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Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?

FDA /

On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”).  FDAAA both enhances and curtails FDA’s authority in many respects.  Specifically, FDAAA removes a requirement that  manufacturers of Class I devices and Class II devices that are not permanently implantable, life supporting, […]

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Not Dead Yet – The Paper PI Lives On

FDA /

In the 1984 film Ghostbusters, Dr. Egon Spengler declared to Janine Melnitz, “Print is dead.”  A quick search of print is dead (electronic search, of course) reveals dozens of books and articles declaring that if traditional print communications are not actually deceased, they are decidedly on life-support. In pharmaceutical and healthcare regulation, electronic communications are

Not Dead Yet – The Paper PI Lives On Read More »

Will FSMA Court-ordered Deadlines Set a Precedent?

FDA /

The Obama Administration recently announced that it will delay the employer health insurance mandate under the Affordable Care Act (aka “Obamacare”) until 2015.  When questioned about the delay, White House Press Secretary Jay Carney said “people who suggest that there’s anything unusual about the delaying of the deadline, implementation of a complex, comprehensive law, are

Will FSMA Court-ordered Deadlines Set a Precedent? Read More »

Dealing With FDA Warning Letters

FDA /

By Casper E. Uldriks The FDA issues Warning Letters to provide firms notice that unless they achieve voluntary correction of the violations noted in the letter, the agency is prepared to initiate an enforcement action without further notice.  Enforcement actions may include, for example, the seizure of goods, injunction and/or prosecution.  Other administrative actions may be

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USDA is Right on Carrageenan

FDA, USDA /

Kudos to Secretary Vilsack and USDA for basing their regulatory decisions on sound science.  Another recent example is the Proposed Rule published on May 3rd that would re-list carrageenan as appropriate for use in organic food products.  The USDA decision is consistent with a recent decision by FDA affirming the safety of carrageenan for all food products.   Moreover,

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Increased FDA Testing of Pet Foods May Provide More Support for the FSMA Proposed Rule on “Preventive Controls for Animal Food”

FDA /

When I was growing up on a farm in Pennsylvania, my twin sister and I always savored the sweet feed that we fed to our horses.  We would also occasionally “chew on the oats,” but Sis and I never found our way to eating the dog or cat food.  This was not the case, however,

Increased FDA Testing of Pet Foods May Provide More Support for the FSMA Proposed Rule on “Preventive Controls for Animal Food” Read More »

FDA Extends Comment Period for FSMA Proposed Rules on Preventive Controls and Produce Safety

FDA /

FDA has announced that it will extend for an additional 120 days the comment periods for two major proposed rules implementing the Food Safety Modernization Act (FSMA): preventive controls for human food (Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food) and produce safety standards (Standards for the Growing, Harvesting,

FDA Extends Comment Period for FSMA Proposed Rules on Preventive Controls and Produce Safety Read More »

Court Orders FDA to Set a Timeline for Issuing Regulations Implementing FSMA

FDA /

Yesterday, the U.S. District Court for the Northern District of California issued an order requiring FDA to propose new deadlines for issuance of regulations implementing the Food Safety Modernization Act (FSMA).  Center for Food Safety v. Hamburg, 4:12-cv-04529 (N.D. Cal. Apr. 22, 2013). In a lawsuit brought by two consumer groups, the court held that

Court Orders FDA to Set a Timeline for Issuing Regulations Implementing FSMA Read More »

DMAA Dietary Ingredient Withdrawn from Market

FDA /

FDA’s publication last week, on April 11th, of a warning to consumers about dietary supplements containing dimethylamylamine (DMAA) (a/k/a 1,3-dimethylamylamine, methylhexanamine or geranium extract) followed up on Warning Letters issued on April 24, 2012, by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) to 10 company purveyors (i.e., Exclusive Supplements, Inc., Fahrenheit Nutrition, Gaspari

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FTC Offers Updates Guidance on Social Media; Still Waiting on FDA

FDA, Health Care /

 At the end of 2012, 850 million users worldwide were on Facebook, more than one million websites have integrated with Facebook and 34 percent of U.S. marketers have generated leads using Twitter.  You can see more social media statistics at the Huffington Post here.  Guidance on legal compliance moves far more slowly than the innovation

FTC Offers Updates Guidance on Social Media; Still Waiting on FDA Read More »

Congress Clears Final Agriculture/FDA Spending Measure for FY 2013

FDA, Public Policy, USDA /

The House of Representatives and Senate have now given final approval to the FY 2013 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill (the Bill) as part of a combined multi-Department omnibus measure, clearing it for the President’s expected signature.  The current Continuing Resolution expires on March 27, 2013.   The Bill

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FDA Cancels Registrations of Food Facilities That Were Not Renewed in Time

1 Comment / FDA /

Some foreign food makers have recently found themselves unceremoniously purged from FDA’s database of registered facilities, and their products stopped at the port. Under the Food Safety Modernization Act (FSMA), all food facilities required to register with FDA must renew their registrations every two years, during the fourth quarter of every even-numbered year.  The first

FDA Cancels Registrations of Food Facilities That Were Not Renewed in Time Read More »

FY 2012 Clinical Investigation Objectionable Activities/Enforcement Trends

FDA /

Forewarned is forearmed. For FDA-regulated clinical investigations, knowledge of the most common violations cited by the agency upon inspection is a useful tool for examining one’s own procedures and practices. It helps ensure they are not vulnerable to the same deficiencies before FDA arrives at your investigational site. Pursuant to its Bioresearch Monitoring (“BIMO”) Program,

FY 2012 Clinical Investigation Objectionable Activities/Enforcement Trends Read More »

Will the Pomegranate be the Bane or Savior of Food Advertisers?

FDA /

By Bruce Silverglade, as published in Food Chemical News on January 25, 2013 POM Wonderful, LLC is treading where no food or beverage company has treaded before, at least not in recent memory. Bets are on that the company will soon be asking a U.S. Court of Appeals (likely the D.C. Circuit) to stay, and eventually overturn, a Federal

Will the Pomegranate be the Bane or Savior of Food Advertisers? Read More »

FSMA Analysis, Webinar

FDA, OFW Law News /

OFW Law has prepared comprehensive memoranda on two major FDA proposed rules, which FDA has characterized as the cornerstones of the new food safety system created by the Food Safety Modernization Act: Proposed Rule under FSMA for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human

FSMA Analysis, Webinar Read More »

FSMA Webinar

1 Comment / FDA, OFW Law News /

January 24, 2013 – 12pm ET Hazard Analysis & Preventive Controls for Human Food OFW Law and The Food Institute, the best “single source” for information about the food industry, will present a 90-minute webinar on Thursday, January 24, 2013, to explore the proposed rule, issued on January 4 by the Food & Drug Administration (FDA). This FDA proposed rule

FSMA Webinar Read More »

Is Standardized Device Labeling On The Way?

FDA /

Changes could be coming for medical device labeling regulations.  On January 7, 2013, the Food and Drug Administration (“FDA”) announced in the Federal Register a public workshop and solicitation of comments concerning “Accessible Standardized Medical Device Labeling.” The Federal Register notice can be viewed here and the public workshop will be held on April 29 and

Is Standardized Device Labeling On The Way? Read More »

FSMA LIVES…..

FDA /

On January 4, 2013, the second anniversary of the enactment of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) released two important proposed rules to implement the new law.  After such a long detour at the White House Office of Management and Budget, the release caught many of us by

FSMA LIVES….. Read More »

Are These Substances “Natural?” Class Action Lawsuits Target Specific Ingredients

FDA /

Consumer class action cases challenging “All Natural” or “100% Natural” claims on food labels are popping up about as fast as dandelions in springtime.  Such cases are typically brought under state consumer protection laws prohibiting, inter alia, false or misleading food labeling and advertising.  Some of these laws, such as those in California and New

Are These Substances “Natural?” Class Action Lawsuits Target Specific Ingredients Read More »

Everyone has an Opinion on Unique Device Identification

1 Comment / FDA /

When the comment period closed on November 7, the Food and Drug Administration’s (FDA) proposed rule on Unique Device Identification (“UDI”) generated a total of 221 comments by various stakeholders.  Although the FDA has come a long way since it first sought comments on the use of an identifier system in 2006, a review of the comments

Everyone has an Opinion on Unique Device Identification Read More »

Compounding, Again

FDA /

The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday.  As you can imagine, food preparation at a food and drug law firm is a very serious business.  We regularly swap favorite turkey brining and stuffing recipes and

Compounding, Again Read More »

Food Labeling Politics – What the Election Results May Mean for Your Company

FDA /

The election is over and the current Administration will stay in the White House. Food labeling may not have been among the top issues on the minds of American voters.  But the election results will have an impact on food manufacturers, retailers, and restaurant operators who are concerned about the prospect of new FDA regulations,

Food Labeling Politics – What the Election Results May Mean for Your Company Read More »

Can FDA Regulate Compounding? FDA Doesn’t Think So. . . But It Kind of Tried To

FDA /

As the impact of the deadly meningitis outbreak grows, questions about FDA’s authority to regulate pharmacy compounding have arisen. New England Compounding Center Inc.’s (NECC) tainted, injectable steroid, methylprednisolone acetate, is now linked to 461 infections, including 32 deaths.  In testimony this week before the House Energy and Commerce Subcommittee on Oversight and Investigations, FDA

Can FDA Regulate Compounding? FDA Doesn’t Think So. . . But It Kind of Tried To Read More »

BPA: The Press Rounds Up the Usual Suspects and Gets it Wrong

FDA /

By Mark L. Itzkoff Over the past few months, articles have been published claiming possible links between bisphenol A (BPA) and a variety of human health problems including obesity, thyroid changes, and male infertility.  Many of the recent stories leave consumers misinformed about possible exposure to BPA and implicate products that do not contain BPA. For example, NBC News

BPA: The Press Rounds Up the Usual Suspects and Gets it Wrong Read More »

The Waiting Game

FDA, Public Policy /

It’s been a weird week.  The “Frankenstorm” also known as Sandy blew through Washington, closing everything from the stalwart federal government to the Metro system.  OFW Law weathered the storm pretty well, though the view outside my window of the muddy, debris-filled Potomac is an ever-present reminder that our problems pale in comparison to those

The Waiting Game Read More »

Safety v. Innovation – How the European Commission’s Proposed Regulation Hopes to Strike the Right Balance

FDA /

By Kathryn E. Balmford Back in January, Jeff Shuren, M.D., the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA), made headlines when comparing the European Union’s (EU) regulation of medical devices to FDA’s.  When asked by a reporter whether proposed changes to FDA’s 510(k) premarket clearance system

Safety v. Innovation – How the European Commission’s Proposed Regulation Hopes to Strike the Right Balance Read More »

Class Action Consumer Litigation: A Rising Enforcement Risk for Aggressive Food Labeling Claims

FDA /

The number of class action lawsuits targeting food labeling claims has risen dramatically over the past few years.  These are cases alleging that a food product’s labeling (and/or advertising) violates state consumer protection laws.  As a result, when a food company now considers whether to include an aggressive claim in commercial marketing, it should consider

Class Action Consumer Litigation: A Rising Enforcement Risk for Aggressive Food Labeling Claims Read More »

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