Spanish regulator condemns sterol-cholesterol ads

The Spanish manufacturer of a plant sterol drink has been told to amend cholesterol-lowering claims for being too ambiguous in dosage and making unsubstantiated disease reduction claims.

Spanish advertising watchdog, AutoControl, took issue with Central Lechera Asturiana’s campaign for NaturCol because it failed to specify what a ‘glass’ of the beverage was.

It also said an element of the advert that stated the drink could maintain cholesterol was a disease reduction claim in need of an article 14, disease reduction claim under the European Union 2006 nutrition and health claims regulation (NHCR).

AutoControl said the claims could be misleading because it was not clear the products were aimed at those with elevated cholesterol levels, rather than healthy members of the population.

Writing in European Food and Feed Law Review (vol. 6, no. 6, 2011), Sebastián Romero Melchor, a managing partner at Brussels-based Food Law Consultants, disagreed with the AutoControl position on the NaturCol advertisements.

We believe that the arguments put forward by Autocontrol are flawed,” Melchor wrote, noting the ad reference to “one glass or two glasses” did not necessarily contravene the NHCR.

The regulation, he said, “provides that it is sufficient to include such a statement (as well as all the mandatory statements outline therein) in the labeling of the product, and not in the advertisement.”

One glass or two?

The ad had a double-barrelled ‘reduces cholesterol’ claim (if two glasses are consumed per day) and ‘maintains cholesterol’ (for one glass), something AutoControl viewed as a united claim. It therefore stressed that the one glass-maintains cholesterol claim needed article 14 backing under the NHCR.

There is a European Food Safety Authority (EFSA) positive opinion for cholesterol maintenance under the general function article 13 list that is set to join the EU register of approved claims in the coming months, but not an article 14 disease risk reduction claim.

As to considering that a ‘maintains cholesterol’ claim becomes an Article 14 claim if accompanied of a ‘reduces cholesterol’ one, we cannot share Autocontrol’s stance either,” Melchor opined, noting the article 13 opinion that backs cholesterol-maintaining products delivering 0.8 g per day of plant sterols/stanols in one or more servings.

Melchor noted the 2004 regulation (608/2004) that deals with stanol and sterol ingredients did not mention efficacy and that the Autocontrol position contravened the EFSA cholesterol-maintenance opinion even if it was not yet in EU law books, along with the NHCR itself.

“EFSA has favourably assessed the claim ‘plant sterols/stanols help to maintain normal blood cholesterol levels’,” Melchor wrote.

“Not only does this contradict Autocontrol’s stance, but, with respect to the specified conditions of use, EFSA has suggested that, ‘the labelling provisions outlined in Commission Regulation (EC) No 608/2004 shall continue to apply for products making the proposed claim’.”

“Therefore, in our view, a cholesterol-maintenance claim can be made without conflicting with the compulsory statements of Regulation 608/2004 or without it being re-classified as an Article 14 claim.”

EFSA’s article 14 cholesterol reduction EU law can be found here.

The article 13 cholesterol maintenance opinion is here.