Manufacturers

News & Analysis as of

Congress Overhauls 1976 Federal Chemical Regulation Law

Gives EPA Broad Mandate to Evaluate Safety of All Chemicals and Practical Authority to Ensure Safe Use - On Tuesday, the U.S. House of Representatives overwhelmingly passed a bipartisan bill that, for the first time in...more

Opportunities for Increased Drug Sales to the VA

Pharmaceutical manufacturers that produce drugs in non-designated countries under the Trade Agreements Act (TAA) may now have an opportunity to increase their sales to the United States government. The Department of Veterans...more

The implications of the transition to a ‘circular economy’, and overview of the content and current status of draft EU...

In this client alert we discuss the implications of the transition to a ‘circular economy’ for producers of, and traders in, raw and/or recycled materials of all kinds, manufacturers of products and actors in all stages of...more

Health Update - May 2016

Actions to Advance Infant and Early Childhood Mental Health - Editor's Note: Children's earliest experiences—both positive and negative—impact their brain formation and in turn their social and emotional, physical,...more

New York, New York: The Status of Regulation of Children's Products in the Empire State

Recently, Albany County, New York enacted the “Toxic Free Toys Act” (the Act) prohibiting the sale of any children’s products in the county that contain certain heavy metals and chemicals. The Safe to Play Coalition (the...more

Chinese High Court Decision Confirms the OEM Exception to Trade Mark Infringement for the First Time

For years, overseas companies that manufacture goods featuring their brands in China only for export have faced issues where a Chinese National had registered their trade mark in China. This is because the owner of the...more

BPA in Plastics Requires a Prop 65 Warning — For Food Containers, California Imposes a Generic Point-of-Sale Warning

Last year the State of California added Bisphenol A (BPA) to its list of chemicals known to cause cancer or reproductive harm under Prop 65 [the Safe Drinking Water and Toxic Enforcement Act of 1986], a law which requires...more

[Webinar] Get the Record Straight: OSHA's New Injury Recordkeeping E-Submission Rule - June 7th, 1:00pm EDT

As the clock winds down on the Obama Administration, OSHA has been rushing out a series of proposed amendments to its Injury & Illness Recordkeeping regulations (29 C.F.R. Part 1904). Among them is a new final rule to...more

Most Frequently Hacked Industries Now Includes Manufacturing

Second only to health care, the manufacturing industry is now one of the most frequently hacked industries (according to IBM’s 2016 Cyber Security Intelligence Index). And more importantly, automotive manufacturing was the...more

FDA’S Draft Guidelines for 3D Printing of Medical Devices

On May 10, 2016, the FDA issued a document entitled Technical Considerations for Additive Manufacturing Devices. The document consists of 25 pages of “draft” guidelines that provide the FDA’s “initial thinking on...more

What We Have Here is a Failure to Communicate (in the Workplace)

For the third consecutive year, OSHA’s second most cited violation was for failure to comply with the Hazard Communication Standard (HCS). The HCS was promulgated in 1983 and requires chemical manufacturers and importers to...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

Oakland’s New Medical Cannabis Regulations

On May 17, 2016, the Oakland City Council approved new detailed regulations intended to mainstream medical cannabis retail and commercial operations and pave the way for the City to accept cannabis business permit...more

Legal Update: Regulation of E - Cigarettes

On May 5, 2016, the federal Food and Drug Administration (FDA) announced new regulations governing the sale of e-cigarettes, hookahs, dissolvable tobacco, pipe tobacco, cigars and other tobacco products (ENDS). The new rule...more

Trimming Some Fat From Statin Litigation With Daubert and Preemption

In the mythical days of product liability yore, a big drug litigation was spurred by a notable event—like a study describing a new risk appearing in a major journal, a significant labeling change because of new or greater...more

EPA Intends to Promulgate Final Nanoscale Materials Rule in October 2016

According to an item in the Spring 2016 Regulatory Agenda, the U.S. Environmental Protection Agency (EPA) is “developing a final rule related to” its April 6, 2015, proposal to require reporting and recordkeeping requirements...more

EPA Promulgates SNUR for Functionalized CNTs (Generic)

On May 16, 2016, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 55 chemical substances that were the subject of premanufacture notices (PMN),...more

FDA Regulation of E-Cigarettes: The What, When, and Warnings

On May 10, 2016, the Food and Drug Administration (FDA) issued a final rule extending its regulation of "tobacco products" to include electronic cigarettes and similar products, sometimes called Electronic Nicotine Delivery...more

Former Currency Manufacturer Manager Convicted and Sentenced In UK for Making Corrupt Payments

On May 11, following a five-week trial in a London court, a former manager of an Australia-based banknote manufacturer was convicted of four counts of making corrupt payments to a foreign official in violation of the...more

Snapchat Sued in Georgia Distracted Driving Lawsuit

A recently filed Georgia lawsuit seeks to hold Snapchat liable for a high speed motor vehicle accident that allegedly occurred as a result of the at-fault motorist’s use of the social media application. Snapchat users...more

What You Need to Know About U.S. Law: Product Regulations and Importing into the United States - What You Don't Know CAN Hurt You...

What do the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Federal Drug Administration (FDA), Department of Agriculture (USDA), and Environmental Protection Agency (EPA) have in common? Each is, of...more

Attention Taxpayers: New IRS Rules May Deem Debt to Be Stock

In April, the IRS proposed rules that would treat debt between related corporations as stock for U.S. tax purposes. These rules would apply to all corporations (including regular C corporations, S corporations, foreign...more

FDA to Regulate E-Cigarettes, Cigars and Other Tobacco Products

Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule. On May 10, 2016, the U.S. Food and...more

Watch Out: Ontario Ministry of Labour Inspection Blitzes/Initiatives Are Coming

The Ontario Ministry of Labour recently announced its 2016 and 2017 enforcement blitz and initiative schedule. In an effort to emphasize the importance of protecting workers’ rights and ensuring employer compliance with both...more

FDA Issues Draft Data Integrity Guidance For Current Good Manufacturing Practices

On April 14, 2016, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Data Integrity and Compliance with CGMP Guidance for Industry” (the “Draft Guidance”). Noting that the FDA has increasingly...more

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