It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we have a federal district court expanding how drug companies can promote drugs; on the other, we have FDA’s Office of Prescription Drug Promotion (“OPDP”) issuing its first genuine Warning Letters in almost 10 months. Here, […]
FDA Drug Promotion Enforcement Update Read More »
In Part 1 of this blog series, I went back to Genetics 101 to provide a brief crash course on whole genome sequencing (WGS). Now that we better understand the technology, it is easier to understand how it can be utilized in the world of food safety. To begin with, the Food and Drug Administration (FDA), Food
Whole Genome Sequencing Part 2: Regulatory and Public Health Uses Read More »
The debate over agriculture biotechnology (aka genetic engineering (GE), genetic modification (GM), and GM organisms (GMOs)) was front and center in July. First, the White House issued an Executive Memorandum (“the Memorandum”) entitled “Modernizing the Regulatory System for Biotechnology Products.” The Memorandum, issued by the White House Office of Science and Technology Policy and Council
The Agriculture Biotechnology Riddle Read More »
Your product is ready. The formulation is finalized, packaging is designed, and your launch date is set. Then a labeling question surfaces — one involving 21 C.F.R. § 101.9 and a nutrient amount that falls in a gray zone between a rounding threshold and a compliance tolerance. Get it wrong, and you face potential misbranding
Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels Read More »
Paper medical device reports (MDR) will soon be a thing of the past. On August 14, 2015, the electronic MDR final rule goes into effect, requiring manufacturers, importers and other firms responsible for reporting to submit MDRs to the FDA electronically through the agency’s Electronic Submission Gateway (ESG) rather than through paper forms, including discs or facsimiles. As detailed in FDA’s February 13, 2014, final rule on Electronic Medical
Are You Ready for Electronic MDR Reporting? Read More »
In an unexpected move, FDA this coming Monday, July 27th, will publish a supplemental proposed rule that would establish a Daily Reference Value (DRV) for added sugars. This DRV would be utilized in calculating the percent Daily Value (%DV) that would be required to accompany the quantitative amount when Added Sugars is declared in nutrition
SURPRISE: FDA Proposes a Daily Value for Added Sugars Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block: Today’s Quiz: What has more alcohol – a 12 oz can of beer? A 5 oz glass of wine? Or, a mixed drink with 1.5 oz of spirits? Answer – they all have the same amount of alcohol. 0.6 fl oz. With
John Block Reports: Let’s Keep A Strong Alcohol Section in the 2015 Dietary Guidelines Read More »
On July 2nd, the White House issued an executive memorandum on “Modernizing the Regulatory System for Biotechnology Products.” The modernization effort will apply to “biotechnology products” defined as “products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes.” It will not affect regulation
FDA announced today it will give restaurants and “similar retail food establishments” an additional year – until December 1, 2016 — to comply with its menu labeling rule. The final rule originally required compliance by December 1, 2015. The FDA notice announcing the extension states that the agency received four requests for an extension citing
FDA Extends Compliance Date on Menu Labeling Read More »
Two billion dollars – that is what FDA estimates the food industry will spend to comply with proposed changes to the iconic “Nutrition Facts” label. Part of that cost includes keeping records showing how much sugars companies add to processed foods and then disclosing that amount, per serving, on the food label. Will it be
Added Sugars Labeling Proposal Dropped by Health Canada Read More »
The Food Safety and Inspection Service (FSIS) has authority under the Federal Meat and Poultry Products Inspection Acts to ensure that products are not adulterated at retail and at all steps in the distribution chain. Retail operations are generally inspected by State or local authorities which have adopted some form of the model Food Code
Doom and Gloom: FSIS Provides Recommendations to Retailers on Listeria Control Read More »
Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and Commerce Committee by a vote of 51-0 on May 21. Known as the 21st Century Cures Act (“Act”),
Device Firms: What You Should Know About The 21st Century Cures Act Read More »
By John R. Block We can’t seem to silence or satisfy the loud scream of opposition to GE crops. The reason probably is that up until now we have ignored them. It’s time to stand up and set the record straight. GE food is safe and even beneficial according to 88% of scientists. We have conducted
John Block: GMOs Under Assault Read More »
Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance). The Federal Register notice accompanying the Draft Guidance can be found here. The agency also withdrew its previous Compliance Policy Guide (CPG) 608.400, Compounding of Drugs for Use in Animals. Though FDA has been actively implementing Title
FDA Releases Draft Guidance on Compounding Animal Drugs Read More »
By Robert A. Hahn The FDA’s food labeling regulations include some traps for the unwary. A few of those traps have to do with the net quantity of contents declaration. Here are a couple of points to keep in mind when declaring a food product’s net contents: When the net contents declaration is expressed in terms
Clearing Up Confusion: The Net Quantity of Contents Declaration on Food Labels Read More »
By John G. Dillard Millions across the globe tuned into this weekend’s Mayweather-Pacquiao bout, which was billed as “the fight of the century.” However, the pay-per-view event was not the only high stakes fight to report on from last week. Far away from the glitz and glamor of Las Vegas, a federal court in Vermont issued
Recapping Round 1 of the Vermont GMO-Labeling Lawsuit Read More »
By Barbara J. Masters, D.V.M. One of the goals of the Food Safety and Inspection Service’s Strategic Plan is to “ensure that facilities implement safeguards and systems to protect food from contamination by people who might try to intentionally and maliciously harm consumers.” The Agency has a FY 2015 target of 90% of all establishments having a
Food Defense Plans Read More »
By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States [(“OUS”)] (“Draft Guidance”) (available here). With this Draft Guidance, FDA aims to minimize the possibility for additional
FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data Read More »
This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to establish prior notice. It communicates the agency’s position on a matter, but it does
Warning Letters Update Read More »
FDA has published a proposed rule that would amend and update its regulatory requirements governing registration of food facilities. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which essentially directed FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S.
Food Facility Registration Rules To Be Updated by FDA Read More »
In earlier blogs, I have mentioned having horses and other animals while growing up on a small farm. Even now, to my husband’s dismay, I have never outgrown being “horse crazy.” But during all this time, I never remember being concerned about the animal feed I have purchased or used. I do qualify this statement
FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm” Read More »
On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan at [email protected].
Regulatory Round-Up Newsletter, Spring 2015 Read More »
The 2015 Dietary Guidelines Advisory Committee (DGAC) submitted its report to the Secretaries of Agriculture and Health and Human Services last month and disbanded. It is now up to the USDA and HHS to take the DGAC’s conclusions and recommendations and issue a revised edition of the Dietary Guidelines for Americans. Interested persons may submit
2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy Read More »
By Marshall L. Matz, as published in Agri-Pulse The March edition of the National Geographic Magazine, in its cover story entitled “The War on Science,” notes that “there’s no evidence that GMO’s are harmful to human health.” A recent Pew poll found that 90% of all scientists believe GMO’s are safe but only 37% of the public
The Vilsapp: Secretary Vilsack’s High Tech Solution to Labeling Read More »
On April 21, OFW Law’s Tish Eggleston Pahl will participate in a webinar being held by the Healthcare Distribution Management Association (HDMA) for dispensers on implementation of the Drug Supply Chain Security Act (DSCSA) Register Today! Learn what is expected of dispensers as it relates to the DSCSA through a HDMA webinar on Tuesday, April 21 from 2:00–3:00
Webinar: Drug Supply Chain Security Act Overview for Dispensers Read More »
We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app. The Federal Trade Commission (FTC) may also be watching how you promote your app. In fact, on February 23, 2015 the
Who Regulates the Advertising of Your App? Read More »
OFW Law is proud to announce the launch of its FDA DevicEd Training Initiative. The initiative is devoted to providing high quality FDA regulatory training to foreign and domestic medical device companies and the advisors who assist them. Interactive in-person seminars will be developed and presented by OFW Law attorneys specializing in FDA regulation of
OFW Law Launches FDA DevicEd Training Initiative Read More »
FDA will hold a “National Kick-Off Meeting on Implementation of the Food Safety Modernization Act (FSMA)” on April 23-24, 2015, in Washington, D.C. The agency has sent out a save-the-date notice to subscribers to its FSMA webpage, but the notice contains few details. FDA says that meeting specifics, including registration information, will be made available
FDA Announces National Kick-Off Meeting on FSMA Implementation Read More »
The passage of the Drug Supply Chain Security Act (DSCSA) in November 2013 led to a very busy 2014 as FDA and manufacturers, wholesale distributors, and dispensers began the statute’s complex 10-year implementation. 2015 promises to be equally busy. A Surge Of Activity At Year-End In 2014 2014 closed in a flurry of DSCSA action.
Drug Supply Chain Security Act – What’s Next? A whole lot. Read More »
There is good news for certain sectors of the medical device industry. FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applications (apps). In a pre-published Federal Register notice (available here, which should issue in the Federal Register on Monday), FDA
We are pleased to announce that Dr. Nina Fedoroff, a renowned plant molecular biologist, has joined OFW Law as Senior Science Advisor focusing on agriculture policy, global food security and government affairs. The former Science and Technology Adviser to the Secretary of State, Dr. Fedoroff has long been involved in regulatory issues surrounding genetic modification of organisms (GMOs)
Dr. Nina Fedoroff Joins OFW Law as Senior Science Advisor Read More »
Earlier this month, FDA’s Center for Devices and Radiological Health issued its FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance. CDRH lists 28 guidance documents in total. The “A-list” includes both draft and final guidances that CDRH intends to publish by January 2016, and the “B-list” includes guidance documents that it intends to
CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents Read More »
As the 114th Congress begins in earnest, there is rough sledding ahead this winter over the gulf between the governing philosophies of the President and the new Congress. Not to belabor the obvious, but early indications are that Republican victories have altered the President’s willingness to deal only very modestly, if at all. With just
114th Congress – What to Expect in Ag and Food Read More »
In what seemed like a bit of end-of-year housekeeping, FDA issued a series of minor guidance documents, notices, and other regulatory paraphernalia related to food. Coming in under the wire in 2014 were: A notice requesting nominations for non-voting industry representatives to the Food Advisory Committee. Nominations are due by January 7, 2015. FDA is
A Flurry of End-of-Year Activity from FDA on Food Read More »
As we say goodbye to 2014 and welcome 2015, it’s time for a little backward and forward looking. Here’s what we saw in the 2014 rear view mirror in our little corner of the Universe devoted to the regulatory aspects of foods, drugs, medical devices, agriculture, and the like. In January, the Food and Drug
