Opening the Dietary Supplement Floodgates
Historically, approximately 70% of dietary supplement notifications to FDA were rejected. This high rejection rate has had a chilling...
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Burdock Group
Oct 6, 20197 min read
Regulatory Framework of Terpenes for Dietary Supplements
Terpenes are responsible for the taste, aroma, and pharmacological activities of many plants like citrus fruits, coriander, and eucalyptus.
Burdock Group
Jul 14, 20197 min read
Reading the Cannabis Leaves: Predicting the Future of CBD in Food and Dietary Supplements
On May 31st, 2019 a panel of ten FDA officials, including the acting Commissioner, Dr. Ned Sharpless, sat for hours listening to over 100...
Burdock Group Consultants
Jun 5, 20188 min read
Can a Food Be a Drug and a Supplement?
“Let food be thy medicine and medicine be thy food” — Hippocrates of Cos (ca.460 BC – ca. 370 BC) The Drug-Like Properties of Foods Many...
Burdock Group Consultants
Dec 2, 20168 min read
New FDA Dietary Supplement Guidance: Unnecessarily High Requirements for Safety Factors: Animal
The FDA’s new guidance document on new dietary ingredient notifications (NDINs) and related issues (1) contains answers to several...
Burdock Group Consultants
Oct 31, 20164 min read
Updated Health Food Registration and Notification Process in China
In China, the concept of “Health Food” encompasses both functional food and dietary supplement. It refers to any food with claimed health...
Burdock Group
Aug 31, 20167 min read
Dietary Supplements in the U.S. and Abroad: Similarities and Differences
Demand for dietary and nutritional supplements worldwide continues to increase, with steady growth in the established markets and more rapid
Burdock Group Consultants
Aug 1, 20165 min read
Some Speculation on Forthcoming Dietary Supplement Guidelines
If you liked the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues of July, 2011,...
Burdock Group Consultants
Jan 1, 20165 min read
A Message from the President: What’s on the Horizon for 2016
The last two years initiated a trend on the food side of the Food and Drug Administration (FDA) to be more responsive to populist...
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