9. Advertising Aspects

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9. Advertising Aspects

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Food for Special Dietary Uses (FSDU)
India

This section provides information on regulations on advertising and if there are any restrictions or approval processes.

9.1 Applicable Advertising Regulation

Category

Food for Special Dietary Uses

1. The Food Safety and Standards Act, 2006 [Ref 1]

Definition: (Section 3 (b)) ―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, invoice or other documents.

Restrictions of advertisement and prohibition of unfair trade practices are defined under Section 24.
Penalty for misleading advertisement under Section 53.

2. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purposes, and Prebiotic and Probiotic Food) Regulations, 2022 [Ref 2]

Food Safety and Standards (Nutra) Regulations, 2022 are in the process of draft publication and its final notifications are likely to take more time. Therefore, it has been decided to operationalize the provisions of these regulations [Ref 2] with effect from 1st April 2022. This will supersede FSS (Health Supplements, nutraceuticals, Food for Special Dietary Use, food for Special Medical Purposes, Functional Food, and Novel Food) Regulations, 2016, and any amendments made thereunder.

This regulation works in accordance with FSS (Claims and Advertisements) Regulations, 2018 for all claims, and if other claims are not listed or any exemption is required, prior approval by FSSAI food authority shall be obtained in accordance with FSS (C&A) Regulations, 2018 by submitting relevant documents and fees.

3. Food Safety and Standards (Advertising and Claims) Regulations, 2018 [Ref 3 & 4]

Consists of:

Section 4 - General principles of claim including labeling claims
Section 10 - Prohibition of claims
Section 11 - Approval of Claims
Section 12 - Procedure for Approval of Claims
Section 15 - Corrective Advertisement

4. Cable Television Network Regulation Act 1995 [Ref 5]

5. Cable Television Network Rules 1994, GSR 729(E) [Ref 6]

Section 6, Chapter II of the Cable Television Networks (Regulation) Act prohibits a person from transmitting or re-transmitting any advertisement through a cable network if such advertisement is not in conformity with the prescribed code.

6. Consumer Protection Act, 2019 [Ref 7]

Consumer Protection Act, 2019, is to inquire or cause an inquiry or investigation to be made into violations of consumer rights and institute complaints/prosecution, order recall of unsafe goods and services, order discontinuation of unfair trade practices and misleading advertisements, impose penalties on manufacturers/endorsers/publishers of misleading advertisements.

9.2 Specific Restrictions on Advertising

Category

Food for Special Dietary Uses

(1) The Food Safety and Standards Act, 2006 [Ref 1] - Restrictions of advertisement and prohibition of unfair trade practices are defined under Section 24.

(1) No advertisement shall be made of any food which is misleading or deceiving or contravenes the provisions of this Act, the rules and regulations made thereunder.

(2) No person shall engage himself in any unfair trade practice for the purpose of promoting the sale, supply, use, and consumption of articles of food or adopt any unfair or deceptive practice including the practice of making any statement, whether orally or in writing or by visible representation which –

falsely represents that the foods are of a particular standard, quality, quantity, or grade composition;
makes a false or misleading representation concerning the need for, or the usefulness;
gives to the public any guarantee of efficacy that is not based on an adequate or scientific justification thereof.

Provided that where a defense is raised to the effect that such guarantee is based on adequate or scientific justification, the burden of proof of such defense shall lie on the person raising such defense.

(2) Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purposes, and Prebiotic and Probiotic Food) Regulations, 2022 [Ref 2]

(Section 5 (12aiii.B)) - The advertisement of each type of article of food, shall provide sufficient information on the nature and purpose of the article of food and detailed instructions and precautions for its use, and the format of information given shall be appropriate for the intended use of the consumer

(Section 5 (13)) - Advertisement shall not claim to treat, cure, mitigate, or prevent any specific disease, disorder, or condition or refer to such properties unless specifically permitted by the Food Authority.

-The statement by a Food business operator (FBO) relating to the structure, function, or general well-being of the body may be allowed by the Food Authority if the statement is supported by generally accepted scientific data.

- FBO may make nutritional or health claims or reduction of disease risk claims (DRR) that are listed under FSS (Claims and Advertisements) Regulations, 2018 [FSS (C&A)]. For making any other claims or any exemption prior approval of the Food Authority shall be obtained in accordance with FSS (C&A) Regulations, 2018 by submitting relevant documents and fees. [Ref 3] & [Ref 4]

(3) Food Safety and Standards (Advertising and Claims) Regulations, 2018 [Ref 3]

(Section 4) - The general principles to be followed by food business operators and marketers while advertising and publishing communication to promote any article of food, including labeling claims, are:

Claims must be truthful, unambiguous, meaningful, and not misleading. It should help consumers to comprehend the information provided;
Claims shall not encourage or condone excess consumption of a particular food;
Claims 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 claim benefit is related to or dependent on the method of preparation of the food the same shall be provided on the label;
Claims shall specify the number of servings of the food per day for the claimed benefit;
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;
No to the use of words/phrases such as natural, fresh, original, traditional, authentic, genuine, real, etc. on the food labels except under specific conditions where the meaning of a trademark, brand name, or fancy name contains these adjectives. In such cases, if the labeling, presentation, or advertising of food is such that it is likely to mislead consumers as to the nature of the food, in such cases a disclaimer of not less than 3mm size shall be given at an appropriate place on the label stating that – “This is only a brand name or trademark and does not represent its true nature”;
All disclaimers related to a claim shall be conspicuous and legible;
No claim or promotion of sale, supply, use, or consumption of articles of foods shall be made using the FSSAI logo and license number;
Advertisements shall also not undermine the importance of healthy lifestyles;
Advertisements for food or beverages shall not be promoted or portrayed as a meal replacement unless otherwise specifically permitted as a meal replacement under any other regulations made under the Food Safety and Standards Act, 2006 (34 of 2006);
Claims in advertisements shall be consistent with the information on the label of the food or beverage;
No advertisement shall be made for food products which are deceptive to the consumers;
Every declaration which is required to be made on advertisements under these regulations shall be conspicuous and legible.

(Section 5-9) [Ref 3] also defines criteria for different types of claims viz. nutritional claims, health claims, conditional claims, equivalence claims, etc. Making any such claims/advertisement related to any food product needs to comply with defined criteria.

In addition, (Section 6 (3g) [2]) advertisement of FSDU for the general public shall clearly indicate that the product is to be taken under medical advice, wherever applicable.

Prohibited claims to note if used in advertisements (Section 10 [Ref 3]):

(1) 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, or particular physiological condition unless specifically permitted under any other regulations made under Food Safety and Standards Act, 2006 (34 of 2006).

(2) There shall not appear on the label of any package, containing food for sale the words “recommended by the medical or nutrition or 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.

(3) No product shall claim the term “added nutrients” if such nutrients have been added merely to compensate for the nutrients lost or removed during the processing of the food.

(4) Foods for special dietary uses or foods for special medical purposes shall not carry a claim unless specifically permitted under any other regulations made under the Food Safety and Standards Act, 2006 (34 of 2006).

(5) Claims which do give rise to doubt or suspicion about the safety of similar food or which may arouse fear shall not be made.

(6) No health claims shall be made for foods that contain nutrients or constituents in quantity that increase the risk of disease or an adverse health-related condition.

(7) No advertisements 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.

Examples of cases:

Advertising Standards Council of India (ASCI) upholds complaints against 299 misleading advertisements [Ref 10] during the month of July 2019, four of which belong to the food and beverages sector.
ASCI upholds complaints against 190 advertisements [Ref 11] - During the month of June 2019, ASCI investigated complaints against 334 advertisements, of these 190 advertisements, 7 belonged to the food & beverages sector.

Penalty for violation

Under the food safety and standards Act, 2006 [Ref 1]

Penalty for misleading advertisement: Maximum ten lakh rupees (approximately US $13,450) (Section 53)

(1) (a) Falsely describes any food; or (b) is likely to mislead as to the nature or substance or quality of any food or gives false guarantee.

(2) In any proceeding the fact that a label or advertisement relating to any article of food in respect of which the contravention is alleged to have been committed contained an accurate statement of the composition of the food shall not preclude the court from finding that the contravention was committed.

Punishment for false information: imprisonment for a term which may extend to three months and also with a fine which may extend to two lakh rupees. (Section 61)

Punishment for subsequent offenses: Cause the offender’s name and place of residence, the offense, and the penalty imposed to be published at the offender’s expense in such newspapers or in such other manner as the court may direct and the expenses of such publication shall be deemed to be part of the cost attending the conviction and shall be recoverable in the same manner as a fine. (Section 64)

Corrective advertisement

If an advertisement is found to be in violation of the provisions of these regulations, the Food Authority may, by order, require the concerned food business operator or advertiser to stop it immediately and to issue a corrective advertisement within thirty days through the same medium for neutralizing the effect of such advertisements. (Section 15 [Ref 3])

9.3 Advertising Approval

Category

Food for Special Dietary Uses

Advertising approval is required from FSSAI only for making any claims not listed or any exemption to prohibited claims in advertisements under FSS (Claims and Advertisements) Regulations, 2018 [FSS (C&A)]. Required prior approval of the Food Authority shall be obtained in accordance with FSS (C&A) Regulations, 2018 by submitting relevant documents and fees. (Section 5 (13) of [Ref 2] )

Food business operators are required to seek prior approval from the Food Authority for the reduction of disease risk claims other than those that are defined and for which criteria are laid out under the regulations as per the Food Safety and Standards (Advertising and Claims) Regulations, 2018 or any other regulations made under the Food Safety and Standards Act, 2006 (34 of 2006). (Section 11 of [Ref 3])

Claims and its approval process (Section 12 of [Ref 3])

Procedure for approval of claims - Information needed for claim approval:

Claim to be made;
Name of ingredient, nutrient, or substance on the basis of which the claim is to be made;
Validated Method of analysis of ingredient or substance for which the claim is to be made;
Scientific information or materials substantiating the claim;
How is the claim clear and meaningful and helps consumers comprehend the information provided;
Well-designed human intervention studies in case of health claims conducted by or under the guidance of established research institutions; and
Any other useful information.

Notice No Stds/WG-Advertising and Claims/FSSAI-2017 dated 04.09.2019 [Ref 8]: ANNEXURE A of this Notice defines the “Application Form for Approval of Claims on food products”.

Notice No Stds./WG-Advertising and Claims/FSSAAI – 2017 dated 5 May 2020 [Ref 9]: This NOTICE defines the Application Format and the Format for providing a summary of claim support data.

Fees for claim approval: Rs 50,000.00 in the form of a demand draft payable to the Senior Accounts Officer, FSSAI [Ref 8]. Such claim applications shall be for a product/ingredient with a maximum of 3 claims statements that shall be assessed against a single application.

9.4 Other Notes or Requirements for Advertising

Category

Food for Special Dietary Uses

More details can be found under FAQ [Ref 12] or consult FSSAI.

[Ref 13] - The ASCI Code is framed by the Advertising Standards Council of India (ASCI), which is a voluntary self-regulatory body and not a Government body. The ASCI Code aims to regulate the content of promotions or advertisements. This Code applies to advertisers, advertising agencies, media, and others such as market research companies who are members of ASCI. This Code has also been accepted by individuals, corporate bodies and associations engaged in or otherwise concerned with the practice of advertising with the ASCI Code serving as the basic guidelines.

Under the ASCI Code, the responsibility for its observance lies with all those who commission, create, place, or publish any advertisement or assist in the creation or publishing of any advertisement. Under the provisions therein, all advertisers, advertising agencies, and media are expected not to commission, create, place, or publish any advertisement that is in contravention of the ASCI Code. The ASCI Code applies to advertisements read, heard, or viewed in India even if they originate or are published abroad so long as they are directed to consumers in India or are exposed to a significant number of consumers in India. It may be noted, though, that the orders of ASCI are not enforceable through the court enforcement mechanism.

9.5 References

[1] The Food Safety and Standards Act, 2006

https://www.indiacode.nic.in/bitstream/123456789/7800/1/200634_food_safety_and_standards_act%2C_2006.pdf

[2] Direction under Section 16(5) of the Food Safety and Standards Act, 2006 regarding Operationalization of FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotics and Probiotic Food) Regulations [FSS (Nutra) Regulations 2022

https://www.fssai.gov.in/upload/advisories/2022/04/624ac1be799dbDirection_Nutra_30_03_2022.pdf

[3] Food Safety and Standards (Advertising and Claims) Regulations, 2018

https://fssai.gov.in/upload/uploadfiles/files/Compendium_Advertising_Claims_Regulations_04_03_2021.pdf

[4] Food Safety and Standards (Advertising and Claims) First Amendment Regulations, 2022

https://www.fssai.gov.in/upload/notifications/2022/09/63106ab314c26Gazette_Notification_Advertisement_01_09_2022.pdf

[5] Cable Television Network Regulation Act 1995

https://www.indiacode.nic.in/bitstream/123456789/1928/1/A1995-07.pdf

[6] Cable Television Network Rules 1994, GSR 729(E)

https://trai.gov.in/sites/default/files/CableTelevisionNetworksRules1994.pdf

[7] The Consumer Protection Act, 2019

https://consumeraffairs.nic.in/acts-and-rules/consumer-protection

[8] Notice No Stds/WG-Advertising and Claims/FSSAI-2017 dated 04.09.2019