Summary of Council decision:
Two issues were investigation, both of which were ‘Upheld.
A magazine ad for a food supplement, Bio-Pycnogenol, featured an image of the product package. Large text stated "Your natural way to prevent springtime sneezes". Further text stated "Pycongenol is powerful, proven, effective and safe. It is the ideal food supplement to help you prepare for the spring and summer season ahead. Now is the time! Start taking Bio-Pycnogenol early so that your body is prepared for when the pollen count rises. In doing this, you will give yourself the best chance of combating seasonally-related symptoms such as sneezing, itchy eyes and runny nose". Text under the heading "The Best Ingredients" included "The longer you take Bio-Pycnogenol the more effective it becomes."
Text on the packaging of the product stated "Pinus Pinaster (French maritime pine bark) works as an antioxidant, helping to maintain good health by protecting cells from oxidative damage".
The ad also featured a quote from a testimonial which included "Pycnogenol is a potent antioxidant that protects us against damage and keeps us healthier for longer" and a logo in the top right-hand corner of the ad which stated "PYCNOGENOL. NATURE'S SUPER ANTIOXIDANT".
The complainant challenged whether:
1. the claims that the product could prevent hay fever symptoms breached the Code, because they were disease prevention claims for a food supplement; and
2. the claim "antioxidant", which was required to be authorised on the EU Register of Nutrition and Health Claims for Foods (the Register), breached the Code.
1. Pharma Nord (UK) Ltd said Pycnogenol (a brand name for Pinus pinaster) was a botanical supplement and that two health claims for Pinus pinaster which had been submitted to the European Food Safety Authority (EFSA) were currently listed as "on hold". They said one of those claims was "contains herbs with lung inflammation reducing, cough up promoting and bronchial spasm reducing properties" and that this was currently listed as "under consideration". They said the ad used wording such as "springtime sneezes" and "pollen count", but did not refer to "hay fever" or "allergic rhinitis". They said the wording applied equally to non-allergic rhinitis, which was not a disease but a condition resulting from physical irritation of the respiratory tract by substances such as pollen. They said clinical studies showed that in healthy individuals Pycnogenol could modulate inflammation resulting from such physical irritation. They provided a data sheet for Bio-Pycnogenol listing the product composition and some further information regarding non-allergic rhinitis. They submitted three studies which they said provided evidence that taking the product had a significant effect on key components of the inflammatory process in healthy human volunteers. They also provided an article which reviewed the available evidence for Pycnogenol.
2. Pharma Nord said one of the EFSA health claims for Pinus pinaster currently listed as "on hold" was "helps to maintain good health by protecting cells and tissues through its antioxidant property". They said the claim was listed as "finalised, negative outcome", but the negative assessment by EFSA had not yet been adopted by the EC, and the claim therefore remained "on hold". They believed this allowed them to continue to use that claim. They also said that all substances could act as antioxidants and that to state that a product had antioxidant property would have no meaning without further qualification. They said they referred to "potent" and "super" antioxidant to indicate the well-established potent antioxidant activity of Pycnogenol, which they said contained a number of active chemical substances, including both polyphenolic and non-polyphenolic constituents. They provided 19 peer reviewed and published studies and papers in support of the claims.
The ASA considered that consumers would understand from the ad, and in particular the claims "Your natural way to prevent springtime sneezes!", "seasonally-related symptoms such as sneezing, itchy eyes and runny nose" and the reference to pollen, that taking the product could prevent hay fever. We therefore considered the ad made disease prevention claims for a food supplement and concluded it breached the Code.
On this point the ad breached CAP Code (Edition 12) rules 15.6.2 15.6.2 Claims that state or imply a food prevents, treats or cures human disease. Reduction-of disease-risk claims are acceptable if authorised by the European Commission (Food, food supplements and associated health and nutrition claims).
We considered that the claims "works as an antioxidant, helping to maintain good health by protecting cells from oxidative damage", "potent antioxidant that protects us against damage and keeps us healthier for longer" and "SUPER ANTIOXIDANT" were health claims and were likely to be interpreted as suggesting a specific health benefit could result from consuming the products.
We understood that a claim had been submitted to EFSA for Pinus pinaster with the wording "helps to maintain good health by protecting cells and tissues through its antioxidant property" and that the claim was currently listed as 'on hold' in a list of botanical substances. ‘On hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). We noted marketers could exercise some flexibility in rewording claims, provided that the reworded claim was likely to have the same meaning for consumers as the authorised (or, in this case, on hold) health claim and the aim of the rewording was to aid consumer understanding, and taking into account factors such as linguistic or cultural variations and the target population. However, we did not consider that the claims in the ad would have the same meaning to consumers as the claim submitted to EFSA. In particular, the claim submitted to EFSA did not refer to "oxidative damage", include a reference to health longevity or use the terms "potent" or "super". We therefore considered the claims in the ad exaggerated the health claim submitted to EFSA. We also noted that EFSA had published a negative scientific opinion on the 'on hold' claim "helps to maintain good health by protecting cells and tissues through its antioxidant property". The EFSA Panel had concluded that a cause and effect relationship had not been established between the consumption of the foods or food constituents evaluated in their opinion (which included Pinus pinaster) and the protection of body cells and molecules such as DNA, proteins or lipids from oxidative damage.
We also understood that in this case a health claim submitted in relation to polyphenols from French maritime pine park (an alternative name for Pinus pinaster) was also listed on the Register as non-authorised. The health claim listed as non-authorised was "Polyphenols from French maritime pine bark ensure antioxidant action. Polyphenols from French maritime pine bark ensure protective effect of the organism". We therefore understood that this claim and claims similar to it, including any which were 'on hold' in the list of botanicals, were not allowed to be used. The claims used in the ad also referred to "antioxidant" properties and we therefore considered that they were similar to the non-authorised health claim and should not be used if they were based on evidence relating to polyphenols from Pinus pinaster. We understood that Pinus pinaster contained non-polyphenolic constituents, in addition to polyphenols.
Pharma Nord had provided us with evidence which, apart from one study, had not been considered by the EFSA Panel and we therefore considered whether the overall body of evidence was sufficient to substantiate the antioxidant claims in the ad, taking into account the EFSA Panel's view of the evidence they had seen. Overall, we did not consider that the body of evidence was sufficiently robust to substantiate that consuming the product had a beneficial physiological effect, and specifically had the effect of protecting against or reducing oxidative stress or damage. Two of the papers were reviews of the evidence available regarding Pycnogenol. However, they appeared to be summaries of the evidence rather than critical systematic reviews and whilst they referred to oxidative stress that was not their sole focus. Two further studies were conducted on mice only. A further ten studies were conducted on human subjects, one of which had previously been considered by the EFSA Panel. Five of those studies were conducted on a small number of subjects, three of which were not blinded or controlled and the majority of the measures did not relate to antioxidant effects. Three studies related to pain from endometriosis, skin appearance and sexual dysfunction (one of which related to a product which contained other active ingredients in addition to Pycnogenol) and we therefore did not consider them to be relevant to the claims in the ad. A double-blinded, placebo controlled study of 101 elderly subjects was provided and reported statistically significant results for one biological measure, a marker of oxidative stress. However, we did not consider that the results could be extrapolated to the general healthy population and also noted that a large number of biological measures had been taken and only one appeared to show a statistically significant effect. A further randomised, double-blinded, placebo controlled study examined the effects of the product on individuals with elevated plasma free radical burden (in this case smokers) and a statistically significant effect was shown after four weeks. However, we did not consider that the results could be extrapolated to the general healthy population and also noted that the dose was not consistent with that recommended by the manufacturer, albeit a lower one. We also noted that none of the studies differentiated between the polyphenolic and non-polyphenolic constituents of the product, and that the doses of the products tested were not consistent, ranging from 20 mg to 200 mg per day. Overall, we did not consider the body of evidence was sufficiently robust to substantiate the claims in the ad.
Because the "antioxidant" claims in the ad exaggerated the claims submitted to EFSA, and because the claims had not been substantiated, we concluded that the claims breached the Code.
On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising),
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim, as specified in the EU Register. Claims must be presented clearly and without exaggeration.
Only nutrition claims listed in the updated Annex of the EU Regulation (as reproduced in the EU Register) may be used in marketing communications.
Only health claims listed as authorised in the EU Register, or claims that would have the same meaning to the consumer may be used in marketing communications.
http://www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/authorised_health_claims_en.htm. (Food, food supplements and associated health and nutrition claims) and 15.7 15.7 Nutrition and health claims for food supplements must be permitted or authorised as provided for at rule 15.1.1 above. Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim as specified in the EU Register. (Food supplements and other vitamins and minerals).
The ad must not appear again in its current form. We told Pharma Nord not to state or imply that Bio-Pycnogenol could prevent hay fever symptoms, or claim that a food supplement could prevent, treat or cure human disease.
We told them not to make the following claims in relation to Pinus pinaster: "works as an antioxidant, helping to maintain good health by protecting cells from oxidative damage"; "potent antioxidant that protects us against damage and keeps us healthier for longer"; "SUPER ANTIOXIDANT" or any other claims referring to "antioxidant" unless they were authorised on the Register.