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FDA Reverses Trump Administration’s Unapproved Drugs Policy

FDA, Healthcare, Life Sciences /

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 […]

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FDA Reverses a Trump Administration Drug Review Transparency Policy

FDA, Healthcare, Life Sciences /

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

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The American Rescue Plan Act of 2021—What’s in It for CDC and FDA?

FDA /

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

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CDRH Cracks Down on Misleading “Registration Certificates”

FDA, Healthcare /

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

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A big pile of bulk blue medical masks

FDA Issues Warning Letters Targeting COVID-19 (and other) Products

FDA /

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

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Candidates Emerge to Lead FDA

FDA /

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 »

Food and Drug Administration building

FDA Funding in the Energy & Commerce Reconciliation Bill

FDA, Government Relations /

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

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Carbon Labeling: Who is Ahead of the Game?

Agriculture & Agribusiness, FDA, Food Manufacturing, Processing, and Marketing /

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

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How Does Buying American Benefit U.S. Food, Agriculture, and Medical Products?

Agriculture & Agribusiness, FDA, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing, Government Relations, Public Policy, USDA /

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

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Register by October 1 to receive $100 discount on OFW/Food Institute Virtual Food Labeling Course

FDA /

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

Register by October 1 to receive $100 discount on OFW/Food Institute Virtual Food Labeling Course Read More »

QHC for Cranberry Products and Reduced Risk of Recurrent Urinary Tract Infection in Healthy Women

FDA /

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

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2020 Dietary Guidelines Near the End of Stage One

FDA, Public Policy /

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 »

FDA Guidance: Enforcement Discretion Under the Qualified Exemption Provisions of the Produce Safety Rule

FDA /

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

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OFW’s John G. Dillard and Mason Weeda to Present the Food Institute’s COVID:19 Webinar on May 12

FDA, USDA /

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

OFW’s John G. Dillard and Mason Weeda to Present the Food Institute’s COVID:19 Webinar on May 12 Read More »

Cows relaxing in the meadow

COVID-19 Webinar: Federal Regulatory Changes Impacting the Food Industry – Recording Available

FDA, For Export, USDA /

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

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John Dillard to Present Free Webinar on COVID-19 and Regulatory Changes Affecting the Food Industry

FDA, USDA /

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

John Dillard to Present Free Webinar on COVID-19 and Regulatory Changes Affecting the Food Industry Read More »

Male hand hand holding Q&A word with wooden cube block

FDA COVID-19 Food Safety Q&A

FDA, For Export /

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 »

fresh eggs in a cardboard tray

Complete Label Exemption for Shell Eggs During Pandemic

FDA, For Export /

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

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woman looking at menu at restaurant

Menu Labeling Flexibility for Covered Establishments During Pandemic

FDA, For Export /

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 »

silver food packaging on a wooden background

New Guidance Documents from the FDA on Foods Labeling and Postponement of Compliance Date for Revised Nutrition/Supplement Facts Panels

FDA, For Export /

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

New Guidance Documents from the FDA on Foods Labeling and Postponement of Compliance Date for Revised Nutrition/Supplement Facts Panels Read More »

Feet in sneakers on top of arrow

FDA and CFSAN on Issuing Guidance Documents Concerning COVID-19

FDA, For Export /

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

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A big pile of bulk blue medical masks

Defense Production Act Update – 3/23/2020

FDA, For Export, Health Care /

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 »

Testing materials for COVID 19 Corona Virus

COVID-19 Update for Diagnostic Device Manufacturers

FDA, For Export /

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 »

Initial NFP Compliance Date – 6 Months Enforcement Discretion

FDA /

In response to requests received from multiple stakeholders, FDA has agreed, in effect, to exercise enforcement discretion relative to the new Nutrition Facts panel (NFP) for six months following the initial January 1, 2020 compliance date.  The agency is doing so through a new Question and Answer (Q&A) in the Compliance section of its Industry

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FDA Publishes Draft Guidance For Sprout Seed Producers

FDA /

Sprouts are associated with numerous foodborne illness outbreaks. According to the U.S. Food and Drug Administration (FDA), more than 2,600 documented illnesses have been associated with consuming contaminated sprouts since 1996. Much of the challenge to controlling risks lies in the fact that seeds are often the source of contamination in sprout products. In FDA’s

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EPA and DHA – Qualified Health Claims for Conventional Foods and Dietary Supplements

FDA /

FDA has issued an enforcement discretion letter that authorizes qualified health claims (QHC) that relate consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food and dietary supplements to reducing the risk of hypertension and coronary heart disease (CHD).  The QHC derives from a health claim petition submitted by Global Organization for EPA

EPA and DHA – Qualified Health Claims for Conventional Foods and Dietary Supplements Read More »

Large assortment of honey and similar syrups

Added Sugars in Pure Honey and Maple Syrup, and Other Single-Ingredient Sugars and Syrups, and in Dried Cranberry and Cranberry Beverage Products

FDA, For Export /

Today, FDA published notice of the availability of a final guidance for industry, entitled: The Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products (June 2019).  The final guidance provides industry with some rational relief from the added sugars nutrition labeling requirements that predated it.  That relief

Added Sugars in Pure Honey and Maple Syrup, and Other Single-Ingredient Sugars and Syrups, and in Dried Cranberry and Cranberry Beverage Products Read More »

FDA Begins to Move on CBD Policy and Enforcement

FDA /

Earlier this week, the FDA made significant movement on issues and policy involving cannabis and its components, including cannabidiol (CBD).  The agency issued a notice in the Federal Register announcing a hearing and requesting comments on “scientific data and information about products containing cannabis or cannabis-derived compounds.”  84 Fed. Reg. 12,969.  FDA and the Federal

FDA Begins to Move on CBD Policy and Enforcement Read More »

FDA holds public meeting in April 2015

FDA’s Final Rule on Intentional Adulteration of Food: Public Meeting and Guidance

FDA, For Export, Uncategorized /

FDA has announced a public meeting to discuss its recent Draft Guidance for industry on the agency’s intentional adulteration of food regulation, promulgated under FSMA, i.e., “Mitigation Strategies to Protect Against Intentional Adulteration” (Final Rule), codified at 21 C.F.R. Part 121.  The public meeting is taking place on April 17, 2019, from 8:30 AM to

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FDA Extends Compliance Date for The Produce Rule’s Agricultural Water Requirement

FDA, Uncategorized /

As initially announced last week by outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., the compliance dates for  FDA’s agricultural water quality requirements under the “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption” rule (Produce Rule) are being extended.  Today, FDA published a final rule in the Federal

FDA Extends Compliance Date for The Produce Rule’s Agricultural Water Requirement Read More »

Organic chocolate cake labeled with low carbs

Low-Carb Food Labeling: What FDA Rules Mean for Food Manufacturers

FDA, For Export /

“Low-carb food labeling” sits in a regulatory gray zone that creates real legal risk for food manufacturers. Keto, paleo, and low-carbohydrate product categories generate billions in annual consumer sales — yet FDA has never established a regulatory definition for what “low-carb” means on a food label. That gap is not an oversight. It is the

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Part 110 Lives Another Day

FDA /

Yesterday FDA withdrew its directive to remove and reserve the Current Good Manufacturing Practice (cGMP) for Human Food regulations found in 21 C.F.R. Part 110. This is not groundbreaking as the cGMP requirements in Part 110 were codified into Part 117, Current Good Manufacturing Practices, Hazard Analysis, and Risk Based Preventive Controls for Human Food.

Part 110 Lives Another Day Read More »

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