Download Handbook of Nutraceuticals Volume I PDF

TitleHandbook of Nutraceuticals Volume I
TagsAyurveda Nutrition Dietary Fiber Nutraceutical
File Size2.4 MB
Total Pages402
Table of Contents
                            Contents
Foreword
Preface
Contributors
Chapter 1. Nutraceuticals of Antiquity
Chapter 2. Nutraceuticals: Definitions, Formulations, and Challenges
Chapter 3. Potential Nutraceutical Ingredients from Plant Origin
Chapter 4. Nutraceuticals with Animal Origin
Chapter 5. Nutraceuticals with Mineral Origin
Chapter 6. Physiochemical Characterization of Nutraceuticals
Chapter 7. Development of Techniques for Analysis of Nutraceuticals with Specific Reference to Glucosamine and Coenzyme Q10
Chapter 8. Pharmacological Characterization of Nutraceuticals
Chapter 9. Biopharmaceutical and Pharmacokinetic Characterization of Nutraceuticals
Chapter 10. Regulatory Considerations for Dietary Supplements and Functional cGMPs
Chapter 11. Nutraceuticals for the Cardiovascular System
Chapter 12. Nutraceuticals in Diabetes Management
Chapter 13. Curcumin: A Versatile Nutraceutical and an Inhibitor of Complement
Chapter 14. Probiotics and Prebiotics as Nutraceuticals
Chapter 15. Nutraceuticals and Weight Management
Chapter 16. Nutraceuticals for Bone and Joint Diseases
Chapter 17. Nutraceuticals for Skin Health
Chapter 18. Tranquilizing Medicinal Plants: Their CNS Effects and Active Constituents—Our Experience
Chapter 19. Dietary Foods
Chapter 20. Antiviral Nutraceuticals from Pomegranate (Punica granatum) Juice
Chapter 21. Herbal Remedy: Safe or Not Safe? How to Use Them?
Chapter 22. Nutraceuticals: Reflections
Index
Back cover
                        
Document Text Contents
Page 2

Handbook of
Nutraceuticals

Volume 1

Ingredients, Formulations,
and Applications

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Page 201

182 HANDBOOK OF NUTRACEUTICALS: VOLUME I

The FDA will permit the use of a qualifi ed health claim provided that the fol-

lowing apply:

1. The FDA has issued a letter stating the conditions under which it will consider

exercising enforcement discretion for the specifi c health claim.

2. The qualifi ed claim is accompanied by an agency-approved disclaimer.

3. The claim meets all the general requirements for health claims in 21 CFR 101.14,

except for the requirement that the evidence for the claim meet the validity stan-

dard for authorizing a claim and the requirement that the claim be made in accor-

dance with an authorizing regulation (see the FDA’s Guidance for Industry, Interim
Procedures for Qualifi ed Health Claims in the Labeling of Conventional Human
Food and Human Dietary Supplements, July 2003).

An agency-approved disclaimer is a statement that discloses the level of scientifi c

evidence used to substantiate the health claim (see FDA Task Force Final Report:
Consumer Health Information for Better Nutrition Initiative, Attachment E—Interim
Procedures for Qualifi ed Health Claims in the Labeling of Conventional Human
Food and Human Dietary Supplements, July 2003).

To use additional health claims, an individual must submit a health claim petition

in accordance with 21 CFR 101.70. A new health claim may be used only after the

FDA issues either an authorizing regulation or a letter stating enforcement discretion

conditions for a qualifi ed health claim (21 CFR 101.14 and 21 CFR 101.70).

Structure/Function Claims

A company may make the following types of structure/function claims under

§ 403(r)(6) of The Act:

1. A statement that claims a benefi t related to a classical nutrient defi ciency disease

and that discloses the prevalence of such disease in the United States;

2. A statement that describes the role of a nutrient or dietary ingredient intended to affect

the structure or function in humans or characterizes the documented mechanism by

which a nutrient or dietary ingredient acts to maintain such structure or function; or

3. A statement that describes the general well-being from consumption of a nutrient or

dietary ingredient (21 U.S.C. 343(r)(6)).

When making structure/function claims, the claim must (1) have substantiation

that such statement is truthful and not misleading, (2) include the disclaimer, and

(3) notify the FDA no later than 30 days after the fi rst marketing of the product that

the company is making the statement in accordance with 21 CFR 101.93.

The following text must be used for the disclaimer, as appropriate:

1. Singular: “This statement has not been evaluated by the Food and Drug Admini stration.

This product is not intended to diagnose, treat, cure, or prevent any disease;” or

2. Plural: “These statements have not been evaluated by the Food and Drug Admini-

stration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

The wording of these disclaimer may not be modifi ed (21 CFR 101.93(c)). The

disclaimer must be placed immediately adjacent to the claim with no intervening

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REGULATORY CONSIDERATIONS FOR DIETARY SUPPLEMENTS 183

material or elsewhere on the same panel or page that bears the statement. In the latter

case, the disclaimer must be placed in a box and linked to the statement by a symbol

(e.g., an asterisk) placed at the end of each statement that refers to an identical symbol

placed adjacent to the disclaimer (21 CFR 101.93(d)).

The notifi cation procedures require that a manufacturer, packer, or distributor

making such a statement must do the following:

1. Notify the FDA within 30 days of fi rst marketing a product whose label or labeling

bears a statement made under § 403(r)(6) of The Act.

2. Submit an original and two copies of the notifi cation to the Offi ce of Nutritional

Products, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety

and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway,

College Park, Maryland 20740-3835.

3. The notifi cation must be signed by a person who can certify that the information in

the notifi cation is complete and accurate and that the notifying fi rm has substantia-

tion that the § 403(r)(6) statement is truthful and not misleading (21 CFR 101.93(a)

(1) and (a)(3)).

When reporting to the FDA, there is no offi cial form to use. The notifi cation may

be made by a letter containing the required information in any format that is

convenient.

The following information must be included in the notifi cation:

1. The name and address of the manufacturer, packer, or distributor of the dietary

supplement that bears the statement.

2. The text of the statement that the company is making.

3. The name of the dietary ingredient or supplement that is the subject of the

statement.

4. The name of the dietary supplement (including its brand name) on whose label, or

in whose labeling, the statement appears (21 CFR 101.93(a)(2)).

REGULATION AROUND THE WORLD

The FDA is not the only governing body trying to improve the quality and reli-

ability of dietary supplements. The governing bodies of Canada, Europe, India, Japan,

and numerous others are all trying to acknowledge the health benefi ts of supplements,

while protecting the general public. Each governing body has a slightly different

approach to controlling manufacturing and labeling, but, ultimately, these governing

bodies are moving in the same direction. As the world economy expands, the manu-

facturers and governing bodies will continue to approach one unifi ed set of standards

that will reduce manufacturer confusion and increase consumer confi dence.

REFERENCE

Food and Drug Administration. http://www.cfsan.fda.gov/~dms/dslg-toc.html. Last accessed

August 24, 2009.

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382 INDEX

conjugated linoleic acid (CLA),

246

medium-chain-triglycerides, 248

phyoestrogens, 248

overweight and obesity

health consequences of, 243–244

prevalence, 244

prevention and treatment,

244–245

Weight management, and functional food

therapeutic uses, 322

Whole Foods Markets®, 20

World Health Organization (WHO)

and Ayurveda, 4

Z

Zeaxanthin, 278

Zinc, 211

absorption, 121

action mechanism, 121

adverse effects, 122

bioavailability, 121

defi ciency, 122

dietary sources, 122

distribution, 121

elimination, 121

interactions, 122

uses, 121

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