On Friday November 12, 2021, President Biden nominated former United States Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, a cardiologist by training, to again be FDA Commissioner, replacing acting Commissioner Dr. Janet Woodcock. Califf, 70, was the FDA Commissioner for a year at the end of the Obama Administration. He garnered broad support […]
Biden to Nominate Dr. Robert Califf as FDA Commissioner Read More »
OFW Law’s John Dillard is a frequent contributor to Farm Journal, the premiere U.S. farm magazine. His latest contribution covers African Swine Fever. African swine fever (ASF) is a nasty bug and it’s getting closer to the U.S. The highly contagious viral infection doesn’t infect humans, but it is 100% fatal to hogs. Countries where
The Potential Time Bomb of African Swine Fever Read More »
Federal Contractors are being given additional time and flexibility to address the vaccination mandate – Employees must be fully vaccinated by January 18, 2022. The Department of Health and Human Services (HHS) and The United States Department of Agriculture (USDA) Contracting Officers Have Enormous Discretion To Add Vaccine Mandate Clause to Product Contracts.
UPDATE: Federal Contractor Vaccine Mandate Read More »
On November 4, 2021, the Occupational Safety and Health Administration’s (OSHA) released the prepublished version of its expected new emergency temporary standard (ETS). The OSHA ETS (interim final rule; request for comments) was published in the Federal Register on November 5, 2021. The OSHA ETS requires employers with 100 or more employees to mandate that all their
OSHA Releases ETS on Vaccine and Testing Mandate Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from October that we took note of. If you have any questions or would like more information, please
October Food and Agriculture Regulatory Recap Read More »
On October 20, the United States Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking that would, in relevant part, repeal a Trump Administration rule on, “Department of Health and Human Services Good Guidance Practices,” (GGP Rule) (Dec 7, 2020). The GGP Rule required: Each guidance document issued by HHS
The United States Food and Drug Administration (FDA) announced that it will be virtually hosting a public meeting on November 16, 2021, on Drug Supply Chain Security Act (DSCSA) implementation. The purpose of this meeting is to allow interested stakeholders the opportunity to provide input to the FDA on the enhanced drug distribution security provisions
FDA Announces a DSCSA Public Meeting and Requests Comments Read More »
Next month, The Food Institute kicks off its 3-day virtual training seminar on Food Labeling and Olsson Frank Weeda Terman Matz PC will be co-hosting the event. Each day has its own unique theme. On day one, attendees may expect to first learn the basics of the Food and Drug Administration’s (FDA) and the U.S.
OFW Law to co-host the 2021 Food Labeling Summit with the Food Institute next month Read More »
On July 1st, the Federal Trade Commission voted 3-2 to publish the final Made in USA Labeling Rule in the Federal Register. The rule is consistent with – and essentially codifies – its prior 1997 Enforcement Policy Statement on U.S. Origin Claims, and provides the agency with enforcement tools to combat fraudulent claims. The rule
FTC to Issue Final Rule to Combat “Made in USA” Fraud Read More »
On June 3, the Food and Drug Administration (FDA) released four guidances implementing the Drug Supply Chain Security Act (DSCSA). Final Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (Suspect Product Final Guidance) Final Guidance for Industry: Product Identifiers under the Drug Supply Chain Security Act – Questions
Long-Awaited DSCSA Guidances Published Read More »
On May 26, the Food and Drug Administration (FDA) reversed a Trump Administration policy that revoked the agency’s longstanding Unapproved Drugs Initiative (UDI). On November 15, 2020, then HHS Secretary Alex Azar issued a notice and a request for information entitled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for Information Regarding
FDA Reverses Trump Administration’s Unapproved Drugs Policy Read More »
On May 5, the Food and Drug Administration (FDA) released a report entitled “Resiliency Roadmap for FDA Inspectional Oversight” discussing its efforts to conduct inspections of food and medical product establishments during COVID-19 and its plan to ensure a more consistent state of operations moving forward. In March 2020, FDA postponed routine domestic and foreign
FDA Releases Report on Inspections Read More »
On April 30, the Food and Drug Administration (FDA) reversed a Policy issued by the Department of Health and Human Services (HHS) near the end of the Trump Administration that was purportedly intended to increase drug review timeline transparency. The Policy was announced in the Federal Register on January 15 and would have required FDA
FDA Reverses a Trump Administration Drug Review Transparency Policy Read More »
On March 10, the House passed the Senate-amended version of the American Rescue Plan Act of 2021 (H.R. 1319), a $1.9 trillion COVID-19 relief package intended to address the impact of the pandemic on the economy, state and local governments, and individuals. The package contains public health provisions intended to boost COVID testing and contact
The American Rescue Plan Act of 2021—What’s in It for CDC and FDA? Read More »
On March 3, Rear Admiral Sean Boyd, Director of the Office of Regulatory Programs at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced an uptick in firms selling and issuing fraudulent “FDA registration certificates” which indicate that a medical device has been authorized, approved, cleared, or reviewed by the
CDRH Cracks Down on Misleading “Registration Certificates” Read More »
Since the COVID-19 pandemic began to intensify in March 2020, the Food and Drug Administration (FDA) has sent warning letters to 146 manufacturers of products claiming to prevent, treat, mitigate, diagnose or cure coronavirus. These products range from teas, tinctures, test kits, soaps, supplements, and CBD products. In January, the FDA’s Office of Criminal Investigations
FDA Issues Warning Letters Targeting COVID-19 (and other) Products Read More »
The Senate Committee on Health, Education, Labor and Pensions (HELP) announced that it will hold a hearing on Tuesday, February 23 to consider Xavier Becerra’s nomination to serve as Secretary of Health and Human Services (HHS). The Senate Finance Committee will hold a hearing on Wednesday, February 24. Becerra has served as Attorney General of California
Xavier Becerra’s Nomination Hearing Set Read More »
As the Biden Administration settles into Washington and works to address the COVID-19 pandemic, many medical products and food safety stakeholders wonder who will lead the Food and Drug Administration. Janet Woodcock, M.D. who long led the Center for Drug Evaluation and Research (CDER) and advised “Operation Warp Speed” on COVID-19 therapeutics currently serves as
Candidates Emerge to Lead FDA Read More »
House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) announced that the committee will hold a markup on Thursday at 11:00 AM ET to consider legislative recommendations for its budget reconciliation instructions. Section 3004 of the bill provides $500 million to the Food and Drug Administration to combat the COVID-19 pandemic by: Supporting the review
FDA Funding in the Energy & Commerce Reconciliation Bill Read More »
With climate change discussions being elevated on a local, regional, and global scale, many individuals are considering how their personal choices, including foods they consume, impact the environment. This has translated to a resurgence of interest in carbon labeling food products. Now that we understand the basics of carbon labeling and what it means for
Carbon Labeling: Who is Ahead of the Game? Read More »
President Biden recently issued an Executive Order (EO) to harness the federal government’s purchasing power to bolster domestic manufacturing. The “Strengthening Buy American Provisions, Ensuring Future of America is Made in America by All of America’s Workers” intends to support American industry and American workers. Overall, this EO looks to close loopholes in existing “Buy American” policies
How Does Buying American Benefit U.S. Food, Agriculture, and Medical Products? Read More »
OFW and The Food Institute will be holding their annual Food Labeling Seminar on October 7, 8, and 9. The virtual training course will cover everything you need to know about food labeling in today’s marketplace. The course will first cover basics of FDA’s and USDA’s food labeling requirements, including recent updates. The seminar will then
FDA has published a letter of enforcement discretion, which it sent to legal counsel for Ocean Spray Cranberries, Inc., that authorizes a qualified health claim (QHC) for specific cranberry products when consumed in specific amounts by specific people. The substantiation for the diet-disease relationship warranted a “limited and inconsistent” or “limited” scientific evidence qualifier. Based
By: Julia Johnson On Wednesday, June 16, the 2020, the Dietary Guidelines Advisory Committee (DGAC) hosted a public meeting to review their draft scientific report. A new edition of the Dietary Guidelines for Americans is published every 5-years and developed in three stages: (I) Reviewing the science; (II) developing the guidelines; (III) implementation. The most
2020 Dietary Guidelines Near the End of Stage One Read More »
The U.S. Food and Drug Administration (FDA) has published an announcement of the availability of a Guidance Document, Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (May 2020). Comments on the Guidance may be submitted to
On May 12, OFW Principals, John G. Dillard and Mason Weeda will be presenting a webinar in collaboration with The Food Institute on the U.S. regulatory response in connection to the novel coronavirus crisis. The focus will be on the policies and practices implemented by USDA, FDA, OSHA, Department of Homeland Security, and Department of
On April 22, OFW Principal John Dillard presented a webinar addressing the federal regulatory changes that have been implemented to respond to the COVID-19 pandemic. The webinar also discussed guidance from USDA, FDA, the Department of Homeland Security, and the Center for Disease Control as well as some of the best practices that have been
John G. Dillard, a principal at OFW. will be presenting a review of several federal agencies’ responses to the COVID-19 crisis that affect food producers and manufacturers. The webinar, “COVID-19: Regulatory Changes Impacting Food Production and Distribution” will be offered by the National Agricultural Law Center on Wednesday, April 22, 2020 at 12pm EST. John
The FDA is currently posting updates in a Q&A format on its Food Safety and the Coronavirus Disease 2019 (COVID-19) webpage. The Q&A provides information to food production/processing facilities and retail food establishments regarding best practices during the ongoing public health emergency. For example, the website provides some salient advice on social distancing in food
FDA COVID-19 Food Safety Q&A Read More »
Today the FDA issued a guidance to provide temporary flexibility regarding the packaging and labeling of shell eggs sold to consumers in retail food establishments. Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency: Guidance for Industry (Apr. 2020) The guidance essentially permits retailers
Complete Label Exemption for Shell Eggs During Pandemic Read More »
The Food and Drug Administration (FDA) has issued a guidance to chain restaurants and similar retail food establishments (“covered establishments”) that sell standard menu items covered under the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide flexibility regarding these menu labeling requirements during the COVID-19
Menu Labeling Flexibility for Covered Establishments During Pandemic Read More »
On Friday, the Food and Drug Administration (FDA) announced the issuance of a new Guidance document pertaining to nutrition labeling during the COVID-19 health crisis. It is intended to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the current pandemic. This guidance does not
The Food and Drug Administration (FDA) published a Notice that set forth the process that it and the Center for Food Safety and Applied Nutrition (CFSAN) will use in expediting the availability of guidance documents concerning the ongoing COVID-19 public health emergency. It will include essential recommendations and policies and will eliminate requisite notice and
FDA and CFSAN on Issuing Guidance Documents Concerning COVID-19 Read More »
Today, the President signed an Executive Order to authorize the Sec. of HHS to designate medical equipment as “critical” or “essential” to the national response to the crisis. Under DPA § 102, the President can take action to prohibit the hording of materials designated as “scarce” or “essential.” Sec. 102 prohibits the accumulation of such
Defense Production Act Update – 3/23/2020 Read More »
The availability of Coronavirus Disease-2019 (COVID-19) diagnostic tests is critical to an effective response to the current pandemic. FDA has taken measures to permit the distribution of such tests in advance of receiving authorization to do so from the agency in an attempt to remove bureaucratic barriers that could affect the nation’s ability to mount
COVID-19 Update for Diagnostic Device Manufacturers Read More »
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