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Burdock Group
Feb 4, 20204 min read
Opening the Dietary Supplement Floodgates
Historically, approximately 70% of dietary supplement notifications to FDA were rejected. This high rejection rate has had a chilling...
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
Oct 1, 20185 min read
The Ever-Elusive Exercise-in-a-Pill
The concept of creating exercise in a pill, which in theory would allow for loss of body fat without a diet or exercise intervention, has...
Burdock Group Consultants
Nov 7, 20176 min read
What’s in My Thanksgiving Food? The Good, the Bad and the Yummy
Football, family and — most important — feasting. It is almost Thanksgiving! In the United States, we have transformed quite a bit as a...
Burdock Group Consultants
Oct 10, 20174 min read
What data will FDA consider as evidence that a substance is a pre-DSHEA dietary ingredient?
On Oct.3, 2017, the Food and Drug Administration (FDA) held a public meeting to discuss the development of a list of substances that were...
Burdock Group Consultants
Sep 7, 20171 min read
Why Is 2017 a Better Year for Dietary Supplements Than 1997?
For FDA, 2017 marks another year that the agency continues to endanger the consumer by demanding such a high threshold for NDIN filing.
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
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If you liked the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues of July, 2011,...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
Apr 1, 201612 min read
International Regulations on Dietary Supplements: Challenges and Opportunities
An aging population has increasingly become a global phenomenon, not just in developed countries, but also among emerging regions. 1 The...
Burdock Group Consultants
Jan 1, 20166 min read
Bayer’s Court Battle with FTC: Implications for the Dietary Supplement Industry
This case illustrates that the government can be found to be unconvincing in its arguments against a manufacturer.
Burdock Group Consultants
Aug 1, 20156 min read
Dietary Supplement Regulation: The Consequences of Multilateral Administrative Actions
The quality of dietary supplements has been under increasing scrutiny as of late. A webinar presented by the Food and Drug Law Institute...
Burdock Group Consultants
Mar 1, 20153 min read
From Snake Oil to Supplements: Understanding Consumer Mindset is Key to Marketing Dietary Supplement
“Snake oil” is used today as an expression that refers to the fraudulent health products or unproven medicine. The term “snake oil” is...
Burdock Group Consultants
Mar 1, 20115 min read
Adverse Event Reporting for Dietary Supplements and OTCs: What is required and when? How does postm
No over-the-counter (OTC) drug or dietary supplement manufacturer wants a consumer to sicken, become incapacitated or otherwise be harmed...
Burdock Group Consultants
Sep 1, 20082 min read
A Changing Landscape with Dietary Supplement Excipients
Few dietary supplements are consumed “naked.” Instead, nearly all dietary supplements are administered in a dosage form that includes...
Burdock Group Consultants
Jun 1, 20065 min read
Dietary Supplements – A Special Case of Regulations
According to the 1994 Dietary Supplement Health and Education Act (DSHEA), a dietary supplement is a “product taken by mouth that...
Burdock Group Consultants
Mar 1, 20063 min read
Dietary Supplements – Second Class Safety? Part I
When Congress passed the Dietary Supplement Heath & Education Act (DSHEA) in 1994, the intent was to give consumers the option to...
Burdock Group Consultants
Dec 1, 20021 min read
Labeling Weight Loss Dietary Supplements
In order to curtail deceptive advertising, the American Herbal Product Association (AHPA) has proposed a draft framework for voluntary...
Burdock Group Consultants
Dec 1, 20021 min read
Claims for Dietary Supplements and Functional Food Ingredients
Health study findings abound! One cannot avoid them. Just turn on the evening news or pick up a magazine and you will encounter yet...
Burdock Group Consultants
Aug 1, 20022 min read
Six Supplements Selected by Institute of Medicine for Safety Determination
The Institute of Medicine (IOM) has selected six dietary supplements for a new evaluation program it developed for the FDA. The safety...
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