Regulation by the National Administration of Medicines, Food and Medical Technology (ANMAT) of advertising of food and non-alcoholic beverages with warning stamps | Abeledo Gottheil

Regulation by the National Administration of Medicines, Food and Medical Technology (ANMAT) of advertising of food and non-alcoholic beverages with warning stamps

2 September 2022 |

In an article published in Abogados.com.ar in November 2021[1] I mentioned, among others, the provisions of Act 27,642 – called “Act for the Promotion of Healthy Eating”, published in the Official Gazette on 11/12/21 – that set forth certain restrictions to the advertising of food and non-alcoholic beverages, packed in the absence of the customer, that contain at least one (1) “warning stamp”.

It is worth recalling that section 4th of Act 27,642, determines that the food[2] and non-alcoholic beverages[3] commercialized in the Argentine Republic, packaged in the absence of the customer in which final composition the content of critical nutrients and their energy value exceed the values set forth by the regulation, shall include per each critical nutrient in excess and for the excess of calories an indelible “warning stamp”[4].

It is clear that the regulation under analysis considers, in the end the food and non-alcoholic beverages, that contain excess of sugars, sodium, saturated fats or total fats or calories do not contribute to healthy eating. Not even those containing sweeteners or caffeine, although in this case it is limited to child nutrition.

Within this framework, section 10th of Annex I of the decree of the National Executive Branch 151/2022, that regulates the Act for the Promotion of Healthy Eating, set forth that the advertising, promotion and sponsorship of said food and beverages, addressed to the public and broadcasted in the traditional and digital mass media, will be supervised and controlled by the National Administration of Medicines, Food and Medical Technology (ANMAT), which was authorized by said decree to issue supplementary regulations based on the guidelines provided for in the regulated law.

By using said powers, the ANMAT issued, on August 26, 2022, provision 6924/2022 (published in the Official Gazette on 8/30/22), which section 3rd approves the “SPECIFIC REGULATIONS FOR THE ADVERTISING OF FOOD CONTAINING AT LEAST ONE (1) warning stamp (including in the same preventive legends on sweeteners and /or caffeine)” (the “Specific Regulations of the ANMAT”), which make an integral part of the provision as Annex I and shall be subject to analysis in this work.

→ Prohibitions in advertising, promotion and sponsoring

The prohibitions applicable to advertising, promotion and sponsoring of food and non-alcoholic beverages, packed in the absence of customer, that contain at least one (1) warning stamp, are included in section 10 of Act 27,642.

In the first place, this regulation forbids every kind of advertising, promotion and sponsoring of food and non-alcoholic beverages that contain excess of sugars, sodium  saturated fats, total fats or calories, packed in the absence of the customer, “which are especially addressed to children and teenagers.”

I said at the time, in my analysis of section 10, that I considered essential that the regulations set forth objective parameters that allow the administered parties to clearly understand when it will be considered that the advertising, promotion or sponsoring is “especially directed” to children and teenagers. Avoiding hence, the path of trial and error, that would cause a clear waste of resources of individuals and the waste of the jurisdictional activity.

Unfortunately, the ANMAT Specific Regulations cannot prevent it.

Because they just say, in their item 1, that advertising, promotion or sponsoring is addressed to children and teenagers “when the communication contains interesting and attractive elements for them.”

“Interest”, according to the Dictionary of the Spanish Language it means, in the meaning that concerns us here: “Inclination of the mood towards an object, person, narration, etc.”; “attractive”, in turn means “That it attracts or has force to attract”. The literal interpretation of the provision of item 1 of the ANMAT’s Specific Regulations would lead, in my opinion, to the absolute prohibition of advertising, promotion and sponsoring, while it could be understood that there is no possible message that may not interest or attract children or teenagers.

Said interpretation would be, of course, unacceptable. Because Act 27,642 does not forbid without further ado the advertising, promotion or sponsoring of said food and beverages, but, only, the one especially addressed to children and teenagers.

In other words, I consider that in this aspect the ANMAT’s Specific Regulations honor the old saying, “When you are in a hole, stop digging” because they do not clarify, but darken things. Then, the path of trial and error, that will certainly cause an excessive and unnecessary expense of resources of individuals and also the waste of the jurisdictional activity, unfortunately looks inevitable.

In addition to said special prohibition, section 10 of the Act, in the other cases of advertising, promotion or sponsoring through any means, of food packaged in the absence of customer and of non-alcoholic beverages containing at least one (1) warning stamp:

(i) Forbids “to highlight” nutritional supplementary statements that point out positive or nutritional qualities of the products, “so as not to promote confusion regarding the nutritional contributions” (section 10, subsection a).

Please note that the regulation does not forbid to “include” (meaning to place something or someone inside a thing) supplementary nutritional statements but to “highlight” (meaning to point out, something noting it).

The ANMAT’s Specific Regulations regarding this issue add nothing to help interpreting the provision allegedly regulated, since in its item 2.2.4. it literally repeats the words of said subsection a) of section 10, when it says that advertising should not “Highlight nutritional supplementary statements that point out positive or nutritional qualities of the products, “so as not to promote confusion regarding the nutritional contributions.”

Consequently, they do not ease the interpretation work for those who must issue opinions on this matter, since – again – it does not offer objective guidelines on the inclusion of supplementary nutritional information, so as to allow casting doubts.

But at least it is clear, then, that the inclusion of supplementary nutritional statements is allowed. Provided that – let’s say – they are mentioned in the advertising discretely, seriously and with decorum.

(ii) Sets forth that the warning stamps corresponding to the product in question must be visualized or stated in whole each time the package is displayed (section 10, subsection b).

This matter is analyzed in item 2.1.3. of the ANMAT’s Specific Regulations, providing that advertising, promotion or sponsoring, should:

“2.1.3. Include in its entirety the warning stamps and/or preventive legends on sweeteners and/or caffeine corresponding to the product. The warning stamps and/or said preventive legends on sweeteners and/or caffeine must be clearly visible for the recipient and must observe the following requirements: 

a) In the graphic, traditional and digital media they must be inserted allowing their easy reading that must contrast with the background of the advertisement.

b) In the street and other similar media, they must be related to size according to the one used in graphics, and must be easy-to-read.

c) In the traditional oral or digital media, they must be communicated with a rhythm and speed allowing their easy understanding.

d) In the traditional and digital audiovisual media, they must be clearly visible and shall be kept for a term allowing their complete reading.”

(iii) Forbids (section 10, subsection c) the inclusion of children’s characters, animations, cartoons, celebrities, athletes or pets and interactive elements, the delivery or promise to deliver gifts, prizes, presents, accessories, adhesives, visuospatial games, digital downloads or any other element and the participation or promise to participate in contests, games, sport, musical, theatre or cultural events, when they incite, promote or encourage the consumption, purchase or election of the products.

Again, in this case the ANMAT’s Specific Regulations do not add anything, since they set forth only, in its item 2.2.3. that advertising, promotion or sponsoring, must not:

“2.2.3 Include children’s characters, animations, cartoons, celebrities, athletes or pets and interactive elements, the delivery or promise to deliver gifts, prizes, presents, accessories, adhesives, visuospatial games, digital downloads or any other element as well as the participation or promise to participate in contests, games, sport, musical, theatre or cultural events, as applicable, when they incite, promote or encourage the consumption, purchase or election thereof.”

Emphases added in the preceding paragraph are the differences between item 2.2.3. of the ANMAT’s Specific Regulations and the letter of the law. Nothing, of course, that minimally helps to elucidate when will the Administration consider that the incitation, promotion or encouraging forbidden by the regulation do appear.

Since they do not provide for – again – objective parameters that allow to clearly understand the conditioned prohibition, so that it may be elucidated without any problems when the conducts that it forbids incite or promote or encourage the consumption, purchase or election of neither the products nor when they do not.

Again, path of trial and error.

Finally, subsection d) of section 10 of the law provides that the advertising, promotion and sponsoring of food and non-alcoholic beverages packed in the absence of customer “Are forbidden to promote or deliver for free”. It is a regulation that, apart from its poor wording would seem to forbid not only the advertising of the delivery of said products for free but also their delivery without costs (and without advertising).

The ANMAT’s Specific Regulations seem to confirm the interpretation contained in my previous work, since in its item 2.2.6. they set forth again that packed food and non-alcoholic beverages that contain any warning stamp (including in them preventive legends on sweeteners and/or caffeine) must not be promoted or delivered for free.

→ Other provisions of the ANMAT’s Specific Regulations

The ANMAT Provision 6924/2022, in its section 4th, states that the advertising, promotion and sponsoring addressed to the public, of the packed food and non-alcoholic beverages that contain at least one (1) warning stamp (including in them preventive legends on sweeteners and/or caffeine), either national or imported, will not be reached by Annex III “Specific Regulations for the advertising of food” of the ANMAT Provision Nº 4980/05.

That is the reason why, the ANMAT’s Specific Regulations, in addition to the foregoing, set forth – in general and in line with the provisions of the above said Annex III – that the advertising, promotion and sponsoring of packed food and non-alcoholic beverages, that contain at least one warning stamp, must:

▪ Tend to the proper consumption of the product, objectively presenting their properties, without deceptions or misunderstandings, offering truthful, precise and clear information (ANMAT’s Specific Regulations, item 2.1.1.),

▪ Include the sales description and the trade name of the product (ANMAT’s Specific Regulations, item 2.1.2.),

▪ Be made in the Spanish language. However, current words or phrases may be used, even if they are in another language and images that define clearly and with everyday terms the use of the product or other qualities, to favor the comprehension by the public in general (ANMAT’s Specific Regulations, item 2.1.4.), and

▪ Completely include the features, usage modes, and/or warnings of the product, if they are subject to advertising (ANMAT’s Specific Regulations, item 2.1.5.).

And must not:

▪ Advertise, promote or sponsor products not authorized by the competent health authority, except for the provisions of section 3rd of Annex II of decree 2126/71, that regulates Act 18,284, modified by decree 2092/91[5]; and if applicable, the adaptations should be made, once the competent health authority issues a decision (ANMAT’s Specific Regulations, item 2.2.1.), 

▪ Advertise, products that do not comply with the Affidavit before the ANMAT, through the NATIONAL INSTITUTE OF FOOD (INSTITUTO NACIONAL DE ALIMENTOS -INAL-), according to section 14th, subsection d) of Annex I and to Annex II of decree 151/2022 and in accordance with the supplementary provisions set forth by the enforcement authority and ANMAT (ANMAT’s Specific Regulations, item 2.2.2.),

▪ Advertise, promote or sponsor a product or a modification of an already existing one in the market as “new”, after two years have elapsed from the date of commencement of its commercialization to the public. In the case of changes in products that are already in the market the novelty must be specified and completely informed (ANMAT’s Specific Regulations, item 2.2.5.),

▪ Promote the purchase of the product with the purpose of donation or humanitarian destination, avoiding the unnecessary consumption of the product (ANMAT’s Specific Regulations, item 2.2.7.),

▪ Include messages related to approvals or recommendations of experts, medical, scientific associations or the like (ANMAT’s Specific Regulations, item 2.2.8.), 

▪ Include phrases involving the national, provincial or international authority such as “Advertising authorized by the Health Authority” or the like (ANMAT’s Specific Regulations, item 2.2.9.), 

▪ Include texts expressly forbidden in the Argentine Food Code (ANMAT’s Specific Regulations, item 2.2.10.),

▪ Modify the tags approved pursuant to the regulations in force as regards the composition, uses and specific properties of the product (ANMAT’s Specific Regulations, item 2.2.11.), 

▪ Promote that the consumption of food is a health guarantee (ANMAT’s Specific Regulations, item 2.2.12.)

▪ Measure the risk-reducing degree to get sick for the consumption of the product (ANMAT’s Specific Regulations, item 2.2.13.), nor

▪ In its item 2.2.14., include phrases and/or messages that:

  1. Attribute therapeutic actions or properties to the product or suggest that the food is a medicinal product or mention that food diagnoses, heals, calms, mitigates, soothes, prevents or protects from a specific disease.
  2. Mention, either directly or indirectly a pathologic or abnormal condition.
  3. Advise on its consumption due to a stimulating action or health improvement or prevention of diseases or healing action.
  4. Cause fear, anguish, suggesting that the health of an individual will be affected if he/she does not use the product.
  5. Tend to mask the specific properties of the product.
  6. State that a food may be used in replacement of a conventional meal or as the only food of a diet.
  7. Modify to any extent the statement of nutritional properties contained in the approved tag.
  8. Refer to the products as “natural” when they are semi-synthetic or jointly formulated with synthetic components. For the products obtained from natural substances, the advertisement may state only the following “obtained from natural substances” or “with ingredients obtained from natural substances”.
  9. Use words, signs, denominations, symbols, emblems, illustrations or other graphic representations that turn said information into false, incorrect or insufficient or that may induce consumer to a mistake, error, confusion or deceit as regards the true nature, composition, origin, type, quality, quantity, duration, performance or way of using the food.
  10. State or specify that a product has a higher comparative attribute or feature than another one as from the bromathological standpoint, or that the announced product is the only possible alternative within the market, expressing for example: “the product”, “the most chosen “, “the only one “, “the most frequently recommended one”, “the best “, and it must not contain expressions that may prove to be deceitful for consumer.

Comparative advertising is dealt with in the ANMAT’s Specific Regulations, item 3., that determines that comparative messages must not: a) create confusion with comparison, b) ridicule or denigrate the other product, c) deform the image of other products, d) adversely affect third parties’ good name and reputation, e) try to create rejection towards the products of the competition or its users, f) mention components not contained in the advertised product, nor g) mention possible adverse or collateral effects of components not contained in the advertised product.

Item 4. of the ANMAT’s Specific Regulations allows that advertising, promotion and sponsoring of packed food and non-alcoholic beverages contain at least one (1) warning stamp (including in it the preventive legends on sweeteners and/or caffeine) that includes, a telephone number or Internet site to answer consultations, provided that the available information complies with the provisions of Annex I of provision ANMAT 4980/05 and of the same.

Non traditional advertising of packed food and non-alcoholic beverages that contain at least one (1) warning stamp (including in them preventive legends on sweeteners and/or caffeine) must comply with the provisions of Annex I, “General Provisions”, of provision ANMAT 4980/05 and the ANMAT’s Specific Regulations and the owners of the products shall be responsible for guaranteeing that the use of the name, attributes or messages, under these media, are the proper ones, bearing in mind the particular characteristics of this advertising modality (ANMAT’s Specific Regulations, item 5.). 

Finally, the ANMAT’s Specific Regulations set forth in item 6., that the advertising, promotion and sponsoring of packed food and non-alcoholic beverages that contain at least one (1) warning stamp (including in them preventive legends on sweeteners and/or caffeine) that are made in digital media must comply with the provisions of said Annex I of provision ANMAT 4980/05 and in the ANMAT’s Specific Regulations and that the owners of the products shall be responsible for guaranteeing the products, shall be responsible for guaranteeing, considering the specific characteristics of each digital media particularly, the good use of the name, attributes and messages spread in connection with the product and that they will be responsible for carrying out the relevant actions to adapt digital contents created or spread by third parties.

→ Perplexities

Act 27,642 and its regulation strongly limit the chance to advertise, promote and sponsor food and non-alcoholic beverages packed in the absence of the customer which contain at least one (1) warning stamp addressed to children and teenagers. And it forbids, without further ado, the sale promotions of said food with delivery of prizes or gifts, without distinguishing each of the recipients

Said everlasting ostracism tries to justify itself, in subsections a) and c) of section 1st of the Act, in public health issues.[6]

But, as I said in my previous article on this matter, aside from this alleged justification – that could be understood as suitable to provide for the obligatoriness of the inclusion of the warning stamps in its containers and inclusive, maybe, to forbid advertising or promotional actions when they are especially addressed to minors – it seems to me excessive and consequently unreasonable, that the prohibitions to make advertising and promotions reaches actions addressed to adults. And that our laws entail that they act with judgment, intent and freedom.

Said prohibitions seem more unjustified to me – if possible – when the law, instead, allows other businessmen, that commercialize what in hundreds of articles published in the Internet they qualify as “junk food”[7], may continue making said promotions and advertisings. Even when they are especially addressed to children (such as the well-known Happy Meals that make Little ones Happy), by the mere fact that the foods they commercialize are not packed in the absence of the public. Because the food and non-alcoholic beverages commercialized by said players are not packed in the absence of the public, even though they are delivered in carton boxes and glasses, they must not contain warning stamps that must be included in food packed in the absence of the public.

Curious.

Buenos Aires, September 2, 2022.


[1] Titled “Act for the Promotion of Healthy Food and labeling and advertising of food and beverages”, published on November 24 and 25, 2021.

[2] The Argentine Food Code defines “Food” in subsection 2 of its section 6, that reads as follows:

2. Food: every substance or mix of natural or manufactured substances which are swallowed by man give to their bodies the necessary materials and energy for the development of their biological processes. The description of “food” includes also substances or mixes of substances that are swallowed by habit, customs, or as coadjuvants, whether or not they have nutritional value.

[3] The definition of “Non-alcoholic Beverages” is set forth in Argentina by section 996 of the Argentine Food Code (Text according to the Joint Resolution SPyRS N° 009 and SAGPyA N° 106 dated 3/6/00), that reads as follows:

“It is understood as Non-alcoholic Beverages, the carbonated or uncarbonated beverages, ready for consumption, prepared with one or more of the following components: Juice, Juice and Pulp, Fruit or Vegetable Juice Concentrates, Milk, Extracts, Infusions, Macerations, Percolations of vegetable substances contemplated in this Code, as well as authorized Aroma/Flavor enhancers. The water used in its elaboration shall meet the requirements of Section 982 or 985.  They shall have the normal color, smell and flavor according to their composition. They must not contain ethyl alcohol in quantities exceeding 0,5% in volume”.

The following may be added to them: a) Nutritive sweeteners authorized by this Code. b) Carbon dioxide that complies with the requirements of Section 1066 at a pressure of not less than 1,5 atmospheres measured at 20°C. c) Acidulants, colorants, conservators, stabilizers, emulsifiers, thickeners, flavor enhancers, foaming agents, humectants, acidity regulators, antioxidants, aroma-flavor enhancers, defoamers and sequestrants mentioned in Resolution (former Ministry of Health and Social Welfare) N° 587/97 and in the usage conditions pointed out therein. Products containing Tartrazine shall inform it in the labeling by its specific name, close to the product name. Products containing Sulphur dioxide shall inform it in the labeling as set forth in Resolution (former Ministry of Health and Social Welfare) N° 3/95. d) When ascorbic acid is added as antioxidant the product shall not mention in the label “It contains Vitamin C”. e) In uncarbonated beverages the addition of Sodium Hexametaphosphate as sequestrant agent shall be admitted with a maximum limit of 0,1 g/100 ml (1.000 ppm). f) Cremogenates that comply with the requirements of Section 1051 of this Code may be used in a quantity not exceeding 3% w/v, per each 10% v/v of juice, and it shall be informed in the label. Under no circumstances it may be computed as juice. Every manufacturer and/or bottler of non-alcoholic beverages, either carbonated or uncarbonated, must keep a record of the health, safety and bromathological controls carried out. Said controls shall comprise those made on raw materials, containers, in the critical control points during elaboration and packaging and on the finished product “

[4] As applicable, the warning stamps must read as follows: “EXCESS OF SUGARS”, “EXCESS OF SODIUM”, “EXCESS OF SATURATED FATS”, “EXCESS OF TOTAL FATS” or “EXCESS OF CALORIES”.

In addition to these warning stamps, if food or non-alcoholic beverages packaged in the absence of customer contain sweeteners, their container must include, immediately below the warning stamps, the following preventive legend:

“IT CONTAINS SWEETENERS, NOT RECOMMENDED FOR CHILDREN”.

If it contains caffeine, the container of the food or non-alcoholic beverage must include, also immediately below the warning stamps, the following preventive legend:

“IT CONTAINS CAFFEINE. AVOID IN CHILDREN”.

The legends that warn on the content of sweeteners or caffeine, as set forth in section 2nd, subsection i), are also “warning stamps”.

[5] Section 3rd of decree 2126/1971, modified by decree 2090/1991, states the following: “For the purposes of the authorization referred to in Section 3rd of Act N° 18284, the corresponding application should be submitted to the competent Health Authority, which shall contain the following information: a) The identification data and domicile, of the applicant, who is the owner of the product. b) Identification data, domicile license of the technical director, when the manufacturing process is in charge of specialized staff c) Trademark or name proposed for the product and designation of the Argentine Food Code and a draft of tags or labels in triplicate. d) Composition of the product according to the provisions of the Argentine Food Code, as well as the volume and net weight of the sale unit. e) Environmental conditions in which the product must be kept; period during which it remains unchanged, changes that may appear by the mere lapse of time and trials performed to set their stability. f) Technique for the manufacturing of the product g) Detailed description of the features and specifications of the materials of the package. h) Specification of the establishment(s) either their own or of third parties, where the product is to be manufactured or fractioned. A certified copy of the authorization certificate, evidencing the compliance with the relevant provisions must be filed. The application for authorization mentioned in this section shall be submitted in a uniform form for the whole country according to the draft to be provided for by the National Health Authority, before the Provincial Health Authority or of the Municipality of the City of Buenos Aires, as applicable, in accordance with the place in which the manufacturing or fractioning plant is located. The competent Health Authority may request, when it judges necessary, a certified copy of the analysis protocols to which the product had been subject in establishments, institutes or official or private services officially recognized. In all cases the competent Health Authority shall issue a decision within 30 days. Upon the expiration thereof, if the submitted application formally qualifies, the applicant may use the number of proceeding or registration and commercialize the product without limitations until its approval for which the competent Health Authority may inspect the establishment and take the necessary samples to certify the hygienic-sanitary and bromathological quality of the product. In case of several manufacturing or fractioning plants located in different jurisdictions, once the authorization for the manufacturing or fractioning of a product in one jurisdiction is obtained, the same shall be considered valid for all the others; each health authority shall determine in its jurisdiction, if the authorized product is subject to be manufactured or fractioned according to the requirements of the Argentine Food Code at the establishment(s) or plant(s) installed in said area. Any modification in the conditions set forth in the authorization granted by virtue of this section shall be previously approved by the competent Health Authority that has granted the previous authorization. The application for registration filed by a national manufacturer may contain the petition of inclusion of products, their ingredients, additives or procedures for the manufacturing, conservation and transport, similar to the imported ones, under the terms of this Decree. The National Health Authority shall issue a decision on the application within a maximum term of 60 running days as from the filing date thereof”.

[6] Section 1st of Act 27,642 states, as regards what concerns us here: “Purpose. The purpose of this law is: a) To guarantee the right to health and to appropriate nutrition through the promotion of healthy eating, by offering simple and understandable nutritional information of packed food and non-alcoholic beverages, to promote assertive and active decision-making, and to protect consumers’ rights and consumers … c) Promote prevention of malnutrition in the population and the reduction of chronic non-communicable diseases.”

[7] For example, by referring to well-known international chains of hamburgers sale: https://www.monografias.com/trabajos20/mcdonalds/mcdonalds.shtml, https://www.businessinsider.es/estragos-comer-hamburguesa-mcdonalds-burger-king-908625, https://www.resumenlatinoamericano.org/2018/04/03/jamie-oliver-y-su-lucha-contra-mcdonalds-y-la-comida-basura/, https://www.elconfidencial.com/alma-corazon-vida/2015-09-24/esto-es-lo-que-pasa-en-tu-cuerpo-justo-despues-de-comerte-un-big-mac-y-no-mola-nada_1033749/, among plenty of others.

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