Dietary fiber is a macronutrient that permissibly may be declared in the Nutrition Facts on a conventional food’s label, and in the Supplement Facts on a dietary supplement’s label. 21 C.F.R. §§ 101.9(c)(6)(i), 101.36(b)(2)(i). To clarify what may be included in nutrition labeling declaration of Dietary Fiber content, § 101.9(c)(6)(i) provides: Dietary fiber is defined […]
Dietary Fiber Permissible in Nutrition/Supplement Facts Read More »
CFSAN/FDA has made available a guidance document and a small entity compliance guide to assist industry in complying with its revised nutrition labeling requirements for conventional foods and dietary supplements: Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category (Feb. 2018) [hereinafter “RACC Guide”]; and Guidance for Industry: Food Labeling:
RACC and Serving Size Guidance Read More »
By Nina Fedoroff and Alison Van Eenennaam, as published in the Des Moines Register In his speech at the recent American Farm Bureau convention, President Trump said his administration was “streamlining regulations that have blocked cutting-edge biotechnology.” Why is this necessary? Paraphrasing New York Times columnist Paul Krugman’s words on economic policy, it’s because we’re still living with “zombie” biotech
How the Federal Government Can Get Biotech Regulation Right Read More »
On February 12, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Public Health Service (PHS) released its most recent revision of the Food Code to reflect the current understanding of best practices in food safety. The Food Code is a model regulation intended for adoption by local, state, tribal, and territorial governments.
FDA Publishes 2017 Food Code Read More »
Food labeling class actions — which food labeling claims put you most at risk of a lawsuit? Popular claims regarding ingredient content or processing methods are often the most common targets for class actions. Read the views of OFW Law, as reported in Food Navigator. The article reports on a recent webinar sponsored by the
Which Food Labeling Claims Put You Most at Risk of a Class Action Lawsuit? Read More »
FDA has released a draft guidance, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff” (1/17/2018). It essentially discloses FDA’s intent to accelerate the release of recall information to the public, to better safeguard consumers’ health and well-being. Recalls of many FDA-regulated products will be
FDA Updates Some Recall Practices Read More »
The FDA recently released a “2018 Strategic Policy Roadmap” outlining (among other things) its nutrition-related policy priorities for the coming year. In the Roadmap, FDA lists nutrition as one of its four top issues for this year. The Agency aims to: “Empower consumers to make better and more informed decisions about their diets and health
Analysis of FDA’s Nutrition Policy Priorities for 2018 Read More »
Last week, the FDA concluded that there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of multiple sclerosis (MS). The petition, submitted on behalf of Bayer, requested use of the claim “Vitamin D may reduce the risk of [MS]” as a qualified health claim. FDA previously denied
FDA Denies Use of Claim for Vitamin D Reducing MS Risk Read More »
The food and beverage industry is facing an unprecedented number of threats from class action cases alleging misleading labeling and advertising. Approximately two new lawsuits against manufacturers, distributors and retailers were filed each week in 2017! Dozens more food and beverage industry members received demand letters that threatened the commencement of such cases and demanded
Upcoming Webinar: Avoiding the Food Labeling Class Action Trap Read More »
According to the Wall Street Journal: “Organic milk sales have cooled as the very shoppers who drove demand for the specialty product not long ago move on to newer alternatives, leaving dairy sellers and producers grappling with oversupply….Now, organic-milk supplies have ballooned just as demand has stalled. Many shoppers have moved on to substitutes such
“Milk” Comes from Breasts/Udders Read More »
OFW Law has joined with the United Fresh Produce Association (UFPA) to provide members access to a legal review of product labels. UFPA brings together companies across every segment of the fresh produce supply chain, including growers, shippers, fresh cut processors, wholesalers, distributors, retailers, foodservice operators, industry suppliers and allied associations. This new service was
United Fresh and OFW Law Launch Legal Labeling Review Service Read More »
In planning for your company’s 2018 regulatory priorities, you might want to review and optimize its recall procedures. Recall policies and procedures likely will be a focus of FDA in the coming year. The Office of Inspector General (OIG) within the Department of Health and Human Services recently published a Report, The Food and Drug
Focus on Food Recalls Read More »
Contributor: Mark L. Itzkoff Principal, The Law Office of Mark Itzkoff, mark@itzkofflaw.com On November 15, 2017, FDA released a proposed guidance document, Best Practices for Convening a GRAS Panel: Guidance for Industry. The Guidance is, in part, a response to 2013 criticism of the GRAS exemption for food ingredients from the Pew Charitable Trust, the
FDA has released a helpful and user friendly Food Safety Modernization Act (FSMA) compliance date webpage to assist farmers, manufacturers of food and food products, and other stakeholders.[1] The webpage includes deadlines for the following rules: Produce Safety (21 C.F.R. Part 112), Preventive Controls for Human Food (21 C.F.R. Part 117), Preventive Controls for Animal
FSMA Update: FDA Releases FSMA Compliance Deadlines Guide Read More »
On October 19, 2017, FDA announced the publication of two guidance documents to assist industry stakeholders in compliance with regulations promulgated pursuant to the Food Safety Modernization Act (FSMA): #235 – Current Good Manufacturing Practice Requirements for Food for Animals; Final Guidance for Industry; Application of the “Solely Engaged” Exemptions in Parts 117 and 507:
On October 26, 2017, OFW Law founding principal Richard L. Frank filled in for former USDA Secretary John R. Block on his weekly radio broadcast. The opioid epidemic is a national crisis. Drug overdoses are killing 64,000 Americans each year. It is the leading cause of death for individuals under 50. It requires urgent action and solutions from across our
John Block Reports: The Opioid Crisis – Stop Pointing Fingers Read More »
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 »
