On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will mark a “game changer” for clinical laboratories. Specifically, these guidances call for the active regulation of a subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs) and the firms that produce them.
Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part I) Read More »
The Food and Drug Administration (FDA) has announced a public meeting to be held on November 13, 2014 to discuss its four supplemental proposed rules under the Food Safety Modernization Act (FSMA). On September 29, FDA published supplemental proposed rules for four of its “foundational” FSMA rulemakings: Produce Safety Preventive Controls for Human Food Preventive
FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules Read More »
By Mark L. Itzkoff On October 20, 2014, FDA and the consumer group called the Center for Food Safety (CFS) filed a consent decree in the U.S. District Court for the District of Columbia that requires FDA to promulgate a final rule regarding the GRAS Notification (GRASN) Program by August 31, 2016. The decree resolves a
Settlement Agreement Reached on GRAS Notification Program Final Rule Read More »
FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA). Those four rules are: Produce Safety; Preventive Controls for Human Food; Preventive Controls for Animal Food; and Foreign Supplier Verification Programs (FSVP). Comments on the supplemental proposed rules are due December 15, 2014. The “Supplementals”
FDA Tweaks Its Four Foundational FSMA Proposed Rules Read More »
A Webinar Presented by OFW Law and Davis, LLP October 15, 2014, 1:00 p.m. EST During this webinar, the second 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 others:
How to Legally Import and Market Pharmaceuticals in the U.S. and Canada Read More »
By John R. Block, as published in the Des Moines Register Every day millions of shoppers are paying out as much as 50 or 100 percent more to buy organic foods for themselves and their families. I have friends who make these choices because they have no reason to question claims on labels, in advertising and
Consumers are Misled About Organic Safety Read More »
Don’t sit back and wait: Be proactive! The comment period for FDA’s proposed regulations revising the “Nutrition Facts” label has closed. The comment period has also closed for FDA’s proposed rule that would lead to more than 30 new serving sizes for foods. This is a big deal because the nutrient content information that appears
FDA has announced that its Risk Communication Advisory Committee (RCAC) will be holding a public meeting on November 3-4, 2014, at its White Oak Campus in Silver Spring, MD. The RCAC meeting will focus on messages about the importance of eating adequate amounts of fish and shellfish, while avoiding certain varieties with higher amounts of
Risk Communication about Methylmercury in Seafood Read More »
A Webinar Presented by OFW Law and Davis, LLP October 29, 2014, 1:00 p.m. EST During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Canada. Topics for each country will include, among others: A general understanding of the regulatory
How to Legally Import and Market Foods and Beverages in the U.S. and Canada Read More »
It is October 1st and time to renew your food facility registration(s) with FDA. Facilities (domestic and foreign) engaged in manufacturing, processing, packing, or holding food (human or animal) for consumption in the United States must register with FDA, unless exempt. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
FDA Food Facility Registrations Must Be Renewed Soon Read More »
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
How to Legally Import and Market Medical Devices in the U.S. and Canada Read More »
Happy Birthday, Hatch-Waxman! You’re a mature 30-year old now, a regular adult. Some personal musings on my stroll down the Hatch-Waxman Memory Lane over the past 30-plus years follow. A small background digression: For those of you in the FDA regulatory arena who are real newbies or who have been in a Rip Van Winkleoid
Hatch-Waxman Turns 30 – A Stroll Down Memory Lane Read More »
The USDA’s Food Safety and Inspection Service (FSIS) plans, effective November 10, 2014, to halt issuing export certificates for FDA-regulated foods that contain an egg product(s) as an ingredient because USDA’s Agricultural Marketing Service (AMS) now provides this service. FDA regulates the safe production, sanitary processing, and labeling of food products containing egg products. Nevertheless,
Export Certificates for FDA-Regulated Foods Containing Egg Products as an Ingredient Read More »
By Mark L. Itzkoff We have previously reported on criticism of the so-called “GRAS Exemption” and FDA’s GRAS Notification Program by the Pew Charitable Trusts, the Natural Resources Defense Council, and the Center for Science in the Public Interest. In response to these criticisms, the Grocery Manufacturers Association (GMA) recently announced a 5-part initiative to improve
GMA Announces Initiative to Address Criticisms of GRAS Exemption Read More »
The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA Food Safety Modernization Act (FSMA). The proposed revisions address: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (for a summary, click here); Standards for the Growing, Harvesting, Packing, and
FDA Updates 4 Proposed Rules Implementing FSMA Read More »
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
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
How to Legally Import and Market Pharmaceuticals in the U.S. and Canada Read More »
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
How to Legally Import and Market Medical Devices in the U.S. and Canada Read More »
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
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
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
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
Lupin, A Legume Becoming More Popular In The US, May Cause Allergic Reactions Read More »
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
FDA’s “Gluten-Free” Labeling Rule Takes Effect Read More »
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.
OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team Read More »
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
Bill Introduced to Ban the Use of Bis-Phenol A in Food Packaging Read More »
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
FDA Issues Guidance Documents on the Use of Nanotechnology in FDA-Regulated Materials Read More »
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
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
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 »
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
Reopening of Comment Period on Reportable Food Registry ANPR Read More »
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
“Eat Your Fish,” Say FDA and EPA Read More »
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
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
Pontifications by Dr. Doom Read More »
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
FDA Issues Final Compliance Policy Guide on Food Facility Registration Read More »
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].
Regulatory Round-Up Newsletter, Spring 2014 Read More »
