ASA Adjudication on New Nordic Ltd

Ad

A national press ad had the headline "The tablet which 'glue' calcium to the bones, helps me from shrinking!". Text underneath stated "At last! A revolutionary discovery that helps fragile bones and bone loss. A secondary benefit is that this natural tablet may help 'polish' our veins. The press call it the 'Pharmaceutical Holy Grail'. Read Margaret's story and be inspired to start taking the tablets sooner rather than later". Below was Margaret's story, which stated "Gradually I noticed that I started to shrink. I was told that it is quite normal and due to bone loss and lack of strength. It was so depressing. Six months ago I read about Nutra K2 tablets which contains something called menaquinone. An active natural substance found in fermented food eaten by Japanese people. The story about how some Japanese women eating this fermented bean lived longer, were more active and rarely experiences bone loss fascinated me. I decided to give it a try. After some weeks I started to feel how I got the spark back in my life. I'm sure it's due to the fact that the tablets help 'polish' my body. I have now taken the tablets for nearly 6 months, and I feel confident they have also helped me with my bones and put a hold to my shrinking ... The natural vitamin K2 is different to the synthetic vitamin K1 which has been known for a long time. Vitamin K2 is absorbed into your body. So far two very important functions has been documented: 1: It activates cells to put calcium into the bones and it inhibits the cells, which is known to break down the bone structure. 2: It helps 'polish' your veins by dissolving calcium blocking your veins".

Issue

The complainant challenged whether:

1. The claims made about the efficacy of the product were misleading and could be substantiated;

2.  The advertisers were making medicinal claims for the product.

CAP Code (Edition 11)

Response

New Nordic Ltd (New Nordic) said they held sufficient documentary evidence in the form of human studies to support the efficacy claims made in the ad. They said there was a long list of published human studies on the effects of the K2 vitamin. New Nordic submitted a copy of a monograph on MenaQ7 (natural vitamin K2), which explained the effects of vitamin K2 and listed several human studies. They also submitted copies of three studies on vitamin K2. New Nordic said they were willing to make any changes to the claims in the ad that may be regarded as medicinal.

Assessment

1. Upheld

The ASA noted the three studies and monograph submitted by New Nordic. We understood that one of the those studies assessed the effect of vitamin K2 on bone metabolism in the cell cultures of mice, and that another of the studies assessed the effect of dietary vitamin K2, mainly derived from dairy products, in men and women over the age of 55 years. However, we considered that neither of those studies were sufficient to support the claims made about the efficacy of the supplement form of vitamin K2 in adult women.

We noted that the third study was a randomised, controlled trial that assessed the Bone Mineral Density (BMD), Femoral Neck Width (FNW) and Bone Mineral Content (BMC) over a three year period in women between the ages of 55 and 75 years. We also noted that the study found an increase in FNW and BMC for those participants taking the vitamin K2 supplement. However, we understood that the study used a very high dose of the menatretrenone (MK-4) derivative of vitamin K2, given to the participants in doses of 45 milligrams per day. We also understood, from the study, that such high doses were typically used as a drug rather than as a food supplement. We noted that the study recommended that a possible alternative for a low dose food supplement of vitamin K2 was the menaquinone (MK-7) derivative. We acknowledged that the New Nordic Nutra 2 vitamin did contain MK-7. However, we considered that we had not seen studies that demonstrated the efficacy of MK-7 or that recommended an optimal dose for MK-7.

We noted that the monograph on MenaQ7 summarised the findings of other studies into the efficacy of the MK-7 strand of vitamin K2, and also listed those studies. However, we did not consider that the list of studies in itself, or their summary in the monograph, was robust enough to support the claims made in the ad that Nutra2 'glued' calcium to the bones, put a hold on shrinking and polished the veins by dissolving calcium blocking the veins.

Because we considered that we had not seen evidence that demonstrated the claimed efficacy of the Nutra K2 supplement, we concluded that on this point the ad was misleading.

On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.1 and 50.5 (Health and beauty products and therapies) and 50.20 (Vitamins, minerals and other food supplements).

2. Upheld

We welcomed New Nordic's willingness to amend any medicinal claims made in the ad. Nevertheless, we understood from the Medicines and Healthcare products Regulatory Authority (MHRA) that the claims "The tablet which 'glue' calcium to the bones, helps me from shrinking ... a revolutionary discovery that helps fragile bones and bone loss" and "It activates cells to put calcium into the bones and it inhibits the cells, which is known to break down bone structure" were disease reduction claims and therefore considered to be medicinal. We also understood that the product did not hold a marketing license for those claims. We therefore concluded that the ad made unauthorised medicinal claims for the product.

On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.11 (Medicines) and 50.20 (Vitamins, minerals and other food supplements).

Action

The ad must not appear again in its current form.

Adjudication of the ASA Council (Non-broadcast)