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

Federal Register

Animal and Plant Health Inspection Service


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



DateBrandProduct DescriptionReason/ProblemCompany
03/23/2019Henry Avocado CorporationCalifornia-grown conventional and organic avocadosPotential to be contaminated with Listeria monocytogenesHenry Avocado Corporation


Mar 22, 2019 | PDF

  • Label Backlog Update and Tips for the Label Approval Process.


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


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 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


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.  


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



  • 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



  • 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.  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  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 .
  • 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
  • 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 .
  • 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 .
  • 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 . 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 .
  • 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 .
  • 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
  • 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 .
  • 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
  • #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 .
  • We’ve increased our interdiction at the nation’s 9 International Mail Facilities where illegal counterfeit and unapproved drugs flow in  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 . 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 . 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 .
  • 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 .
  • 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 .
  • 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


Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 03/26/2019 at 8:45 am Scheduled Pub. Date: 03/27/2019

FR Document: 2019-05796 PDF 4 Pages (88.1 KB) Permalink

Animal and Plant Health Inspection Service

Proposed Rules

Brucellosis and Bovine Tuberculosis; Update of General Provisions

Filed on: 03/26/2019 at 8:45 am Scheduled Pub. Date: 03/27/2019

FR Document: 2019-05851 PDF 5 Pages (163 KB) Permalink

Agricultural Marketing Service


Agency Information Collection Activities; Proposals, Submissions, and Approvals:

National Sheep Industry Improvement Center

Filed on: 03/26/2019 at 8:45 am Scheduled Pub. Date: 03/27/2019

FR Document: 2019-05846 PDF 5 Pages (167 KB) Permalink


Plant Variety Protection Board

Filed on: 03/26/2019 at 8:45 am Scheduled Pub. Date: 03/27/2019

FR Document: 2019-05782 PDF 3 Pages (80.8 KB) Permalink

Environmental Protection Agency


Pesticide Tolerance:


Filed on: 03/26/2019 at 8:45 am Scheduled Pub. Date: 03/27/2019

FR Document: 2019-05877 PDF 17 Pages (129 KB) Permalink


Pesticides: Availabilities:

Draft Guidance for Pesticide Registrants on Plant Regulator Label Claims, Including Plant Biostimulants

Filed on: 03/26/2019 at 8:45 am Scheduled Pub. Date: 03/27/2019

FR Document: 2019-05879 PDF 7 Pages (225 KB) Permalink



DateBrandProduct DescriptionReason/ProblemCompany
03/22/2019LeopardDietary SupplementUndeclared sildenafilUSA LESS


  • FDA-2011-P-0745, Natural Resources Defense Council (NRDC) – Citizen Petition, Requesting that FDA set tolerance levels for eighteen polycyclic aromatic hydrocarbons in seafood.  FDA denies petition stating PAHs are ubiquitous in the environment and NRDC has failed to demonstrate that setting tolerances for PAHs in seafood would not achieve the aims advocated for – improved federal response to oil spills in the future.
  • FDA-2018-P-4590, Citizen Petition from Ascend Laboratories, LLC, Requests that the FDA assign to claim the drug product, Cannabidiol Oral Solution, 100 mg/mL as Schedule V.

GRAS Notices

GRN No.SubstanceDate of ClosureFDA’s Letter
790Steviol glycosides (minimum purity 95%)Feb 26, 2019FDA has no questions (in PDF)8 (448 kB)
773Dried biomass of Chlamydomonas reinhardtiiFeb 22, 2019FDA has no questions (in PDF)9 (148 kB)
789ErythritolFeb 20, 2019FDA has no questions (in PDF)10 (79 kB)
796Orange extract (85% hesperidin)Feb 20, 2019FDA has no questions (in PDF)11 (458 kB)


FTC Signs Memorandum of Understanding with United Kingdom’s Competition and Markets Authority to Strengthen Consumer Protection Enforcement Cooperation


  • USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil