ASA Adjudication on Pohl Boskamp

Ad

a. A magazine ad was headlined "NYDA Get rid of head lice with just one treatment". Text continued "NYDA is effective, safe, easy to use, and only needs one application to kill all head lice and nits ... NYDA kills head lice within five minutes and eggs - nits - within eight hours. Applied as directed, a single application is enough to treat each infestation - there is no need for repeat treatment ... NYDA contains no toxic insecticides or pesticides ... Clinically proven. NYDA eradicates head lice at all 3 stages of development - lice, larvae and eggs. Scientific studies have proved that it is effective, safe and well tolerated".

b. A TV ad showed the silhouette of a woman combing a child's hair. The voice-over stated "Headlice, they just never seem to go away. With traditional remedies it can seem like an uphill struggle to keep lice at bay. Enter NYDA, its dual formula is specifically designed to knock out lice and nits in round one. There is no resistance. Ask your pharmacist for NYDA and win the fight against head lice with just one application”. On-screen text stated "CLINICALLY PROVEN" in the form of a red stamp of approval. The ad showed an animated boxing match between headlice and the product, in which the product won with one punch.

Issue

Thornton & Ross Ltd challenged whether:

1. the claims in both ads that the product could successfully treat or eradicate headlice with only a single treatment could be substantiated;

2. ad (a) misleadingly implied that the product was completely safe to use and had no harmful side effects; and

3. the claim "Clinically proven. NYDA eradicates head lice at all 3 stages of development - lice, larvae and eggs" in ad (a) and "Clinically proven" in ad (b) was misleading, because it implied that the product had been shown to be effective in killing lice in clinical trials, rather than in laboratory studies only.

CAP Code (Edition 11)

BCAP TV Code

Response

Pohl Boskamp said NYDA was a class IIa registered medical device. They said the product box contained instructions for use. They said traditionally head lice products contained neurotoxic acting insecticides. However as a result of extensive use, resistance to these had increased in the UK. They said both their product and Thornton-Ross's product contained dimeticone, but in different formulations.

1. Pohl Boskamp said they were confident they could substantiate the sufficiency of a single treatment of NYDA. They said headlice products, when used as a single application, needed to show a sufficient efficacy against all developmental stages: the adult louse, the nymph and the egg, because only then would they be able to stop the infestation and interrupt the life cycle of the head louse. They said NYDA's mode of action as well as its formulation accounted for its high effectiveness. They explained that NYDA killed headlice at all their developmental stages by suffocating them, it was effective at immobilising lice within one minute, it was irreversible in its effects and resulted in their death. They sent laboratory studies to confirm that effect on lice and eggs and said the studies showed that in the lab NYDA had 100% pediculicidal (lice-killing) and 100% ovicidal (egg-killing) action after a single application, with the recommended incubation of at least eight hours for the eggs. They said the results of the laboratory studies had also been confirmed by a randomised, controlled, observer-blinded clinical trial and sent a copy of that. They said their studies showed that NYDA killed all development stages of lice, but they nevertheless recommended that patients should check the results of the treatment after 8 to 10 days and repeated the application if necessary, because user treatment failures, for example through not enough solution being used, the application time being too short or re-infestation occurring, could not be completely excluded.

Pohl Boskamp believed the overall impression likely to be conveyed by their ads to the average consumer was that the product was highly likely to be effective in a single application. They said, in relation to the notoriously difficult treatment of head lice, a customer troubled by an infestation was likely to understand that if errors were made in the application (to themselves or a child) it would not work and they would therefore be likely to check. However, they said no claim about NYDA was made that could not be achieved under normal circumstances.

Clearcast said they were mindful that no "one treatment" claim for nits had been approved previously and they had sought advice from an expert. They said the script had been amended several times in accordance with that advice.

2. Pohl Boskamp believed it was appropriate to describe NYDA as safe and did not think that a reasonable consumer could be misled by that. They said all components of NYDA had a long history of safe use, for example in products for the treatment of infant colic as well as in cosmetics such as hair care products. They said NYDA consisted of a dimeticone liquid which enabled the spread of the product. They said the use of dimeticones by humans was very well tolerated. They said dimeticones were widely used in medicinal products, medical devices and cosmetics. They said the NYDA clinical trial proved the high tolerability as well as safety of NYDA. They said, during the clinical trial, only two recorded adverse events occurred, after the product had accidentally entered the eyes, and were resolved after rinsing with clean water. They did not believe that was a "harmful side effect" but quite a common complication of products applied to the hair, with which consumers would be familiar. They said the risk of hypersensitivity was a risk against all substances. However due to the non-toxic and tolerable components of NYDA, hypersensitivity reactions were very rare. They said they had sold approximately 1.5 million bottles of NYDA but had had only 25 complaints. They said, for reasons of product liability, they included a warning in their instructions for use regarding inhalation of the product although there was no scientific evidence that any health threat existed.

Pohl Boskamp said a mandatory part of the conformity assessment for a medical device was a risk analysis, which had identified the theoretical risks of hypersensitivity, irritation of the eyes or mucous membranes, and the flammability of NYDA. To minimize these, they provided appropriate warnings in their instructions for use. Additionally, the product was tested according to the appropriate requirements for skin contacting devices and the results showed NYDA to be safe. They believed the description of the product as "safe" did not convey to the average consumer that there was no conceivable possibility of a temporary adverse consequence as a result of using the product.

Clearcast said they did not believe there was any claim, implied or otherwise in the ad about it being "completely safe" to use.

3. Pohl Boskamp said consumers were likely to infer from the claim "clinically proven" that the product had been tested in scientific circumstances for its efficacy rather than making a distinction between laboratory and clinical trials. However, they said NYDA had been the subject of a randomised, controlled observer-blinded clinical trial. They said the clinical study confirmed the results of the extensive laboratory studies which had confirmed its lice and egg killing activity. They said their assertion that NYDA eradicated head lice at all three stages of development, lice, larvae and eggs was supported by several laboratory studies.

Clearcast said the script had been amended several times in accordance with their expert's advice. They did not believe the claim "clinically proven" was misleading as the advertisers had both clinical trial data and laboratory studies.

Assessment

1. Upheld

The ASA noted the clinical trial report sent by the advertiser stated that 24 hours after one application of an appropriate mix of dimeticone (identical to that in the product, NYDA) the cure rate (those found to be lice free under the test protocols) amongst the trial group was 94.5%, which meant 69 out of 73 children were judged infestation free. However, we also noted that when the dimeticone group's hair was looked at again on day seven of the trial, active lice were found on more of those children than previously and the cure rate had gone down to 64.4%. After a second application the cure rate rose again to 97.2% in that group (on day nine of the trial). We understood that the children in the NYDA group were housed for the duration of the trial with children receiving treatment with another remedy for lice. We understood the drop in cure rate at day seven for the NYDA group could have been the result of re-infestation from the children in the other group, and noted the study suggested that, because the life-cycle of lice meant that no adult lice could develop from eggs in a seven day time period yet many of the NYDA group children who had been found lice-free under the test protocols on day two were carrying adult lice on day seven, which indicated those lice had transferred from other children. However, we also noted the trial report stated that "A few children [in the NYDA group] had mixed stages including nymphs (data not shown). As larval stages were not further defined during the study we were unable to prove that in some cases eggs may not have been killed by the initial treatment".

We concluded that, whilst the clinical trial showed that 24 hours after one application of a NYDA formulation of dimeticone the claim "Get rid of lice with just one treatment" was accurate, for over 95% of children, it did not show that claim continued to hold true seven days later. We concluded that, whilst the evidence submitted was good, it was not sufficient to prove the strong claims "Get rid of head lice with just one treatment ... NYDA ... only needs one application to kill all head lice and nits ... a single application is enough to treat each infestation - there is no need for repeat treatment ..." in ad (a), and the claims "... knock out lice and nits in round one. There is no resistance ... win the fight against head lice with just one application" in ad (b).

On this point the magazine ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and beauty products and therapies: evidence).

The TV ad breached CAP (Broadcast) TV Advertising Standards Code rules 5.1.1 (Misleading advertising) 5.1.2 (Omission) 5.2.1 (Evidence) 5.2.2 (Implications) and 5.2.3 (Qualifications).

2. Not upheld

We noted no significant risks were identified by product safety testing and that it was standard for medicines and medical devices to contain a list of contra-indications in the instructions for use. We considered that readers and viewers would not infer from the claim "NYDA is ... safe and well tolerated" in press ad (a) that the product would have no conceivable side effects on any individual whatsoever, or that they should not read the instructions for use to determine whether the product was appropriate for them.

On this point we investigated the magazine ad under CAP Code clause 7.1 (Truthfulness) but did not find it in breach.

3. Upheld

We understood that there could sometimes be significant differences in scientific results between laboratory tests and clinical trials on people, and noted it was the ASA's view that the claim "clinically proven" was likely to be understood to refer to trials on people. We noted the clinical trial provided by the advertiser showed very high success rates with the product (over 95%) after one treatment. However, we also noted the trial stated that, because larval stages were not defined during the trial, the experimenters were unable to prove that in some cases eggs may not have been killed by the initial treatment. Because we had not seen evidence to show that NYDA was effective at killing all three stages of headlice "in one round" in clinical trials on people, we concluded that the claims "NYDA only needs one application to kill all head lice and nits ... Clinically proven. NYDA eradicates headlice at all 3 stages of development - lice, larvae and eggs" in ad (a) and the claims "knock out lice and nits in one round ... win the fight against headlice with just one application ... CLINICALLY PROVEN" in ad (b) were not sufficiently supported by the evidence.

On this point the magazine ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and beauty products and therapies: evidence).

Tthe TV ad breached CAP (Broadcast) TV Advertising Standards Code rules 5.1.1 (Misleading advertising) 5.1.2 (Omission) 5.2.1 (Evidence) 5.2.2 (Implications) and 5.2.3 (Qualifications).

Action

The ads must not appear again in their current form.

Adjudication of the ASA Council (Broadcast)

Adjudication of the ASA Council (Non-broadcast)