FSSAI Issues Draft Notification on Advertisements and Claims Regulation, 2018

Through a notification uploaded on 23 March 2018, the FSSAI has notified the draft regulations pertaining to claims and advertisements by food business operators in respect of their food products. These regulations are aimed at establishing fairness in claims and advertisements of food products and make food businesses accountable for such claims/ advertisements so as to protect consumer interests. The FSSAI has also invited comments, views, and suggestions which are to reach the FSSAI by 21 April 2018. This Food Safety and Standards (Advertisements and Claims) Regulation, 2018 (after consideration of stakeholder comments and finalization) will come into force on the date of their final publication in the Gazette on India.

While some claims, listed in various schedules of these regulations are permitted to be made by FBOs without the need for seeking prior approval but there are other non-standardised claims that require approval and these must also have the sound scientific basis when applying for approval. FSSAI has laid down the detailed procedure for approval nutrition and health claims other than those specified in these regulations.

These regulations contain :

• general principles for claims and advertisements
• criteria for nutrition claims (including nutrient content or nutrient comparative claims) non-addition claims (including non-addition of sugars and sodium salts)
• health claims (reduction of disease risk)
• claims related to dietary guidelines or healthy diets
• conditional claims
• claims that are specifically prohibited
• procedures for approval of claims and redressal of non-compliances under these regulations

Advertisements in respect of a food product that undermines the importance of healthy lifestyles or portrays the food product as a complete replacement of normal meal are not permitted. Further, food businesses are also prohibited to advertise or make claim undermining the products of other manufacturers so as to promote their own food products or influence consumer behavior. Any person, including a third party, who advertises or is a party to the publication of any misleading advertisement not complying with these regulations would be penalized with a fine extending up to Rs.10 lakh, as per Section 53 of the Food Safety and Standards Act 2006.

Clause1: Definitions

The FSSAI has defined terms that will be used in the regulation like

• Advertisement: means any audio or visual publicity, representation or pronouncement made by means of any light, sound, smoke, gas, print, electronic media, internet or website and includes through any notice, circular, label, wrapper, or other documents
• Claim: means any representation which is printed, oral, audio or visual and states, suggests, or implies that a food has particular qualities relating to its origin, nutritional properties, nature, processing, composition or otherwise
• Digital interactive media: any media platform, service or application providing electronic communications, using the Internet, online services, and/or electronic and communication networks, personal digital assistant including mobile phone and interactive game consoles which allows the receiving party to interact with the platform, service or application
• Reduction of disease risk claims: suggest or imply that consumption of such food(s) or food constituents, in the context of total diet, reduce the risk factor of developing a disease or health-related condition. Reduction of disease risk means significantly altering a major risk factor(s), for a disease or health-related condition. Diseases have multiple risk factors and altering one of these risk factors may or may not have a beneficial effect. The presentation of risk reduction claim must ensure, for example, by use of appropriate language and relevance to risk factors, that consumers do not interpret them as prevention claims

Examples:

1. A healthful diet low in nutrient or substance A may reduce the risk of disease D. Food X is low in nutrient or substance A.”
2. A healthful diet rich in nutrient or substance A may reduce the risk of disease D. Food X is rich in nutrient or substance A.”;

• Health claim: any representation that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health
• Marketer: persons or companies, including advertisers, sales promoters and direct marketers, including e- platforms who or on whose behalf marketing communications are published or disseminated for the purpose of promoting their products or influencing consumer behavior;
• Marketing Communications: includes advertising as well as other techniques, such as promotions, sponsorships, and direct marketing, and shall be interpreted broadly to mean any communications produced directly by or on behalf of marketers intended primarily to promote products or to influence consumer behavior;
• Nutrition claim: suggests or implies that a food has particular nutritional properties including but not limited to the energy value and to the content of protein, fat, and carbohydrates, as well as the content of vitamins, minerals and other, permitted listed nutrients;
• Nutrient content claim: directly or indirectly describes the level of a nutrient contained in a food. (Examples: contains/source of; high in; rich in; low in etc.);
• Nutrient comparative claim compares the nutrient levels and/or energy value of two or more foods. (Examples: reduced; less than; fewer; increased; more than etc.);
• Non-addition claim: is made when an ingredient has not been added to a food, either directly or indirectly. The ingredient is one whose presence or addition is permitted in the food and which consumers would normally expect to find in the food
• Nutrient Function Claim: describes the physiological role of the nutrient in growth, development and normal functions of the body. Example: nutrient ‘A’ (naming a physiological role of nutrient A in the body in the maintenance of health and promotion of normal growth & development). Food X is a rich source of / high in nutrient ‘A’;
• Other Function Claim: describes the specific beneficial effects of the consumption of food(s) or their constituents, in the context of the total diet or normal functions or biological activities of the body. Such claims relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health. Example: “Substance A (naming the effect of substance A on improving or modifying physiological function or biological activity, associated with health). Food Y contains X grams of substance A.”
• Recommended Dietary Allowances (RDA)” means the amounts of dietary energy and nutrients considered sufficient for maintaining good health by the people of a country.

Note: For this regulation, RDA values as provided in ICMR Dietary Guidelines for Indians shall be applicable. If Indian RDA is not available for any nutrient then values provided in Codex/WHO Guidelines shall be applicable.

Clause 2

All other words and expressions used herein and not defined, but defined in the Act, rules or regulations made thereunder, shall have the meanings assigned to them in the Act, rules or regulations, respectively.

Clause 3 General Principles

Every Food Business Operator and marketer while advertising and publishing or disseminating marketing communication meant for promotion of the sale of any article of food including labeling claims shall comply with the following general principles.

Provided that advertisements and claims in respect of food meant for infants shall be in accordance with the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply, and Distribution) Act, 1992 as amended in 2003 (IMS Act).

General Principles

1. Claims must be truthful, unambiguous, meaningful, not misleading and help consumers to comprehend the information provided as given below

• It shall not encourage or condone excess consumption of a particular food.
• It shall not state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients as required by the body.
• Where the claimed benefit is related to or dependent on the method of preparation of the food the same shall be provided on the label
• It shall specify the number of servings of the food per day for the claimed benefit.

2. The claim that a food has certain nutritional or health attributes shall be scientifically substantiated by validated methods of quantifying the ingredient or substance that is the basis for the claim.
   1. Where the meaning of a trademark, brand name or fancy name appearing in the labeling2, 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.
3. All disclaimers related to a claim shall appear in the same field of vision.
4. No claim or promotion of sale, supply, use,  f5and consumption of articles of foods shall be made using FSSAI logo and license number.
5. Advertisements shall also not undermine the importance of healthy lifestyles.
6. Advertisements for food or beverages shall not be promoted or portrayed as a meal replacement.
7. Claims in advertisements shall not be inconsistent with information on the label or packaging of the food or beverage.
8. Every declaration which is required to be made on advertisements under these regulations shall be conspicuous, legible and prominent.

Nutrition Claims

Nutrition claims made may be:

• Nutrient content claim
• Nutrient comparative claim

The following do not constitute nutrition claims

• The mention of substances in the list of ingredients
• The mention of nutrients as a mandatory part of nutrition labeling;
• Quantitative or qualitative declaration of certain nutrients or ingredients on the label if required by any other national legislation

Nutrient content or Nutrient comparative claim or any synonymous claims

Maybe made in accordance with the conditions specified in Schedule I provided flexibility in the wording of a nutrition claim may be made as per Schedule II or the use of any other word if they are in accordance with conditions specified in Schedule I and the meaning of the claim are not altered. Where a nutrient comparative claim is made, the foods shall be different versions of the same food or similar foods being compared and shall be easily identifiable and the relative difference of the claimed parameter between the compared foods is

• at least 25% in the energy value or nutrient content and a minimum absolute difference equivalent to the figure defined as “low” or as a “source” in Schedule I, for claims about energy or macronutrients and sodium respectively
• at least 10% of RDA, for claims about micronutrients other than sodium
• In addition, where a comparative claim is made, the identity of the food(s) being compared and the amount of difference expressed as a percentage, fraction or an absolute amount shall be given in close proximity to the claim.

Non-Addition Claims

Non-addition of sugars – Claims regarding the non-addition of sugars to a food may be made provided the following conditions are met

• No sugars of any type have been added to the food (Examples: sucrose, glucose, honey, molasses, corn syrup, etc.)
• The food contains no ingredients that contain sugars as an ingredient (Examples: jams, jellies, sweetened chocolate, sweetened fruit pieces, etc.)
• The food contains no ingredients containing sugars that substitute for added sugars (Examples: non-reconstituted concentrated fruit juice, dried fruit paste, etc.)
• The sugars content of the food itself has not been increased above the amount contributed by the ingredients by some other means (Example: the use of enzymes to hydrolyze starches to release sugars).

Non-Addition of Sodium Salts – Claims regarding the non-addition of sodium salts to a food, including “no added salt”, may be made provided the following conditions are met:

• The food contains no added sodium salts, including but not limited to sodium chloride, sodium tripolyphosphate
• The food contains no ingredients that contain added sodium salts, including but not limited to sauces, pickles, pepperoni, soya sauce, salted fish, fish sauce
• The food contains no ingredients that contain sodium salts that are used to substitute for added salt.

Additional Conditions

Additional conditions and/or disclaimer statements may be used with non-addition claims to assist consumer understanding of the claims within countries. Disclaimer statements should appear in close proximity to, on the same side and in the same prominence as the claim.

Health Claims

Health claims shall comply with all the conditions and declarations as given below:

Health claim 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

If the claimed benefit is attributed to a constituent in the food, for which an RDA value is established, the food in question shall be

• a source of or high in the constituent, in accordance with conditions specified in Schedule I, in the case where increased consumption is recommended
• or low in, reduced in or free of the constituent, in accordance with conditions specified in Schedule I, in the case where reduced consumption is recommended.
• A statement of the quantity of a nutrient or a substance that is the subject of the claim, per serve and 100g or 100ml of the food.
• Where applicable mention of the target group or where certain contraindications exist the mention of vulnerable groups.
• The use of the food to obtain the claimed benefit in the context of the diet and other lifestyle factors where appropriate.
• The maximum safe intake of the food or it’s constituent, if necessary.
• No reduction of disease risk claims shall be made that is not in accordance with the conditions specified in Schedule III.
• Food articles that are fortified as per Food Safety and Standards (Fortification of Foods) Regulations, 2017 may make health claims as provided in Schedule IV.
• Where a claimed benefit is attributed directly to the product or used on labels, advertisements or any other means as a mode of communication to the consumer, it shall be based on statistically significant results from appropriate scientific research study(s), OR a well-designed, randomized double blind (Unless technically not feasible) clinical study(s), conducted by OR under guidance of established research institutions, in line with the principles of GCP (Good Clinical Practices) and Peer Reviewed OR published in a Peer reviewed reputed scientific journal with an impact factor of not less than 1 at the time of submission of paper

Claims related to Dietary Guidelines or Healthy Diets

• Claims may be made related to a “healthy diet” or any synonymous term referring to the pattern of eating as per ICMR dietary guidelines for Indians and the label shall carry a statement relating the food to the pattern of eating described thereof.
• Foods, which are described as part of a healthy diet, balanced diet, shall not be based on selective consideration of one or more aspects of the food. They shall also satisfy the criteria for other major nutrients related to the dietary guidelines, based on scientific evidence.
• Foods shall not be described as “healthy” or be represented in a manner that implies that a food in and of itself will impact health.

Conditional Claims

• A claim may be made where a food is by its nature high or low or free of a specific nutrient provided the name of the nutrient or substance is preceded by the words ‘natural / naturally’ in the claim statement.

Explanation: “a naturally low (naming a nutrient or substance) food” or “a naturally (naming the nutrient or the substance) free food”.

• Claims containing adjectives such as ‘natural’, ‘fresh’, ‘pure’, ‘original’, ‘traditional’, ‘premium’, ‘Finest’, ‘Best’, ‘Authentic’, ‘Genuine’, ‘Real’ etc. when used, shall be in accordance with conditions laid down in Schedule V. However, claims containing words or phrases like “home-made”, “home cooked” etc. which may give an erroneous impression to the consumer shall not be used.

Prohibited Claims

• No claims shall be made which refer to the suitability of the food for use in the prevention, alleviation, treatment or cure of a disease, disorder of particular physiological condition.
• Labels not to use words implying recommendations by medical/ nutrition/ health professionals: There shall not appear in the label of any package, containing food for sale the words “recommended by the medical/nutrition/health professionals” or any words which imply or suggest that the food is recommended, prescribed, or approved by medical practitioners or approved for medical purpose.
• No product shall claim the term ‘added nutrients’ if such nutrients have been added merely to compensate the nutrients lost or removed during processing of the food.
• Foods for Special dietary uses or foods for special medical purposes shall not carry a claim unless specifically permitted under any other regulation
• Claims which could give rise to doubt or suspicion about the safety of similar food or which could arouse fear shall not be made.
• No advertisements and/or claims for articles of foods shall be made by any food business operator that undermines the products of any other manufacturer for the purpose of promoting their products or influencing consumer behavior.

Approval of claims

The Food Business Operator or marketer may seek prior approval from the Food Authority for nutrition and health claims /claims other than those that are defined and for which criteria are laid out under these regulations or any other regulations made under FSS Act,

• Procedure for approval of claims FBOs may submit an application along with applicable fees as prescribed by FSSAI consisting of the following information, namely
• Hard/soft copy of the claim to be made
• Name of the ingredient, nutrient or substance on the basis of which the claim is made
• Validated Method of analysis of ingredient or substance for which the claim to be made
• Scientific information or materials substantiating the claim
• How a claim is clear and meaningful and helps consumers to comprehend the information provided?
• Any other useful information.
• The Food Authority itself or may appoint an agency/panel to carry out preliminary scrutiny of the application submitted by Food Business Operators/marketers for approval of their claims.
• On scrutiny, deficiencies, if any, shall be informed to applicant within 30 days from the date of receipt of application. The applicant shall provide the information required by the Food Authority within 15 days of the receipt of the communication, failing which the application shall be rejected without any further reference. The fees paid by the applicant for recognition shall not be refunded under any circumstances.
• After scrutiny, the Food Authority may pass a speaking order either for approval or rejection of concerned claims. The Food Authority may also suggest an amendment for the concerned claim. The amended claim may be submitted within 30 days for reconsideration
• In case of rejection, the Food Business Operator/marketer shall not use that claim in their advertising and marketing communication in respect of articles of food offered for sale or for the promotion of sale, supply, use or consumption.

Redressal of non-compliance

Any person who advertises or is a party to the publication of any advertisement or claim(s) not complying with this regulation shall be penalized as per section 53 of Food Safety and Standards Act, 2006

Procedure for redressal of non-compliance

• The misleading claims shall be referred to the Food Authority or maybe the suo moto activity of the Authority. The Food Authority itself or may appoint an agency or panel to analyze the misleading claims.
• In case the agency or Food Authority requires information from the Food Business Operator/marketer, the Food Authority will seek clarification failing which action will be initiated as per regulation
• The Food Business Operator or the marketer shall submit the information sought within 15 days from the issue of the letter.
• After scrutiny of the submitted information, the Officer nominated by the Authority will pass a speaking order either for acceptance or rejection of submitted clarification on misleading claims.
• The Food Authority may also suggest an improvement for the concerned. The improved claim shall be intimated to the Food Authority within 15 days after issuance of the letter.

Corrective Advertisement

If the advertisement is found to be in violation of these regulations, the Food Authority by an order may require them concerned FBO/advertiser to issue corrective advertisement(s) through the same medium for neutralizing the effect of misleading advertisement.

                                                       Schedule – I

NUTRITION CLAIMS

A claim that a food containing the nutrient mentioned in column (2) is likely to have the benefits as mentioned in column (3) or has the same meaning for the consumer may be made subject to the conditions as mentioned in column (4) below

# 1 kcal =4.2kj

*To make these claims the specific nutrient in the food must provide the minimum amount of energy specified.

Schedule – II

Synonyms which may be used for claims defined in these regulations

Schedule – III

HEALTH CLAIMS: REDUCTION OF DISEASE RISK

Schedule – IV

Health Claims for Fortified Food Articles

Schedule – V

Use of certain words or phrases

The following words or phrases used as specified in column 1 shall be used according to the conditions listed in column 2: