“[Final guidance] should be out by the end of the fiscal year” said Christy Foreman, Director of the Office of Device Evaluation, in her testimony before the House Oversight and Investigations Subcommittee on March 21, 2012. Ms. Foreman’s testimony can be viewed at the committee website, here. In July 21, 2011, FDA released draft guidance
Mobile Medical Application Guidance From FDA is Coming Read More »
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 »
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
Congress Clears Final Agriculture/FDA Spending Measure for FY 2013 Read More »
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 »
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 »
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 »
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 »
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
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 »
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
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 »
Now that that the Christmas stockings, Hanukkah menorahs and Kwanzaa harvest symbols have been put away until year end, and resolutions for 2013 have been written (and hopefully not broken yet!), it’s time for a little reflection. What follows is my month-by-month list of noteworthy events of 2012 in the food, drug, medical device and
2012 in the Rear View Mirror Read More »
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 »
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 »
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 »
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 »
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 »
Among the casualties on election day this year was California Prop 37, defeated by a vote of 53% to 47%. Proposition 37, the California Right to Know Genetically Engineered Food Act, was a ballot initiative that would have required special labeling of foods that have been genetically engineered or contain genetically engineered ingredients. According to
California Prop 37 Fails to Pass Read More »
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
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
There are some spectacles we geeks in the food and drug bar follow as avidly as any mini-series. The epic, two-year battle between POM Wonderful (producer of pomegranate products) and the Federal Trade Commission (FTC) is almost as addictive as HBO’s “Game of Thrones” – only without all the beheadings. Though POM Wonderful extols the health
POM Wonderful vs. FTC: The Epic War Continues Read More »
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
By Casper E. Uldriks The verification of design specifications and functional validation of software is predicated on its intended use with a particular device or as a “stand alone” device. The U.S. Food and Drug Administration (FDA) and the industry have understood and used software validation principles ever since the enactment of the Medical Device
The FDA Regulatory Challenges of Software Interoperability and Part 806 Read More »
Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. They often use a thought process that is unacceptable to FDA. In other cases, they do not
