FDA

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 15, 2014, 1:00 p.m. EST During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among […]

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How to Legally Import and Market Medical Devices in the U.S. and Canada

FDA, OFW Law News / Chris Kirksey

A Webinar Presented by OFW Law and Davis, LLP October 1, 2014, 1:00 p.m. EST During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market a medical device in the U.S. and Canada. Topics

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Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

1 Comment / FDA, OFW Law News / Chris Kirksey

Announcing OFW Law and Davis LLP’s New Four-Part Webinar Series: REGULATORY REQUIREMENTS FOR THE IMPORT OF MEDICAL PRODUCTS AND FOODS INTO THE U.S. AND CANADA OFW Law and Davis LLP have joined together to present a new webinar series to provide attendees with an overview of laws with which a firm must comply when importing

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How Would an FDA Standard of Identity for Honey Benefit Consumers, the Honey Industry, and U.S. Agriculture? USDA Wants to Know.

FDA, USDA / Chris Kirksey

The U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) has published a Federal Register notice requesting comments on a possible federal standard of identity for honey. Although the Food and Drug Administration (FDA) is the agency that would be responsible for developing a standard of identity for honey, the 2014 Farm Bill charged the

How Would an FDA Standard of Identity for Honey Benefit Consumers, the Honey Industry, and U.S. Agriculture? USDA Wants to Know. Read More »

Salt

FDA, Public Policy, USDA / Chris Kirksey

What should we be eating? We are getting hammered from every angle about what is good for us versus what is bad. Too many carbs, stay away from red meat, don’t trust GE foods, sugar will make you fat. The government wants to regulate. We have been through this before but never with the intensity

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Lupin, A Legume Becoming More Popular In The US, May Cause Allergic Reactions

FDA / Chris Kirksey

FDA has issued a Consumer Update (Allergies to a Legume Called Lupin: What You Need to Know) and FAQs (Frequently Asked Questions on Lupin and Allergenicity) on lupin, a legume belonging to the same plant family as peanuts. According to the agency, lupin can cause severe allergic reactions, including life-threatening anaphylaxis, in allergic individuals. While

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FDA’s “Gluten-Free” Labeling Rule Takes Effect

FDA / Chris Kirksey

On August 5th, FDA’s regulation defining the claim “gluten-free” for voluntary use in food labeling became effective. FDA cautions consumers that there may still be some products on store shelves labeled “gluten-free” that do not comply with the new definition, but all foods entering commerce on or after August 5, 2014 must comply. Here are

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OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team

FDA, OFW Law News, Public Policy / Chris Kirksey

Thirty-five (35) years ago, the Washington, DC law firm presently known as Olsson Frank Weeda Terman Matz PC, or simply “OFW Law,” originated as Olsson and Frank, P.C. It was comprised of two (2) founding attorneys, Philip C. (Phil) Olsson and Richard L. (Rick) Frank, who left another DC law firm to start their own.

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Bill Introduced to Ban the Use of Bis-Phenol A in Food Packaging

FDA / Chris Kirksey

By Mark L. Itzkoff On July 10, 2014, Senator Ed Markey (D-MA) introduced a bill (S. 2572) to ban the use of Bis-phenol A (BPA) in food packaging. The bill was also introduced in the House of Representatives (H.R. 5033) by Reps. Lois Capps (D-CA) and Grace Meng (D-NY). According to a press release issued by

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FDA Issues Guidance Documents on the Use of Nanotechnology in FDA-Regulated Materials

1 Comment / FDA / Chris Kirksey

By Mark L. Itzkoff On June 24, 2014, the Food and Drug Administration (FDA) released three final and one draft guidance document regarding the use of nanotechnology in the manufacture of FDA-regulated products. Specifically, the agency issued the following: Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Final Guidance for

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Supreme Court Holds FD&C Act Does Not Bar Competitor Food Label Challenges under the Lanham Act

FDA, Public Policy / Chris Kirksey

By Michael J. O’Flaherty and Stewart D. Fried In a recent opinion delivered by Justice Kennedy (with Justice Breyer recused), the U.S. Supreme Court unanimously held that competitors may bring Lanham Act claims challenging food labels, even if such labels technically comply with regulations promulgated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and

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Political Science or Sound Science – Is the White House Dictating Nutrition Labeling Reform?

3 Comments / FDA, USDA / Chris Kirksey

The White House’s role with USDA’s regulations for school foods and the WIC feeding program has been widely reported. Lesser known is the White House involvement in FDA food labeling policy. To commemorate the anniversary of the Let’s Move! campaign, the first lady hosted a week-long series of events in March, one of which included

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Ms. Gloom Wants to Know: Does Your Product Hold Program Really “Hold” When Needed?

FDA, USDA / Chris Kirksey

Anyone who has been involved in the quality assurance and food safety side of the food business for any length of time knows that one of the top items on the list of those that will keep you awake at night is whether or not your product “hold” or retention program will be effective in

Ms. Gloom Wants to Know: Does Your Product Hold Program Really “Hold” When Needed? Read More »

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 [email protected].

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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

Fishy Fishy – MOU between FSIS and FDA to Improve Interagency Cooperation Read More »

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

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

What Importers Must Know About FDA Regulation of Ackee Fruit Products

FDA / J. Mason Weeda

Ackee fruit is one of the most heavily regulated food imports entering the United States. The FDA maintains a standing import alert – Import Alert 21-11 – that authorizes automatic detention of all ackee products at U.S. ports of entry unless the manufacturer has earned placement on the agency’s approved Green List. For Caribbean food

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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

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

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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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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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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How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

How to Legally Import and Market Medical Devices in the U.S. and Canada

Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

How Would an FDA Standard of Identity for Honey Benefit Consumers, the Honey Industry, and U.S. Agriculture? USDA Wants to Know.

Salt

Lupin, A Legume Becoming More Popular In The US, May Cause Allergic Reactions

FDA’s “Gluten-Free” Labeling Rule Takes Effect

OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team

Bill Introduced to Ban the Use of Bis-Phenol A in Food Packaging

FDA Issues Guidance Documents on the Use of Nanotechnology in FDA-Regulated Materials

Supreme Court Holds FD&C Act Does Not Bar Competitor Food Label Challenges under the Lanham Act

Political Science or Sound Science – Is the White House Dictating Nutrition Labeling Reform?

Ms. Gloom Wants to Know: Does Your Product Hold Program Really “Hold” When Needed?

Reopening of Comment Period on Reportable Food Registry ANPR

“Eat Your Fish,” Say FDA and EPA

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

Pontifications by Dr. Doom

FDA Issues Final Compliance Policy Guide on Food Facility Registration

Regulatory Round-Up Newsletter, Spring 2014

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

FDA Announces Public Meeting on Nutrition Labeling Proposed Rules

FDA Extends Comment Period for Proposed Rules on Nutrition Labeling

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

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

House Agriculture Appropriations Subcommittee Reports FY 2015 Bill Without Any Amendments

FDA Explains How to Exempt an Ingredient from Allergen Labeling

FDA Restricts Nutrient Content Claims for Omega-3s

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

What Importers Must Know About FDA Regulation of Ackee Fruit Products

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

FDA Issues Guidance on Labeling of Honey

FDA Final Rule and Guidance on Emergency Records Access

HHS Releases HIPAA Security Rule Risk Assessment Tool

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

FDA Updates Its Guidance on Prior Notice of Imported Foods

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