AG/FDA Blog

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 la… Read More
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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 chal… Read More
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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… Read More
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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 t… Read More
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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 req… Read More
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Egg Carton Labeling Petitions Fail to Hatch

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… Read More
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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 r… Read More
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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 broug… Read More
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Medical Device “Top 5” for 2016

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 i… Read More
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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 regul… Read More
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