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LABELLING REQUIREMENT & LABEL
CLAIM FOR DIETARY SUPPLEMENTS
&RDA IN THE US
By Dimple Marathe
SanjivaniCollege of Pharmaceutical Education and Research Kopargaon.
REGULATORY AGENCIES FORTHE
REGULATION:
 Dietary Supplement Health& Education Act, 1994
 Federal trade commission (FTC)
 DSHEA authorized to provide accurate information to consumers. Label
must include: Must be labeled as “Dietary Supplements”
1) Name of each ingredient
2) Quantity of each ingredient
3)Total weight of all ingredient if a blend
4) Identity of part of plant derived from
5) Term “Dietary Supplement”
6) Must contain nutritional labeling information also
7)Calories, fat, sodium
8)Name and place of business of manufacturer, packer, or distributor
9)Directions for use
Upld Labelling requirement & label claim for dietary supplements.pptx
LABEL CLAIMS
 According to the FDA regulations, three types of claims can be made on
the food and dietary supplement:
 health claims.
 nutrient content claims.
 structure/function claims.
 Other claims.
 These are governed by the:
 Nutrition Labeling and Education Act (NLEA),
 Food and Drug Administration Modernization Act (FDAMA)
 Dietary Supplement Health and Education Act of 1994 (DSHEA)
HEALTH CLAIMS
 DSHEA authorized use of FDA approved “Health claims” on label
 Describe the connection between a nutrient or food substance and a
disease or health-related condition (diet/disease relationship)
 Statements may be included on the label that give the manufacturers
description of the role of the D/S
 Not authorized by FDA
 Manufacturer resp. for accuracy and truth of statement
FDA APPROVED HEALTH CLAIMS
 Folic acid and neural tube pregnancies
 Calcium and osteoporosis
 Sodium and hypertension
 Fruits and vegetables and cancer
 Dietary lipids and cancer
 Saturated fat and cholesterol and coronary artery disease
NUTRIENT CONTENT CLAIMS
 Nutrient content claims describe the level of a nutrient in the product, using
terms such as free, high, and low, or they compare the level of a nutrient in
a food to that of another food, using terms such as more, reduced, and lite.
 e.g., “not a low sodium food”, "only 200 mg of sodium“
STRUCTURE AND FUNCTION CLAIMS
 Manufacturers may use S/F claims
 Not authorized by FDA
 Must be true and not misleading
 Must be accompanied by disclaimer
 “This statement has not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure or prevent any disease” Examples:
 “Calcium builds strong bones”
 “Antioxidants maintain cell integrity”
OTHER CLAIMS
 Health-maintenance claims:
“Maintains healthy circular system”
 Non-disease claims:
“helps you relax”
“for muscle enhancement”
 Cannot make maintenance claims about osteoporosis and other “serious
diseases”
 Can make health claim about relationship between a product or substance
and the disease if approved
RECOMMENDED DAILY ALLOWANCE IN US:
RDA. The average amount of a nutrient a healthy person should get each day. RDAs
vary by age, gender and whether a woman is pregnant or breastfeeding. For example,
the RDA for vitamin C is 80 mg a day for a pregnant teenager and 90 mg a day for men.
RDAs are developed by the Food and Nutrition Board at the Institute of Medicine of the
National Academies.
Upld Labelling requirement & label claim for dietary supplements.pptx
Upld Labelling requirement & label claim for dietary supplements.pptx
Upld Labelling requirement & label claim for dietary supplements.pptx
REFERENCE
 1. https://www.slideshare.net
 2. https://www.ncbi.nlm.nih.gov
 3. https://www.fda.gov

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  • 1. LABELLING REQUIREMENT & LABEL CLAIM FOR DIETARY SUPPLEMENTS &RDA IN THE US By Dimple Marathe SanjivaniCollege of Pharmaceutical Education and Research Kopargaon.
  • 2. REGULATORY AGENCIES FORTHE REGULATION:  Dietary Supplement Health& Education Act, 1994  Federal trade commission (FTC)  DSHEA authorized to provide accurate information to consumers. Label must include: Must be labeled as “Dietary Supplements” 1) Name of each ingredient 2) Quantity of each ingredient 3)Total weight of all ingredient if a blend
  • 3. 4) Identity of part of plant derived from 5) Term “Dietary Supplement” 6) Must contain nutritional labeling information also 7)Calories, fat, sodium 8)Name and place of business of manufacturer, packer, or distributor 9)Directions for use
  • 5. LABEL CLAIMS  According to the FDA regulations, three types of claims can be made on the food and dietary supplement:  health claims.  nutrient content claims.  structure/function claims.  Other claims.  These are governed by the:  Nutrition Labeling and Education Act (NLEA),  Food and Drug Administration Modernization Act (FDAMA)  Dietary Supplement Health and Education Act of 1994 (DSHEA)
  • 6. HEALTH CLAIMS  DSHEA authorized use of FDA approved “Health claims” on label  Describe the connection between a nutrient or food substance and a disease or health-related condition (diet/disease relationship)  Statements may be included on the label that give the manufacturers description of the role of the D/S  Not authorized by FDA  Manufacturer resp. for accuracy and truth of statement
  • 7. FDA APPROVED HEALTH CLAIMS  Folic acid and neural tube pregnancies  Calcium and osteoporosis  Sodium and hypertension  Fruits and vegetables and cancer  Dietary lipids and cancer  Saturated fat and cholesterol and coronary artery disease
  • 8. NUTRIENT CONTENT CLAIMS  Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite.  e.g., “not a low sodium food”, "only 200 mg of sodium“
  • 9. STRUCTURE AND FUNCTION CLAIMS  Manufacturers may use S/F claims  Not authorized by FDA  Must be true and not misleading  Must be accompanied by disclaimer  “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease” Examples:  “Calcium builds strong bones”  “Antioxidants maintain cell integrity”
  • 10. OTHER CLAIMS  Health-maintenance claims: “Maintains healthy circular system”  Non-disease claims: “helps you relax” “for muscle enhancement”  Cannot make maintenance claims about osteoporosis and other “serious diseases”  Can make health claim about relationship between a product or substance and the disease if approved
  • 11. RECOMMENDED DAILY ALLOWANCE IN US: RDA. The average amount of a nutrient a healthy person should get each day. RDAs vary by age, gender and whether a woman is pregnant or breastfeeding. For example, the RDA for vitamin C is 80 mg a day for a pregnant teenager and 90 mg a day for men. RDAs are developed by the Food and Nutrition Board at the Institute of Medicine of the National Academies.
  • 15. REFERENCE  1. https://www.slideshare.net  2. https://www.ncbi.nlm.nih.gov  3. https://www.fda.gov