FDA

EPA and DHA Qualified Health Claims: A Compliance Guide for Food and Supplement Labels

FDA / J. Mason Weeda

A qualified health claim is one of the few tools FDA gives food and supplement companies to link an ingredient to a reduced disease risk on a label. For EPA and DHA omega-3s, FDA authorizes two sets of qualified health claim language covering coronary heart disease and hypertension – but the enforcement discretion letters that […]

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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

FDA, For Export / Michael J. O'Flaherty

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

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FDA Proposes New Fluoride Limits for Bottled Water

FDA / Joi Jackson

On April 3, 2019, the Food and Drug Administration (FDA) released a proposed rule that lowers the maximum amount of fluoride allowed in some bottled water products. If finalized, the rule would place an upper limit of 0.7 milligrams per liter of fluoride in bottled water to which fluoride is added. The proposed limits would

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FDA Begins to Move on CBD Policy and Enforcement

FDA / Joi Jackson

Earlier this week, the FDA made significant movement on issues and policy involving cannabis and its components, including cannabidiol (CBD). The agency issued a notice in the Federal Register announcing a hearing and requesting comments on “scientific data and information about products containing cannabis or cannabis-derived compounds.” 84 Fed. Reg. 12,969. FDA and the Federal

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FDA holds public meeting in April 2015

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

FDA, For Export, Uncategorized / Michael J. O'Flaherty

FDA has announced a public meeting to discuss its recent Draft Guidance for industry on the agency’s intentional adulteration of food regulation, promulgated under FSMA, i.e., “Mitigation Strategies to Protect Against Intentional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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FDA Extends Compliance Date for The Produce Rule’s Agricultural Water Requirement

FDA, Uncategorized / Joi Jackson

As initially announced last week by outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., the compliance dates for FDA’s agricultural water quality requirements under the “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption” rule (Produce Rule) are being extended. Today, FDA published a final rule in the Federal

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Organic chocolate cake labeled with low carbs

Low-Carb Food Labeling: What FDA Rules Mean for Food Manufacturers

FDA, For Export / Michael J. O'Flaherty

“Low-carb food labeling” sits in a regulatory gray zone that creates real legal risk for food manufacturers. Keto, paleo, and low-carbohydrate product categories generate billions in annual consumer sales — yet FDA has never established a regulatory definition for what “low-carb” means on a food label. That gap is not an oversight. It is the

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Part 110 Lives Another Day

FDA / Joi Jackson

Yesterday FDA withdrew its directive to remove and reserve the Current Good Manufacturing Practice (cGMP) for Human Food regulations found in 21 C.F.R. Part 110. This is not groundbreaking as the cGMP requirements in Part 110 were codified into Part 117, Current Good Manufacturing Practices, Hazard Analysis, and Risk Based Preventive Controls for Human Food.

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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 / J. Mason Weeda

FDA does not set a single caffeine cap for dietary supplements. The rules sit across multiple statutes and regulations – the Dietary Supplement Health and Education Act (DSHEA), 21 CFR Part 182, the FD&C Act’s adulteration provisions, and FDA’s guidance on highly concentrated caffeine products. For supplement manufacturers, the real compliance risk is not “how

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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 / 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 / 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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