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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

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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

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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

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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

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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

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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

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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

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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

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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

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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 »

I’m a FSVP Importer: How Do I Know When I Need To Comply?

FDA /

That is one of the most common – and difficult – questions to answer when OFW Law teaches a Food Safety Modernization Act Foreign Supplier Verification Programs (FSMA FSVP) course.  Determining the compliance dates is typically more challenging for the affected importers.  To make it easier, OFW Law has created flow diagrams and examples to

I’m a FSVP Importer: How Do I Know When I Need To Comply? Read More »

The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule

FDA /

FSMA – The D.C. acronym for the Food Safety Modernization Act.  When I am working with clients or speaking with industry, everyone is familiar with FSMA.  But they think of FSMA as the Preventive Controls or Produce Safety Rules.  Some are also aware of the Sanitary Transportation Rule, but the Foreign Supplier Verification Programs (FSVP)

The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule Read More »

Drone delivering first aid kit

OFW Law Supports Medical Device Innovators at the 2017 Rice Business Plan Competition

FDA, For Export, OFW Law News /

On April 8, 2017, Forest Devices, Inc. from Carnegie Mellon University was awarded OFW Law’s Regulatory Strategy Prize at the 2017 Rice Business Plan Competition in Houston, Texas.  Forest Devices bested 41 other competitors hailing from some of the world’s top universities in the overall competition, as well, earning about $700,000 in prize money. Forest

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Prior Notice of “Grey Market” Food Imports

FDA /

Yesterday, FDA published a final rule making some technical amendments to its prior notice of imported food regulations.  The prior notice regulations implement section 801(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(m)), which requires that FDA receive prior notice of food imported into the United States.  Coordinating the Automated Broker Interface/Automated

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CFSAN Soon Will Issue Certificates of Free Sale for Exports Online

FDA /

U.S. purveyors of foods, food additives, dietary supplements, and cosmetics for export are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA.  Review of a certificate may be required by foreign countries as part of the process to import a product into those countries. A Certificate of

CFSAN Soon Will Issue Certificates of Free Sale for Exports Online Read More »

Biotech scientist testing chemicals

Biotech Regulations Must be Based on Facts, Not Fears

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

By Dr. Nina Fedoroff, as published in Agri-Pulse The Coordinated Framework (CF) for the Regulation of Biotechnology was first implemented 30 years ago. The CF was developed by the White House Office of Science and Technology Policy (OSTP). OSTP brought together representatives of the three federal agencies seeking to regulate commercial applications of biotechnology to

Biotech Regulations Must be Based on Facts, Not Fears Read More »

Adverse Event Information Now Available Online for CFSAN-Regulated Products

FDA /

FDA has begun posting online (and intends to update quarterly) information derived from adverse event reports the agency has received about conventional foods (including food/color additives), dietary supplements, and cosmetics.  This information is now made available in the CFSAN Adverse Event Reporting System (CAERS) database.  This is information that was once only available through Freedom

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Up in Flames: Ninth Circuit Upholds Certification in “100% Natural” Wesson Oil Class Action

FDA, Litigation /

In a January 3, 2017, decision likely to have broad implications in food class action litigation, the Ninth Circuit Court of Appeals affirmed a California federal district court judge’s decision certifying a consumer class action brought by purchasers of Wesson-brand cooking oil. In Briseño v. ConAgra, residents of eleven states, alleged that the “100% Natural”

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Long-Awaited Guidance Documents on Revised Nutrition Labeling Released in Draft by FDA

FDA /

FDA has published two Federal Register notices (see here and here) announcing the availability of draft guidance documents that are intended to help address issues raised by the agency’s final rules (see here and here) amending Nutrition Facts and Supplement Facts labeling requirements.  The draft guidance documents are: Draft Guidance for Industry: Questions and Answers

Long-Awaited Guidance Documents on Revised Nutrition Labeling Released in Draft by FDA Read More »

FDA Expands Authorized Health Claims for Raw Fruits and Vegetables

FDA /

The U.S. Food and Drug Administration (FDA) has promulgated an interim final rule, effective December 19, 2016, amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol, and risk of coronary heart disease (CHD) to permit a broader array of raw fruits and vegetables (further described below) to be

FDA Expands Authorized Health Claims for Raw Fruits and Vegetables Read More »

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