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Product: Food & Non-Alcoholic Beverages (Follow-on Milk)
Advertiser: Nestle Nutrition
ASAI Code 7th Edition: 2.4(c), 4.1, 4.4, 8.33
A radio advertisement for SMA Advanced Follow-On Milk stated:
“100 years ago we began our research into baby nutrition. The latest breakthrough HMO's or Human Milk Oligosacharides. New SMA Advanced Follow-On Milk from 6 months is the first in Ireland that contains two structurally identical HMO's. It is also enriched with Vitamin D to help support the normal function of baby's immune system.
To find out more visit smababy.ie. Breastmilk is best for babies and breastfeeding should continue for as long as possible. SMA Advanced Follow-On Milk is for babies over 6 months as part of a varied weening diet. Not intended to replace breastfeeding.”
The complainant considered that the term Human Milk Oligosaccharides (HMO) was misleading as it suggested that some part of the product was derived from human milk. The complainant also considered that infant formula manufacturers should not be allowed to suggest that their product contained human milk or was similar to human milk.
The advertisers stated that they take compliance with the 2007 Regulations on Infant Formula and Follow-On Formula very seriously. They said that they had not used terms such as “humanised”, “maternalised” or “adapted” in the advertisement, they were simply describing ingredients as required by the legislation in an accurate and not misleading manner. They said that they had not claimed in the advertisement that their product was derived from human milk or that it contained or was similar to human milk.
The advertisers referred to the requirements under Regulation (EU) No. 1169/2011 on the provision of food information to consumers which included a requirement that “ingredients shall be designated by their specific name, where applicable, in accordance with the rules laid down in Article 17 and in Annex VI.” They also referred to Article 17.1 of the same Regulation which stated that “The name of the food shall be its legal name. In the absence of such a name, the name of the food shall be its customary name, or, if there is no customary name of the customary name is not used, a descriptive name of the food shall be provided.” They advised that “descriptive name” was defined in Article 2.2 (p) as “a name providing a description of the food and, if necessary of its use, which is sufficiently clear to enable consumers to know its true nature and distinguish it from other products with which it might be confused.”
The advertisers advised that the term “structurally identical human milk oligosaccharides” was the correct descriptive name for the ingredients found in their product for the following reasons:
• Although the two human milk oligosaccharides (2’-O-fucosyllactose/2’FL and lacto-N-neotetraose/LNnT) were found in human milk, they could also be synthetically processed through a fermentation process for industrial use, as was the case with the HMO’s in their product.
• The two HMO’s, (2’FL) and (LNnT) found in their Advanced Follow-on Milk were manufactured by Glycom and it had been confirmed that, based on 1H-, 13C-NMR-spectroscopy, mass spectrometry and x-ray crystallography data, the 2’FL and LNnT within their Advanced Follow-on milk were structurally and chemically identical to the 2’FL and LNnT that were present in human breast milk.
• They said that an oligosaccharide was a generic term for a carbohydrate which were found in many sources, from chicory root to cow’s milk, however, human milk contained structure-specific oligosaccharides that were not commonly found in other sources.
• They said that because of these clear structural differences, the oligosaccharides from human milk were viewed differently from other oligosaccharides which originate from plants. They said that in 2017 the International Scientific Association for Probiotics and Prebiotics (ISAPP) published its consensus statement on prebiotics, where HMOs were clearly separated from other oligosaccharides, rather then put together under an ‘oligosaccharides’ group.
• The advertisers said that 2’FL and LNnT were accurately named as “structurally identical human milk oligosaccharides” as it would be inaccurate to refer to the generic term ‘Oligosaccharide’, therefore it was essential for them to use the term ‘structurally identical human milk oligosaccharides’ to distinguish this ingredient from other kinds of oligosaccharides and make it more transparent to consumers.
• They said that the term “oligosaccharides of human milk” was coined in 1957/58 and the 1958 review from Malpress & Hytten also used the inverted term “human milk oligosaccharide” for the first time and since then this term or “HMOs” was widely used in scientific literature to describe the ingredients contained in their product and on their advertising. They said that this was the only way for them to make it clear which ingredient they were talking about. They stated that only 2’FL and LNnT used in their product were identical to the HMOs naturally found in breast milk and only by using the term “structurally identical human milk oligosaccharides” could they differentiate themselves from confusing ingredients and provide consumers with adequate information and transparency.
The advertisers said that when they are creating their advertisements, they take great care to ensure that their materials do not discourage breastfeeding and they also make it clear on their products and in their follow-on milk adverts about the superiority of breast milk by stating in the Important Notice: “Breast milk is best for babies and breastfeeding should continue for as long as possible. SMA Advanced Follow-On Milk is for babies over 6 months, as part of a varied weaning diet. Not intended to replace breastfeeding.”
They said that they strongly disagreed that providing the ingredient’s descriptive name, as required by the legislation, breaches the Regulation or the ASAI Code. They said that the inclusion of the words “structurally identical” in the descriptive name made it clear to consumers that the ingredient in question was not derived from human milk, and therefore, that the product was not the same as, or in any way superior, to breast milk.
The ASAI Executive sought advice from the Food Safety Authority of Ireland (FSAI) on the use of the term “Human Milk Oligosaccharides” as the ASAI Code requirement at 8.33(b) (See below) was based on European Regulation. The FSAI advised that Article 6 (6) of Delegated Regulation 2016/127 and Article 13 (3) and 13 (8) of Commission Directive 2006/141 (EC) state that the labelling, presentation and advertising of infant formula and Follow-on formulae shall not use the terms “humanised”, “maternalised”, “adapted” or terms similar to them. They stated therefore, that the terms HMO, human milk oligosaccharide and structurally identical human milk oligosaccharide were in breach of EU food law and were not permitted.
The Complaints Committee considered the detail of the complaint and the advertisers’ response.
The Committed noted the Code requirement that marketing communications for follow on formula addressed to the general public should not use the terms ‘humanised’, ‘maternalised’, ‘adapted’ or similar terms (8.33b). They considered whether the terms such as ‘HMO’, ‘human milk oligosaccharide’ and ‘structurally identical human milk oligosaccharide’ were similar terms to ‘humanised’ and, considered that they were. The Committee also noted the opinion from the FSAI.
In the circumstances the Committee considered that the advertising was in breach of Section 8.33 of the Code.
The advertisement must not reappear in its current form. The Committee told the advertisers not to use terms such as, or similar to, ‘humanised’, ‘maternalised’ or ‘adapted’.