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FDA vs. FSSAI – Nutrient Claims – I

July 13, 2018

India ranks 7th in the top 64 US food import sources list prepared by the US Department of Agriculture. Data in the following table throws light on the dollar-spend of the US on packaged food sourced from India along with growth percentage in comparison with the previous calendar year.

Product Categories CY 2017 Food Imports from India to US,

In Thousands of Dollars


CY 16 – CY 17

Packaged Food (Ag Only) 1,376,786 22.78%
Packaged Food (Total) 3,634,340 35.34%

Note: The “ag only” total processed foods category excludes distilled spirits, other alcoholic beverages, and prepared/preserved seafood.

Source: U.S. Census Bureau Trade Data

Many of the products in the packaged food products category manufactured by Indian companies are sold in multiple geographies including the US. The onus is on the manufacturer/exporter to be aware of local regulations concerning food safety, claims, packaging and labelling. An Indian manufacturer who sells products in India has to ensure compliance with the Food Safety and Standards Act while the same product has to be compliant with the provisions of The Federal Food, Drug, and Cosmetic Act for it to be fit for selling in the US.

As per the Food Labeling Guide developed by the US Department of Health and Human Services, “The Food and Drug Administration (FDA) is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA’s jurisdiction. The Nutrition Labeling and Education Act (NLEA), which amended the FD&C Act requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements.”

This blog series will demystify basis for making various claims about a product as defined by the FDA as well as look at the equivalent Draft Food Safety and Standards (Claims and Advertisement) Regulations (FSSR) 2018, on such claims, for the benefit of importers who also cater to the domestic market here.

Nutrient Content Claim (NCC), according to FDA, is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., “low fat”, “high in oat bran” or “contains 100 calories”). A NCC may be no more than twice as prominent as the statement of identity (the name of the food) on a label. Specifically, the type size of the claim may be no more than two times the type size of the statement of identity. If the style of the type makes the claim unduly prominent compared to the statement of identity, it will be in violation of the regulations (even if the size of the type is appropriate). 21 CFR 101.13(f). 

NCC Synonyms:

Regulation “Free” “Low” “Reduced/Less” Others
FDA Zero, No, Without, Trivial source of, Dietary insignificant source of


Definitions for “Free” for meals and main dishes are the stated values per labeled serving but are not defined for calories

Little, Few (for calories), Contains a small amount of, low source of Lower, Fewer (for calories)


“Modified” maybe used in statement of identity


Definitions for meals and main dishes are same as for individual foods on a per 100 g basis

For “Free”, “Very Low”, or “Low”, must indicate if food meets a definition without benefit of special processing, alteration, formulation or reformulation; e.g., “broccoli, a fat-free food” or “celery, a low calorie food”
FSSR Zero, No, Without, Trivial, Negligible Source, Dietary insignificant source of Little, few (for calories), contains a small amount of, low source of Lower, fewer (for calories) “Increased/More” – Higher

NCC Definitions:

Nutrients Regulation Free Low Reduced/Less Comments
Calories FDA

21 CFR 101.60 (b)

Less than 5 cal per RACC[1] and per labeled serving 40 cal or less per RACC (and per 50g if RACC is small)


Meals and main dishes: 120 cal or less per 100 g

At least 25% fewer calories per RACC than an appropriate reference food (for meals and main dishes, at least 25% fewer calories per 100 g) “Light” or “Lite”: if 50% or more of the calories are from fat, fat must be reduced by at least 50% per RACC. If less than 50% of calories are from fat, fat must be reduced at least 50% or calories reduced at least 1/3 per RACC

(under the header – Energy)

Not more than 4 kcal per 100 ml for liquids Not more than 40 kcal per 100 g for solids


20 kcal per 100 ml for liquids


Table-top sweeteners (which have equivalent sweetening properties to 6g of sucrose – approx. 1 teaspoon of sucrose providing 24 kcal) can bear this claim if they contain no more than 4 kcal (17kJ)/portion

In our next blog, we will look at how the regulations stand for Total Fat and Cholesterol declarations.


Courtesy: Aravind Ravi, Technical Documentation Manager at ManageArtworks.

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