facts panel that we have become accustomed to on foods. In addition to some

Will the Trump Administration Align Compliance Dates for Nutrition Facts Update, GMO Labeling? Read More »

Medical Privacy Ramifications Of Hurricane Harvey – HHS Issues: Limited Waiver of HIPAA Privacy Rule Protections; and Bulletin Addressing HIPAA Rules in Emergency Situations

In response to the tragic fallout from Hurricane Harvey, an unprecedented storm that decimated the city of Houston and a large swath of the Gulf Coast of Texas and Louisiana, the U.S. Department of Health and Human Services (HHS) declared a public health emergency in both states and will waive certain sanctions and penalties under

Medical Privacy Ramifications Of Hurricane Harvey – HHS Issues: Limited Waiver of HIPAA Privacy Rule Protections; and Bulletin Addressing HIPAA Rules in Emergency Situations Read More »

FDA Adds New Chapter on Heat Treatment to its Preventive Controls Guidance under FSMA

Today, the Food and Drug Administration (FDA) announced the installment of Chapter Six to its “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Draft Guidance). The Draft Guidance explains FDA’s current thinking on how food facilities may comply with the FDA’s final rule on Hazard Analysis and Risk Based Preventive

FDA Adds New Chapter on Heat Treatment to its Preventive Controls Guidance under FSMA Read More »