FDA

FDA Announces FY 19 User Fee Rates for Third Party Certification Program

FDA / Joi Jackson

Yesterday, FDA announced in the Federal Register, the Agency’s 2019 user fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program. Under the current third-party certification program, as required by the Food Safety Modernization Act (FSMA), FDA established a […]

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EAFUS Inventory Replaced by “Substances Added to Food” Inventory

FDA / Joi Jackson

CFSAN/FDA’s Office of Food Additive Safety (OFAS) has replaced the original Everything Added to Food in the U. S. (EAFUS) inventory with an upgraded version – the Substances Added to Food inventory. This new inventory — which contains about 4000 substances and is searchable — includes information on: Generally recognized as safe (GRAS) substances in

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FDA Nutrition Innovation Strategy

FDA, For Export / Michael J. O'Flaherty

FDA has announced a public meeting, entitled “FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy,” (Strategy) to be held on July 26, 2018, from 8:30 a.m. until 5:30 p.m. EDT, at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. The public meeting also will be made available via live webcast. In March 29, 2018

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Intentional Adulteration Mitigation Strategies – Initial Draft Guidance

FDA / Joi Jackson

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, For Export / Michael J. O'Flaherty

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

FDA, For Export / Michael J. O'Flaherty

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 / Joi Jackson

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

FDA / Joi Jackson

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

FDA / Joi Jackson

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

FDA Caffeine Regulations for Dietary Supplements

FDA, For Export / Michael J. O'Flaherty

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

FDA, For Export, Public Policy / Bruce Silverglade

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

FDA, USDA / Joi Jackson

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

FDA / Joi Jackson

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

FDA, For Export / Michael J. O'Flaherty

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

FDA / Joi Jackson

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

EPA, FDA, For Export, Public Policy, USDA / Dr. Nina V. Federoff

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

FDA / Joi Jackson

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?

FDA, Litigation / Joi Jackson

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 / Joi Jackson

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

FDA / Joi Jackson

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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FDA Denies Use of Claim for Vitamin D Reducing MS Risk

FDA / Joi Jackson

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

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Upcoming Webinar: Avoiding the Food Labeling Class Action Trap

FDA, Litigation, OFW Law News / Joi Jackson

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

FDA, For Export, Public Policy, USDA / Michael J. O'Flaherty Jolyda O. Swaim

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

FDA, For Export, OFW Law News / Firm Announcement

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

FDA / Joi Jackson

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

FDA / Joi Jackson

Contributor: Mark L. Itzkoff Principal, The Law Office of Mark Itzkoff, [email protected] 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 / Joi Jackson

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

FDA, For Export / John G. Dillard

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

FDA, Public Policy / Joi Jackson

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

FDA, Health Care, OFW Law News, Public Policy / Joi Jackson

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 Report on Food Code Adoption

FDA / Joi Jackson

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

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FDA Inspector General Report on Progress of FSMA Inspections

FDA / Joi Jackson

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

FDA / Joi Jackson

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

FDA, Public Policy / Joi Jackson

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

FDA / Joi Jackson

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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