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FDA today published notification of the availability of an updated, draft guidance on food facility registration, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (Nov. 2016). Publication of this draft guidance coincides with the 2016 Food Facility Registration biennial renewal period, which began on October 1, 2016, and will end on […]

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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 »

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. 

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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

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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

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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

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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

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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,

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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

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FDA’s Strategic Plan for Foods and Veterinary Medicine

FDA /

The agency on July 14, 2016 published FDA Foods and Veterinary Medicine Program (FVM) – Strategic Plan — Fiscal Years 2016–2025.  This FVM Program outlines goals and objectives for the next 10 years: GOAL 1: Food Safety Hazards — Protect America’s Consumers and Animals from Foreseeable Hazards             1.1: Establish and gain high rates of

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Senate Ag Leaders Unveil Compromise GMO Labeling Bill

FDA, Public Policy, USDA /

Yesterday, Senate Agriculture Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI) released their long-awaited bill that would establish a federal GMO labeling regime and preempt any state laws, such as Vermont’s Act 120. This legislation, unlike earlier attempts, is expected to garner enough support to gain enough support to pass in the

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FDA Publishes Draft Guidance on Dissemination of Patient-Specific Data – But Doesn’t Say Much About HIPAA

FDA, Health Care /

Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share patient-specific information recorded, stored, processed, retrieved, and/or derived from a medical device with the patient who is either treated or diagnosed with

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FDA FSMA Final Rule – Mitigation Strategies to Protect Food Against Intentional Adulteration

FDA /

The Food and Drug Administration (FDA) has published in the Federal Register a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration, 81 Fed. Reg. 34,165 (May 27, 2016), 21 C.F.R. Part 121 (Final Rule).  The proposed rule was issued on December 24, 2013. The revisions in the Final Rule are largely designed

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“Voluntary” FDA Sodium Targets May Bind Food Companies

FDA /

FDA yesterday released so-called “voluntary” targets for sodium reduction for 150 categories of foods.  A spreadsheet issued by the agency details baseline sodium content for each of the categories and lists short-term and long-term targets.  In its draft guidance, the agency says it “recognizes the important role of sodium in food for microbial safety, stability,

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FSMA Final Food Safety Rule: Mitigation Strategies to Protect Food against Intentional Adulteration

FDA /

FDA has finalized a new food safety rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent wide-scale public health harm by requiring companies in the U.S. and abroad to take steps to prevent intentional adulteration of the food supply, including acts of terrorism targeting the food supply.  While such insidious

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FDA Nixes “Evaporated Cane Juice” as Ingredient Name

FDA /

Pursuant to consideration of public comments submitted on its October 2009 draft guidance document (see our prior article here), FDA today announced (81 Fed. Reg. 33,538) the availability of its finalized guidance document, Guidance for Industry: Ingredients Declared as Evaporated Cane Juice (May 2016). The guidance document essentially conveys FDA’s view that sweeteners derived from

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FDA Issues Final Regulations for Nutrition Facts Labeling and Serving Size Changes

FDA /

FDA has issued final regulations changing the requirements for the Nutrition Facts label required on almost all foods since 1994. A picture tells a thousand words, or in this case, more than 1000 pages of typewritten text detailing the new regulations that will appear in the Federal Register on May 27, 2016.  The following is

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FDA Finalizes Guidance Document about Medical Foods

FDA, Health Care /

FDA has updated and published its Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition (05/12/2016).  The guidance document is consistent with the agency’s good guidance practices regulation, 21 C.F.R. § 10.115. FDA published earlier versions of the guidance document in May 1997 and May 2007.  This guidance is a second edition of

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Final Menu Labeling Guidance Issues: Setting Effective Date for Menu Labeling Final Rule

FDA /

FDA has published a Level 1 guidance document, entitled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu  Labeling Requirements in Accordance with 21 CFR 101.11).”  81 Fed. Reg. 27,067 (May 5, 2016).  The guidance document is issued consistent with the agency’s good guidance practices regulation (21 C.F.R. § 10.115), and

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EU-US Regulatory Cooperation: Strides Made, but More Can Be Done

FDA, Uncategorized /

Earlier this week, the George Washington University Regulatory Studies Center released a significant report, “International Regulatory Cooperation:  Benefits, Limitations, and Best Practices.”  This report builds on earlier work done by the Center and examines opportunities to improve regulatory cooperation between the European Union and the United States.  The report is timely because negotiators from the

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Expect More Food Labeling Changes Even After FDA Finalizes its New “Nutrition Facts” Regulations

FDA, Public Policy /

FDA is scheduled to issue regulations finalizing its proposed Nutrition Facts label soon according to the US Regulatory Agenda. Many food companies and trade associations are eagerly awaiting the final rules to see how the agency will handle the most controversial provisions.  One part of the proposed rules would require the disclosure of added sugars,

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“Dietary Supplement” is a Proper Statement of Identity

FDA /

FDA has revised a guidance document to acknowledge that “Dietary Supplement” alone properly may be used as the statement of identity in labeling a dietary supplement.  Announcement of this revision was published in a Federal Register notice on March 7th. The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended section 403 of the

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Interstate Structure to Oversee and Regulate Medical Marijuana

EPA, FDA, Public Policy /

There is a need for an interstate structure to provide coordination and regulatory oversight of medical marijuana (cannabis) use in the 23 states that have approved its use by either referendum or legislation.  Five jurisdictions — Colorado, Washington, Oregon, Alaska and the District of Columbia — have now also authorized the recreational use of cannabis.

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It’s Not What You Call It – It’s How You Manage It

FDA, USDA /

By OFW Law and HACCP Consulting Group Under the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) made the decision that registered facilities would be required to implement food safety plans based on preventive controls rather than the principles of HACCP.  Since HACCP is already mandatory for identified hazards in seafood, juice and foods

It’s Not What You Call It – It’s How You Manage It Read More »

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