News & Analysis as of

Why The Recent Indictments of Nutritional Supplement Executives Matter To All Manufacturers/Distributors

Our firm has substantial experience in representing nutritional supplement manufacturers.  For that reason, the news that the Justice Department and federal agencies (such as the FTC) is engaged in a nationwide sweep of such...more

Will the FDA’s Proposed Rule on the Sanitary Transportation of Food Apply to International Shipments?

Yes, the FDA’s Proposed Rule, required to be published by March 31, 2016, will apply to food shipments being transported into the U.S., directly, by motor or rail vehicle, or transferred onto a motor or rail vehicle for...more

BUY NOW: Use in Commerce for Mobile Applications

For a mobile application developer, clearing the Apple® App Store's® often lengthy approval process and seeing the mobile application available for purchase may seem like the last necessary step to establish use of the name...more

Three Issues That Manufacturers/Distributors Should Consider When Drafting Terms and Conditions (T&Cs)

Over the last few years, our team has worked with several manufacturers and distributors on their terms and conditions of sale and/or purchase.  We have even developed a questionaire that we typically use when we speak to a...more

Due Diligence and Risk Priorities (Part III of IV)

Believe it or not, life principles can be used in compliance, especially in due diligence. I always tell my kids that life has a way of setting priorities. As you get older, life becomes simpler and your priorities become...more

Food Recall Events: The Importance of Evaluating Your Insurance Coverage Before a Voluntary and Mandatory Food Recall

Food recalls are on the rise as consumer protection regulations become more stringent, and they can be costly events. There can be significant expenses associated with removing impacted products from stores; reimbursing...more

FDA promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive

The U.S. Food and Drug Administration (FDA) continues to publish new Rules as part of its implementation of the Food Safety and Modernization Act (FSMA). In addition to new animal feed and food safety rules, the FDA recently...more

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

Food Safety Does Not Exist In A Vacuum, and Neither Do the FSMA’s Rules: What the New Rules on Preventive Controls for Human and...

On September 17, 2015 the FDA published the first two of its seven rules in conjunction with the Food Safety Modernization Act’s (the “FSMA”) regulatory scheme. The rules, which focus on Current Good Manufacturing Practices...more

What’s the Real Effect of OSHA’s Revamped Inspection Process, the “Enforcement Weighing System?”

On October 1, OSHA started its “Enforcement Weighing System,” which means that OSHA Compliance Officers and Area Offices will be under less pressure to complete a number of inspections and will receive credit for separate...more

Class Certification Victory in Building Products Case

In a case that should be of interest to manufacturers and distributors, and especially to suppliers of building products, lawyers from our class action defense team recently defeated class certification in a building products...more

Watch out for Modern Slavery

The Modern Slavery Act 2015 comes into force next month. The UK is at the forefront of a global move to tackle human trafficking and prevent slavery in supply chains. In June the G7 leaders declared their commitment to the...more

SEC Announces First “Distribution in Guise” Case

The Securities and Exchange Commission (“SEC”) on September 21, 2015, brought the first of its long-awaited “distribution in guise” cases against a mutual fund adviser and distributor. The case follows a number of warnings...more

Competition News September 2015

The French Macron law and the framework of commercial relations - Promulgated on August 6, 2015, the law to promote growth, activity and equal economic opportunity, known as the “Macron law”, provides for a series of...more

Antitrust Matters - September 2015

Antitrust investigations are no longer limited to a nation’s borders, or even to a region. Enforcers are more and more sharing information and coordinating their investigative efforts as they strive to uniformly enforce the...more

Swag: What Can Your Hotel Restaurant Accept for Free?

A distributor is knocking on your hotel restaurant’s door, offering key chains from a hot new distillery for your customers. A brewery just dropped off coasters for use in the restaurant’s bar. And a winery offered cork...more

FSMA Rules for Preventive Controls for Human and Animal Food Manufacturing Finalized

On September 10, 2015, FDA issued a prepublication notice of its long-anticipated preventive control rules for human and animal food under the Food Safety Modernization Act (FSMA). The Current Good Manufacturing Practice,...more

Food Safety’s Shifting Paradigm

The recent news that Stewart Parnell, convicted former Peanut Corporation of America CEO, is facing a possible life sentence as a consequence of his role in the nine deaths and hundreds of illnesses caused by PCA’s salmonella...more

EPA Proposes New Rules for Pharmaceutical Wastes That Qualify as RCRA Hazardous Wastes

On August 31, 2015, the Administrator of the U.S. Environmental Protection Agency (“EPA” or the “Agency”) signed a proposed rule that would establish special management standards for pharmaceutical wastes that are classified...more

Successful Strategies for Doing Business in Asia: Taiwan (Updated)

WHAT ROLE WILL THE GOVERNMENT OF TAIWAN PLAY IN APPROVING AND REGULATING FOREIGN DIRECT INVESTMENT? Three types of Taiwan government approval requirements may be relevant to direct foreign investment in Taiwan: •...more

Congressional Decision Looms on U.S. Export-Import (Ex-Im) Bank

For those in the manufacturing community, one of the significant events of the summer was when Congress allowed the authority of the Export-Import Bank of the United States (Ex-Im) to lapse. The main goal of the bank is to...more

Successful Strategies for Doing Business in Asia: Korea (Updated)

WHAT ROLE WILL THE GOVERNMENT OF KOREA PLAY IN APPROVING AND REGULATING FOREIGN DIRECT INVESTMENT? The Korean government takes an active, investor-friendly role in approving and regulating foreign direct investment....more

Successful Strategies for Doing Business in Asia: India (Updated)

1. WHAT ROLE WILL THE GOVERNMENT OF INDIA PLAY IN APPROVING AND REGULATING FOREIGN DIRECT INVESTMENT? Historically, India has been a regulated economy since its independence. The government of India (GOI) launched a new...more

The Case Of GINA And The "Devious Defecator"

In a case dubbed “the mystery of the devious defecator” by a Georgia federal district judge, an Atlanta jury recently awarded a $2.2 million verdict against a company that requested DNA samples from two workers in an attempt...more

Distribution Basics

The process of distribution is critically important to craft breweries; but, it is commonly misunderstood in relation to the overall operational success of a brewery. A common misconception by those entering the craft beer...more

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