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CFSAN Issues Updated Guidance on Food Facility Registration

FDA /

FDA today published notification of the availability of an updated, draft guidance on food facility registration, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (Nov. 2016). Publication of this draft guidance coincides with the 2016 Food Facility Registration biennial renewal period, which began on October 1, 2016, and will end on […]

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John Block Reports: Election Day 2016 & the Need for a Balanced Government

Public Policy /

On October 27, 2016, OFW Law founding principal Richard L. Frank filled in for former USDA Secretary John R. Block on his weekly radio broadcast: Tuesday, November 8, is Election Day.  A free and fair election is what separates the U.S. from many of our toughest competitors – for example, China, Russia, and Iran.  And – make

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Aspartame Potentially Subject to California Prop 65 Listing – Update

FDA, Health Care /

As previously reported, at an upcoming, November 15, 2016, public meeting of the Proposition 65 Carcinogen Identification Committee (CIC), aspartame will be discussed prior to the CIC sending advice to the Office of Environmental Health Hazard Assessment (OEHHA) relative to the prioritization of aspartame for possible preparation of hazard identification materials and prospective inclusion on

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FDA Considering Amendments to New “Reference Amount Customarily Consumed” Regulation, Used to Set Serving Sizes on Nutrition Facts Label

FDA /

The Food and Drug Administration (FDA) is showing a willingness to modify its recently finalized rule establishing Reference Amounts Customarily Consumed (RACCs) used to set serving sizes on the Nutrition Facts label.  The agency announced two requests for information (RFI) inviting comments on 1) the appropriate RACC and product category for flavored nut butter spreads

FDA Considering Amendments to New “Reference Amount Customarily Consumed” Regulation, Used to Set Serving Sizes on Nutrition Facts Label Read More »

Hakim’s Effort to Skewer Biotech Crops in Sunday’s NY Times

Public Policy /

Danny Hakim’s attempt to skewer biotech crops in his recent article on the front page Sunday’s New York Times (Doubts About the Promised Bounty of Genetically Modified Crops, Oct. 29, 2016) is skewed from beginning to end.  His insight – what he says the debate has missed – is that genetic modification has not accelerated

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Oh, SNAP! Connecticut Judge Affirms Permanent Disqualification of New Haven Grocery

USDA /

The U.S. Food and Nutrition Service (“FNS”) administers the Supplemental Nutrition Assistance Program (“SNAP”).  Formerly known as “food stamps,” this important federal nutrition benefit program serves over 45 million Americans by increasing “food purchasing power for all eligible households who apply for participation.” 7 U.S.C. §2011.   FNS licenses eligible supermarkets and convenience stores to participate

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Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals

FDA /

FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act.   See generally Food for Animals Small Entity Compliance Guide Availability; Human Food Small Entity Compliance Guide Availability.  The final rules

Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals Read More »

Draft FSMA Guidance for Industry: Describing a Hazard that Needs Control because Permissibly Not Controlled Upstream

FDA /

FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include a disclosure statement, in documents accompanying a food, that certain hazards requiring a control have not been controlled by that entity. 

Draft FSMA Guidance for Industry: Describing a Hazard that Needs Control because Permissibly Not Controlled Upstream Read More »

Splitting Headaches for Slack-Fill Plaintiffs

Miscellaneous /

“Take two Advil® and don’t call me in the morning.” That might be the “prescription” that lawyers at a New York plaintiffs’ firm gave to their clients after reviewing an October 18, 2016, decision by Senior District Court Judge Sterling Johnson, Jr. dismissing a nationwide slack-fill class action lawsuit brought in federal court in Brooklyn.   Slack-fill

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Hillary on Agriculture

Public Policy /

By Marshall Matz, as published in Agri-Pulse While agriculture, like many other issues, has been overshadowed in the presidential campaign this year, if you look closely there is evidence on how Secretary Clinton would approach agriculture policy and rural America: Senator Clinton had a strong record in support of agriculture while serving in the Senate and consistently

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D.C. Circuit Orders OSHA to Follow Notice and Comment Requirements When Imposing New Standards on Agricultural Retailers

OFW Law News, Public Policy /

A fundamental principle of administrative law is that federal agencies must provide the public with reasonable notice and the opportunity to comment on proposed administrative issuances that impose substantive obligations that did not previously exist.  Not every agency issuance, including guidance and policy interpretations, rise to that level.  Whether agency action requires notice and comment

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OFW Founder Rick Frank Named Best Lawyers® Washington DC Health Care Lawyer of the Year

FDA, Health Care, OFW Law News /

Five OFW Law Attorneys Named to 2017 Best Lawyers in America for FDA Law One of OFW Law’s Founding Principals, Richard L. Frank, was recognized as the Health Care Lawyer of the Year in the 2017 Washington, D.C., edition of The Best Lawyers in America. Only a single attorney in each practice area and designated metropolitan

OFW Founder Rick Frank Named Best Lawyers® Washington DC Health Care Lawyer of the Year Read More »

CDRH Proposes Submission Requirements of Labeling for Certain Home-Use Devices

FDA /

Today, FDA’s Center for Devices and Radiological Health published a proposed rule that would require manufacturers to electronically submit the device label and package insert for Class II and Class III devices labeled for “home-use.” The proposed rule is intended to implement the listing requirement for the submission of labels and package inserts for home-use

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FDA Revises Food Product Categories for Food Facility Registrations

FDA /

FDA has issued a revised guidance that explains the necessity of having food product categories in food facility registrations submitted to FDA under section 415 of the FD&C Act (21 U.S.C. 350d), and that updates the food product categories to be used in food facility registrations. See generally Necessity of the Use of Food Product

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“Healthy” Regulatory Definition To Be Revised?

FDA /

FDA has defined the term, “healthy” (and related terms, including “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”), when used as an implied nutrient content claim in labeling human food products, at 21 C.F.R. § 101.65(d)(2). Today, FDA published a Federal Register notice announcing that the agency has established a docket to receive information

“Healthy” Regulatory Definition To Be Revised? Read More »

The Bridger-Teton National Forest

Public Policy, USDA /

By Marshall Matz, as published in Agri-Pulse For almost thirty years, August has meant returning to Jackson, Wyoming, the Grand Teton National Park, the Bridger-Teton National Forest and the Yellowstone ecosystem. It is fishing, hiking, photography, reading under the aspens, the Grand Teton Music Festival….and more fishing. Most importantly, it is quality family time. The Bridger-Teton National

The Bridger-Teton National Forest Read More »

Dr. Betsy Booren Joins OFW Law as Senior Policy Advisor

OFW Law News /

We are pleased to announce that Dr. Betsy L. Booren, who specializes in food safety policy development and analysis, has joined OFW Law as Senior Policy Advisor.  Most recently, Dr. Booren served as Vice President of Scientific Affairs for the North American Meat Institute, where she represented and provided informed analysis for the majority of

Dr. Betsy Booren Joins OFW Law as Senior Policy Advisor Read More »

Aspartame Potentially Subject to Prop 65 Listing

FDA /

The Carcinogen Identification Committee (CIC) – California’s qualified experts on carcinogenicity for purposes of Proposition 65 (Prop 65)) – pursuant to a meeting scheduled for November 15, 2016, will be providing the state’s Office of Environmental Health Hazard Assessment (OEHHA) with advice on the prioritization of aspartame for possible preparation of hazard identification materials.  While

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FDA Extends Comment Periods on “Voluntary” Sodium Reduction Goals for Foods

FDA /

FDA has published Federal Register notice of an extension of the comment periods for issues pertaining to its draft guidance, entitled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.”  The agency is taking this action in response to requests to extend the two comment

FDA Extends Comment Periods on “Voluntary” Sodium Reduction Goals for Foods Read More »

FDA Issues Initial Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

FDA /

FDA issued today a new draft guidance to help industry comply with certain requirements in the final rule on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.  The new draft guidance was issued only in part because the agency is still working on additional chapters.  See generally Hazard Analysis

FDA Issues Initial Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food Read More »

FDA Extends Certain FSMA Compliance Dates

FDA /

FDA has published seven foundational rules to implement FSMA, and compliance dates are quickly approaching: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Earliest compliance date: September 19, 2016 Current Good Manufacturing Practice [CGMP], Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Earliest compliance date: September 18,

FDA Extends Certain FSMA Compliance Dates Read More »

Ken Ackerman’s Newest Book, TROTSKY IN NEW YORK, 1917, Set for Release in September 2016

OFW Law News /

This week, Counterpoint Press announced the release of the newest book by OFW Law’s own Ken Ackerman called TROTSKY IN NEW YORK, 1917: A Radical on the Eve of Revolution.   Far afield from agriculture and crop insurance — Ken’s usual specialties at OFW Law — this is Ken’s latest entry in a prolific writing career

Ken Ackerman’s Newest Book, TROTSKY IN NEW YORK, 1917, Set for Release in September 2016 Read More »

FDA Finalizes GRAS Rule

FDA /

FDA has published a final rule (81 Fed. Reg. 54,959 (Aug. 17, 2016)), based on its 1997 proposed rule (62 Fed. Reg. 18,937 (Apr. 17, 1997); see also 75 Fed. Reg. 81,536 (Dec. 28, 2010) (reopening comment period)), which: Clarifies the criteria for when the use of a substance in a food for humans or

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CFSAN Changes Address

FDA /

Today, the Food and Drug Administration (FDA) published in the Federal Register a final rule that amends relevant FDA regulations in Title 21 of the C.F.R. to change the address of the Center for Food Safety and Applied Nutrition (CFSAN).   81 Fed. Reg. 49894 (Jul. 29, 2016).  CFSAN did not actually move its physical location

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FDA Amends Food Additive Regulations to Expand Permitted Uses of Vitamin D in Food

FDA /

Contributor: Rachel Rosenberg As of July 16, 2016, FDA’s amendment to expand the safe uses of vitamin D2 and D3 as nutrient supplements in food for human consumption became effective. This amendment stems from a food additive petition (FAP 3A4801) filed by Dean Foods Company and WhiteWave Foods Company. Vitamin D2 may now be used

FDA Amends Food Additive Regulations to Expand Permitted Uses of Vitamin D in Food Read More »

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