Laws and Regulations Committee Update 3/25 – 3/26, 2019

March 29, 2019 in Federal Register Updates

Federal Register

Animal and Plant Health Inspection Service

Notices

List of Regions Affected by African Swine Fever:

Addition of China

Filed on: 03/25/2019 at 8:45 am Scheduled Pub. Date: 03/26/2019

FR Document: 2019-05680 PDF 3 Pages (157 KB) Permalink

Supplemental Requirements for Importation:

Fresh Citrus from Colombia into the United States

Filed on: 03/25/2019 at 8:45 am Scheduled Pub. Date: 03/26/2019

FR Document: 2019-05679 PDF 11 Pages (106 KB) Permalink

FDA

Recalls

Date	Brand	Product Description	Reason/Problem	Company
03/23/2019	Henry Avocado Corporation	California-grown conventional and organic avocados	Potential to be contaminated with Listeria monocytogenes	Henry Avocado Corporation

FSIS

Mar 22, 2019 | PDF

Label Backlog Update and Tips for the Label Approval Process.

Recalls

Product Recalled	Date of Recall
037-2019 North Country Smokehouse Recalls Ready-To-Eat Sausage Products due to Possible Foreign Matter Contamination	Mar 23, 2019
036-2019 Tip Top Poultry, Inc. Recalls Fully Cooked, Diced Chicken Products due to Misbranding and Undeclared Allergens	Mar 23, 2019
035-2019 Two Brothers Pork Skins Recalls Pork Skin Products Due to Misbranding and Failure to Produce Under A HACCP Plan	Mar 22, 2019

AMS

AMS Reaches a Consent Decision and Civil Penalty with John P. McGraw

USDA Seeks Comments on Proposed Amendments to Regulations for Meat, Poultry, Rabbit and Shell Egg Grading

USDA Seeks Nominees for Peanut Standards Board

USDA Announces Fruit and Vegetable Industry Advisory Committee to Meet in May

APHIS

APHIS Seeks Comment on the Importation of Fresh Jujube Fruit from China into the Continental United States

USDA Updates Scrapie Regulations and Program Standards

USDA Shifts Emergency Funds to Address Virulent Newcastle Disease in California

OEHHA

Amendment to Section 25805 Maximum Allowable Dose Levels for n-Hexane (Oral and Inhalation): This amendment establishes an oral MADL of 28,000 micrograms per day and an inhalation MADL of 20,000 micrograms per day for n-hexane.

NAD

Following NAD Inquiry, Rite Aid Permanently Discontinues “#1 Health Care Professional Recommended Brands” And Other Related Claims.

Food & Water Watch

Michigan Environmental and Social Justice Groups Call for a Ban on Industrial Agriculture Polluting Practices

@FrankYiannasFDA

THREAD: FOOD SAFETY ALERT, CA-grown whole avocados distributed by Henry Avocado Corporation are being voluntarily recalling due to potential Listeria contamination. These avocados are sold in bulk at retail stores in AZ, CA, FL, NH, NC, and WI. https://go.usa.gov/xEzNv
Consumers/retailers can identify recalled non-organic avocados by looking for a “Bravocado” sticker. Organic, recalled products are labeled “organic” & include “California” on the stickers. Retailers can identify Henry Avocado organic products by the bar code on the stickers.
#FDA is urging consumers who believe they’ve purchased recalled avocados not to consume them, and to discard or return them. We appreciate Henry Avocado taking steps to confirm impacted product is removed from shelves & protect the public from this potential food safety issue
Soon, you may be able to trace your coffee from bean to cup with your smart phone. Traceability is going mainstream. Let’s work together to make it the social/industry norm. https://www.restaurantdive.com/news/starbucks-teases-coffee-traceability-app-feature-compostable-cup-trial/550954/ … #traceability #blockchain
Colorado considers establishing an advisory group to evaluate blockchain for supply chain traceability, monitoring activities & facilitating farmer payments. #smartersupplychains #traceability #blockchain https://statescoop.com/colorado-considers-blockchain-for-agricultural-supply-chain/
We must invest to prevent problems from happening by solidifying the agency’s tools under FSMA. We must also embrace new innovations to improve our ability to secure the food supply chain & more effectively track & trace food from farm to fork. https://progressivegrocer.com/fda-moves-bolster-food-safety-program

@FDA_ORA

FDA’s Special Agents/@TheJusticeDept: Five individuals and two companies plead guilty to felony charges in multimillion dollar scheme to fraudulently sell popular dietary supplements https://go.usa.gov/xEMCM

@FDAfood

Learn how FDA is easing the pathway for new dynamic foods into the marketplace through our Voluntary Plant #Biotechnology Consultation Program. And continuing to meet the FDA’s high #foodsafety standards. https://go.usa.gov/xEeSy

@SGottliebFDA

THREAD: CONSUMER FOOD ALERT: Henry Avocado Corporation is voluntarily recalling California-grown whole avocados due to potential Listeria contamination. Impacted Henry Avocado products are sold in bulk at retail stores in AZ, CA, FL, NH, NC, and WI. https://go.usa.gov/xEzNv 1/4
· There are no reported illnesses associated with this avocado recall. However, consumers who believe they’re consumed recalled product and have listeria symptoms (fever, muscle aches, and nausea or diarrhea), should contact a health care professional https://go.usa.gov/xEzNf 2/4
·Henry Avocado has taken steps to voluntarily recall these products, contacted all impacted customers and is working with retailers to remove products from stores. If you believe you have recalled avocados, don’t eat them and dispose or return to the store. ¾
#FDA is looking into the issue and will continue to update as new information becomes available.
Many companies making/selling FDA-regulated products comply with #FDA rules to protect the public. But some firms willfully disregard them, prompting us to take action. In today’s #FDA #SundayTweetorial, I’ll highlight a # of FDA’s key enforcement actions during my 2-year tenure.
We all expect our medical products to meet quality standards and be marketed truthfully and responsibly, our food to be safe, and for those selling tobacco products to do what’s required to prevent youth from becoming addicted to nicotine. Most firms strive to accomplish that.
But there is a subset of bad actors who flout our rules with no concern for public safety through intentional product adulteration, fraudulent regulatory submissions, the sale of counterfeit, substandard or unapproved medical products and unlawful sales.
n such cases, the #FDA – often working with our colleagues across government, including @TheJusticeDept – has an obligation not just to step in and address the public health risk, but to do all we can to take actions that deter future misconduct.
FDA has many tools to use against bad actors, depending on the violation: warning letters (WLs) that cite violations and seek corrective actions, mandatory recall (for some products), seizure, injunction, civil penalties, and criminal prosecution. And we’re not shy to use them!
Consider these stats from FY 2018: FDA issued 14,285 WLs, oversaw 7,562 recalled products, initiated 14 injunctions and 1 product seizure, issued 231 import alerts to detain potentially violative products and made 317 criminal arrests. We also make sure to publicize bad actors.
We consider enforcement – protecting consumers from those who would prey on them with bogus claims and fraudulent products – to be the cornerstone of our consumer protection mission. We’ve dedicated new resources to this work https://go.usa.gov/xEthK .
Our aggressive actions against bogus stem cell clinics, where bad actors have been leveraging the scientific promise of cell-based regenerative medicine to peddle unapproved treatments that risk patient’s health and even harm them, provides a good example of our efforts.
We’ve pursued a series of escalating actions against these outfits, culminating in federal cases for permanent injunctions to stop two stem cell clinics from marketing their products without #FDA approval and for major deviations from CGMP requirements https://go.usa.gov/xEtw4
Enforcement is a priority. #FDA worked together to confront numerous health fraud scams and worked on the successful prosecution of companies and individuals who marketed dietary supplements with dangerous ingredients during the last two years https://go.usa.gov/xEth9 .
As part of our new risk-based enforcement approach to drug products labeled as homeopathic, we’ve taken action against companies marketing such unapproved products with claims they can treat addiction and chronic pain and/or other conditions https://go.usa.gov/xEtus .
We’ve also taken action against companies marketing pills and capsules labeled as dietary supplements with unproven drug claims about protecting consumers from harms that come from sun exposure https://go.usa.gov/xEtuP . They put consumer’s health at risk and provide false security
And we’ve been vigilant in going after companies that market fraudulent cancer products, issuing > a dozen WLs in 2017, including 4 WLs to companies marketing unproven products purporting to contain cannabidiol (CBD) claiming to treat/cure cancer https://go.usa.gov/xEtuE .
Most recently we sent 17 WLs to companies illegally marketing Alzheimer’s disease products, often sold on websites and social media platforms. Such health fraud preys on vulnerable populations, wastes money and often delays proper medical care https://go.usa.gov/xEQME .
A key part of #FDA’s efforts to promote safe and effective medical devices is our enforcement work related to unsafe practices and bad actors. In December, an FDA criminal investigation resulted in a guilty plea & fines for medical device maker ev3 Inc https://go.usa.gov/xEt7Y
The company had marketed their neurovascular device for unapproved and potentially dangerous surgical uses, gave sales reps quotas and bonuses for selling the device for such uses and trained their reps to instruct physicians on the unapproved use of these devices.
In 2012, 750 people developed fungal meningitis across multiple states and over 60 died after they were injected with contaminated compounded steroid drugs. Enforcement was an integral part of our approach to this tragedy and it remains integral in our work with compounders.
Congress responded by updating our authority for overseeing compounders (who provide medications to patients when there is no FDA-approved drug). Since 2012, we’ve issued more than than 220 WLs, overseen > 230 recall events and have continued going after the industry’s bad actors
This month, working with #DOJ, we obtained a permanent injunction against a company for making supposedly sterile injectable drugs in insanitary conditions whose eye injections resulted in impaired vision https://go.usa.gov/xEtJm .
Enforcement has been an essential tool in tackling the opioid epidemic, especially illicit opioids, which are accounting for a sharply increasing percentage of the total exposure to these drugs and fueling a growing addiction crisis https://go.usa.gov/xEtSV
#FDA has moved to block the flow of opioid drugs on the web, recently warning 23 networks operating > 450 websites illegally marketing potentially dangerous, unapproved, and misbranded opioid medications, including tramadol and oxycodone https://go.usa.gov/xEtSd .
We’ve increased our interdiction at the nation’s 9 International Mail Facilities where illegal counterfeit and unapproved drugs flow in https://go.usa.gov/xEtSf and have begun implementing new authority making it easier for us to stop illegally imported drug articles
· We’ve also worked to halt the illegal sale of unapproved kratom-containing drug products that have unproven claims about treating opioid addiction/withdrawal https://go.usa.gov/xEtVc . Kratom is an opioid analogue that may contribute to the epidemic and puts patients at risk.
·Enforcement is also helping us address another emerging addiction issue: the epidemic-rise in youth e-cigarette use. E-cigs contain highly-addictive nicotine, which can rewire teen brains to make them crave more.
Even more concerning: kids using e-cigs are more likely to start using combustible cigarettes -d not all would have otherwise smoked cigarettes. To combat these trends, we’ve moved aggressively to prevent companies from selling and marketing these products to youth.
Last May, #FDA, working with the Federal Trade Commission, issued 17 WLs for e-liquids with false or misleading advertising or labeling https://go.usa.gov/xEtVR . The products were made up to look like kid-friendly juice boxes, candies and cookies.
And from June – September 2018, we issued > 1,300 WLs and civil money penalty complaints to retailers illegally selling e-cigs to minors in brick and mortar stores as well as online, the largest coordinated enforcement action in #FDA history https://go.usa.gov/xPbCy .
Finally, we’ve invoked new Food Safety Modernization Act (FSMA) authorities against violative food facilities. When listeriosis was found in Working Cow Homemade’s ice cream we suspended their facility registration until they made corrections https://go.usa.gov/xEtVH .
And we ordered a mandatory recall against Triangle Pharmanaturals for refusing to recall food containing powdered kratom after samples tested positive for Salmonella. It was the FDA’s first use of our mandatory food recall authority under FSMA https://go.usa.gov/xEtVy .
I’ve cited only a small number of FDA’s robust enforcement actions the past 2 years. Credit for these successes goes to FDA’s dedicated staff in the Office of Regulatory Affairs, Office of Criminal Investigation, Office of Chief Counsel and our product centers’ compliance offices
Our consumer protection role is the heart of the #FDA and the bedrock of our mission to protect Americans. I’m proud to have helped our outstanding professional staff advance this mission with the acquisition of new authorities and resources, and my deep admiration for their work

March 26, 2019

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals