ASA Adjudication on Good Health Naturally
Good Health Naturally
16 January 2013
Health and beauty
Number of complaints:
Summary of Council decision:
Four issues were investigated, all of which were Upheld.
An ad in 'What Doctors Don't Tell You' magazine, for three supplements which included the enzyme Serrapeptase, was headed "CHANGING LIVES The 'Miracle Enzyme' is Serrapeptase". Further text stated "Serrapeptase is making headway in the natural health industry as the 'must have' dietary supplement. May help to support healthy: Joints & Tendons, Bronchial & Lung Function, Veins & Arteries, Digestive System & Colon, Heart & Circulation, Relief from Trauma, Swelling (eg post operative) & Sports Injury What is Serrapeptase? Also known as the 'miracle enzyme' it is a critical & multifunctional proteolytic enzyme and can help to support healthy inflammation. Unhealthy inflammation is one of the major factors in the majority of modern day health issues. Its wide use throughout the past 30 years includes 23 studies, successful use by doctors throughout the world, and a fantastic library of testimonials. Text at the bottom of the ad stated "Serrapeptase is ... safe to take with other supplements or prescribed medicine and no known side effects".
The Nightingale Collaboration challenged whether:
1. the health claims;
2. the claims that Serrapeptase was safe to take with other supplements and/or prescribed medicines; and
3. the claim that Serrapeptase had no known side effects
were misleading and could be substantiated.
4. The Nightingale Collaboration also challenged whether the ad made medicinal claims for a food supplement.
CAP Code (Edition 12)
1. Good Health Naturally (GHN) said they were happy to remove the claim that Serrapeptase "may help to support healthy ... Relief from Trauma, Swelling (eg post operative) & Sports Injury", because it could be seen as a health claim. However, they considered the other claims were not health claims, because they did not mention any health conditions or names of diseases, and only stated that serrapeptase "may" help to support healthy aspects of the body. They sent 15 documents in support of the claims in the ad.
2. & 3. GHN said they would remove the claims.
4. GHN said the ad did not make claims that Serrapeptase could treat, prevent or cure human diseases. They considered the ad did not make medicinal claims.
The ASA acknowledged the ad did not specifically reference any diseases. However, we considered the claims that serrapeptase "may help to support healthy" aspects of the body, and "can help to support healthy inflammation" implied that serrapeptase, and therefore the three supplements which featured in the ad, had a beneficial effect on the body either by helping to ease conditions which affected the listed parts of the body or by helping to protect against conditions from developing. We considered the claims were therefore health claims which must be substantiated by robust evidence.
Thirteen of the 15 documents sent by GHN were abstracts of papers which described tests relating to the efficacy of serrapeptase; we considered abstracts were not adequate evidence on which to base claims of efficacy. Of the remaining two documents, one was a letter to a pharmacology journal which described a study that tested the anti-inflammatory activity of serrapeptase on rats; whilst the study appeared to relate to claims in the ad which referenced inflammation, we considered that because the document was not a full study paper, and because the study was not conducted on humans, it was not adequate evidence on which to base claims of efficacy for serrapeptase in humans. The final document was a study paper, published in a pharmacology journal, which investigated the feasibility of developing a topical serrapeptase preparation, also tested on rodents. Because the study did not relate to the efficacy of oral serrapeptase supplements in humans, we considered it was not adequate to support the claims in the ad.
We concluded that the claims in the ad which implied that serrapeptase had a beneficial effect on the body had not been substantiated and were therefore misleading.
On this point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 15.7 (Food Supplements and other Vitamins and Minerals).
2. & 3. Upheld
We noted GHN did not provide any evidence to support the claims that serrapeptase was safe to take with other supplements or medicines and had no known side effects. We concluded the claims were misleading. We welcomed GHN's willingness to remove the claims.
On points 2 and 3, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation).
We understood from the MHRA that the claims that serrapeptase could help to support "healthy ... Relief from Trauma, Swelling (eg post operative) & Sports Injury" and "healthy inflammation" were medicinal claims, but that the MHRA did not classify serrapeptase as medicinal by function; the products marketed in the ad were not classified as medicines.
We therefore understood that the products were food supplements and the ad must therefore comply with the relevant Code rules on 'Food, food supplements and associated health and nutrition claims', including rule 15.6.2, which stated "Claims that state or imply a food prevents, treats or cures human disease" were not acceptable in marketing communications for foods supplements. We considered that the claims identified by the MHRA as medicinal implied that products containing serrapeptase could treat human disease and we therefore concluded the ad breached the Code in that regard.
On this point, the ad breached CAP Code (Edition 12) rule 15.6.2 (Food, food supplements and associated health or nutrition claims).
The ad must not appear again in its current form. We told GHN they should not make health claims or other claims of efficacy for their products, or ingredients of those products, unless they held robust evidence to substantiate the claims. We told them they should not state or imply that their products, or ingredients of those products, were safe to take with other supplements or medicines, and had no known side effects, unless they held robust evidence to substantiate the claims. We told them they should not make medicinal claims for foods.