Background
Summary of council decision:
Eleven issues were investigated, all of which were Upheld.
Ad description
Various claims, which related to Biocalth, a food supplement, appeared on the website www.principlehealthcare.com. They included "Biocalth is a unique patented, scientifically proven, calcium supplement that improves bone density and encourages formulation of collagen and cartilage to strengthen bones". Other claims included those that described how the product was intended to work, a condition it claimed to treat and the product's claimed benefits.
Issue
The complainant challenged the following claims, which were required to be authorised on the EU Register:
1. "Biocalth is a unique patented, scientifically proven, calcium supplement that improves bone density and encourages formulation of collagen and cartilage to strengthen bones";
2. "It is the only product to contain Calcium L-Threonate which directs calcium through your intestines and deposits the calcium more effectively to the bones. In addition to the advantages of its bioavailability, Biocalth actually results in … Bones which are not merely stronger but more flexible … Increased collagen formation (collagen is not formed as a result of calcium supplementation … Promotion of cartilage development (cartilage is not formed as a result of calcium supplementation)";
3. "The blood therefore becomes concentrated much faster with calcium L'threonate and as a result builds the bones faster and more effectively to combat the ageing erosion of bone cells";
4. "BioCalth is associated with an increase in bone and joint health parameters";
5. BioCalth delivers calcium more effectively to the bone where it stimulates the cells specialised to form bone (osteoblasts) and cartilage";
6. "A number of studies conducted with BioCalth have revealed its abilities to help maintain cartilage and joint structure by promoting cartilage production, helping to inhibit bone loss and assisting in the maintenance of connective tissue";
7. “More importantly, L-threonate is directly involved in the process of bone formation by stimulating the activity of osteoblasts";
8. "Biocalth contains Calcium L-Threonate with [sic] is a unique ingredient proven to help deliver Calcium more efficiently to the bones and increases the absorption rate of calcium to a massive 95% compared to 40% of ordinary calcium supplements";
9. "Scientific Studies revealed significant increases in the absorption and utilisation by the body of the L-threonate form compared to other calcium forms"; and
10. "As we get older the renewal process of bone generation slows down and the degradation of the bone happens at a faster rate than the building of new bone. This continued cycle can lead to the bone becoming more and more fragile and therefore the condition Osteoporosis. Biocalth has been scientifically proven to help prevent this process".
The complainant also challenged whether the following claim was misleading and could be substantiated:
11. "The Calcium L'Threonate enables the much needed calcium to pass through the intestine faster and more effectively than any other calcium supplement. This is because the unique chemical structure is absorbed through he [sic] intestine passively ie: requires no additional energy, such as Vit C, to help it absorb through to the blood stream".
Response
1. - 10. Principle Healthcare International provided various documents which they said supported the claims. The documents included US Patents, a paper on the prevention or treatment of cartilage related diseases through the administration of L-threonate and preventing, inhibiting and curing osteoporosis and rickets, a journal article on the pharmacokinetics and safety profile of the product, an unpublished and unnamed overview of various studies on their product, an EU patent that related to the use of the product for the treatment of bone fractures, and a European Foods Standards Authority (EFSA) Opinion on L-threonate as a source of calcium in food supplements on its safety and bioavailability.
11. Principle Healthcare International provided a research paper and an Opinion published in the EFSA journal which they said supported the claim. They also said the claim included an error and the ad should have referenced vitamin D instead of vitamin C.
Assessment
1. - 7. Upheld
The ASA noted that according to EU Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims listed as authorised on the EU Register of Nutrition and Health Claims made on Foods (the EU Register) were permitted in marketing communications.
Principle Healthcare International provided one document from EFSA, however, that related only to the safety and bioavailability of calcium L-threonate and not to the assessment of the health claims. We understood that health claims were being stated which should be made only if they were authorised on the EU Register and complied with the conditions of use. Because we did not see any evidence that the claims were authorised, we concluded they breached the Code.
On these points, the ad breached CAP Code (Edition 12) rules
15.1
15.1
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.
15.1.1
15.1.1
Only nutrition claims listed in the updated Annex of the EU Regulation (as reproduced in the EU Register) may be used in marketing communications.
http://www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/nutrition_claims_en.htm
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.
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, food supplements and associated health or nutritional claims).
8. & 9. Upheld
We understood that these claims were health claims with a comparative element. Similarly to the points made above, because we did not see any evidence that the claims were authorised on the EU Register and because the ad contained a comparative claim that was not authorised or listed as a separate authorised claim, we concluded they breached the Code.
On these points, the ad breached CAP Code (Edition 12) rules
15.1
15.1
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.
15.1.1
15.1.1
Only nutrition claims listed in the updated Annex of the EU Regulation (as reproduced in the EU Register) may be used in marketing communications.
http://www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/nutrition_claims_en.htm
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.
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, food supplements and associated health or nutritional claims).
10. Upheld
We considered that the claims "the renewal process of bone generation slows down" and "This continued cycle can lead to the bone becoming more fragile and therefore the condition osteoporosis. Biocalth has been scientifically proven to help prevent this process" were reduction of disease risk claims, i.e. claims that stated, suggested or implied that the consumption of a food category, a food or one of its constituents significantly reduced a risk factor in the development of a human disease.
Health claims and reduction of disease risk claims were only acceptable under the CAP Code if they were listed as authorised in the EU Register. We had not seen evidence that the claims in the ad were authorised by the EU Register. We therefore concluded it had breached the Code.
On this point, the ad breached CAP Code (Edition 12) rules
15.1
15.1
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.
15.1.1
15.1.1
Only nutrition claims listed in the updated Annex of the EU Regulation (as reproduced in the EU Register) may be used in marketing communications.
http://www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/nutrition_claims_en.htm
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.
15.6
15.6
These are not acceptable in marketing communications for products within the remit of this section:
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
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, food supplements and associated health or nutritional claims).
11. Upheld
On this point, because the claim did not relate to the benefits of calcium L-threonate for human health we considered it was a comparative efficacy claim rather than one that was required to be authorised on the EU Register. As with points 1 to 7 above, the EFSA journal document related to safety and the bioavailability of calcium L-threonate, did not compare Principle Healthcare International's product with other forms of calcium and the majority of studies had not been conducted on humans, as required by the Code. Similarly, the research document was mainly conducted on non-human subjects and the additional paper did not compare calcium L-threonate with other forms of calcium. We therefore considered the evidence submitted was not sufficient to substantiate the claim.
Because Principle Healthcare International had not provided documents to adequately support the claim, in comparison with other forms of calcium, we concluded it was misleading.
On this point, the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
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.
Substantiation) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health and beauty products).
Action
The claims must not appear again in their current form. We told Principle Healthcare International not to make health claims or reduction of disease risk claims for foods if they were not listed as authorised in the EU Register or to make general efficacy claims in the absence of adequate substantiation.
CAP Code (Edition 12)
12.1 15.1 15.1.1 15.6 15.6.2 15.7 3.1 3.7
