Kristen O’Brien serves as Counsel in OFW Law’s Health Industry Policy and Regulatory Practice, which represents clients in the health care delivery system and innovative life sciences areas. She is principally responsible for the group’s work with health care delivery system clients, including large physician groups, integrated health systems and other provider organizations. She also […]
As manufacturers of food products, it is significant to understand the food safety regulations for retailers and the food service industry, such as restaurants and grocery stores, and institutions, such as nursing homes. On October 4, 2017, FDA released its report on “Adoption of the FDA Food Code…” which, in relevant part, provides that all
FDA Report on Food Code Adoption Read More »
On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on the agency’s domestic food facility inspections: Challenges Remain in FDA’s Inspections of Domestic Food Facilities (the Report). The Report concluded that FDA is on track to meet the initial domestic food facility inspection timeframes
FDA Inspector General Report on Progress of FSMA Inspections Read More »
While generally expected for months (e.g., since the menu labeling compliance date extension) and recently the subject of a “tweet” from FDA Commissioner Gottlieb, the agency now officially has proposed to extend by about 1.5 years the compliance date for the final rules that will provide updated nutrition information on the labels of most conventional
Extension of Compliance Date for Revised Nutrition Labeling of Foods and Supplements Read More »
Over 30 years ago, the National Conference on Weights and Measures (NCWM) collaborated with the Association of Food and Drug Officials to establish an initial open dating regulation. This regulation — now the Uniform Open Dating Regulation (UODR), published by the National Institute of Standards and Technology within the U.S. Department of Commerce — is
Open Date Labeling Revisions for Food Appear To Be on the Horizon Read More »
Last Thursday, at the Politico Policy Summit, Commissioner Scott Gottlieb announced that the new Nutrition Facts requirements compliance date will be pushed back one-year and, subsequently, announced via Twitter that the compliance date extension will be “closer to 18 months.” As described in our last blog on this topic, industry groups met with the Trump
Nutrition Facts Update: Compliance Date Expected to be Delayed 18 Months Read More »
Several food industry groups hope so. The responsibility for implementing two major changes to food labeling requirements has fallen on the Trump Administration: Nutrition Facts Panel – On May 27, 2016, FDA published a final rule that will overhaul the Nutrition Facts panel that we have become accustomed to on foods. In addition to some
The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 – almost a quarter century ago. It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) in a number of significant ways that set the stage for present marketing of this important category of consumer goods. However, aspects of DSHEA never were
“Grandfathered” Dietary Ingredients – It’s About Time Read More »
Today, the Food and Drug Administration (FDA) announced the installment of Chapter Six to its “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Draft Guidance). The Draft Guidance explains FDA’s current thinking on how food facilities may comply with the FDA’s final rule on Hazard Analysis and Risk Based Preventive
FDA Adds New Chapter on Heat Treatment to its Preventive Controls Guidance under FSMA Read More »
By former USDA Secretary John R. Block Today, I have a fishy story to talk about, but before I get started on that, what do you think of the nation’s economy? I know the farm economy is not booming, but consumer confidence is off the charts – a 20% jump from last year. Unemployment is down
John Block: GE Salmon Read More »
OFW Law is pleased to announce the creation of a new Health Industry Policy and Regulatory Practice. The practice will be focused on government health program payment issues and FDA-related policy issues for clients in the health care delivery system and innovative life sciences areas. To provide leadership for this practice, OFW Law is also
Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”). Section 3059 of the Cures Act requires FDA to publish a list of reusable device types that must include validated instructions for use, in addition
FDA implements 21st Century Cures Act Requirements for Reusable Devices Read More »
By Dr. Nina Fedoroff, as published in Agri-Pulse USDA and FDA proposals to regulate genetically engineered (GE) plants and animals following the recent update of the regulatory framework are on their websites awaiting public comment by June 19, 2017. The documents on which comments are requested are long, dense and, at times, internally inconsistent. Here’s a detailed
Think This is Biotech Regulatory Relief? Not Yet. Read More »
This morning, FDA’s Office of Nutrition and Food Labeling announced that it intends to extend the compliance date for the new Nutrition Facts requirements. FDA’s announcement, which is included on its “Changes to the Nutrition Facts Label” webpage, notes that, after feedback from industry and consumer groups: FDA determined that additional time would provide manufacturers covered
FDA Announces Intent to Extend the Compliance Date for New Nutrition Facts Rules Read More »
Today’s Federal Register announces a technical amendment to FDA’s regulation of medical devices to align the regulations with the the Food, Drug, and Cosmetic Act (FD&C Act). The 21st Century Cures Act became law on December 13, 2016, and amended the FD&C Act by removing the requirement for local Institutional Review Board (IRB) review for
FDA Implements 21st Century Cures Requirements for Devices Read More »
NYC just announced that its revised calorie labeling rule for food service establishments will take effect on May 22, 2017, and will begin being enforced with notices of violation subject to fines on August 21, 2017. This pre-dates the recently re-delayed effective date for federal menu labeling of May 7, 2018. The NYC rule,
NYC Menu Labeling Law – Enforceable? Read More »
FDA is again extending the compliance date for menu labeling – just days before the regulatory requirements of § 101.11 were to have become effective. On May 4, 2017, the agency will publish an interim final rule that extends the compliance date from May 5, 2017, to May 7, 2018, and that opens a 60-day
The restaurant industry was bracing for FDA’s menu labeling regulation, requiring mandatory calorie disclosure on menus at chains that have 20 or more locations. The final compliance date was coming up next week on May 5, 2017. However, in a last minute change, FDA submitted an interim final rule to the White House Office of
That is one of the most common – and difficult – questions to answer when OFW Law teaches a Food Safety Modernization Act Foreign Supplier Verification Programs (FSMA FSVP) course. Determining the compliance dates is typically more challenging for the affected importers. To make it easier, OFW Law has created flow diagrams and examples to
I’m a FSVP Importer: How Do I Know When I Need To Comply? Read More »
FSMA – The D.C. acronym for the Food Safety Modernization Act. When I am working with clients or speaking with industry, everyone is familiar with FSMA. But they think of FSMA as the Preventive Controls or Produce Safety Rules. Some are also aware of the Sanitary Transportation Rule, but the Foreign Supplier Verification Programs (FSVP)
The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule Read More »
On April 8, 2017, Forest Devices, Inc. from Carnegie Mellon University was awarded OFW Law’s Regulatory Strategy Prize at the 2017 Rice Business Plan Competition in Houston, Texas. Forest Devices bested 41 other competitors hailing from some of the world’s top universities in the overall competition, as well, earning about $700,000 in prize money. Forest
OFW Law Supports Medical Device Innovators at the 2017 Rice Business Plan Competition Read More »
Yesterday, FDA published a final rule making some technical amendments to its prior notice of imported food regulations. The prior notice regulations implement section 801(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(m)), which requires that FDA receive prior notice of food imported into the United States. Coordinating the Automated Broker Interface/Automated
Prior Notice of “Grey Market” Food Imports Read More »
Egg cartons in the United States are not required by federal regulations to bear labels which identify the living conditions of the hens. Two animal rights non-profit organizations and six individuals sought to change that by filing petitions with four different federal agencies under the apparent strategy of not putting all their eggs in one
Egg Carton Labeling Petitions Fail to Hatch Read More »
U.S. purveyors of foods, food additives, dietary supplements, and cosmetics for export are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA. Review of a certificate may be required by foreign countries as part of the process to import a product into those countries. A Certificate of
CFSAN Soon Will Issue Certificates of Free Sale for Exports Online Read More »
By Dr. Nina Fedoroff, as published in Agri-Pulse The Coordinated Framework (CF) for the Regulation of Biotechnology was first implemented 30 years ago. The CF was developed by the White House Office of Science and Technology Policy (OSTP). OSTP brought together representatives of the three federal agencies seeking to regulate commercial applications of biotechnology to
Biotech Regulations Must be Based on Facts, Not Fears Read More »
The opening days of a new year are, to some, an apropos time to look back and reflect on the year that is now “one for the books.” Unable to resist the urge to do so ourselves, we have compiled our “Top-5” list for medical device regulation in 2016. Device Modification Guidance It has been
Medical Device “Top 5” for 2016 Read More »
FDA released a draft Guidance statement on how food companies should calculate the added sugar content in their products for the purposes of nutrition labeling. Comments are due on March 6. Guidance documents are supposed to help simplify FDA regulations (added sugars content is required to be disclosed on Nutrition Facts labels starting July 26,
FDA’s Guidance on Added Sugars is as Thick as Molasses Read More »
FDA has begun posting online (and intends to update quarterly) information derived from adverse event reports the agency has received about conventional foods (including food/color additives), dietary supplements, and cosmetics. This information is now made available in the CFSAN Adverse Event Reporting System (CAERS) database. This is information that was once only available through Freedom
Adverse Event Information Now Available Online for CFSAN-Regulated Products Read More »
In a January 3, 2017, decision likely to have broad implications in food class action litigation, the Ninth Circuit Court of Appeals affirmed a California federal district court judge’s decision certifying a consumer class action brought by purchasers of Wesson-brand cooking oil. In Briseño v. ConAgra, residents of eleven states, alleged that the “100% Natural”
FDA has published two Federal Register notices (see here and here) announcing the availability of draft guidance documents that are intended to help address issues raised by the agency’s final rules (see here and here) amending Nutrition Facts and Supplement Facts labeling requirements. The draft guidance documents are: Draft Guidance for Industry: Questions and Answers
Long-Awaited Guidance Documents on Revised Nutrition Labeling Released in Draft by FDA Read More »
Happy 2017, everyone! 2016 has come and gone. Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention. As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!), individuals in a position of responsibility can be prosecuted criminally for what are often
2016 – Gone But Not Forgotten Read More »
The U.S. Food and Drug Administration (FDA) has promulgated an interim final rule, effective December 19, 2016, amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol, and risk of coronary heart disease (CHD) to permit a broader array of raw fruits and vegetables (further described below) to be
FDA Expands Authorized Health Claims for Raw Fruits and Vegetables Read More »
Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and Cosmetic Act (added by Food Safety Modernization Act (FSMA)). In November 2015, the FDA promulgated the final rule on “Accreditation of Third-Party Certification Bodies to Conduct Food Safety
FDA Finalizes FSMA Third-Party Certification User Fee Program Read More »
Ever since the election we have been asked which Obama Administration regulations and executive actions are likely to be stricken by the new Trump Administration or the 115th Congress. Will the focus be on the rules issued since mid May of this year, as provided for by the Congressional Review Act of 1996, or is
Food Rules Potential Targets for Elimination or Revision Read More »
FDA has set January 1, 2020, as the uniform compliance date for new or amended food labeling regulations that are issued between January 1, 2017, and December 31, 2018. Use of a uniform compliance date provides for an orderly and economical industry adjustment to new labeling requirements by allowing sufficient lead time to plan for
Uniform Compliance Date for Upcoming Food Labeling Regulations Read More »
