FDA

Intentional Adulteration Mitigation Strategies – Initial Draft Guidance

The FDA Food Safety Modernization Act contained provisions aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.  This was the first time that covered companies were legally required to create a food defense plan.  Covered companies generally include both domestic and …

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Close up of flax seeds

Isolated or Synthetic Non-Digestible Carbohydrates that Qualify as Dietary Fiber

FDA has published a guidance that specifies eight (8) additional substances that qualify as dietary fiber for purposes of nutrition labeling: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels: Guidance for Industry (June 2018). When it revised its Nutrition Facts and Supplement Facts regulatory requirements …

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Collection of artificially flavored candy

Synthetic Flavors’ Safety Questioned – Strategy Needed to Address Consequence

Food manufacturers using the following seven (7) synthetic flavoring substances and adjuvants should take note that the safety of these ingredients is being challenged: Benzophenone (a/k/a diphenylketone), Ethyl acrylate, Eugenyl methyl ether (a/k/a 4-allylveratrole, methyl eugenol, or Methyleugenol), Myrcene (a/k/a 7-methyl-3-methylene-1,6-octadiene), Pulegone (a/k/a p-menth-4(8)-en-3-one), Pyridine, and Styrene. Each of these substances is authorized for food …

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FDA Announces Medical Device Quality System Regulation Change

FDA recently announced a potential massive overhaul to its Medical Device regulations.  Specifically, the agency intends to “harmonize and modernize” its medical device Quality System Regulation (21 C.F.R. Part 820) with an international consensus standard for medical device manufacturing (ISO 13485).  The rulemaking entitled “Harmonizing and Modernizing Regulation of Medical Device Quality Systems” appears on …

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FDA Finalizes Nutrition Facts Compliance Date Extension by 1.5 Years

On May 4, 2018, the FDA issued its final rule extending the compliance date for the updated nutrition information on the labels of most conventional foods and dietary supplements. The final rule is consistent with FDA’s October 2, 2017 proposed rule, and implements a 1.5 year (approximate) compliance date extension: From July 26, 2018, to …

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Menu Labeling – Supplemental Guidance

On the same day that FDA’s menu labeling regulation became effective for compliance by industry, the agency published notice of the availability of its finalized Menu Labeling: Supplemental Guidance for Industry (May, 2018). This guidance is “supplemental” because FDA also already has published A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – …

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Coffee beans on table

Caffeine in Dietary Supplements

The Office of Dietary Supplement Programs within CFSAN at FDA has prepared and published guidance for industry, warning that powdered and liquid dietary supplements containing pure or highly concentrated caffeine may be deemed to be adulterated under section 402(f)(1)(A) of the FD&C Act: Highly Concentrated Caffeine in Dietary Supplements: Guidance for Industry (Apr. 2018). Caffeine …

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Lawyer filing lawsuit

Food Labeling Modernization Act of 2018 Likely Reveals Consumer Groups’ Priorities for FDA Nutrition Innovation Strategy – May Spur More Class Action Lawsuits

The Food Labeling Modernization Act of 2018 (H.R. 5425) was introduced on April 4, 2018, by Rep. Frank Pallone, Jr. (D-NJ), the ranking member of the House Energy and Commerce Committee.  A joint press statement announcing the bill was released by Rep. Pallone and co-sponsor Rep. Rosa DeLauro (D-CT), the ranking member of the House …

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John Block: Clean Meat

By former USDA Secretary John R. Block All the time, we hear the loud voices of consumer groups that insist the public must be informed about the food we eat. “Label it organic.”  “If it has GMOs, the consumer must know.”  “You should not label it natural if it is not natural,” whatever ‘natural’ means. Now, …

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FDA Maintains Focus on Nutrition to Foster Human Health

In a speech, entitled “Reducing the Burden of Chronic Disease,” delivered on March 29th by FDA Commissioner Scott Gottlieb before the National Food Policy Conference in Washington, D.C., FDA kicked-off its Nutrition Innovation Strategy.  FDA has identified several areas where it believes there is opportunity to improve public health and encourage industry innovation towards reducing …

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Fiber rich nuts and seeds

Dietary Fiber Permissible in Nutrition/Supplement Facts

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 …

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RACC and Serving Size Guidance

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: …

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Tomato injected with growth hormones

How the Federal Government Can Get Biotech Regulation Right

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 …

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FDA Publishes 2017 Food Code

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.  …

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Which Food Labeling Claims Put You Most at Risk of a Class Action Lawsuit?

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 …

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FDA Updates Some Recall Practices

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 …

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Analysis of FDA’s Nutrition Policy Priorities for 2018

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 …

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Upcoming Webinar: Avoiding the Food Labeling Class Action Trap

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 …

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Bottle of milk

“Milk” Comes from Breasts/Udders

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 …

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Elderly man reading food product label

United Fresh and OFW Law Launch Legal Labeling Review Service

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 …

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Focus on Food Recalls

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 …

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FDA’s Proposed Guidance on Convening a GRAS Panel May Result in Higher Costs for GRAS Notifiers

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 …

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FSMA Update: FDA Releases FSMA Compliance Deadlines Guide

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 …

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Assortment of dog food

FSMA Update: FDA Releases Guidance Documents on CGMP Requirements of Animal Food Rule and Exemptions from FSMA Requirements of Human and Animal Food Rules

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: …

FSMA Update: FDA Releases Guidance Documents on CGMP Requirements of Animal Food Rule and Exemptions from FSMA Requirements of Human and Animal Food Rules Read More »

John Block Reports: The Opioid Crisis – Stop Pointing Fingers

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 …

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Kristen O’Brien Joins OFW Law as Counsel in the Health Industry Policy and Regulatory Practice

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 …

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FDA Inspector General Report on Progress of FSMA Inspections

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 …

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Extension of Compliance Date for Revised Nutrition Labeling of Foods and Supplements

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 …

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Open Date Labeling Revisions for Food Appear To Be on the Horizon

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 …

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Nutrition Facts Update: Compliance Date Expected to be Delayed 18 Months

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 …

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Will the Trump Administration Align Compliance Dates for Nutrition Facts Update, GMO Labeling?

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 …

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Assortment of dietary supplements

“Grandfathered” Dietary Ingredients – It’s About Time

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 …

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FDA Adds New Chapter on Heat Treatment to its Preventive Controls Guidance under FSMA

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 …

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