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The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule

FDA /

FSMA – The D.C. acronym for the Food Safety Modernization Act.  When I am working with clients or speaking with industry, everyone is familiar with FSMA.  But they think of FSMA as the Preventive Controls or Produce Safety Rules.  Some are also aware of the Sanitary Transportation Rule, but the Foreign Supplier Verification Programs (FSVP) […]

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Drone delivering first aid kit

OFW Law Supports Medical Device Innovators at the 2017 Rice Business Plan Competition

FDA, For Export, OFW Law News /

On April 8, 2017, Forest Devices, Inc. from Carnegie Mellon University was awarded OFW Law’s Regulatory Strategy Prize at the 2017 Rice Business Plan Competition in Houston, Texas.  Forest Devices bested 41 other competitors hailing from some of the world’s top universities in the overall competition, as well, earning about $700,000 in prize money. Forest

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Prior Notice of “Grey Market” Food Imports

FDA /

Yesterday, FDA published a final rule making some technical amendments to its prior notice of imported food regulations.  The prior notice regulations implement section 801(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(m)), which requires that FDA receive prior notice of food imported into the United States.  Coordinating the Automated Broker Interface/Automated

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CFSAN Soon Will Issue Certificates of Free Sale for Exports Online

FDA /

U.S. purveyors of foods, food additives, dietary supplements, and cosmetics for export are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA.  Review of a certificate may be required by foreign countries as part of the process to import a product into those countries. A Certificate of

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Biotech scientist testing chemicals

Biotech Regulations Must be Based on Facts, Not Fears

EPA, FDA, For Export, Public Policy, USDA /

By Dr. Nina Fedoroff, as published in Agri-Pulse The Coordinated Framework (CF) for the Regulation of Biotechnology was first implemented 30 years ago. The CF was developed by the White House Office of Science and Technology Policy (OSTP). OSTP brought together representatives of the three federal agencies seeking to regulate commercial applications of biotechnology to

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Adverse Event Information Now Available Online for CFSAN-Regulated Products

FDA /

FDA has begun posting online (and intends to update quarterly) information derived from adverse event reports the agency has received about conventional foods (including food/color additives), dietary supplements, and cosmetics.  This information is now made available in the CFSAN Adverse Event Reporting System (CAERS) database.  This is information that was once only available through Freedom

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Up in Flames: Ninth Circuit Upholds Certification in “100% Natural” Wesson Oil Class Action

FDA, Litigation /

In a January 3, 2017, decision likely to have broad implications in food class action litigation, the Ninth Circuit Court of Appeals affirmed a California federal district court judge’s decision certifying a consumer class action brought by purchasers of Wesson-brand cooking oil. In Briseño v. ConAgra, residents of eleven states, alleged that the “100% Natural”

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Long-Awaited Guidance Documents on Revised Nutrition Labeling Released in Draft by FDA

FDA /

FDA has published two Federal Register notices (see here and here) announcing the availability of draft guidance documents that are intended to help address issues raised by the agency’s final rules (see here and here) amending Nutrition Facts and Supplement Facts labeling requirements.  The draft guidance documents are: Draft Guidance for Industry: Questions and Answers

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FDA Expands Authorized Health Claims for Raw Fruits and Vegetables

FDA /

The U.S. Food and Drug Administration (FDA) has promulgated an interim final rule, effective December 19, 2016, amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol, and risk of coronary heart disease (CHD) to permit a broader array of raw fruits and vegetables (further described below) to be

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FDA Finalizes FSMA Third-Party Certification User Fee Program

FDA /

Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and Cosmetic Act (added by Food Safety Modernization Act (FSMA)). In November 2015, the FDA promulgated the final rule on “Accreditation of Third-Party Certification Bodies to Conduct Food Safety

FDA Finalizes FSMA Third-Party Certification User Fee Program Read More »

Food Rules Potential Targets for Elimination or Revision

EPA, FDA, Health Care, Public Policy, USDA /

Ever since the election we have been asked which Obama Administration regulations and executive actions are likely to be stricken by the new Trump Administration or the 115th Congress.  Will the focus be on the rules issued since mid May of this year, as provided for by the Congressional Review Act of 1996, or is

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What Is “Dietary Fiber”(for Purposes of Nutrition Labeling)?

FDA /

FDA has issued two notices for publication in the Federal Register: A Request for Scientific Data, Information, and Comments (comments due within 45-days of publication); and A notice of availability about a draft guidance (comments due within 60-days of publication), Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of

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Homeopathic Drugs Now Have To Have Proof As Well As Provings

FDA /

On November 15, 2016, the Federal Trade Commission (FTC) released a new Policy Statement on marketing claims for over the counter (OTC) homeopathic drugs. The Policy Statement is here and the press release and accompanying report are available here and here. The Policy Statement signals the end of the FTC’s decades-long approach of rarely challenging

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FDA Issues Final Guidance on VQIP

FDA /

FDA today announced the availability of its finalized “FDA’s Voluntary Qualified Importer Program: Guidance for Industry.”  It also published a Fact Sheet on the Final Guidance, as well as Instructions for Submission of Voluntary Qualified Importer Program (VQIP) Application. The FDA Food Safety Modernization Act (FSMA), signed into law in January 2011, provided FDA with

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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

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,

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