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Federal Register notice of a 30 day (albeit 60 days had been requested) reopening of the comment period on its Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition, updated in August 2013.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 »
“[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
