Dietary Supplement Marketing and the EU: Putting the Squeeze on Health Claims

It is a difficult time to be operating in the European functional foods space. Ingredient suppliers in particular have endured months of nervous anticipation as they wait for European Food Safety Authority (EFSA; Parma, Italy) opinions on health claims being assessed under the Nutrition and Health Claims Regulation (EU Regulation EC/1924/2006).

Very few suppliers have been given good news so far. Article 13 (general health claim opinions) in particular have endured heavy scrutiny, resulting in negative opinions returned to the European Commission.

Few Claims Approved
Of the 44,000 claims that were originally submitted to the national authorities, 4185 claims ended up on the Commission’s consolidated list. With each batch of published opinions, it has become clear that EFSA is applying the same strict criteria for Article 13 claims as it has for Article 13.5 claims (claims based on newly developed scientific evidence) and Article 14 claims (disease-risk reduction/children’s development claims).

The numbers speak for themselves. Of approximately 500 claim opinions published in October 2009, 105 were positive; of 416 claim opinions published in February last year, only six were positive; and of 808 health claims assessed in October last year, 162 were positive.

As of November of last year, only 1745 of the 4185 health claims had been assessed, which means that EFSA is behind schedule. This is one of the reasons why a decision on claims for botanicals has been delayed.

Most recently (December 8, 2010), an EFSA scientific panel published its positive opinion on a disease-risk reduction health claim dossier for oat beta-glucan, following an Article 14 application from CreaNutrition AG (Postfach, Switzerland). According to the positive opinion of the EFSA Panel for Dietetic Products, Nutrition, and Allergies, foods providing 3 g of oat beta-glucan per day can bear the health claim: “Oat beta-glucan has been shown to lower/reduce blood cholesterol. Blood cholesterol–lowering may reduce the risk of heart disease.”

This EFSA statement concerning the naturally occurring oat beta-glucan found in oat bran is the first positive cereal-based, disease-risk reduction opinion. (A generic Article 13 claim for “oat beta-glucan and cholesterol maintenance” had already been achieved.)

An Increase in “Proven” Claims
Companies that have successfully navigated the health claims maze will be keen to highlight their ingredient in this regard. A skeptical consumer can be encouraged to try out a functional food product if scientific proof exists. Thus, manufacturers are pushing this.

Use of the word proven has therefore grown dramatically on new products since 2008, when roughly 40 new products per quarter carried the word. This number rose significantly to 71 at the beginning of 2009, and between 80 to 90 products during Q3 and Q4 of 2009 and Q1 and Q2 of 2010.

In France, Danone uses the words scientifically proven on its Danacol product with plant stanols. The following health claim passed the EFSA hurdle: “Low-fat fermented milk product (Danacol) enriched with plant sterols/stanols and lowering/reducing blood cholesterol and reduced risk of (coronary) heart disease.”

Another ingredient that is likely to enjoy significant activity in 2011 is FruitFlow (added active tomato extract) from UK-based Provexis, which managed to achieve an Article 13.5 ingredient-specific claim and now has the marketing support of ingredient giant DSM Nutritional Products (Basel, Switzerland) behind it.

Negative Impact
For those failing to cross the EFSA hurdle, however, the future looks far less bright.

News of CreaNutrition’s successful application came on the same day that EFSA turned down a Danone Article 14 health claim opinion in France on the scientific substantiation of a health claim related to a fermented milk drink Actimel, containing Lactobacillus casei, and the “reduction of the presence of Clostridium difficile toxins in the gut, which reduces the incidence of acute diarrhoea.” Danone is currently challenging the opinion, but notes that it is a new claim and will not affect the company’s current communication strategies.

The cloud of uncertainty over health claims has already impacted new-product activity in Western Europe. From January through June of last year, Innova Market Insights tracked 1960 new products with an “active” health positioning-a decline compared to 2189 new products with this positioning in the corresponding period in 2009.

This decline in active (food-plus or fortified) health products came despite an increase in “passive” (food-minus or low-and-light) health claims on new products. Tracked from January through June of last year, 10,350 products carried a passive health claim, compared with 8747 new products over the same period in 2009. You can expect this trend to continue, thanks to uncertainty about the future-claims rejections in the European probiotics sector were particularly rife-if “hard” claims can no longer be made.

In the meantime, manufacturers will be assessing the benefits and legal risks of opting for “soft” claims. The area of soft claims will be a difficult one, however, as no such thing officially exists from a legal perspective. The definition of claims under EU Regulation EC/1924/2006 is quite broad in terms of what may be expressed and whether a claim implicitly or explicitly suggests or implies a health benefit. According to Article 2.2.1 of the Regulation, a “‘claim’ means any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic, or symbolic representation, in any form, which states, suggests, or implies that a food has particular characteristics.”

This part of the legislation is designed to capture all types of messages. The wording is so broad that it effectively means that the use of any health claim that has been rejected by EFSA will be deemed illegal (even in a “soft” form). This is what industry is busy with now in terms of looking at ways in which they can get around the regulation and still take advantage of the benefits of having a recognizable nutrient.