That is one of the most common – and difficult – questions to answer when OFW Law teaches a Food Safety Modernization Act Foreign Supplier Verification Programs (FSMA FSVP) course. Determining the compliance dates is typically more challenging for the affected importers. To make it easier, OFW Law has created flow diagrams and examples to […]
I’m a FSVP Importer: How Do I Know When I Need To Comply? Read More »
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)
The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule Read More »
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
OFW Law Supports Medical Device Innovators at the 2017 Rice Business Plan Competition Read More »
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
Prior Notice of “Grey Market” Food Imports Read More »
Egg cartons in the United States are not required by federal regulations to bear labels which identify the living conditions of the hens. Two animal rights non-profit organizations and six individuals sought to change that by filing petitions with four different federal agencies under the apparent strategy of not putting all their eggs in one
Egg Carton Labeling Petitions Fail to Hatch Read More »
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
CFSAN Soon Will Issue Certificates of Free Sale for Exports Online Read More »
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
Biotech Regulations Must be Based on Facts, Not Fears Read More »
The opening days of a new year are, to some, an apropos time to look back and reflect on the year that is now “one for the books.” Unable to resist the urge to do so ourselves, we have compiled our “Top-5” list for medical device regulation in 2016. Device Modification Guidance It has been
Medical Device “Top 5” for 2016 Read More »
FDA released a draft Guidance statement on how food companies should calculate the added sugar content in their products for the purposes of nutrition labeling. Comments are due on March 6. Guidance documents are supposed to help simplify FDA regulations (added sugars content is required to be disclosed on Nutrition Facts labels starting July 26,
FDA’s Guidance on Added Sugars is as Thick as Molasses Read More »
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
Adverse Event Information Now Available Online for CFSAN-Regulated Products Read More »
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”
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
Long-Awaited Guidance Documents on Revised Nutrition Labeling Released in Draft by FDA Read More »
Happy 2017, everyone! 2016 has come and gone. Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention. As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!), individuals in a position of responsibility can be prosecuted criminally for what are often
2016 – Gone But Not Forgotten Read More »
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
FDA Expands Authorized Health Claims for Raw Fruits and Vegetables Read More »
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 »
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
Food Rules Potential Targets for Elimination or Revision Read More »
FDA has set January 1, 2020, as the uniform compliance date for new or amended food labeling regulations that are issued between January 1, 2017, and December 31, 2018. Use of a uniform compliance date provides for an orderly and economical industry adjustment to new labeling requirements by allowing sufficient lead time to plan for
Uniform Compliance Date for Upcoming Food Labeling Regulations Read More »
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
What Is “Dietary Fiber”(for Purposes of Nutrition Labeling)? Read More »
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
Homeopathic Drugs Now Have To Have Proof As Well As Provings Read More »
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
FDA Issues Final Guidance on VQIP Read More »
Irrespective of whether you voted for or against Donald Trump, last night’s election results will lead to a significant changing of the guard in how food is regulated by FDA and USDA. In his Contract with America, soon-to-be-President Trump promised that for “every new regulation, two existing regulations must be eliminated.” The Obama Administration has
Food Regulation: A Changing of the Guard Read More »
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
CFSAN Issues Updated Guidance on Food Facility Registration Read More »
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
Aspartame Potentially Subject to California Prop 65 Listing – Update Read More »
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 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
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.
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 »
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
CDRH Proposes Submission Requirements of Labeling for Certain Home-Use Devices Read More »
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
FDA Revises Food Product Categories for Food Facility Registrations Read More »
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 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
Aspartame Potentially Subject to Prop 65 Listing Read More »
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 »
You thought FDA was the only agency implementing the Food Safety Modernization Act (FSMA), well think again. The Occupational Safety and Health Administration (OSHA) promulgated a final rule that defines whistleblower protections for employees that disclose information about alleged food safety issues in violation of the Federal Food Drug and Cosmetic Act (FDCA). FSMA
OSHA and FSMA (No, Not FDA This Time) Read More »
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 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 »
