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.
The Ministry of Health will be extending the Nutri-Grade labeling requirements and advertising restrictions to products high in sodium and saturated fats, such as prepacked salt, sauces and seasonings; instant noodles; and cooking oil. These measures aim to help consumers make healthier choices and encourage industry reformulation.
The Food and Drug Administration now allows for the referencing of medical device application dossiers and transfer of product registration licenses.
In keeping with tradition, we are pleased to invite you to our annual Global Year-End Review of Import/Export & Trade Compliance Developments Conference. The conference will provide valuable insights on the latest developments, challenges and opportunities in the ever-changing landscape of international trade.
We are holding this conference in a split-hybrid format, with an in-person event in Santa Clara, CA, on 12 November and virtual panels on 19-21 November.