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 »
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
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
FDA Announces Public Meeting on Nutrition Labeling Proposed Rules Read More »
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
FDA Extends Comment Period for Proposed Rules on Nutrition Labeling Read More »
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
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 »
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
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
FDA Explains How to Exempt an Ingredient from Allergen Labeling Read More »
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
FDA Restricts Nutrient Content Claims for Omega-3s Read More »
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
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
What Importers Must Know About FDA Regulation of Ackee Fruit Products Read More »
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 »
