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December 2014 Issue
Last Updated Monday, December 22 2014
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Related Searches: CRO Testing Regulatory Functional Food
Maximizing Your IP Portfolio
Gregory Stephens, RD, Windrose Partners
January 2, 2014
Patent protection can strengthen your company’s position in the marketplace.   Read More »
2013 Regulatory Review
Todd Harrison & Erin Warren, Venable
January 2, 2014
FDA upped the ante in terms of its Warning Letters related to GMP violations and permissible health claims.   Read More »
The End of Botanical Supplements in the U.K.?
Joerg Gruenwald, President, analyze & realize ag
January 2, 2014
Lack of clarity regarding what constitutes an unregistered herbal medicine vs. a legal botanical food supplement may jeopardize legitimate products.   Read More »
Shut Up & Take Your Meds
Erik Goldman, Holistic Primary Care
December 3, 2013
While there has been progress in the movement of holistic approaches into the mainstream, U.S. healthcare is still by and large all about the meds.  Read More »
Product Liability Insurance Exclusions: What’s in Your Policy?
Greg Doherty, Poms & Associates
December 3, 2013
Each carrier has its own unique exclusionary wording, which is constantly changing, so it’s important to examine your exclusion list each year.  Read More »
Rough Road Ahead for Medical Foods?
Gregory Stephens, RD, Windrose Partners
November 1, 2013
Recent FDA activity suggests increased scrutiny of the category and more aggressive enforcement.  Read More »
Structure/Function Claims: A Bright-Line Rule or Ambiguity?
Todd Harrison, Partner, Venable
November 1, 2013
Keep claims simple and write them in a manner that assumes your product helps to support a normal structure/function of the body, rather than trying to correct an abnormal condition.  Read More »
Notes on Novel Foods
Joerg Gruenwald, President, analyze & realize ag
November 1, 2013
Safety assessments are essential for manufacturers in order to market new ingredients successfully.   Read More »
Building Better Botanical Ingredient Documentation
Donna Webster, PhD & Steven Dentali, PhD, Herbalife
November 1, 2013
Doubtless you have heard ‘if it’s not written down, it didn’t happen.’ What should you have in writing when it comes to botanical ingredients?  Read More »
Monsanto Takes Healthcare Conference Out for a ‘Spin’
Erik Goldman, co-founder and editor, Holistic Primary Care
October 1, 2013
A few months ago I received a master class in how the Big Boys play the spin game.   Read More »
Product Liability Insurance Basics: An Update
Greg Doherty, Poms & Associates
October 1, 2013
Here are some important tips to ensuring your company gets the best coverage.  Read More »
Pharmaceuticals & Dietary Supplements Converge
Gregory Stephens, RD, Windrose Partners
September 9, 2013
It appears the relationship between these two markets may not be as adversarial as it was in years past.  Read More »
Foreign Supplier Verification
Todd Harrison, Erin Seder & Matthew Rabinowitz, Venable
September 9, 2013
FDA has issued a proposed regulation detailing requirements for importers of food, including dietary supplements.   Read More »
European Health Claim Regulation: Unifying the EU?
Joerg Gruenwald, analyze & realize ag
September 9, 2013
Absence of guidance regarding the regulatory status of botanicals continues to leave industry questions unanswered.  Read More »
Strength & Potency: Do You Know The Difference?
Steven Dentali, PhD, Herbalife International of America, Inc.
September 9, 2013
Constituent percent of extracts should be referred to as strength, with potency measurements to define the biological impact.  Read More »

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