Newsletters 9/14

Dec 1, 20093 min read

A Disingenuous Interpretation of the Word “Primarily”

The Food and Drug Administration (FDA) was originally thwarted from preventing the marketing a food for any reason other than “taste,...

Burdock Group Consultants

Sep 1, 20094 min read

GRAS Notification for Animal Feed Ingredients

The FDA’s Center for Veterinary Medicine (CVM) has announced it will begin accepting generally recognized as safe (GRAS) Notifications...

Burdock Group Consultants

Sep 1, 20092 min read

Food Factoids: Root Causes

The Wonder of Valerian Root Valerian root has a long history of use as a sedative as well as in the treatment of headaches and high blood...

Burdock Group Consultants

Sep 1, 20094 min read

Dietary Supplements for Pets and Structure Function Claims

In 2002, FDA’s Center for Veterinary Medicine (CVM) made it abundantly clear it does not believe the Dietary Supplement Health and...

Burdock Group Consultants

May 1, 20092 min read

What is Needed for a Successful GRAS? Part III

“Zig” Zigler, the motivational speaker, likes to tell the story of the $65 bargain bicycle he bought for his son many years ago. The $100...

Burdock Group Consultants

May 1, 20094 min read

Rx for Claim Substantiation (Part III) – Budgeting –

In Part I and II of this series on claim substantiation, we addressed the fact that a health claim has two essential components: a...

What is Needed for a Successful GRAS? Part II

Burdock Group Consultants

Mar 1, 20093 min read

What is Needed for a Successful GRAS? Part II

GRAS was under constant attack and FDA couldn’t offer definition for “generally recognized,” nor could the legislative history.

Burdock Group Consultants

Mar 1, 20094 min read

Rx for Claim Substantiation (Part II) – Asking the Question –

In Part I of this series on claim substantiation, we addressed the fact that a health claim has two essential components: a substance and...

Burdock Group Consultants

Mar 1, 20093 min read

Food Factoids Section

Boost Endurance with Energy Drinks Taurine, caffeine and vitamin B12. These are just some of the most popular ingredients used in...

Burdock Group Consultants

Dec 1, 20083 min read

What is Needed for a Successful GRAS?

For a successful submission, the petitioner must meet the “burden of proof” as well as the “burden of persuasion.”

Burdock Group Consultants

Dec 1, 20083 min read

Rx for Claim Substantiation (Part I) – The Claims –

A health claim can be made for a food or supplement ingredient provided the claim is substantiated by human clinical data. By definition,...

Burdock Group Consultants

Dec 1, 20083 min read

Food Factoids: Nuts, Carbs, Protein, Caffeine, Chocolate and Omega-3’s

‘Tis the Season to be Jolly – and Energized! Carbohydrates may be the enemy of some adhering to fad diets, but they are important energy...

Roadmap for Claims: A guide to establish a claim for food, food ingredients or dietary supplements

Burdock Group Consultants

Sep 1, 20081 min read

Roadmap for Claims: A guide to establish a claim for food, food ingredients or dietary supplements

Establishing a claim for foods, food ingredients or dietary supplements is not as straight-forward as it sounds, but is a complex...

Burdock Group Consultants

Sep 1, 20082 min read

Food Factoids: Health Claims

Study Implies Reaffirmed Health Claims for Oatmeal In 1997, the FDA approved a health claim statement for food labels that indicated a...

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

Aug 1, 20083 min read

Section 912 of the FDAAA could produce headaches for health and supplement claims

There has been considerable speculation about the potential fallout from Section 912 of the newly passed FDA Additives Amendment as it...

Burdock Group Consultants

Jun 1, 20082 min read

When Flavors Don a Mask: Leveraging flavor modification for a variety of nutritional ingredients

When preparing new dishes, many food innovators strive to enhance taste while retaining nutritional value. It calls for the right...

Burdock Group Consultants

Jun 1, 20085 min read

Food Factoids: Functional Foods and Beverages

Packing a “Berry” Big Punch! The acai fruit has found its way into a variety of drinks including smoothies, teas and juices, and has...

Burdock Group Consultants

Mar 1, 20082 min read

Nanotechnology and Cosmetics: Optimize Efficacy

Often, cosmetics and fragrances will produce immediate, desired results, but quickly fade as the day wears on. However, product...

Burdock Group Consultants

Mar 1, 20083 min read

Food Factoids: Nanoparticles, Vitamin B-12

“Nanovehicles” Add Nutrients to Foods There could be a new twist to your daily vitamin routine in the near future, as current research...

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