Dietary Supplement

Dietary Supplement Legal Update

10/5/2016| Article

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement industry has grown to more than $35 billion in annual sales. This robust growth of the industry reflects not only increased interest among consumers in these products, but also significant advancements in nutrition and wellness science and new legal and regulatory challenges to appropriately monitor this marketplace. There have been several recent developments on the legal and regulatory issues challenging the dietary supplement industry, both on the federal and state level.

 

Porzio Dietary Supplement Cover Page (1)

Dietary Supplement Legal Update – September 2016

9/22/2016| Article

Editors: Kevin M. Bell, W. John McKeague, Ph.D. and Richard J. Oparil

The dietary supplement industry continues to confront legal and regulatory challenges. The recent significant developments in this Dietary Supplement Legal Update issue include: 

  • FDA'S New Dietary Ingredient Guidance and Patents
  • FDA Issues Final GRAS Rule on Food Ingredients
  • FDA Questions Status of Vinpocetine as a Dietary Supplement
  • DEA Lists Kratom as a Controlled Substance

To read the full issue, please click here.

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Dietary Supplement Legal Update - April 2016

4/15/2016| Article

Editors: Kevin M. Bell and Richard J. Oparil

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement industry has grown to more than $35 billion in annual sales. This robust growth of the industry reflects not only increased interest among consumers in these products, but also significant advancements in nutrition and wellness science and new legal and regulatory challenges to appropriately monitor this marketplace. There have been several recent developments on the legal and regulatory issues challenging the dietary supplement industry, both on the federal and state level. 

In this issue:

  • Voluntary GMO Labeling Bill Fails In Senate; Vermont GMO Law Challenge Pending
  • Senator McCaskill Requests DOJ Records Of Enforcement Actions After Attorney General Lynch Warns On Supplements
  • Senator Heinrich Asks FDA To Increase Enforcement
  • FTC Reaches Settlement With Companies Falsely Promoting Their Personal Care 
  • California Supreme Court Holds "Organic" Unfair Competition Claim Is Not Preempted By Federal Law
  • FDA Sued Over Legality Of Action On GE Salmon
  • FDA Issues Revised Guidance Concerning Dietary Supplements Labeling
  • Comments Requested on Label Statements
  • FDA Sends Warning Letters On Acacia Rigidula
  • Groups Seek FDA's Revocation Of Perchlorate As A Food Additive
  • Pom Wonderful Loses False Advertising Case Against Coca-Cola 
  • Chobani Yogurt Labelling Case On Appeal To Ninth Circuit 
  • New Jersey Supplement Company Owner Pleads Guilty
  • Pure Green Coffee Companies Enter Into Consent Order
  • 5-Hour Energy Wins Trademark Infringement Case
  • California Proposes Changes to Prop. 65 Regulations

 To read the full issue, please click here.

 

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Dietary Supplement Legal Update - August 2016

8/12/2016| Article

Editors: Kevin M. Bell and Richard J. Oparil

A variety of legal and regulatory challenges exist in the dietary supplement industry, including federal and state legislatures, agencies and courts. Some of the more significant developments are summarized in the current issue, including:

  • FDA Issues NDI Draft Guidance
  • GMO Labeling Bill Signed into Law
  • Puerto Rico Secretary of Health Issues Administrative Order on Dietary Supplements
  • FDA Issues Medical Food Guidance
  • FDA Deeming Regulations Made Final
  • Chobani Yogurt Labeling Appeal Stayed
  • Senator McCaskill Makes Inquiry After Study Shows Dietary Supplements Can Make Chemotherapy Less Effective
  • Update on CBD
  • Summary of California Supreme Court Proposition 65 Case, Environmental Law Foundation v. Beech-Nut Nutrition Corp.

To read the full issue, please click here.

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Patent Trial and Appeal Board Issues Updated Rules for Post-Issuance Proceedings

4/6/2016| Article

DC Client Alert - April 2016

by Scott A.M. Chambers, Ph.D. and Matthew D. Zapadka

On March 31, 2016, the U.S. Patent and Trademark Office updated the rules of its Patent Trial and Appeal Board (PTAB) for inter partes review, post-grant review, and covered business method patent proceedings. These most recent rule changes could shift the calculus of challenging patents before the PTAB and could alter the timing in which a patent owner files suit.

Notable rules changes include the following:

• New testimonial evidence can now be submitted with a patent owner's preliminary response;
• A Rule 11-type certification must now be filed with papers filed in a proceeding, exposing attorneys to possible sanctions for failing to conduct an adequate pre-filing investigation;
• Certain situations now call for a narrower, district court-like claim construction that could reduce the number of patents found unpatentable; and
• The current page limit is replaced with a word count limit.

Some of these changes will have greater impact than others, the scope of which will take time to be seen. Nonetheless, the change that allows a patent owner to file testimonial evidence with its preliminary response and potentially narrowed claim constructions will undoubtedly alter strategies employed by both parties.

Continued PTAB rule changes will impact the way parties assert patents and defend against alleged patent infringement. These new rules may change the strategies that have been evolving over the last several years. Litigants must fully consider their options during patent lawsuits to fully leverage the most advantageous options to reach their desired outcome.

To read the full article, please click here.

CRISPR Interference at the USPTO

4/21/2016| Article

DC Client Alert

by John McKeague, Ph.D.

The CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) Technology was first identified in bacteria and is an RNA based system to help protect bacteria against viral infections. It has broad applications and is poised to be a valuable tool in genome engineering.

Earlier this year, the United States Patent and Trademark Office (USPTO) declared an interference between a patent application owned by University of California Berkeley, University of Vienna and Emmanuelle Charpentier (collectively, University of California), and patents owned by Massachusetts Institute of Technology and The Broad Institute, Inc. and patents owned by Massachusetts Institute of Technology, The Broad Institute, Inc. and the President and Fellows of Harvard College (collectively, Broad Institute). In doing so, the USPTO declared that the University of California is the Senior Party and the Broad Institute is the Junior Party, and proposed one count in the interference. 

The interference is in the motions phase, and each party has already requested permission to file various motions. The USPTO has authorized some motions and deferred authorization on others.

To read the full article, please click here

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