The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018. The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5
The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).
The European Commission has published a draft implementing Regulation setting out the proposed official EU list of authorised novel foods. A ‘novel food’ is a food or ingredient that has not been consumed to a significant degree in the EU prior to 15 May 1997. These include products traditionally eaten outside the EU prior to
Initial responses to the European Commission’s public consultation on how to make the EU food supply chain fairer suggest that, bar retailers, the majority of significant stakeholders (including Member States, farmer groups, agricultural organisations and NGOs) are in favour of action at EU level to increase fairness and balance in the food supply chain. The
The European Court of Justice has held that Member States may not adopt emergency measures prohibiting genetically modified food and feed (GMOs) unless there is clear evidence that a particular GMO presents a serious risk to health or the environment in accordance with Article 34 of the GMO Regulation (EC) No 1829/2003. Ruling in favour
Many have questioned what affect a proposed legislative facelift, to the cosmetic industry, will have on manufacturers, retailers and, of course, on consumers.
The Court of Justice of the European Union (“CJEU“) has issued a ruling on the interpretation of Directive 2002/46/EC on food supplements, finding that a French law prohibiting the sale of food supplements from other EU Member States containing vitamins and minerals above French national limits is contrary to EU law. The CJEU held that
The Centers for Medicare & Medicaid Services (CMS) released the final Medicaid covered outpatient drug regulation on Thursday, January 21, 2016. Read More: Medicaid Drug Rebate Program: CMS releases final covered outpatient drug regulation
On November 17, 2015, leaders from both the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) testified before the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health regarding regulation of Laboratory Developed Tests, or LDTs. Read More: FDA and CMS Make Case Before Congress for
On January 26, 2016, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (Draft Guidance). Read More: FDA Offers New Recommendations for Interoperability of Connected Devices
The tax and spending bill signed into law by President Obama last week included a two year suspension of the medical device excise tax. After years of effort by industry to abolish the tax, proponents of the suspension speculate that it may represent a window to full repeal. Read More: Congress Suspends Medical Device Tax for Two
On November 2, 2015, the Food and Drug Administration (FDA) released a draft guidance document, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” describing the types of EMC information that should be provided in a premarket submission for electrically-powered medical devices. Read More: New EMC Guidance Released by FDA
On January 4, 2016, FDA officially released a draft guidance document Unique Device Identification: Convenience Kits, with further information regarding the Unique Device Identifier (UDI) requirements for labeling and data submission for kits. Read More: FDA Offers Clarity of UDI Application to Kits
This past year, FDA’s (Center for Devices and Radiological Health CDRH) has dealt with several widely-publicized public health issues related to medical devices. Read More: When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices
Belgian endives are a divisive vegetable: their bitterness delights some but repulses others. And even amongst Belgian endive enthusiast you’ll find some that prefer them raw – to maintain their crispness – while others like them cooked so that their bitterness comes out even more. But Belgian endives are no longer the exclusive battleground of
The U.S. Food and Drug Administration (FDA) is required by statute to maintain a list of drug products that cannot be manufactured by pharmaceutical compounding because they are demonstrably difficult to compound. In a notification released on Wednesday, December 4, FDA announced that it is accepting nominations for drug products to include on the list. In order to be considered for the inaugural list, nominations must be received by March 4, 2014.
The following is a summary of some of the key issues Congress and the Administration will be debating in 2013. Please contact us with any questions. We are happy to provide further analysis as well as insight into other areas of interest. Agriculture: Tom Vilsack is expected to stay on as Secretary of Agriculture. The
On November 26, the Food and Drug Administration (FDA) suspended the food facility registration of Sunland, Inc., a producer of nuts, and nut and seed spreads. Notably, this is the first time FDA has used its registration suspension authority, which was established by Section 102(b) of the FDA Food Safety Modernization Act (FSMA). Significantly, this
Each of the 500 largest businesses in America has been asked by the Senate Commerce Committee to describe how it deals with cybersecurity, demonstrating that government’s focus on cybersecurity is not going away despite stalled legislative efforts. On 19 September, Senator Jay Rockefeller (D-WV) sent an unprecedented letter to the chief executives of the 500 largest companies
FDA and the White House Office of Management and Budget (OMB) were recently sued by two consumer advocacy groups for failing to meet several statutory rulemaking deadlines in the FDA Food Safety Modernization Act (FSMA). In late 2011, FDA submitted four proposed rules implementing FSMA to OMB for review. The proposed rules cover Preventive Controls
The Federal Trade Commission (FTC) has obtained a $25 million settlement against the marketers of the Ab Circle Pro, an abdominal exercise device, for alleged deceptive advertising. According to the Commission, the defendants, including Fitness Brands, Inc. and Fitness Brands International, Inc., falsely promised that a three-minute workout with the Ab Circle Pro was the
President Obama recently signed into law The Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA will reauthorize for another five years the Prescription Drug User Fee Act (PDUFA V) and the various related user fee agreements between the drug and device industries and FDA. FDASIA includes provisions related to drugs, devices, generic drugs,
The Food and Drug Administration (FDA) is undergoing a major culture change, and nowhere is that impact being felt more than in the food industry. While visibly preparing new regulations to implement the Food Safety Modernization Act (FSMA), the agency has quietly become much more inspection-oriented and enforcement-minded, even under its historic authorities. Here is
U.S. businesses and foreign multinationals with U.S. tax obligations should be on alert that the elements of a major U.S. tax reform legislative package are already in development within the U.S. Congress, the Obama Administration, and in interest groups and think tanks in Washington. The make-up of this tax reform package – to be debated