FDA

Reopening of Comment Period on Reportable Food Registry ANPR

FDA / Chris Kirksey

The Food and Drug Administration (FDA) has reopened the comment period for an additional sixty (60) days on its advance notice of proposed rulemaking (ANPR), entitled “Implementation of the Food and Drug Administration Food Safety Modernization Act (FSMA) Amendments to the Reportable Food Registry (RFR) Provisions of the Federal Food, Drug, and Cosmetic Act.” 79 […]

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“Eat Your Fish,” Say FDA and EPA

EPA, FDA / Chris Kirksey

The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have released draft updated advice on seafood consumption, Fish: What Pregnant Women and Parents Should Know. The two agencies also published a Federal Register notice creating a docket and requesting public comments on their new fish consumption advice. The draft updated advice is

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Following the Money: House And Senate Appropriations Release Draft Bills & Reports Funding FDA For FY 2015

FDA, Health Care, Public Policy / Chris Kirksey

The House and Senate Appropriations Committees with oversight of FDA have been very busy. Both voted out draft bills for FY 2015 that include appropriations for FDA and released draft reports. Roger Szemraj and the rest of our government relations practice have scoured the draft bills and reports looking for insight into what FDA drug-related activities

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Pontifications by Dr. Doom

FDA, USDA / Chris Kirksey

As described by Dennis Johnson in his recent article from our Regulatory Round-Up Newsletter, the current human illness rate for E. coli O157:H7 has not gone down as documented by the Centers for Disease Control and is, in fact, trending upwards. This is very concerning. Our firm has been advocating that the beef industry be aware of this

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FDA Issues Final Compliance Policy Guide on Food Facility Registration

FDA / Chris Kirksey

The Food and Drug Administration (FDA) has issued a final Compliance Policy Guide (CPG) on food facility registration. Compliance Policy Guide Sec. 100.250; Food Facility Registration – Human and Animal Food. The CPG provides guidance to FDA staff on enforcement of the requirement to register food facilities. Comments may be submitted at any time. All

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Regulatory Round-Up Newsletter, Spring 2014

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

On behalf of OFW Law’s Agriculture practice group, here is a copy of our new newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan at cmorgan@ofwlaw.com.

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Mandated Labeling for Genetically Engineered Foods: Vermont’s Legislation Implicates the First Amendment

FDA, OFW Law News / Chris Kirksey

By Robert A. Hahn and John G. Dillard Note: OFW Law’s Bob Hahn and John Dillard recently authored a legal backgrounder on the First Amendment implications of Vermont’s new genetically engineered food labeling law for the Washington Legal Foundation, a widely respected non-profit legal organization. Vermont has become the first state to require labeling of genetically engineered foods. On

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FDA Announces Public Meeting on Nutrition Labeling Proposed Rules

FDA, USDA / Chris Kirksey

The Food and Drug Administration (FDA) has announced a public meeting on June 26, 2014 to discuss its two pending proposed rules to update the Nutrition Facts label (and the Supplement Facts label for dietary supplements). Those proposed rules are: Food Labeling: Revision of the Nutrition and Supplement Facts Labels Food Labeling: Serving Sizes of

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FDA Extends Comment Period for Proposed Rules on Nutrition Labeling

FDA / Chris Kirksey

FDA has announced a 60-day extension of the comment period for two major proposed rules on nutrition labeling. The extended comment period will close on August 1, 2014. In March, FDA published two proposed rules on nutrition labeling: one a major overhaul of the Nutrition Facts and Supplement Facts panels, and the other updating the

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Senate Ag Appropriations Subcommittee Reports FY 2015 Bill Without Amendments–Discretionary Spending Allocation Lower than Amount Provided to House

FDA, Public Policy, USDA / Chris Kirksey

The Senate Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee also voted today by voice vote to approve its draft FY 2015 bill and report it to the full Senate Appropriations Committee. The full Committee is scheduled to consider this bill on Thursday, May 22. Neither the bill text nor the

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Fishy Fishy – MOU between FSIS and FDA to Improve Interagency Cooperation

FDA, Public Policy, USDA / Chris Kirksey

There have been on-going questions regarding the regulatory oversight of catfish inspection. To address this concern, the 2014 Farm Bill required the Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) to create a Memorandum of Understanding (MOU) to “improve interagency cooperation on food safety and fraud prevention and to maximize

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House Agriculture Appropriations Subcommittee Reports FY 2015 Bill Without Any Amendments

1 Comment / FDA, Public Policy, USDA / Chris Kirksey

The House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee today voted by voice vote to approve its draft FY 2015 bill and report it to the full House Appropriations Committee. The full Committee is expected to consider this bill on Thursday, May 29, with the goal of having the bill

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FDA Explains How to Exempt an Ingredient from Allergen Labeling

FDA / Chris Kirksey

The Food and Drug Administration (FDA) has published a draft guidance document explaining what information it is looking for in petitions and notifications to exempt ingredients from allergen labeling. Comments on the draft guidance are due September 5, 2014. In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA), which amended the

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FDA Restricts Nutrient Content Claims for Omega-3s

EPA, FDA / Chris Kirksey

The Food and Drug Administration (FDA) has issued a final rule restricting the nutrient content claims that may be made for omega-3 fatty acids. Specifically, FDA is prohibiting existing nutrient content claims for the two omega-3s found in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and is restricting nutrient content claims for alpha-linolenic

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FDA/ONC/FCC Health IT Report Signals Possible Deregulation of Certain Software Medical Devices

FDA, Public Policy / Chris Kirksey

Has the U.S. Food and Drug Administration (FDA) opened the door to deregulation of certain software medical devices? Its recently issued Health IT Report seems to indicate so, and FDA is seeking comments on the report. Now is the time to weigh in on what FDA ultimately should do. Federal law enacted by Congress in

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FDA Regulation of Ackee Fruit Products

FDA / Chris Kirksey

Ackee fruit is harvested from the ackee tree (Blighia sapida), which is native to West Africa, but is also found in Central and South America, many Caribbean countries, and southern Florida. Ackee is an evergreen tree that grows about 10 meters tall, with a short trunk and a dense crown. Its fruit is pear-shaped. When

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NRDC Issues Report Critical of GRAS Self-Determinations and CSPI Joins in Criticism

FDA / Chris Kirksey

By Mark L. Itzkoff On April 7, 2014, the Natural Resources Defense Council (NRDC) issued its latest report on GRAS self-determinations, entitled Generally Recognized as Secret: Chemicals Added to Food in the United States. We previously reported on NRDC’s and the Pew Charitable Trust’s prior criticism of the GRAS provision here and here. The new article

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FDA Issues Guidance on Labeling of Honey

FDA / Chris Kirksey

The Food and Drug Administration (FDA) has issued a draft guidance document on labeling of honey and honey products. According to FDA, “honey” is the common or usual name for “a thick, sweet, syrupy substance that bees make as food from the nectar of flowers and store in honeycombs.” The floral source of honey may

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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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