FDA

Assortment of dietary supplements

“Grandfathered” Dietary Ingredients – It’s About Time

The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 – almost a quarter century ago.  It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) in a number of significant ways that set the stage for present marketing of this important category of consumer goods.  However, aspects of DSHEA never were …

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FDA Adds New Chapter on Heat Treatment to its Preventive Controls Guidance under FSMA

Today, the Food and Drug Administration (FDA) announced the installment of Chapter Six to its “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Draft Guidance). The Draft Guidance explains FDA’s current thinking on how food facilities may comply with the FDA’s final rule on Hazard Analysis and Risk Based Preventive …

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Health care professional working on computer

OFW Law Launches New Health Industry Practice; Ladd Wiley Joins Firm as Principal and Chair of Practice

OFW Law is pleased to announce the creation of a new Health Industry Policy and Regulatory Practice.  The practice will be focused on government health program payment issues and FDA-related policy issues for clients in the health care delivery system and innovative life sciences areas. To provide leadership for this practice, OFW Law is also …

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Stethoscope and a heart

FDA implements 21st Century Cures Act Requirements for Reusable Devices

Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”).   Section 3059 of the Cures Act requires FDA to publish a list of reusable device types that must include validated instructions for use, in addition …

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Think This is Biotech Regulatory Relief? Not Yet.

By Dr. Nina Fedoroff, as published in Agri-Pulse USDA and FDA proposals to regulate genetically engineered (GE) plants and animals following the recent update of the regulatory framework are on their websites awaiting public comment by June 19, 2017.  The documents on which comments are requested are long, dense and, at times, internally inconsistent.  Here’s a detailed …

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FDA Announces Intent to Extend the Compliance Date for New Nutrition Facts Rules

This morning, FDA’s Office of Nutrition and Food Labeling announced that it intends to extend the compliance date for the new Nutrition Facts requirements.  FDA’s announcement, which is included on its “Changes to the Nutrition Facts Label” webpage, notes that, after feedback from industry and consumer groups:  FDA determined that additional time would provide manufacturers covered …

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FDA Implements 21st Century Cures Requirements for Devices

Today’s Federal Register announces a technical amendment to FDA’s regulation of medical devices to align the regulations with the the Food, Drug, and Cosmetic Act (FD&C Act).  The 21st Century Cures Act became law on December 13, 2016, and amended the FD&C Act by removing the requirement for local Institutional Review Board (IRB) review for …

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FDA Extends Menu Labeling Compliance Date One Year Consistent with Trump Administration Policy

FDA is again extending the compliance date for menu labeling – just days before the regulatory requirements of § 101.11 were to have become effective.  On May 4, 2017, the agency will publish an interim final rule that extends the compliance date from May 5, 2017, to May 7, 2018, and that opens a 60-day …

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Delay of FDA Menu Labeling Regulation Provides Blueprint for Modification of Nutrition Labeling Rules

The restaurant industry was bracing for FDA’s menu labeling regulation, requiring mandatory calorie disclosure on menus at chains that have 20 or more locations.  The final compliance date was coming up next week on May 5, 2017.  However, in a last minute change, FDA submitted an interim final rule to the White House Office of …

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I’m a FSVP Importer: How Do I Know When I Need To Comply?

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 …

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The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule

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

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

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

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

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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FDA’s Guidance on Added Sugars is as Thick as Molasses

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, …

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Adverse Event Information Now Available Online for CFSAN-Regulated Products

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

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 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

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

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 …

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Food Rules Potential Targets for Elimination or Revision

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 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

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 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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Food Regulation: A Changing of the Guard

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 …

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CFSAN Issues Updated Guidance on Food Facility Registration

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

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

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 …

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