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Category Archives: Food & Agriculture

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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On November 2, 2015, the Food and Drug Administration (FDA) released a draft guidance document, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” describing the types of EMC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On January 4, 2016, FDA officially released a draft guidance document Unique Device Identification: Convenience Kits, with further information regarding the Unique Device Identifier (UDI) requirements for labeling and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 FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices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 FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices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,

FDA’s Changing Culture: What Food Companies Need to Know

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. tax reform: elements of reform already being developed by Congress

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

Ninth Circuit Suggests Flexibility in Type Size for Food Statements of Identity

While the Ninth Circuit’s recent ruling in POM Wonderful v. Coca-Cola has received attention for its holding on preemption, the decision provides interesting statements in the technical realm of the FDA’s type-size requirements for statements of identity in food labeling. The issue involved the statement of identity for Coca-Cola’s Pomegranate Blueberry Minute Maid drink, “Pomegranate

FTC Requires Two “Gold-Standard” Studies in Sketchers Consent Decree

For the second time in eight months, the Federal Trade Commission (FTC) has obtained a multi-million dollar settlement as the price paid for alleged deceptive advertising of footwear promoted to help customers lose weight and strengthen muscles. The FTC announced its $40 million settlement with Sketchers earlier this week. According to the FTC, Sketchers incorrectly

FDA Strategic Plan Emphasizes Food Safety Law Implementation

The Food and Drug Administration has released the final strategic plan for its Foods and Veterinary Medicine Program for 2012–2016, which will guide the agency’s food-related priorities for the foreseeable future.  The plan in large part reflects FDA’s efforts to implement the Food Safety Modernization Act and leaves little doubt that FSMA implementation is the agency’s

Welcome to HL Focus on Regulation

Hello and welcome to the Hogan Lovells Focus on Regulation. We are delighted to introduce you to our government regulatory blog. In an increasingly complex global market, it’s more important than ever to understand, anticipate, and quickly respond to a wide range of regulatory challenges. Our goal is to use this blog to bring you