Food Manufacturing, Processing, and Marketing

2020 Food Labeling Seminar Hosted by OFW and The Food Institute

OFW and The Food Institute will be holding their annual Food Labeling Seminar on October 7, 8, and 9. The virtual training course will cover everything you need to know about food labeling in today’s marketplace. This seminar will review the basics of FDA’s and USDA’s food labeling requirements, including recent updates. It will review …

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Food and Drug Administration building

FDA Guidance: Enforcement Discretion Under the Qualified Exemption Provisions of the Produce Safety Rule

The U.S. Food and Drug Administration (FDA) has published an announcement of the availability of a Guidance Document, Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (May 2020). Comments on the Guidance may be submitted to the …

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Cows relaxing in the meadow

COVID-19 Webinar: Federal Regulatory Changes Impacting the Food Industry – Recording Available

On April 22, OFW Principal John Dillard presented a webinar addressing the federal regulatory changes that have been implemented to respond to the COVID-19 pandemic. The webinar also discussed guidance from USDA, FDA, the Department of Homeland Security, and the Center for Disease Control as well as some of the best practices that have been …

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Factory worker cleaning hands

Sanitation Measures to Control COVID-19 in Manufacturing Facilities

Facility managers – not just food facility managers – are being “encouraged” to take strong preventative measures to help mitigate the risks of COVID-19 for individuals within their premises.  Managers are also reminded that the actions taken need to be documented.  It is recognized that certain of the recommended measures made by the Center for …

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FDA COVID-19 Food Safety Q&A

The FDA is currently posting updates in a Q&A format on its Food Safety and the Coronavirus Disease 2019 (COVID-19) webpage.  The Q&A provides information to food production/processing facilities and retail food establishments regarding best practices during the ongoing public health emergency.  For example, the website provides some salient advice on social distancing in food …

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fresh eggs in a cardboard tray

Complete Label Exemption for Shell Eggs During Pandemic

Today the FDA issued a guidance to provide temporary flexibility regarding the packaging and labeling of shell eggs sold to consumers in retail food establishments.  Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency: Guidance for Industry (Apr. 2020) The guidance essentially permits retailers …

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woman looking at menu at restaurant

Menu Labeling Flexibility for Covered Establishments During Pandemic

The Food and Drug Administration (FDA) has issued a guidance to chain restaurants and similar retail food establishments (“covered establishments”) that sell standard menu items covered under the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide flexibility regarding these menu labeling requirements during the COVID-19 …

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silver food packaging on a wooden background

New Guidance Documents from the FDA on Foods Labeling and Postponement of Compliance Date for Revised Nutrition/Supplement Facts Panels

On Friday, the Food and Drug Administration (FDA) announced the issuance of a new Guidance document pertaining to nutrition labeling during the COVID-19 health crisis. It is intended to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the current pandemic.  This guidance does not …

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Fresh produce sold at a market by farmer

Food and Agriculture in the Phase 3 Coronavirus Bill

By Julia Johnson Food and agriculture continues to be a priority for Congress and the Administration as the government tackles the coronavirus pandemic in the United States. After tense negotiations, the Senate passed a third stimulus bill late last night. Here is what is in it for food and agriculture. Before the second coronavirus stimulus …

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FDA and CFSAN on Issuing Guidance Documents Concerning COVID-19

The Food and Drug Administration (FDA) published a Notice that set forth the process that it and the Center for Food Safety and Applied Nutrition (CFSAN) will use in expediting the availability of guidance documents concerning the ongoing COVID-19 public health emergency. It will include essential recommendations and policies and will eliminate requisite notice and …

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Large assortment of honey and similar syrups

Added Sugars in Pure Honey and Maple Syrup, and Other Single-Ingredient Sugars and Syrups, and in Dried Cranberry and Cranberry Beverage Products

Today, FDA published notice of the availability of a final guidance for industry, entitled: The Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products (June 2019).  The final guidance provides industry with some rational relief from the added sugars nutrition labeling requirements that predated it.  That relief …

Added Sugars in Pure Honey and Maple Syrup, and Other Single-Ingredient Sugars and Syrups, and in Dried Cranberry and Cranberry Beverage Products Read More »

FDA holds public meeting in April 2015

FDA’s Final Rule on Intentional Adulteration of Food: Public Meeting and Guidance

FDA has announced a public meeting to discuss its recent Draft Guidance for industry on the agency’s intentional adulteration of food regulation, promulgated under FSMA, i.e., “Mitigation Strategies to Protect Against Intentional Adulteration” (Final Rule), codified at 21 C.F.R. Part 121.  The public meeting is taking place on April 17, 2019, from 8:30 AM to …

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Organic chocolate cake labeled with low carbs

“Low-Carb” Food Labeling

The keto (ketogenic) diet, paleo diet, and low-carb diets for diabetics are not well-served by FDA’s food labeling regulations presently.  A nutritional tenet of each of these diets is keeping carbohydrate consumption low.  A low-carb diet limits foods that are significant sources of carbohydrates, such as cereal grains (e.g., breads, pasta, rice, corn chips), foods …

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Food and Drug Administration logo

FDA Nutrition Innovation Strategy

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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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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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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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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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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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 »

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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Judge hitting gavel in court

Should Your Establishment Appeal a FSIS Decision?

By Brett Schwemer, as published in The National Provisioner To appeal or not to appeal; that is the question Establishments regulated by the Food Safety and Inspection Service (FSIS) frequently face the dilemma on whether to appeal agency decisions that could have a negative impact on their businesses. Even when there are valid grounds for an …

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