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Category Archives: Food & Agriculture

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One step closer to new rules on organic farming

After three years of negotiations, the European Union is nearing the end of a long process to simplify and harmonise the rules for organic food production and the labelling of organic products. Council Regulation (EC) 834/3007 currently defines the minimum standards for organic products that are produced, manufactured, imported into, sold or traded within the

UK ‘Sugar Tax’ – Draft Regulations Published

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

UK Food Standards Agency reviewing Feed Law Code and Guidance

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).

Draft EU List of Authorised Novel Foods Published

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

Majority in favour of improving fairness in EU food supply chain

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

ECJ sides with farmers on genetically modified crops

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

CJEU upholds principle of free movement of goods for food supplements

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

FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests

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

New EMC Guidance Released by FDA

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

FDA Offers Clarity of UDI Application to Kits

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

When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices

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 on the frontline for price fixing by farmers

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

FDA Calls for Nominations of Difficult to Compound Drugs

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.

Review of issues for 2013

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

FDA Suspends Sunland’s Registration; First Use of New Suspension Authority

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

Senate Commerce Committee’s Probe of Fortune 500 Corporate Cybersecurity is Unprecedented; Responses Requested Oct. 19

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 OMB Sued For Failing to Meet FSMA Deadlines

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

FTC Obtains Multi-Million Dollar Settlement Against Marketer of Fitness Gear

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 signs The Food and Drug Administration Safety and Innovation Act: Summary of certain key provisions

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,