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Product Regulation & Liability

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On 16 October 2024, the Federal Trade Commission (FTC) announced its final “Click-to-Cancel” Rule that applies to businesses that offer goods and services through automatically renewing payment plans, free or discounted trials that convert into full plans, or other “negative option features” that interpret a consumer’s silence as permission to keep charging them (collectively, “recurring subscriptions”). Under the finalized rule, the FTC may seek civil penalties of over USD 50,000 per violation, injunctive relief and consumer redress for companies that violate the requirements of having detailed transparent, consent and simple cancellation processes for recurring subscriptions and memberships.

On 13 December 2024, the new Regulation (EU) 2023/988 on general product safety (GPSR) will finally apply in all EU Member States, replacing the current Directive 2001/95/EC on general product safety.
The GPSR addresses risks related to new technologies and online trading, covering a wide range of products. It represents the most comprehensive reform of European product safety law in over 20 years and will impact most economic operators (manufacturers, importers, distributors, fulfillment service providers, etc.) in the EU market.

In response to the persistent issue of fraud, the Fraud Crime Hazard Prevention Act (FCHPA) was passed by the Legislative Yuan and came into force on 31 July 2024. The FCHPA requires financial institutions, virtual asset service providers, telecom enterprises, online advertising platform operators, third-party payment service providers, e-commerce and online gaming companies to respectively take certain fraud prevention measures.
In September 2024, the Ministry of Digital Affairs (MODA) published the criteria of the online advertising platforms that would be subject to the FCHPA, designated four foreign online advertising platform operators that meet the criteria, and asking them to report their legal representative (can be a law firm) in Taiwan by 31 October 2024.

On 7 November 2024, the FTC announced it will be sending refunds to 536,000 consumers deceived by Rejuvica’s and its owners’ unsupported claims that Sobrenix, a dietary supplement marketed and sold by Rejuvica, could reduce and eliminate alcohol cravings and consumption. In addition to the refunds, the FTC’s proposed order requests a permanent injunction and other relief due to violations under the FTC Act and the Opioid Addiction Recovery Fraud Prevention Act of 2018

The recently published OECD survey involving 43 member countries found that less than half of the countries require the publication of drug list prices, while the remaining countries are affected by legal and/or contractual constraints that prevent the publication of drug price information.

EU Regulation 2024/1689 on Artificial Intelligence has the aim to introduce strict rules for the design, implementation and placing on the market of Artificial Intelligence systems, to be applied both to suppliers established in European territory and to suppliers established outside the European Union.

In October 2024, the Health Sciences Authority (HSA) updated its Guidance on the Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers (“Guidance”).
This is a timely amendment to the Guidance as the requirement for chemical DS manufacturers to provide evidence of GMP compliance became mandatory with effect from 1 October 2024, after a one-year grace period.

The European Council adopted the new Product Liability Directive on 10 October 2024, and it is now awaiting publication in the Official Journal of the European Union. From its entry into force, member states will have two years to transpose it into their national law. The new directive derogates Directive 85/374/CEE. Considering the current context in which digitalization and business models based on sustainability and the circular economy are booming, it was crucial to carry out an update of the rules governing the civil liability of manufacturers and other operators of defective products.

A law amending the Act Against Unjustifiable Premiums and Misleading Representations came into effect on 1 October 2024. The Consumer Affairs Agency has broadly divided the amendments into three categories: “promotion of voluntary efforts by entrepreneurs,” “strengthening violation deterrence” and “developing regulations to ensure smooth enforcement, etc.”

Legal action against sustainability or green claims (‘greenwashing’) is on the rise. Consumers and NGOs are increasingly seeking out legal avenues to hold companies accountable for allegedly misleading advertisements on sustainability. One of these avenues in the Netherlands is the Advertising Code Committee (ACC), which regularly handles complaints on greenwashing and other potential misleading statements.