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FDA vs. FSSAI – Health Claims Part Finale


Summary: Following the blog series on nutrition claims, this series compares and demystifies 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’. Part I focused on the basis for health claims and concluded with food-health relationships – calcium and vitamin D with osteoporosis. Part II discussed the relationships between Fat and Cancer, Sodium and Hypertension and Saturated Fat, Cholesterol and Heart Disease. Part III discussed the relationships between Potassium, Blood Pressure and Stroke and also touched upon some of the unique nutrient-health relationships stipulated in the FDA regulation.

As FDA and FSSAI govern foods and nutrients in different geographies, there are certain unique food-health relationships specific to each of these geographies. It is recommended to peruse the respective regulations for more details on claim requirements for these unique foods/nutrients.

In this series finale, we will discuss:

  1. The basis for packaged food brands to use certain words or phrases in their pack labels for promoting the product as per the latest FSSAI regulation.
  2. Relative claims specified in the FDA 21 CFR.

Use of certain words or phrases in pack labels:

  • Natural – As per FSSAI, a single food, derived from a recognized source, plant, animal, microorganism or mineral and to which nothing has been added and which have been subjected only to such processing which would only render it suitable for human consumption like:
    • Smoking without chemicals, cooking processes such as roasting, blanching and dehydration;
    • Freezing, concentration, pasteurization, and sterilization; and
    • Packaging done without chemicals and preservatives
    • Permitted food additives that are obtained from natural sources
    • Prohibition: Compound foods shall not themselves be described directly or by implication as “natural” but such foods may be described as “made from natural ingredients.”
  • Fresh
    • FSSAI
      • Shall only be used on products which have not been processed in any manner except, washed, peeled, chilled, trimmed or cut, or other processing necessary for making the product safe for consumption without altering its basic characteristics in any manner. If such processing also leads to extension in the shelf-life of the product the term “fresh” shall not be used.
      • Food containing additives and/or subjected to packaging, storing or any other supply chain processes that control freshness shall not be termed as “freshly stored”, “freshly packed” etc.
    • FDA
      • When used in a manner which suggests that a food is unprocessed, the term “fresh” means that the food is in a raw state and has not been frozen or subjected to any form of thermal processing or preservation, except:
        • The addition of approved waxes or coatings;
        • The post-harvest use of approved pesticides;
        • The application of a mild chlorine wash or mild acid wash on produce; or
        • The treatment of raw foods with ionizing radiation not to exceed the maximum dose of 1 kiloGray in accordance with 21 CFR 179.26, 21 CFR 101.95(a) and 21 CFR 101.95(c)
        • “Fresh frozen” or “frozen fresh” means the food has been quickly frozen while still fresh (i.e., recently harvested when frozen). Appropriate blanching before freezing is permitted. “Quickly frozen” means freezing using a system such as blast-freezing (i.e., sub-zero Fahrenheit temperature with fast moving air directed at the food) for a sufficient length of time to freeze quickly to the center of the food with virtually no deterioration. 21 CFR 101.95(b)
      • Pure
        • Shall only be used to describe a single ingredient food to which nothing has been added and which is free from avoidable contamination and the levels of unavoidable contaminants shall need to be significantly below the levels given in the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 or in any other standard given under Food Safety and Standards Act, Rules and Regulations thereof. Prohibited: Compound foods. But compound foods can claim “made with pure ingredients.”
        • “Pure” shall not be included in any brand or fancy names, nor in coined or meaningless phrases, in such a way as to imply that a food that does not meet the criteria above is pure or made from pure ingredients.
      • Healthy
        • The term “healthy” and related terms (“health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily” and “healthiness”) may be used if the food meets the following requirements: 21 CFR 101.65(d)(2)
      • Premium, Finest, Best, Authentic, Genuine, Real
        • Used only if the label and/or advertisement also clarify in what way the overall quality is tangibly justified and why the particular term has been used.
      • Traditional
        • Shall demonstrably be used to describe a recipe, fundamental formulation or processing method for a product that has existed for a significant period running over generations, should have been available substantially unchanged, for that same period.
      • Original
        • Shall only be used to describe a food that is made to a formulation, the origin of which can be traced, and that has remained essentially unchanged over time. It should not contain replacements for major ingredients. It may similarly be used to describe a process, provided it is the process first used in the making of the food, and which has remained essentially unchanged over time, although it may be mass-produced
        • To be termed “original”, a product shall not have changed to any material degree and shall remain available as the ’standard’ product when new variants are introduced. A product re-introduced onto the market after a period of absence shall only be described as “original” if it can be shown to meet these criteria. 

Relative Claims:

As per FDA, to bear a relative claim about the level of a nutrient, the amount of that nutrient in the food must be compared to an amount of nutrient in an appropriate reference food as specified below (21 CFR 101.13(j)(1)):

“Light”

  • A food representative of the type of food bearing the claim (e.g., average value of top three brands or representative value from valid data base), and Similar food (e.g., potato chips for potato chips)

“Reduced” and “Added” (or “Extra,” “Plus,” “Fortified,” and “Enriched”)

  • An established regular product or average representative product, and Similar food.

“More” and “Less” (or “Fewer”)

  • An established regular product or average representative product, and
  • A dissimilar food in the same product category which may be generally substituted for the labeled food (e.g., potato chips for pretzels) or a similar food

Notes:

  1. For all relative claims, the percent (or fraction) of change and identity of reference food must be declared immediately adjacent to the most prominent claim. 21 CFR 101.13(j)(2)(i) and 21 CFR 101.13(j)(2)(ii)
  2. Quantitative comparison of the amount of the nutrient in the product per labeled serving with that in the reference food must be declared either adjacent to the claim or on the information panel. 21 CFR 101.13(j)(2)(iv)(A)
  3. A relative claim for decreased levels of a nutrient may not be made if the nutrient content of the reference food meets the requirement for a “low” claim for that nutrient (e.g., 3 g fat or less). 21 CFR 101.13(j)(3)

The purpose of this blog series is to sensitize the readers about the basic regulatory requirements in FDA and FSSAI for making health claims on packaged food products. The regulations also cover implied claims, other nutrient content claims in addition to what was discussed in this series. If there is a claim that is not covered in either of the regulations, then there are provisions that state that explicit permission need to be taken from the nodal agencies before a brand prints these claims on a product label. With this, we have come to the end of this final article. Hope the series was informative and useful. Appreciate if you can share your thoughts and comments.

Courtesy: Aravind Ravi, Technical Documentation Manager at ManageArtworks.

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