Laws and Regulations Committee Update 1/7 – 1/11, 2019

FDA

Recalls

USDA

USDA Notes that NASS and OCE-WAOB Reports are Suspended

FSIS

Recalls

@SGottliebFDA

• THREAD: Update on Shutdown – We have many dedicated staff conducting critical inspections of food and drug facilities who are in an “unpaid, excepted status,” meaning they’re working on critical public health functions, without pay or reimbursement. This hasn’t gone unnoticed.
• We’ll support them in any way we can in their execution of these vital public health functions. Toward these goals we’re adopting new procedures that’ll reduce the likelihood that they accrue balances on their government travel credit cards for cost of airfare and hotel/lodging.
• I admire very much the dedication of #FDA colleagues during these challenging times. This is especially true for field force who perform front-line inspection functions, and incur costs on personal credit cards related to travel. Our new steps are aimed at mitigating those costs.
• #FDA is a critical institution that provides services and protections Americans depend on to sustain, improve their lives. We continue our mission through challenging circumstances. I’m grateful to our professional staff, who are carrying on that mission amidst personal challenge
• We’re going to be taking other steps, where we can, to reduce the personal burdens on our colleagues.
• THREAD: we’ve received questions from reporters and others related to the generic drug review program at #FDA; and what review activities will continue during the shutdown. I want to provide some information related to these inquiries: https://twitter.com/SGottliebFDA
• THREAD: We have received questions about how much user fee funding we have as carryover balances from 2018; to allow us to continue to work on user-fee related applications and medical product development programs. Some facts and details here: https://twitter.com/SGottliebFDA
• #FDA treats products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. These products are subject to the same authorities and requirements as FDA-regulated products containing any other substance. www.mdedge.com article: With hemp now legal, FDA reaffirms rules for cannabis compounds

@FDArecalls

• Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds http://dlvr.it/Qw06tY
• Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy’s Wavy Potato Chips 10 Oz http://dlvr.it/Qw06vJ

January 8, 2019

FDA

Recalls

OEHHA

Meeting Synopsis from the Developmental and Reproductive Toxicant Identification Committee Meeting Held on October 11, 2018: the committee considered nickel and nickel compounds for listing as known to the state to cause reproductive toxicity.

@SGottliebFDA

• Despite the #shutdown, today I was pleased to welcome 32 new user-fee funded employees to FDA. We’re delighted to have them, and thankful that carryover balances allow us to finalize their start. Important to note, it represents only 48% of new staff we planned to on-board today.
• We have lots of questions from media about hiring during this lapse in appropriations. We’ve had to hold off on unfunded recruitment efforts. All our staff is critical. We look forward to bringing additional new scientific and professional staff into FDA once funding is restored

@FrankYiannasFDA

• In a first of its kind, ‘Food Safety’ to take center stage in opening keynote at the Consumer Electronic Show @CES this year. As the world becomes more digital, a New Era of Smarter Food Safety is upon us. #CES2019 #technology #prevention #blockchain www.usatoday.com
• During the partial shutdown, @US_FDA continues to promptly respond to recalls.
• Interesting article on predicted food trends for 2019. Tech-enabled food traceability & transparency high on the list. #traceability #technology #blockchain www.foodingredientsfirst.com
• [*retweet*] New: FDA is changing its policy to allow inspectors working w/o pay (think high-risk food safety inspection in China) to incur less debt from travel expenses during shutdown, per memo obtained by POLITICO. www.politico.com

@FDArecalls

• Grand Strand Sandwich Company Recalls Lunch Box Sandwiches Italian Subs Lunch Box Sandwiches Ham & Swiss Croissants And Lunch Box Sandwiches Ham & Cheese Due To Possible Listeria Monocytogenes Contamination http://dlvr.it/QwBK4p 
• Hy-Vee Voluntarily Recalls Cheesecakes Made with Diamond Crystal Mix http://dlvr.it/Qw9S0p

January 9, 2019

FDA

Recalls

USDA

USDA Announces Plan to Protect SNAP Participants’ Access to SNAP in February

FSIS

Recalls

APHIS

USDA Confirms Virulent Newcastle Disease in a Commercial Chicken Flock in California

@SGottliebFDA

• THREAD – UPDATE ON SHUTDOWN: We’re making decisions across our portfolio to focus #FDA resources to key consumer protection functions. One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post market drug safety surveillance.
• We’ll release more details on these re-allocations in coming days. We’re systematically reviewing our portfolio and making sure that our safety functions remain resourced as best they can, for as long as they can. Our consumer protection role is our most critical mission.
• All of our work at the #FDA is critical, so nothing we stand down is unimportant. But the functions that can most directly impact consumer safety will continue, to the best of our abilities, subject to the legal and financial limitations of the current circumstances

@FrankYiannasFDA

• #nowreading Five Food Trends To Watch in 2019 by @FoodInsight. Interestingly, “Food Traceability” makes the top of the list. “Consumers want to know how their food is produced, where it came from and the quality of the ingredients.” https://globenewswire.com/news-release/2019/01/08/1682246/0/en/Five-Food-Trends-To-Watch-in-2019.html#.XDXfVL2OTBQ.twitter … #traceability

@FDA_ORA

• Scott Loughan is a Compliance Officer in #FDAORA. He evaluates evidence collected during FDA inspections that could indicate a possible lack of compliance w/enforced laws & regs. He makes a difference – protecting the food that we eat. http://go.usa.gov/xP6RA  #IAmORA

@FDArecalls

• Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil http://dlvr.it/QwG7hW

January 11, 2019

FSIS

Recalls

APHIS

USDA Confirms Virulent Newcastle Disease in a Third Commercial Chicken Flock in California

OEHHA

Meeting Synopsis from the Carcinogen Identification Committee Meeting Held on November 1, 2018

• The committee considered N-Nitrosohexamethyleneimine and gentian violet for listing as known to the state to cause cancer.

@SGottliebFDA

• FDA looks to restart safety inspections for risky foods amid shutdown – POLITICO article