The 2014 Global Child Nutrition Forum is fast approaching and, while space is limited, there is still opportunity to attend, exhibit and/or sponsor the Forum. This year’s event is being held by the Global Child Nutrition Foundation and World Food Program outside Johannesburg, South Africa, from September 29-October 3. This conference is held annually to […]
2014 Global Child Nutrition Forum, Sept. 29-Oct. 3 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
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 »
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 »
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 »
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 »
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 National Organic Program (NOP) of the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) has issued a final guidance document on “made with organic ___” labeling. The guidance became effective on May 2, 2014. The guidance document explains that the claim “made with organic ___” may be made if the following conditions are met:
USDA Offers Guidance on “Made with Organic ___” Label Claims Read More »
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 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 »
Vermont has become the first state in the nation to enact a law requiring labeling of genetically engineered foods. (Connecticut and Maine has enacted labeling laws, but their laws do not go into effect unless a critical mass of neighboring states enact similar requirements.) On April 23, 2014, the Vermont state legislature passed H.112 requiring
As Vermont Goes….? GMO Labeling Becomes the Law in Vermont Read More »
I am often asked to review responses to regulatory noncompliance or establishment corrective actions. Many times facilities are wondering why they have repeated occurrences of the “same problem,” or why the regulatory agency is repeatedly documenting the same findings. When asked whether the facility has conducted a “root cause analysis,” I am always amazed at
Get to the Roots, Don’t Just Pluck the Weeds — A Practice Tip from Dr. Gloom Read More »
We are pleased to announce that Edward J. Farrell, Esq., an expert on international trade, customs and agriculture matters, has joined OFW Law as a Principal. Please click the announcement, below, to enlarge it.
Edward Farrell, Esq., Joins OFW Law 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
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 »
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
FDA Issues Guidance on Labeling of Honey Read More »
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
FDA Final Rule and Guidance on Emergency Records Access Read More »
Last week’s headlines announced the arrival of higher food prices with more increases to come because of widespread drought in California and Texas. Talk of climate change and its effect on food production in some circles has taken on a new sense of urgency. But among all the handwringers, one common characteristic stands out. They
Food Security from the Tractor Seat Read More »
There has been a great deal of noise in the media recently about “plants running without inspection” and the significance to both the establishment and to FSIS. It is important to remember that no operations requiring inspection shall be conducted “except under the supervision of a program employee.” FSIS provides that supervision in a variety
“Time”-ly Tip from Dr. Doom Read More »
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
FDA Issues Statement on GRAS Determination of Senomyx Read More »
On March 4, 2014, the U.S. Supreme Court ruled in Lawson v. FMR LLC, No. 12-3 that “whistleblower” protection under the Sarbanes-Oxley Act of 2002 extends to the employees of a public company’s private contractors and subcontractors. The Sarbanes-Oxley Act was enacted in the wake of the Enron scandal largely to protect investors in public companies
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
Good Reprint Practices Revamped Read More »
FSIS has indicated that based on some recent “negative events;” they will be increasing verification activities. Increased verification should not mean increased noncompliance. We should do what we say we are going to do and document that we did it—each and every time. That said, we all know life isn’t always perfect. Therefore, I would
Tune up and Be Ready – A Practice Tip from Dr. Doom Read More »
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
A Consumer Group Files Suit to Vacate FDA’s GRAS Notification Program Read More »
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
Deadlines for FSMA Final Rules Pushed Back Read More »
By Nathan Fretz On February 7, the President signed the Agricultural Act of 2014 (the “Farm Bill”) into law. Over a series of blog posts, we will focus on various provisions within the Farm Bill, with a particular focus on some of the provisions that may not have received the level of media attention as
Farm Bill Redefines Dairy and Trade Activities Read More »
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
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
Hidden Gems in the Farm Bill Read More »
