FDA

Kenneth Ackerman

FDA Final Rule and Guidance on Emergency Records Access

FDA / Chris Kirksey

The Food and Drug Administration (FDA) has issued a final rule expanding its emergency records access authority, as provided by the Food Safety Modernization Act (FSMA). Establishment, Maintenance, and Availability of Records: Amendments to Record Availability Requirements; 79 Fed. Reg. 18799 (April 4, 2014). The final rule adopts, without change, an interim final rule issued […]

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Kenneth Ackerman

HHS Releases HIPAA Security Rule Risk Assessment Tool

FDA, Health Care / Reed Diskey

The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), Office of the National Coordinator for Health Information Technology (ONC), and Office of the General Counsel (OGC), have released their Security Risk Assessment (SRA) tool. The SRA tool is designed to assist Covered Entities and their Business Associates (BA) ensure compliance with

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Steps to Prevent Allergen Recalls – A Practice Tip from Ms. Gloom

FDA, USDA / Chris Kirksey

Anyone who is remotely involved in the food arena knows that the number one reason for a recall of meat and poultry regulated under USDA’s Food Safety and Inspection Service (FSIS) or all other types of food regulated under the Food and Drug Administration (FDA) is an undeclared allergen. In fact, a quick review of

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FDA Updates Its Guidance on Prior Notice of Imported Foods

FDA / Chris Kirksey

The Food and Drug Administration (FDA) has published an updated guidance document, Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3). This draft guidance is being distributed for comment purposes only. Although comments on FDA guidance documents may be submitted at any time (see 21 C.F.R. § 10.115(g)(5)), to ensure

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Draft Methodological Approach for Designating High-Risk Foods — Comment Period Extended

FDA / Chris Kirksey

The Food and Drug Administration (FDA) has published notice of a 45-day extension, until May 22, 2014, of the comment period on its Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of FSMA. 79 Fed. Reg. 16,800 (Mar. 26, 2014). Notice of the draft guidance document originally was published in the Federal Register

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Intentional Adulteration – Comment Period Extended

FDA / Chris Kirksey

The Food and Drug Administration (FDA) has published notice of a 90-day extension, until June 30, 2014, of the comment period on its proposed rule addressing intentional adulteration of food and on an associated draft document, both published in the Federal Register on December 24, 2013 (see blog postings dated January 7, January 31, and February

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FDA denies Remodulin® Citizen Petition; Treprostinil Injection ANDAs can proceed with labeling carve-out

FDA / Chris Kirksey

Last week, FDA announced the latest in a line of decisions demonstrating the agency’s continued support for approval of generic drugs with labeling that “carves-out” information protected by a brand drug’s patents or marketing exclusivity. Section 505(j)(2)(A)(i) of the Food, Drug and Cosmetic Act requires that an Abbreviated New Drug Application (ANDA) contain “information to

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FDA Issues Statement on GRAS Determination of Senomyx

FDA / Chris Kirksey

By Mark L. Itzkoff On March 12, 2014, FDA issued an unusual statement regarding the GRAS status of a new flavor ingredient. FDA issued the statement in response to a March 11 press release from Senomyx regarding the GRAS status of a new flavor ingredient, Sweetmyx. FDA stated that the press release “appeared to suggest that

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Good Reprint Practices Revamped

FDA / Chris Kirksey

By Casper E. Uldriks The Food and Drug Administration (FDA) issued a revised draft guidance document in February 2014 entitled, “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.” The guidance updates the draft guidance issued in January 2009 entitled, “Good Reprint Practices for the Distribution of Medical Journal Articles and

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“Evaporated Cane Juice” — Comment Period Reopened

FDA / Chris Kirksey

“Evaporated cane juice” is an ingredient name for a sweetener often seen in food labeling. In October 2009, FDA issued a draft guidance document, essentially advising industry of FDA’s view that the common or usual (C/U) name for the solid or dried form of sugar cane syrup is “dried cane syrup,” and that a sweetener

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FDA Proposes Major Changes to the “Nutrition Facts” Label – Price Tag $2 Billion

1 Comment / FDA / Chris Kirksey

Two billion dollars – That is what FDA estimates the food industry will spend to comply with proposed changes to the iconic “Nutrition Facts” label. That’s about all we know for sure. The agency says the new information will provide $20-$30 billion in benefits to consumers by the year 2035, primarily by lowering risk of

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A Consumer Group Files Suit to Vacate FDA’s GRAS Notification Program

FDA / Chris Kirksey

By Mark L. Itzkoff In a formal challenge to FDA’s GRAS Notification Program, a consumer group called the Center for Food Safety (CFS) filed a lawsuit on Thursday alleging that FDA’s operation of the program under a proposed rule since 1997 and its failure to promulgate a final rule governing the program is a violation of

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Wide-Reaching FDA Proposed Rule on Sanitary Transportation Could Have Greatest Impact on Food Carriers

FDA / Chris Kirksey

On February 5, 2014, the Food and Drug Administration (FDA) published in the Federal Register its proposed rule on “Sanitary Transportation of Human and Animal Food.” The proposed rule would require shippers, carriers, and receivers that transport food by motor or rail vehicles to use certain sanitary transportation practices to ensure the safety of the

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Nutrition Labeling – The Second Time Around

FDA / Chris Kirksey

The Nutrition Labeling and Education Act (NLEA) was enacted in 1990 and the familiar “Nutrition Facts” panel became mandatory in 1994. Now, twenty years later, the Food and Drug Administration (FDA) says the list of nutrients, serving sizes, and Daily Values on the label need to be updated. Expect the announcement this week, with lots

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Deadlines for FSMA Final Rules Pushed Back

FDA / Chris Kirksey

The court-ordered deadlines by which FDA is required to issue final rules under the Food Safety Modernization Act (FSMA) have been pushed back pursuant to a consent decree between FDA and two consumer groups. The two consumer groups, the Center for Food Safety and the Center for Environmental Health, had sued FDA (Center for Food

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I Filed My Comment on FDA’s Proposed FSMA Regulations – Now What Do I Do?

FDA, Public Policy / Chris Kirksey

The comment periods for many of FDA’s proposed regulations implementing the Food Safety Modernization Act (FSMA) have closed or are soon slated to end. Hundreds of companies and trade associations have filed comments with the agency; some believe that is the end of the public participation process. Nothing could be further from reality. Filing a

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HIPAA, the TCPA and Robodialing

FDA / Chris Kirksey

Over the past several months, we have received several questions regarding how HIPAA interacts with the FCC’s implementation of rules under the Telephone Consumer Protection Act (TCPA). Specific questions center around when authorization may be required for calling cell phones or sending text messages to cell phones that include health-related content, such as a reminder

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OSHA Interim Final Rule Outlines New Whistleblower Protections for Food Company Employees

FDA / Chris Kirksey

Does your Company have an up-to-date Whistleblower Protection Policy? The answer to that question has become all the more important for food-related companies in light of a new interim final rule that the Occupational Safety and Health Administration (OSHA) has issued for handling allegations by employees who believe companies illegally retaliated against them for reporting violations

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Hidden Gems in the Farm Bill

EPA, FDA, Public Policy, USDA / Chris Kirksey

By Nathan Fretz After three years of work, Congress passed the Agricultural Act of 2014 (the “farm bill”), which the President signed into law on Friday, February 7. Despite a tumultuous and partisan 2012 and summer of 2013, the farm bill conference report was approved by conferees and sailed through the House and Senate with

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Practical Tips From “Dr. Doom and Ms. Gloom”

FDA, OFW Law News, USDA / Chris Kirksey

Meet “Dr. Doom” and “Ms. Gloom” “Dr. Doom” Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters. Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator. During her rise to the

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Washington Post Recognizes OFW Law’s FDA Regulatory Practice

FDA, OFW Law News, Public Policy / Chris Kirksey

Today, the Washington Post recognized OFW Law for being a leader in U.S. Food and Drug Administration law, and food safety regulatory matters. We are proud of the role we have played in advancing public health through the development of food safety statutes and regulations. As a result of our involvement, we are intimately familiar

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FDA Announces Two More Public Meetings on its Intentional Adulteration Proposed Rule

FDA / Chris Kirksey

The Food and Drug Administration has announced that it will hold two additional public meetings on its proposed rule “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.” 79 Fed. Reg. 5353 (Jan. 31, 2014). On December 24, 2013, FDA published a proposed rule on food defense. 78 Fed. Reg. 78013. Under the proposed rule,

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Consumers Union Testing Raises New Questions Re: Safety of Caramel Coloring

FDA / Chris Kirksey

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Dietary Supplements: New Online Method Now Available for Reporting Serious Adverse Events

FDA / Chris Kirksey

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2013 Voluntary National Retail Food Regulatory Program Standards Are Published by FDA

FDA / Chris Kirksey

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Changes to FDA’s Regulation of Acidified and Low-Acid Canned Foods Are on the Horizon

FDA / Chris Kirksey

A draft guidance document, recently published by FDA for public comment, describes changes being contemplated for the procedures that manufacturers of acidified foods and low-acid canned foods prospectively will use to submit information about the processes they use to ensure that the foods they produce are safe for consumers. The draft guidance addresses: Administrative procedures

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What’s New at CDRH?

FDA / Chris Kirksey

Since January 1, it seems that the Center for Devices and Radiological Health (CDRH) has been out of the agency’s spotlight, and even FDA’s “News & Events” webpage has been lacking in its reporting of medical device related activity. This is not to say that there have been no recent developments in the last eighteen

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Act 2, The FDA’s Final IND Guidance – A Bitter Pill for Food and Nutrition Research – Is this the Spoonful of Sugar?

FDA / Chris Kirksey

Today, FDA announced that it has decided to reopen, for 60 days, the comment period for certain parts of its controversial final guidance, “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND,” which was announced in the September 10, 2013 Federal Register. We blogged about the many

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Nutrition Labeling Reform Is on the Horizon

FDA / Chris Kirksey

Two long-awaited, proposed rules to revise the regulatory requirements for nutrition labeling of conventional foods and of dietary supplements have been sent by FDA to the Office of Information and Regulatory Affairs within OMB for final review before publication. The first proposed rule, “Food Labeling; Revision of the Nutrition and Supplement Facts Labels,” would amend

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FDA Declines To Define “Natural” for Foods Formally, Leaving Its Informal Policy in Place

FDA / Chris Kirksey

FDA once again has “respectfully declined” to define the term “natural” when used in food labeling. In a January 6, 2014, letter from Leslie Kux, Assistant Commissioner for Policy, to three federal judges handling civil litigation brought against manufacturers over “natural”-type claims made for foods containing bioengineered ingredients, FDA denied their requests essentially to define “natural”

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The FDA’s Final IND Guidance – A Bitter Pill for Food and Nutrition Research

1 Comment / FDA / Chris Kirksey

“Let food be thy medicine and medicine be thy food.” So Hippocrates, the father of medicine, stated. Unfortunately, the Food and Drug Administration (FDA) has taken Hippocrates too literally, with immediate and severe consequences to food and nutrition research in the United States. In September, FDA issued a final Guidance for Clinical Investigators, Sponsors, and

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FDA Takes on Intentional Adulteration

FDA / Chris Kirksey

As required by the Food Safety Modernization Act, FDA has published a proposed rule that would require registered food facilities to implement food defense plans to reduce the risk of intentional adulteration. The proposed rule represents FDA’s first attempt to establish regulatory requirements to address intentional adulteration of food. As the preamble states: “We acknowledge

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OFW Law’s MMXIII in Retrospect

FDA, Health Care, OFW Law News, Public Policy, USDA / Chris Kirksey

As MMXIV starts, it’s time for a retrospective look at MMXIII. What follows is a list of noteworthy events from MMXIII in our food, drug, medical device, and agriculture corner of the universe, focusing on matters that were of particular interest to OFW Law’s attorneys and Senior Policy Advisors and our clients. We start, of

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FDA was Busy in 2013 and its Sleigh is Packed Heading into the New Year

FDA / Chris Kirksey

While often rightly the subject of criticism for delay or inaction on important regulatory matters, FDA in late 2013 has been bustling. The FDA, during the second Obama term, has been pursuing a very aggressive regulatory agenda. In addition to the widely discussed FSMA regulations (e.g., FSMA LIVES…..; FDA Tells Food Importers How It Wants Them

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Generic Drug User Fee Act Information Technology Plan

FDA / Chris Kirksey

Today, FDA published a notice in the Federal Register announcing the availability of the Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan. The plan explains FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the GDUFA Performance Goals and Procedures for Fiscal Years 2013

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