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FDA vs. FSSAI – Health Claims Part I


Summary: Following the blog series on nutrition claims, this series will compare and demystify basis for health claims on food products as prescribed by the United States Code of Federal Regulations (CFR) Title 21 Section 101.14 and the equivalent Indian regulation, ‘Food Safety and Standards (Claims and Advertisement) Regulations, 2018’.

This post introduces the reader to the basis for health claims and concludes with food-health relationships – calcium, vitamin D with osteoporosis.

According to 21 CFR 101.14, “Health claim means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition.” The eligibility is determined as follows: the substance must be associated with a disease or health-related condition for which the general U.S. population, or an identified U.S. population subgroup (e.g., the elderly) is at risk, or, alternatively, the petition submitted by the proponent of the claim otherwise explains the prevalence of the disease or health-related condition in the U.S. population.

The 2018 draft of the Food Safety and Standards (Claims and Advertisement) Regulations define a health claim as “any representation that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health.” This draft regulation lists nutrient/food health relationship and standardized statements for health claims (reduction of disease risk). E.g. a food low in sodium may have a label claim as ‘diets low in sodium may reduce the risk of high blood pressure; a disease associated with many factors’.

Note:

    1. In India, food businesses have to seek prior approval from FSSAI for nutrition and health claims other than those specified in the regulation.
    2. Where the meaning of a trade mark, brand name or fancy name appearing in the labelling, presentation or advertising of a food is such that it may imply a nutrition or health claim, all the general & specific conditions, prohibitions and restrictions as laid down in these Regulations shall be applicable.

According to 21 CFR 101.14(a)(5) the model health claim statement will have the following structure:

Substance (nutrient, food component) + May reduce risk of + Name of disease or condition + Reference to total dietary patterns + Does not imply degree of risk reduction

Disqualifying nutrient levels for health claims are:

    • Total Fat <=13.0 g (<=19.5 g for main dish and <=26 g for meal products)
    • Saturated Fat <=4.0 g (<=6 g for mail dish and <=8 g for meal products)
    • Cholesterol <=60 mg (<=90 mg for mail dish and <=120 for meal products)
    • Sodium <=480 mg (<=720 mg for main dish and <=960 for meal products)
    • Minimum nutrient contribution requirements (Jelly Bean Rule): 10% or more of at least one of vit. A (500 IU), vit. C (6 mg), calcium (100 mg), iron (1.8 mg), fiber (2.5 mg) or protein (5 g)

As per Food Safety and Standards (Claims and Advertisement) Regulations, 2018, health claims must consist of two parts:

    • Information on the physiological role of the nutrient or substance or an acceptable diet-health relationship followed by
    • Information on the composition of the product relevant to the physiological role of the nutrient or substance or the accepted diet-health relationship

For a given nutrient/food-health relationship, let us look at the model statements prescribed by FDA as well as the Indian Regulation.

Nutrient/Food – Health RelationshipModel StatementCriteria for Claim
FDA2018 Food Safety and Standards Regl., IndiaFDA2018 Food Safety and Standards Regl., India
Calcium and

Osteoporosis

21 CFR 101.72

Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis

or

Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.

Adequate Calcium (or Calcium and Vitamin D) intake throughout life, in a balanced

diet are essential for bone health and to reduce the risk of osteoporosis

High in calcium (excellent source) and

A. Phosphorus cannot exceed calcium content

B. Identifies target population

C. Must be in bioavailable form

D. States factors other than calcium is important

E. States that calcium is important throughout life

A. The food is a source or high in calcium or in calcium and vitamin D

and

B. A statement that the beneficial effect is

obtained with a daily recommended intake

(RDA)

Calcium and Vitamin D and OsteoporosisAdequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis

or

Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.

High in calcium and vitamin D (excellent source)

Next up in this series, we will be comparing the health claim requirements for Fat and Cancer and Sodium and Hypertension.

Courtesy: Aravind Ravi, Technical Documentation Manager at ManageArtworks.

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