OFW logo
1-202-933-5394
MENU

FDA

FDA Maintains Focus on Nutrition to Foster Human Health

FDA /

In a speech, entitled “Reducing the Burden of Chronic Disease,” delivered on March 29th by FDA Commissioner Scott Gottlieb before the National Food Policy Conference in Washington, D.C., FDA kicked-off its Nutrition Innovation Strategy.  FDA has identified several areas where it believes there is opportunity to improve public health and encourage industry innovation towards reducing […]

FDA Maintains Focus on Nutrition to Foster Human Health Read More »

Fiber rich nuts and seeds

Dietary Fiber Permissible in Nutrition/Supplement Facts

FDA, For Export /

Dietary fiber is a macronutrient that permissibly may be declared in the Nutrition Facts on a conventional food’s label, and in the Supplement Facts on a dietary supplement’s label.  21 C.F.R. §§ 101.9(c)(6)(i), 101.36(b)(2)(i). To clarify what may be included in nutrition labeling declaration of Dietary Fiber content, § 101.9(c)(6)(i) provides: Dietary fiber is defined

Dietary Fiber Permissible in Nutrition/Supplement Facts Read More »

RACC and Serving Size Guidance

FDA /

CFSAN/FDA has made available a guidance document and a small entity compliance guide to assist industry in complying with its revised nutrition labeling requirements for conventional foods and dietary supplements: Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category (Feb. 2018) [hereinafter “RACC Guide”]; and Guidance for Industry: Food Labeling:

RACC and Serving Size Guidance Read More »

Tomato injected with growth hormones

How the Federal Government Can Get Biotech Regulation Right

EPA, FDA, For Export, Public Policy, USDA /

By Nina Fedoroff and Alison Van Eenennaam, as published in the Des Moines Register In his speech at the recent American Farm Bureau convention, President Trump said his administration was “streamlining regulations that have blocked cutting-edge biotechnology.” Why is this necessary?  Paraphrasing New York Times columnist Paul Krugman’s words on economic policy, it’s because we’re still living with “zombie” biotech

How the Federal Government Can Get Biotech Regulation Right Read More »

FDA Publishes 2017 Food Code

FDA /

On February 12, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Public Health Service (PHS) released its most recent revision of the Food Code to reflect the current understanding of best practices in food safety. The Food Code is a model regulation intended for adoption by local, state, tribal, and territorial governments. 

FDA Publishes 2017 Food Code Read More »

Which Food Labeling Claims Put You Most at Risk of a Class Action Lawsuit?

FDA, Litigation /

Food labeling class actions — which food labeling claims put you most at risk of a lawsuit?  Popular claims regarding ingredient content or processing methods are often the most common targets for class actions.  Read the views of OFW Law, as reported in Food Navigator.  The article reports on a recent webinar sponsored by the

Which Food Labeling Claims Put You Most at Risk of a Class Action Lawsuit? Read More »

Upcoming Webinar: Avoiding the Food Labeling Class Action Trap

FDA, Litigation, OFW Law News /

The food and beverage industry is facing an unprecedented number of threats from class action cases alleging misleading labeling and advertising. Approximately two new lawsuits against manufacturers, distributors and retailers were filed each week in 2017! Dozens more food and beverage industry members received demand letters that threatened the commencement of such cases and demanded

Upcoming Webinar: Avoiding the Food Labeling Class Action Trap Read More »

Bottle of milk

“Milk” Comes from Breasts/Udders

FDA, For Export, Public Policy, USDA /

According to the Wall Street Journal: “Organic milk sales have cooled as the very shoppers who drove demand for the specialty product not long ago move on to newer alternatives, leaving dairy sellers and producers grappling with oversupply….Now, organic-milk supplies have ballooned just as demand has stalled.  Many shoppers have moved on to substitutes such

“Milk” Comes from Breasts/Udders Read More »

Elderly man reading food product label

United Fresh and OFW Law Launch Legal Labeling Review Service

FDA, For Export, OFW Law News /

OFW Law has joined with the United Fresh Produce Association (UFPA) to provide members access to a legal review of product labels.  UFPA brings together companies across every segment of the fresh produce supply chain, including growers, shippers, fresh cut processors, wholesalers, distributors, retailers, foodservice operators, industry suppliers and allied associations. This new service was

United Fresh and OFW Law Launch Legal Labeling Review Service Read More »

Focus on Food Recalls

FDA /

In planning for your company’s 2018 regulatory priorities, you might want to review and optimize its recall procedures.  Recall policies and procedures likely will be a focus of FDA in the coming year. The Office of Inspector General (OIG) within the Department of Health and Human Services recently published a Report, The Food and Drug

Focus on Food Recalls Read More »

FDA’s Proposed Guidance on Convening a GRAS Panel May Result in Higher Costs for GRAS Notifiers

FDA /

Contributor: Mark L. Itzkoff Principal, The Law Office of Mark Itzkoff, mark@itzkofflaw.com On November 15, 2017, FDA released a proposed guidance document, Best Practices for Convening a GRAS Panel: Guidance for Industry.  The Guidance is, in part, a response to 2013 criticism of the GRAS exemption for food ingredients from the Pew Charitable Trust, the

FDA’s Proposed Guidance on Convening a GRAS Panel May Result in Higher Costs for GRAS Notifiers Read More »

FSMA Update: FDA Releases FSMA Compliance Deadlines Guide

FDA /

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 »

Assortment of dog food

FSMA Update: FDA Releases Guidance Documents on CGMP Requirements of Animal Food Rule and Exemptions from FSMA Requirements of Human and Animal Food Rules

FDA, For Export /

On October 19, 2017, FDA announced the publication of two guidance documents to assist industry stakeholders in compliance with regulations promulgated pursuant to the Food Safety Modernization Act (FSMA): #235 – Current Good Manufacturing Practice Requirements for Food for Animals; Final Guidance for Industry; Application of the “Solely Engaged” Exemptions in Parts 117 and 507:

FSMA Update: FDA Releases Guidance Documents on CGMP Requirements of Animal Food Rule and Exemptions from FSMA Requirements of Human and Animal Food Rules Read More »

John Block Reports: The Opioid Crisis – Stop Pointing Fingers

FDA, Public Policy /

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

FDA, Health Care, OFW Law News, Public Policy /

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

FDA /

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

FDA /

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

FDA, Public Policy /

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

FDA /

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 »

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

FDA, Public Policy, USDA /

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 »

Assortment of dietary supplements

“Grandfathered” Dietary Ingredients – It’s About Time

FDA, For Export /

The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 – almost a quarter century ago.  It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) in a number of significant ways that set the stage for present marketing of this important category of consumer goods.  However, aspects of DSHEA never were

“Grandfathered” Dietary Ingredients – It’s About Time Read More »

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

FDA /

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 »

Health care professional working on computer

OFW Law Launches New Health Industry Practice; Ladd Wiley Joins Firm as Principal and Chair of Practice

FDA, For Export, Health Care, OFW Law News, Public Policy /

OFW Law is pleased to announce the creation of a new Health Industry Policy and Regulatory Practice.  The practice will be focused on government health program payment issues and FDA-related policy issues for clients in the health care delivery system and innovative life sciences areas. To provide leadership for this practice, OFW Law is also

OFW Law Launches New Health Industry Practice; Ladd Wiley Joins Firm as Principal and Chair of Practice Read More »

Stethoscope and a heart

FDA implements 21st Century Cures Act Requirements for Reusable Devices

FDA, For Export /

Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”).   Section 3059 of the Cures Act requires FDA to publish a list of reusable device types that must include validated instructions for use, in addition

FDA implements 21st Century Cures Act Requirements for Reusable Devices Read More »

Think This is Biotech Regulatory Relief? Not Yet.

FDA, Public Policy, USDA /

By Dr. Nina Fedoroff, as published in Agri-Pulse USDA and FDA proposals to regulate genetically engineered (GE) plants and animals following the recent update of the regulatory framework are on their websites awaiting public comment by June 19, 2017.  The documents on which comments are requested are long, dense and, at times, internally inconsistent.  Here’s a detailed

Think This is Biotech Regulatory Relief? Not Yet. Read More »

FDA Announces Intent to Extend the Compliance Date for New Nutrition Facts Rules

FDA /

This morning, FDA’s Office of Nutrition and Food Labeling announced that it intends to extend the compliance date for the new Nutrition Facts requirements.  FDA’s announcement, which is included on its “Changes to the Nutrition Facts Label” webpage, notes that, after feedback from industry and consumer groups:  FDA determined that additional time would provide manufacturers covered

FDA Announces Intent to Extend the Compliance Date for New Nutrition Facts Rules Read More »

FDA Extends Menu Labeling Compliance Date One Year Consistent with Trump Administration Policy

FDA /

FDA is again extending the compliance date for menu labeling – just days before the regulatory requirements of § 101.11 were to have become effective.  On May 4, 2017, the agency will publish an interim final rule that extends the compliance date from May 5, 2017, to May 7, 2018, and that opens a 60-day

FDA Extends Menu Labeling Compliance Date One Year Consistent with Trump Administration Policy Read More »

Delay of FDA Menu Labeling Regulation Provides Blueprint for Modification of Nutrition Labeling Rules

FDA /

The restaurant industry was bracing for FDA’s menu labeling regulation, requiring mandatory calorie disclosure on menus at chains that have 20 or more locations.  The final compliance date was coming up next week on May 5, 2017.  However, in a last minute change, FDA submitted an interim final rule to the White House Office of

Delay of FDA Menu Labeling Regulation Provides Blueprint for Modification of Nutrition Labeling Rules Read More »

Industries

Food & Agriculture
Medical Products
Customs and Trade
Consumer and Commercial Litigation
Cannabis

Our Firm

Home
People
Alumni
About
Contact

Insights

News & Insights
Blog
Facebook Twitter Linkedin