On August 8, 2016 the U.S. Food and Drug Administration's (FDA's) "Deeming Regulation" became effective, extending the Agency's regulatory authority over tobacco products beyond traditional cigarettes, smokeless tobacco and roll-your-own tobacco products to include "other" tobacco product categories such as cigars, pipe tobacco, hookah/shisha, electronic vapor and e-liquid products, and components and parts of such products. Now, manufacturers of newly deemed products are subject to the Tobacco Control Act (TCA) requirements, including reporting ingredients to FDA. Section 904(a)(1) of the TCA requires "each tobacco product manufacturer or importer, or agents thereof" to submit to FDA a list of all ingredients that are "added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product...." On October 28, 2016, the FDA Center for Tobacco Products (CTP) released a revised Draft Guidance document regarding Listing of Ingredients in Tobacco … [Read more...] about FDA’s Ingredient Listing Deadline Rapidly Approaching for Manufacturers of E-Vapor, E-Liquid and Other Deemed Tobacco Products
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Michigan's amendments to Part 121 of the Natural Resources and Environmental Protection Act become effective on March 16, ninety days after they were signed into law by Governor Snyder on Dec. 16, 2015. The statutory amendments were developed through a stakeholder process and are designed to provide more flexibility in order to increase recycling and decrease costs for generators of liquid industrial by-products, which include materials like used oil, leachate and industrial wastewaters.There are many familiar terms and requirements you will no longer find in the revised statutory language. Most noticeably, the word “waste” has been replaced by “by-product” to assist with removing any barriers the word “waste” may imply and allow more flexible disposition of these materials. For determining what is a “liquid industrial by-product” (“LIB” or “by-product”), the revised definition has removed the enumerated list of … [Read more...] about Flexibility is Key Under Michigan’s Revised Liquid Industrial By-Products Statute
OSHA enforces the whistleblower provisions of 22 separate statutes. The number of retaliation claims filed under the various statutes has risen steadily each year and the cost of investigating them has placed a tremendous strain on OSHA’s fiscal and physical resources. Searching for a way to reduce the costly and time consuming process of an investigation and litigation, OSHA conducted pilot Alternative Dispute Resolution (ADR) programs in two of its regions from October 2012 to September 2013. The pilot programs were well received by employers and whistleblowers alike, allowing for quick resolutions of disputes without the need of enduring a lengthy and burdensome OSHA investigation. These pilot programs were such a success that on August 19, 2015, OSHA published CPL 02-03-006, Alternative Dispute Resolution (ADR) Processes for Whistleblower Protection Program, which affords all OSHA regions with the option of adopting an ADR program at the discretion of … [Read more...] about OSHA’s New Option for Resolving Whistleblower Complaints: What Employers Need to Know
On December 23, 2015, the Food and Drug Administration’s (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. This was a positive step towards helping pharmaceutical companies invest and implement emerging technologies that improve overall drug quality.Pharmaceutical companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies. These issues have caused significant delays in providing patients access to drugs and have the potential of harming patients. Manufacturers have argued that new and emerging technologies will help avoid these kinds of issues but use of such technologies may delay the approval of new drugs. This guidance provides a pathway for pharmaceutical companies wanting to modernize manufacturing technology to help prevent adverse drug quality.By the very nature of new, innovative technology, … [Read more...] about FDA Releases Guidance to Assist Development of Advanced Technology to Modernize Pharmaceutical Manufacturing
I’ve strongly felt like there’s a lot of noise when you’re trying to understand consensual dispute resolution (also known as, CDR) in India. There’s, unfortunately, no uniformity in the way we understand labels like ‘conciliation’ and ‘mediation’ – our law and literature, both scarce and pointing towards a divide.I’m of the belief that the dichotomy is damaging to mediation practice, as well as the efforts of many who are preaching the gospel of CDR and access to justice. This piece has the following four propositions to deliver – (A) that mediation and conciliation are the same, and in doing so, reconciling the key defences that suggest the opposite, that they are exclusive to each other in absolute terms;(B) how does one reconcile the use of two separate words (‘mediation’ and ‘conciliation’) in the 1996 Act, and the CPC; (C) how does one reconcile the logic behind the use of two different sets … [Read more...] about Why Do We Need A Mediation Law? After All, Mediation & Conciliation Are The Same Thing, Right?