GRAS Questions: Why Should I Invest in a GRAS when Everyone is Already Selling My Ingredient?
“Why should I invest in a GRAS when everyone is already selling my ingredient?” Well, to be frank – it’s the law. “Any substance that is...
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Burdock Group
- Jul 14, 2019
- 7 min
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...
burdockgroupconsul
- Sep 6, 2018
- 3 min
Dietary Supplements Containing Pure or Highly Concentrated Caffeine – Potential Adulteration
In response to the increase in caffeinated dietary supplements in the marketplace and public health risks associated with oral intakes of...
burdockgroupconsul
- Jul 10, 2018
- 3 min
Phytonutrients Beneficial Food Components, but Safety Testing Still Necessary
The term “phytonutrient” is defined in the Merriam-Webster dictionary as “a bioactive plant-derived compound (such as resveratrol)...
burdockgroupconsul
- Jun 5, 2018
- 8 min
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...
burdockgroupconsul
- May 1, 2018
- 4 min
“Informed Decision Making” a Priority for Responsible Stakeholders in Dietary Supplement
The University of Mississippi (Ole Miss) is the home to the National Center for Natural Products Research (NCNPR), a division of the...
burdockgroupconsul
- May 1, 2018
- 10 min
FDA’s Hostile Take-Over of GRAS, Part III: It Started Earlier Than We Think
You would think any application of the GRAS1 process would be a legitimate pathway to federal compliance unless expressly prohibited by...
burdockgroupconsul
- Apr 3, 2018
- 11 min
Modernization of Cosmetics Regulation Act of 2018
The cosmetics industry has been largely self-regulating since passage of the Food, Drug, and Cosmetic Act of 1938; however, the proposed...
burdockgroupconsul
- Apr 3, 2018
- 4 min
“Natural” Ingredients in Dietary Supplements for Sports Nutrition: Unfounded Assumption of Safety
In 2016, sports nutrition dietary supplements sales in the United States (U.S.) totaled $5.7 billion dollars, which was approximately...
burdockgroupconsul
- Mar 6, 2018
- 6 min
FDA’s Hostile Take-Over of GRAS, Part II: FDA’s Assault on Legitimacy of GRAS Expert Pan
The week of November 13, 2017, is notable because FDA released two documents relating to guidance for conclusions of GRAS1 status and...
burdockgroupconsul
- Feb 6, 2018
- 5 min
“Self”-GRAS in AAFCO’s Official Publication a Win-Win
A newsletter article published in the Burdock Advisor a year ago1 described an existential threat to the AAFCO system of approval of Feed...
burdockgroupconsul
- Feb 6, 2018
- 4 min
FSMA Key Requirements: Food Safety Plans and Preventive Controls Qualified Individuals
In case you were not already overwhelmed with the acronyms used in the food industry and associated regulations, the Food Safety...
burdockgroupconsul
- Jan 9, 2018
- 5 min
Filing a Citizen Petition to FDA: How It Works and What It Can Accomplish
Is there a regulation or order related to food that you would like the U.S. Food and Drug Administration (FDA) to issue, amend or revoke?...
burdockgroupconsul
- Dec 5, 2017
- 10 min
Is This FDA’s Hostile Take-Over of GRAS or Is It Simply Establishing Some Ground Rules?
Quantity & Quality of Evidence The first, “Regulatory Framework,” brings up some interesting issues, if not in a slightly overbearing...
burdockgroupconsul
- Oct 10, 2017
- 4 min
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...
burdockgroupconsul
- Sep 7, 2017
- 3 min
Burdock Group’s Work With BioTech Startup Captozyme Results in Successful GRAS Determination o
After working with the Burdock Group to recently obtain a successful self-contained GRAS (Generally Recognized As Safe) determination for...
burdockgroupconsul
- Sep 7, 2017
- 1 min
Why Is 2017 a Better Year for Dietary Supplements Than 1997?
Looking at industry, 2017 is a better year than 1997 for dietary supplements, as industry has matured from a plethora of cowboys (with...
burdockgroupconsul
- Aug 1, 2017
- 5 min
Don’t Build Me a Cadillac: All I Want Is a Ford
The above dialogue is a common one in consulting and usually refers to an opinion on the safe use of an ingredient, or a GRAS...
burdockgroupconsul
- Jul 11, 2017
- 4 min
“Clean” Labels Must Also Mean Safe Foods
There has recently been an increased interest in cooking, as evidenced by the increase in the number of televised cooking shows, internet...
burdockgroupconsul
- Mar 21, 2017
- 1 min
Petfood Forum 2017: Speaking Engagement Teaser on ‘The FDA GRAS Final Rule: Impacts on Getting
To be compliant with federal law, an ingredient added to food (including pet food) must be approved by FDA for its intended use as a food...
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