The Food Standards Agency (FSA) has launched a campaign highlighting the risks of food labelled as vegan to people with allergies. Research from the FSA has shown that 62% of consumers with an animal-based allergy were confident that products labelled as ‘vegan’ were safe to eat. The FSA says this confidence is incorrect and is putting people at risk ...
The Food Standards Agency (FSA) is seeking views on potential approaches to precautionary allergen labelling for prepacked and non-prepacked foods. This consultation follows new rules that came into force in relation to allergen labelling on prepacked for direct sale foods last year (see our article about Natasha’s Law here) and will consider how precautionary allergen labelling can be communicated more clearly and consistently to consumers ...
One of the most common questions I receive from clients is around the termination of leases, with confusion reigning around the terminology and procedures used in Scotland. It is not surprising that when given a remit to consider the law of commercial leases, the Scottish Law Commission (SLC) first turned its attention to the law relating to the termination of leases at expiry. In October 2022, following consultations, the SLC published its Report on Aspects of Leases: Termination ...
April 17, 2023 By: Meghna Parikh ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between the FDA and medical device manufacturers. Providers using medical devices in their practice should pay attention to these rulings because they impacts the providers’ ability to educate and engage their patients ...
Over the last few years, news that some of the nation's most iconic retail stores have closed has become more frequent. Yesterday, Poundworld entered administration. Last week, House of Fraser announced it would be closing 31 stores, many of which are in some the UK's largest cities. It is no secret that many retailers have been adversely affected by the shopping habits of consumers, ever since the advent of a new pastime - buying online ...
The rise of e-commerce and the struggle many brick-and-mortar retail stores face is nothing new. Customers are increasingly choosing to shop for clothes, furniture and even groceries from the convenience of their own homes. More recently, however, this shift in the way consumers shop has given rise to new types of retail stores – small showrooms and “pop-up shops ...
It is evident that the current lockdown is having an unprecedented slowdown in the movement of persons between EU Member States. This is not due to a restriction which was imposed by the EU itself but because of the restrictions which the Member States themselves imposed through their respective Public Health officials. It is noticeable that the legal restrictions on immigration were driven by the Member States' individual rules rather than by a general guideline from the EU ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
Judgement of the European Court of Justice in case C-212/03 – Commission v. France, dated 26 May 2005 The Commission acted against France on the grounds that certain French rules on the importation of medicines are contrary to Article 28 of EC Treaty on the free movement of goods. The relevant national rules and administrative practice required a licence for the importation of medicines for personal use in France ...
The Court of Appeal of Quebec has issued an important judgment pertaining to a franchisor’s implicit obligations towards its franchisees. In June 2012, the Superior Court of Quebec ordered Dunkin’ Donuts Brands Canada Ltd. (“Dunkin’ Donuts”) to pay an amount of $16.4M (plus interests and costs) to 21 of its franchisees in Quebec the sum of $16 ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
The Supreme Court of Appeal recently handed down a rare trade mark judgment. The protagonists were Adidas and Pepkor, and the main issue was whether Pepkor had infringed certain trade mark registrations belonging to Adidas for its famous three-stripe mark. Adidas was founded by a German called Adi Dassler in 1920 ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
As Hurricane Harvey continues to cause far-reaching disruptions, it is important to understand how to effectively assert or respond to assertions of force majeure. This summary outlines the steps to take to assert force majeure, and initial considerations for those who have received several notices of force majeure from counterparties ...
The ongoing global COVID-19 pandemic is upending regular commercial activity across the United States and around the world, and that disruption is expected to escalate. Among the issues confronting our clients, the effect of public health orders and other measures to address COVID-19 is threatening, impacting, and in some cases, outright prohibiting the performance of material contractual obligations ...
The establishment by the Scottish Government of a food security task force is a necessary and timely response to the war in Ukraine. In addition to the harrowing humanitarian crisis, the conflict has prompted significant concern among food producers. The UK food sector and consumers are currently facing a perfect storm just as we begin to emerge from the pandemic ...
The coronavirus pandemic has impacted the food industry, just as it has many others. The good news is that food-to-person transmission of the disease does not seem to be a risk. The challenge remains keeping workers safe from airborne and surface transmission. However, the FDA and the USDA have provided guidance and recommendations to food producers to deal with COVID-19, links to which have been provided below. The guidance focuses on stopping the person-to-person spread of the disease ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
The Florida Agency for Health Care Administration (“AHCA”) earlier this month fined Humana $3.4 million for failing to promptly report suspected cases of Medicaid fraud and abuse by others, as required by statute and Humana’s Medicaid HMO contract. Though many states have similar laws or regulations, this appears to be the first enforcement action of its kind in the nation ...
“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...
Shoosmiths’ mobility head, Jonathan Smart, was a speaker at the SMMT International Automotive Summit 2023, hosted in London. Jonathan moderated a panel discussion focused on the competitive challenges facing the UK’s automotive manufacturing sector. The summit was aimed at addressing the challenges facing the automotive sector, including building resiliency, international collaboration, unlocking potential, competitiveness and innovation ...
Article PDF Practical Insights Five Points to Negotiate in a 'Black Box' Product Development Agreement What is a “black box” product development agreement? How do you protect your product idea? What intellectual property can a Manufacturer expect to own? Can a Manufacturer limit a Processor’s right to work for others? What about co-manufacturing agreements? What is a “black box” product development agreement? A food
The Health Care Arbitral Tribunal (Arbitral Tribunal) has pronounced a decision on a dispute between an independent medical specialist and a Medical Specialist Company (MSC) for the first time since the introduction of the comprehensive rates on 1 January 2015. Although neither party has terminated the existing (membership) agreement between them, the Arbitral Tribunal is of the opinion that termination of membership and deregistration of the specialist from the members' register are justified ...
