Since January 1, it seems that the Center for Devices and Radiological Health (CDRH) has been out of the agency’s spotlight, and even FDA’s “News & Events” webpage has been lacking in its reporting of medical device related activity. This is not to say that there have been no recent developments in the last eighteen
What’s New at CDRH? Read More »
Today, FDA announced that it has decided to reopen, for 60 days, the comment period for certain parts of its controversial final guidance, “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND,” which was announced in the September 10, 2013 Federal Register. We blogged about the many
Two long-awaited, proposed rules to revise the regulatory requirements for nutrition labeling of conventional foods and of dietary supplements have been sent by FDA to the Office of Information and Regulatory Affairs within OMB for final review before publication. The first proposed rule, “Food Labeling; Revision of the Nutrition and Supplement Facts Labels,” would amend
Nutrition Labeling Reform Is on the Horizon Read More »
FDA once again has “respectfully declined” to define the term “natural” when used in food labeling. In a January 6, 2014, letter from Leslie Kux, Assistant Commissioner for Policy, to three federal judges handling civil litigation brought against manufacturers over “natural”-type claims made for foods containing bioengineered ingredients, FDA denied their requests essentially to define “natural”
“Let food be thy medicine and medicine be thy food.” So Hippocrates, the father of medicine, stated. Unfortunately, the Food and Drug Administration (FDA) has taken Hippocrates too literally, with immediate and severe consequences to food and nutrition research in the United States. In September, FDA issued a final Guidance for Clinical Investigators, Sponsors, and
The FDA’s Final IND Guidance – A Bitter Pill for Food and Nutrition Research Read More »
As required by the Food Safety Modernization Act, FDA has published a proposed rule that would require registered food facilities to implement food defense plans to reduce the risk of intentional adulteration. The proposed rule represents FDA’s first attempt to establish regulatory requirements to address intentional adulteration of food. As the preamble states: “We acknowledge
FDA Takes on Intentional Adulteration Read More »
As MMXIV starts, it’s time for a retrospective look at MMXIII. What follows is a list of noteworthy events from MMXIII in our food, drug, medical device, and agriculture corner of the universe, focusing on matters that were of particular interest to OFW Law’s attorneys and Senior Policy Advisors and our clients. We start, of
OFW Law’s MMXIII in Retrospect Read More »
While often rightly the subject of criticism for delay or inaction on important regulatory matters, FDA in late 2013 has been bustling. The FDA, during the second Obama term, has been pursuing a very aggressive regulatory agenda. In addition to the widely discussed FSMA regulations (e.g., FSMA LIVES…..; FDA Tells Food Importers How It Wants Them
FDA was Busy in 2013 and its Sleigh is Packed Heading into the New Year Read More »
Today, FDA published a notice in the Federal Register announcing the availability of the Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan. The plan explains FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the GDUFA Performance Goals and Procedures for Fiscal Years 2013
Generic Drug User Fee Act Information Technology Plan Read More »
This past Monday (November 18), the FDA Center for Devices and Radiological Health (CDRH) launched a new webpage describing the revamped structure of its Office of Compliance (OC). One of the stated goals of the reorganization is to better align OC’s resources to its mission. While the stated goal in and of itself is fairly
FDA/CDRH Revamps Structure of its Office of Compliance Read More »
In a time when internecine conflicts within the Congress and between the legislative and executive branch stymie so much important work, the easy passage of the bipartisan Drug Quality and Security Act (DQSA) (H.R. 3204) is cause for celebration. Having passed the House of Representatives in September on a voice vote, the Senate overwhelmingly voted
FDA published in yesterday’s Federal Register notice of a 30 day (albeit 60 days had been requested) reopening of the comment period on its Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition, updated in August 2013. Prior versions of the guidance document had been published in May 1997 and May 2007.
Regulatory Mismanagement of Medical Foods? Read More »
FDA’s Office of Prescription Drug Promotion (OPDP) just issued a warning letter to the CEO of Aegerion Pharmaceuticals Inc. (Aegerion) for making unapproved drug claims during two television interviews on CNBC. FDA says Aegerion CEO, Marc Beer, on two separate occasions earlier this year, made off-label, unapproved claims, and failed to provide risk information. You
FDA Margin Call On Off-Label Promotion Read More »
By Bruce Silverglade* Consumption of trans fatty acids in the United States has decreased sharply in recent years due to efforts by the food industry to reformulate foods and replace partially hydrogenated oils (PHOs) with other ingredients. According to FDA, intake of trans fat from PHOs decreased more than 75 percent, from 4.6 grams per day
By Mark L. Itzkoff In a recent blog post, we discussed the realignment among some public advocacy groups that resulted in several researchers moving from the Pew Charitable Trusts (Pew) to the Natural Resources Defense Council (NRDC). At the time, we noted that the review process for food ingredients that are generally recognized as safe (GRAS)
NRDC Steps Up Fight Against GRAS Notices Read More »
FDA published its proposed animal food rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, in the Federal Register yesterday. The proposed rule, which FDA promulgated pursuant to section 103 of the Food Safety Modernization Act (FSMA), will require entities in the livestock feed and pet food industry
FDA Released its Proposed Animal Food Rule: What’s in it? Read More »
Recently, FDA finalized its guidance on Mobile Medical Applications (MMA), which is available here. The release of this guidance document lifted much of the regulatory uncertainty regarding which types of mobile apps FDA would and would not be actively regulating. Some of the regulated MMAs are developed (i.e., manufactured) by entities that have little to
My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now? Read More »
With so many of our respected friends and colleagues furloughed, federal agency budgets decimated, or wholly dependent on user fees to operate, and so much important business on hold due to the intransigent federal budget showdown, it’s not surprising that the States have stepped up to fill the vacuum. One example is the State of
Bienvenue Aux Etats-Unis! Read More »
At least once a month, our USDA or FDA practice group receives that phone call…the phone call that comes from an existing or prospective food client at that point in time (and no sooner) when the proverbial “slop is about to hit the fan.” In our experience, most food companies do a good job recognizing
The Phone Call that Comes Too Late Read More »
By Bruce Silverglade and Mark L. Itzkoff As reported in Politico this week, there has been a shake-up of sorts within the public interest advocacy community regarding the tactics used to pressure the Food and Drug Administration (FDA) into changing the way food ingredients deemed to be Generally Recognized as Safe (GRAS) are regulated or reviewed by FDA.
FDA’s GRAS Review Process for Foods May Be Tested by Litigious Public Interest Group Read More »
Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers must report adverse events involving their devices to FDA when information reasonably suggests that: Their device may have caused or contributed to a death or serious injury; or Their device has malfunctioned, and it or
MDR Reporting of Foreign Adverse Events — What is Your Obligation? Read More »
Get ready, set, go! After years of delay, FDA is now on a fast-track to finalize its proposed regulation on accreditation of third-party auditors in accordance with the Food Safety Modernization Act (FSMA), 78 Fed. Reg. 45,781 (July 29, 2013) Accreditation of Third-Party Auditors and Certification Bodies. The agency also issued a proposed rule on
FDA Proposed Reg will be “Game Changer” for Auditing and Certification Organizations Read More »
By Mark L. Itzkoff As someone who has worked with numerous food companies on food additive and GRAS issues for 25 years, I read with interest the August 7, 2013, article, Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe, in JAMA Internal Medicine. The article reports on a
PEW Report’s Mischaracterization of GRAS Process Leads to Questionable Conclusions Read More »
FDA has published a final rule defining the term “gluten-free” for voluntary use in food labeling. Food labels will have to comply with the new regulatory definition starting August 5, 2014, roughly ten years after Congress directed FDA to define “gluten-free” in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The “gluten-free”
“Gluten-Free” Now Has an Official FDA Definition Read More »
FDA has published two proposed rules to implement to provisions of the Food Safety Modernization Act (FSMA) related to the safety of imported foods. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications See our memoranda on
FDA Tells Food Importers How It Wants Them To Verify the Safety of the Foods They Import Read More »
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,
Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong? Read More »
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 »
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 »
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
Dealing With FDA Warning Letters Read More »
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,
USDA is Right on Carrageenan Read More »
You have probably heard that on May 6, 2013, FDA issued a proposed rule requiring warning labels to be affixed to tanning beds. It has been all over the news – FDA’s Center for Device and Radiological Health (CDRH) was like a moth to a tanning bed light bulb, touting its latest warning requirement to
Warning: FDA Tightens Up Regulations for Tanning Beds Read More »
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,
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,
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 »
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
DMAA Dietary Ingredient Withdrawn from Market Read More »
