As with its decision to implement a ban on cigarette smoking in public places, Ireland is ahead of the EU curve on the issue of requiring warning labels to be placed on alcohol products.  With 72% of Irish consumers welcoming the initiative and the EU Commission recently giving it a green light, it seems likely that Ireland will press ahead with enforcing the measure.

Some background

Section 12 of Ireland’s Public Health (Alcohol) Act 2018 includes a provision requiring health warning labels to be placed on alcohol products. In June 2022, Ireland took first steps towards implementation of that provision by notifying the draft Public Health (Alcohol) (Labelling) Regulations 2022 (the Draft Regulations) to the European Commission. 

This so-called Technical Regulation Information System (TRIS) notification was required under the Single Market Transparency Directive 2015/1535 (SMTD), which seeks to ensure transparency of technical regulations adopted at a national level and reduce the risk of fragmentation of the single market by creating different marketing standards and requirements at national level.  This is particularly relevant for food labelling, which is harmonized at the EU level, by, amongst others, the Food Information to Consumers Regulation (EU) 1169/2011.  This Regulation requires certain national proposals for technical regulations, such as the Irish labelling proposal, to obtain a TRIS notification to allow Member States to comment on them and if necessary, raise concerns.  There is a three month standstill period following notification during which the notifying country cannot adopt the technical regulation, which is extended by another three months if the Commission or a Member State submits a detailed opinion.  If a detailed opinion is received, the notifying country must inform the Commission of the measures it intends to take to address the issues raised in the opinion.

Continue Reading Alcohol Labelling in Ireland

For over a decade, Covington has published a detailed survey of the “pay-to-play” laws of all 50 states.  Now, for the first time, Covington is updating the survey with a new section covering federal pay-to-play rules, in addition to those of the 50 states and many cities and counties.  This new section details the federal government contractor contribution ban and pay-to-play rules adopted by the Securities & Exchange Commission (SEC Rule 206(4)-5 and SEC Rule 15Fh-6), the Municipal Securities Rulemaking Board (MSRB Rule G-37), Commodity Futures Trading Commission (CFTC Rule 23.451), and Financial Industry Regulatory Authority (FINRA Rule 2030).

To help in-house lawyers and compliance professionals with reviewing proposed contributions, Covington publishes a detailed survey of the pay-to-play laws of the federal government, all 50 states, and all major cities and counties. This almost 460-page survey:

  • Details all federal and statewide pay-to-play rules.
  • Describes over one hundred “specialty” pay-to-play rules that apply to contractors doing business with certain agencies or companies operating in certain regulated industries, including those that apply to investment firms that manage state or local public funds, lottery and gaming companies, public utilities, redevelopment contractors, and insurance companies.
  • Includes pay-to-play laws for major cities and counties across the country.

The survey also includes user-friendly charts and legal citations answering questions such as:

  • Which donors are affected?
  • Which contributions are restricted?
  • Is there a de minimis exception? What are the other exceptions?
  • Which types of contracts are covered?
  • How long after a contribution does the restriction run?
  • Does the rule restrict political fundraising and other solicitations?
  • Are there reporting and disclosure requirements?
  • What are the penalties?

Covington is pleased to be able to offer the survey for purchase in its entirety.  Alternatively, groups of states may be made available at discounted rates.  For questions or to purchase the survey, please contact

The US Inflation Reduction Act (the IRA) has raised concerns in the EU about the potential impact on international investment – particularly the possibility that such investment will be pulled into the US, rather than directed to the EU and may encourage ‘green industries’ to relocate production to the US. The EU has been working on an appropriate response that would increase the attractiveness of the EU as a green investment destination without breaching either WTO rules or its own State Aid rules.


The IRA has provoked diverse reactions across EU Members States.  Whilst some countries have lined up behind calls for a “Made in Europe” strategy which would accelerate production targets (cf the EU Chips Act); weaken state aid rules; establish an EU emergency sovereign fund; and mobilize WTO-compliant trade defense instruments.  Other Member States have expressed concern that such an approach would risk undermining EU provisions on State Aid and fragmenting the EU internal market. 

With some justification, smaller EU Member States are concerned that weakening the EU’s State Aid rules would favour more fiscally powerful Member States (52% of the Temporary Crisis Framework (“TCF”) established following Russia’s invasion of Ukraine was notified by Germany and a further 24% by France).  Such Member States would prefer the creation of a joint EU fund – a proposal in turn opposed by fiscally conservative Member States who reject any further joint EU borrowing. 

On 1 February, the Commission released its Communication for A Green Deal Industrial Plan for the Net Zero Age (The Communication) which contains a series of proposals for discussion at the EU Council Summit on February 9-10.  The differences between the various Member States noted above, are likely to influence the discussions at the Council Summit and impact the formal proposal which is expected to be presented to the European Council in late-March.

Continue Reading The EU’s Green Deal Industrial Plan for the Net-Zero Age

The Federal Election Commission has announced contribution limits for 2023-2024.  The new “per election” limits are effective for the 2023-2024 election cycle (November 9, 2022 – November 5, 2024), and the calendar year limits are effective January 1, 2023. The new limits represent the largest election cycle increase since the limits started being indexed for inflation in the 2003-2004 election cycle.

The FEC increased the amount an individual can contribute to a candidate to $3,300 per election, up from $2,900.  Because the primary and general count as separate elections, individuals may give $6,600 per candidate per cycle.

The limit on contributions from individuals to national party committees also increased from $36,500 to $41,300 per year.  This increase also affects the limit on contributions to additional specialized accounts of the party committees, which were first allowed through legislation passed in 2014.  Each of these accounts can receive contributions that are triple the amount that can be given to the main party account, or $123,900 per account per year.  These accounts can be used to pay for expenses related to presidential nominating conventions, headquarters buildings of the party, and election recounts, contests, and other legal proceedings.

The following chart shows more details on the limits for individuals in 2023 and 2024:

An individual may contribute to …
Federal Candidates$3,300per election
National party committees — main account$41,300per year
National party committees — convention account (RNC and DNC only)$123,900per year
National party committees — party building account$123,900per year
National party committees — legal fund account$123,900per year
State or local party committees’ federal accounts$10,000per year
Federal PACs$5,000per year

On February 1, the Federal Trade Commission (“FTC”) announced its first-ever enforcement action under its Health Breach Notification Rule (“HBNR”) against digital health platform GoodRx Holdings Inc. (“GoodRx”) for failing to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to third-party advertisers.  According to the proposed order, GoodRx will pay a $1.5 million civil penalty and be prohibited from sharing users’ sensitive health data with third-party advertisers in order to resolve the FTC’s complaint. 

This announcement marks the first instance in which the FTC has sought enforcement under the HBNR, which was promulgated in 2009 under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, and comes just sixteen months after the FTC published a policy statement expanding its interpretation of who is subject to the HBNR and what triggers the HBNR’s notification requirement.  Below is a discussion of the complaint and proposed order, as well as key takeaways from the case.

The Complaint

As described in the complaint, GoodRx is a digital healthcare platform that advertises, distributes, and sells health-related products and services directly to consumers.  As part of these services, GoodRx collects both personal and health information from its consumers.  According to the complaint, GoodRx “promised its users that it would share their personal information, including their personal health information, with limited third parties and only for limited purposes; that it would restrict third parties’ use of such information; and that it would never share personal health information with advertisers or other third parties.”  The complaint further alleged that GoodRx disclosed its consumers’ personal health information to various third parties, including advertisers, in violation of its own policies.  This personal health information included users’ prescription medications and personal health conditions, personal contact information, and unique advertising and persistent identifiers.

Continue Reading FTC Announces First Enforcement Action Under Health Breach Notification Rule

On January 31, 2023, FDA Commissioner Robert M. Califf announced a proposed redesign of the human foods program at FDA. The proposal follows the findings and recommendations of a Reagan-Udall Foundation expert panel that Dr. Califf had charged with evaluating the agency’s existing human foods program. Commissioner Califf called the redesign “transformative” and believes the proposed structures will have clear priorities to protect and promote a safe and nutritious food supply in the current and evolving environment.

Overall Structure

In the high-level proposal, FDA intends to unify various functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and Office of Regulatory Affairs (ORA) under an organization called the Human Foods Program. A Deputy Commissioner for Human Foods will lead that program and have decision-making authority over policy, strategy, and regulatory program activities, as well as resource allocation and risk-prioritization. The Deputy Commissioner will report directly to the FDA Commissioner. The Human Foods Program will have a larger executive team with clearly defined lines of authority to ensure decisive leadership. This will include a Principal Associate Commissioner reporting to the Deputy Commissioner. Based on the organizational chart provided in the proposal, the Deputy Commissioner for Human Foods appears to be on the same level as the Director of the Center for Veterinary Medicine (CVM).

In addition, a Human Foods Advisory Committee of external experts will be formed to advise FDA on issues in food safety, nutrition, and innovative food technologies.


FDA also plans to create a Center for Excellence in Nutrition within the Human Foods Program, that will work with industry to offer healthier, more nutritious foods. The Center is intended to elevate and empower action on nutrition science, policy, and initiatives to reduce diet-related chronic diseases and improve health equity. The Center will include an Office of Critical Foods responsible for the regulation of infant formula and medical foods, presumably also to help ensure a robust supply of such critical products.

Food Safety

FDA intends to establish an Office of Integrated Food Safety System Partnerships to prioritize and unify FDA’s work with state and local regulators. The aim is to ensure greater collaboration and support to state-level inspectional activities. The changes to ORA mentioned below will strengthen the goals in the New Era of Smarter Food Safety.

Office of Regulatory Affairs

The proposal also reimagines ORA. The new model will focus on setting the global gold standard in inspections, investigations, laboratory analysis, and import operations. ORA will support the Human Foods Program and other regulatory programs by focusing on critical activities. As a result, ORA will take a more prevention-based approach to food safety inspections. It will also will modernize and increase its specialization alongside the regulatory programs. Certain ORA functions such as state and local food safety partnership functions will be realigned into the Human Foods Program to streamline the agency’s oversight over foods.

Center for Veterinary Medicine

FDA proposes to create an Office of Animal Biotechnology Innovation within CVM, which will work on advancing FDA’s regulation of animal biotechnology. The office will collaborate with the Human Foods Program on agricultural biotechnology innovation. The CVM Director’s role will be expanded to include duties as Chief Veterinary Officer (CVO) to reinforce CVM’s One Health mission; where the Director is not a veterinarian, the duties will be held by a senior veterinarian within CVM. 

Next Steps

Commissioner Califf will next turn this high level proposal into a concrete reorganization plan. To do so, the Commissioner will engage with internal and external stakeholders on this proposal, and will provide an additional update on FDA’s progress on reorganization and timeline by the end of February.

*           *           *

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements or Animal Food and Drug practices.

*This guide was originally published in 2018 and we have updated it periodically.

January 31, 2023, Covington Guide

In 1938, Congress enacted the Foreign Agents Registration Act (“FARA”), requiring “foreign agents” to register with the Attorney General. As amended over the years, it applies broadly to anyone who acts on behalf of a “foreign principal” to, among other things, influence U.S. policy or public opinion. Until recently, it was a backwater of American law—and a very still backwater at that, with just seven prosecutions between 1966 and 2016.

That now has changed. Like the once obscure Foreign Corrupt Practices Act, which prosecutors revived from hibernation some years ago, FARA is receiving its close-up. Prosecutors have brought more FARA prosecutions in the last several years than they had pursued in the preceding half century. In-house lawyers have scrambled to bone up on this famously vague criminal statute, at a time when the nation’s tiny bar of experienced FARA lawyers can still hold its meetings in the back of a mini-van.

While cases related to Special Counsel Robert Mueller’s investigation are the most salient examples, the renewed focus on foreign agents actually began prior to the Mueller investigation and has continued long after the Special Counsel closed up shop. A significant uptick in audits of registered foreign agents by the FARA Unit (the Department of Justice office that administers FARA), followed by significant staffing changes in the FARA Unit, and then noticeably more aggressive interpretations of the statute in advisory opinions and informal advice from the FARA Unit, all have signaled a sea change.

Continue Reading The Foreign Agents Registration Act (FARA): A Guide for the Perplexed

Executive Summary

In this alert, we look at Colombian President Gustavo Petro’s first months in office and the outlook for his reform agenda in 2023.  We discuss the implications for U.S.-Colombia relations and for doing business in the country.

  • Petro’s election has led to a reconfiguration of power structures in Colombia and a change in the way policies are designed and implemented. The administration has a statist bent and views the private sector’s role as less prominent than prior administrations. There is less emphasis on attracting investment.
  • This year will be crucial for Petro’s reform agenda and for his party, Pacto Histórico. The government’s energy transition policy and labor, health care, and pension reforms will shape Colombia’s economy in the decades to come and companies will need to be on notice that coming changes may be profound.
  • The Biden and Petro administrations have made efforts to find common ground. But the change of leadership in the House of Representatives, the proximity of the 2024 U.S. presidential election, an emboldened Florida GOP, and implementation of controversial reforms in Colombia could test the relationship in 2023.
  • Security remains a key concern for companies doing business in Colombia and conditions have deteriorated in the past few years. Progress on peace negotiations and the government’s new crime and drug policies will determine whether conditions improve.

Petro’s First Months in Office

“Today begins the Colombia of the possible. Today begins our second opportunity,” Petro told a cheering crowd in Bogotá on August 7. His inauguration as President of Colombia, he said, marked the end of Gabriel García Márquez’s One Hundred Years of Solitude for the Colombian people. The election and orderly transition to a left-wing former guerrilla president and the first Afro-Colombian vice president in the country’s history showed the strength of Colombia’s democracy, one of the oldest and most stable in the Americas.

Continue Reading Colombia in 2023: A Crucial Year for Petro’s Reform Agenda

On January 5, 2023, the Federal Trade Commission (“FTC”) issued a groundbreaking proposed rule that would, if finalized:

  • prohibit most employers from entering into non-compete clauses with workers, including employees and individual independent contractors;
  • prohibit such employers from maintaining non-compete clauses with workers or representing to a worker that the worker is subject to a non-compete clause; and
  • require employers to rescind any existing non-compete clause with workers by the compliance date of the rule and notify the affected workers that their non-compete clause is no longer in effect.

The FTC’s notice of proposed rulemaking explains that the FTC considered possible limitations on the rule—such as excluding senior executives or highly paid employees from the ban—but it ultimately proposed a categorical ban on non-competes.  The only exception is for non-competes related to the sale of a business.  However, even this exception is unusually narrow: it would only apply to selling business owners who own at least 25% percent of the business being sold.  (The proposal also would not apply to most non-profits, certain financial institutions, common carriers, and others who are also outside the scope of FTC regulation.)

As discussed in Covington’s January 5 client alert, the FTC explained that it issued the proposed rule due to its belief that non-competes reduce wages, stifle innovation and business, and are exploitative and unnecessary. 

Continue Reading FTC Proposes Rule to Ban Most Non-Competes

The Federal Energy Regulatory Commission (“FERC”) issued a final rule (Order No. 887) directing the North American Electric Reliability Corporation (“NERC”) to develop new or modified Reliability Standards that require internal network security monitoring (“INSM”) within Critical Infrastructure Protection (“CIP”) networked environments.  This Order may be of interest to entities that develop, implement, or maintain hardware or software for operational technologies associated with bulk electric systems (“BES”).

The forthcoming standards will only apply to certain high- and medium-impact BES Cyber Systems.  The final rule also requires NERC to conduct a feasibility study for implementing similar standards across all other types of BES Cyber Systems.  NERC must propose the new or modified standards within 15 months of the effective date of the final rule, which is 60 days after the date of publication in the Federal Register.  


According to the FERC news release, the 2020 global supply chain attack involving the SolarWinds Orion software demonstrated how attackers can “bypass all network perimeter-based security controls traditionally used to identify malicious activity and compromise the networks of public and private organizations.”  Thus, FERC determined that current CIP Reliability Standards focus on prevention of unauthorized access at the electronic security perimeter and that CIP-networked environments are thus vulnerable to attacks that bypass perimeter-based security controls.  The new or modified Reliability Standards (“INSM Standards”) are intended to address this gap by requiring responsible entities to employ INSM in certain BES Cyber Systems.  INSM is a subset of network security monitoring that enables continuing visibility over communications between networked devices that are in the so-called “trust zone,” a term which generally describes a discrete and secure computing environment.  For purposes of the rule, the trust zone is any CIP-networked environment.  In addition to continuous visibility, INSM facilitates the detection of malicious and anomalous network activity to identify and prevent attacks in progress.  Examples provided by FERC of tools that may support INSM include anti-malware, intrusion detection systems, intrusion prevention systems, and firewalls.   

Continue Reading FERC Orders Development of New Internal Network Security Monitoring Standards