Notes of Guidance

8. Medical Claims

Medical Claims Index
8.1 MHRA Marketing Authorisation
8.2 PAGB
8.3 Mandatory Information to be given in Advertising
8.4 Relief of Symptoms
8.5 Information and Evidence
    8.5.1 Claim Support
    8.5.2 Marketing Authorisations
    8.5.3 Clinical Trials
    8.5.4 Product Packs and Enclosed Leaflets
    8.5.5 References to other Advertisements
8.6 Unacceptable Products, Claims and Presentations
    8.6.1 Unacceptable Products
    8.6.2 Superlative Claims
    8.6.3 Lengthy Courses of Treatment
    8.6.4 Misleading Indications and Exaggerations
    8.6.5 Viewer Comprehension
    8.6.6 Self Diagnosis
    8.6.7 Appeals to Fear
    8.6.8 'Necessary'
    8.6.9 Indiscriminate and Prophylactic Use
    8.6.10 Trivialisation
    8.6.11 Disparagement
    8.6.12 Tonic
    8.6.13 Refunds and Special Promotions
    8.6.14 Professional Endorsement
    8.6.15 Infectious Situations
    8.6.16 Serious Conditions
    8.6.17 Distasteful Presentations
    8.6.18 Vitamins
    8.6.19 Correct Dosage
8.7 Types of Claim and Presentation
    8.7.1 'New', 'Improved', 'Breakthrough', etc.
    8.7.2 Medical Efficacy and Sales Claims
    8.7.3 Comparative Claims for Medical Products
    8.7.3.1 Naming Comparisons
    8.7.3.2 Comparative Claims
    8.7.4 Presenters
    8.7.5 Consulting a Doctor
    8.7.6 Testimonials
8.8 Safety
    8.8.1 Natural Products
    8.8.2 Unqualified Claims
    8.8.3 Unsafe Situations
8.9 Particular Conditions, Products and Services
    8.9.1 Clinics for the Treatment of Hair and Scalp
          8.9.1.1 Baldness
    8.9.2 Colds and Influenza
          8.9.2.1 Relief, Not Cure
          8.9.2.2 Serious Conditions
          8.9.2.3 Portrayal of Symptoms, Treatments or Recovery
          8.9.2.4 Vitamins
          8.9.2.5 Infectious Situations
    8.9.3 Coughs, Catarrh, Sore Throat, etc.
          8.9.3.1 Pain
          8.9.3.2 Cures
          8.9.3.3 References to Germs
          8.9.3.4 Congestion
          8.9.3.5 Gargles
    8.9.4 Analgesics
          8.9.4.1 Headaches and Minor Conditions
          8.9.4.2 Arthritis, Rheumatic and Allied Pains
    8.9.5 Indigestion
          8.9.5.1 Intestinal Disorders
    8.9.6 Skin Ailments and Treatments
          8.9.6.1 'Spots'
          8.9.6.2 Suntan Lotions
          8.9.6.3 Mildness Claims for Detergents
          8.9.6.4 Cosmetics Claims and the effects of Ageing
          8.9.6.5 Penetration Claims
    8.9.7 Antiperspirants
    8.9.8 Products for the treatment of Sleeplessness
    8.9.9 Diets
          8.9.9.1 Very Low Calorie Diets (VLCD)
          8.9.9.2 Substitutes for Main Meals
          8.9.9.3 Vitamins and Slimming
          8.9.9.4 Mechanical Devices
    8.9.10 Vitamins and Minerals
    8.9.11 Eating and Dental Health
8.10 Toothpastes and other Oral Hygiene Products
    8.10.1 Plaque Removal
    8.10.2 Prevention Decay
          8.10.2.1 Tested Fluoride Toothpastes
          8.10.2.2 Other Toothpastes
    8.10.3 Bad Breath
    8.10.4 Impressions of Professional Support
8.11 Antiseptics and Disinfectants
8.12 Smoking Deterrents
8.13 Pregnancy Testing Services and Kits
    8.13.1 Pregnancy Testing Services
    8.13.2 Pregnancy Testing Kits
8.14 Opticians
8.15 Contact Lenses
8.16 Homeopathic Medicines and Treatments
8.17 Medicines and Children
    8.17.1 Symptoms
    8.17.2 Medicines Suitable for Children
    8.17.3 Restrictions on Times of Transmission
    8.17.4 Confusion with Sweets
    8.17.5 References to Pain, etc.
    8.17.6 Children as Presenters
    8.17.7 Child Safety
    8.17.8 Claims to enhance Performance
    8.17.9 Health Education

There is a dedicated section 8 of the Code and guidance may be found in these Notes. The advertising of medicines and treatments on television is confined to medicines that can be purchased over-the-counter. The Code is designed to ensure that advertisements:

(i) do not lead to self-diagnosis or self-treatment of any condition for which in the first instance medical advice should properly be sought;
(ii) do not exaggerate the efficacy of any over-the-counter remedy, or the benefit to be obtained from it;
(iii) do not lead to the misuse of such products, or any other kind of harm;
(iv) do not appeal to fear.

The Code contains a special appendix about the advertising of medicines, treatments and health claims. These notes are meant to be read in conjunction with it.

Clearcast has access to a panel of consultants in medical areas and new or complex material will be assessed by a member of this panel who will advise Clearcast.

It should be noted that advertising of medicines is subject to legal requirements and it remains the responsibility of the advertiser to ensure compliance with those legal requirements. Clearance by Clearcast is given on the understanding that advertisers have warranted the legality of claims made.

8.1 MHRA Marketing Authorisation
Advertisements may only make medicinal claims if the product has a Marketing Authorisation issued by the MHRA. Products which do not hold an Authorisation may not include medical claims in their advertising.

8.2 PAGB
Advertisers should be aware that the trade association of the over-the-counter pharmaceutical industry – the Proprietary Association of Great Britain (PAGB) - produces its own code of practice which has rules on advertising. Clearcast does not apply this code but does advise that PAGB approval of television scripts is obtained at the same time or before, submission to the Clearcast.

8.3 Mandatory information to be Given in Advertising
Essential items of information to be carried in advertisements are:

the name of the product;
what the product is for (indication);
the single active ingredient if there is only one; An invitation to read the leaflet or label.

8.4 Relief of Symptoms
All claims must be in line with the product’s Marketing Authorisation. For example, products must not claim to prevent a medical condition if the Marketing Authorisation only states that the product relieves the symptoms. No product or treatment may claim that it ‘cures’ a medical condition as this would breach the prohibition on the use of guarantees in medicines advertising.

8.5 Information and Evidence
8.5.1 Claim Support
Evidence in support of claims made in advertising must be submitted in full and sufficient time must be given to allow for that evidence to be assessed by the Clearcast’s Medical advisers. This will be particularly important in the case of new products coming to market and where changes to existing claims are proposed.

8.5.2 Marketing Authorisations
Where a product has been issued with a Marketing Authorisation by the MHRA a copy of the appropriate sections or the Summary of Product Characteristics (SPC) must be submitted.

8.5.3 Clinical Trials
Where evidence is submitted in support of claims for medicines or treatments, it will be assessed by one or more of Clearcast's medical advisers. Such evidence should be based on clinical research and normally should either have been accepted for publication in a reputable professional journal operating on the 'peer-review' principle, or be of comparable quality. The entire paper is required, rather than merely the abstract.

Evidence that is unlikely to be acceptable in support of medical claims is likely to include:

reports of poorly designed research giving rise to questionable results;
animal studies, where this is the only evidence submitted;
out of date evidence.

8.5.4 Product Packs and Enclosed Leaflets
Where products, including reformulated products, have not previously been advertised on television, the product packs and enclosed literature should accompany the script. The inclusion on the pack or in any promotional material of anything contrary to the Code is likely to make the proposed advertisement unacceptable.

8.5.5 References to Other Advertisements
If the commercial refers to advertisements, coupons, etc., in other media, care should be taken not to breach Code rule 3.2 which prohibits indirect advertising of unacceptable products.

8.6 Unacceptable Products, Claims and Presentations
8.6.1 Unacceptable Products
The following may not be advertised on television:

prescription only (POM) medicines or treatments. (Veterinary products are excepted from this prohibition but this is likely to change);
products for the treatment of alcoholism and substance abuse or dependence;
pregnancy testing services. This ban does not, however, extend to pregnancy testing kits available from pharmacies without prescription, provided they are approved by the Medical Advisory Panel;
hypnosis, hypnotherapy, psychology, psychoanalysis or psychiatry; this prohibition does not, however, extend to clinics and institutions, provided they are approved by the Medical Advisory Panel;
services that offer to prescribe or treat remotely.

8.6.2 Superlative Claims
Superlative claims for medicines and treatments are acceptable. Advertisements including such claims should not, however, suggest superiority over identifiable medicines or treatments. Superlative claims require substantiation in their support.

8.6.3 Lengthy Courses of Treatment
No advertisement should suggest or imply that any medicine should be taken for a longer duration than is described on the products packaging and in-pack leaflet.

8.6.4 Misleading lndications & Exaggerations
All terms used to refer to an ingredient or to describe a product and its effect must be acceptable to Clearcast's medical advisers, but the following examples indicate some of the areas where special care is needed:

(i) no advertisement may state or imply that the product, or an ingredient, has some special property or quality which is incapable of being established;
(ii) nothing in an advertisement should suggest that the product is invariably effective or convey an exaggerated impression of its speed of action. In 'before and after' treatments especially, care must be taken to indicate a suitable period of time for relief of symptoms. The duration of the relief provided must not be overstated;
(iii) terms such as 'revolutionary advance', 'dramatic improvement', 'medical breakthrough', etc., can be accepted only if there is proper medical justification for them: they are not acceptable as mere hyperbole;
(iv) slogans should be used with care, ensuring that they are not open to misinterpretation by virtue of ambiguity, brevity or for any other reason.

8.6.5 Viewer Comprehension
Advertisements should use language that is readily understood by the viewer. Pseudo-scientific terms or jargon are not acceptable.

Statistics, graphs, diagrams, research data, etc., even when valid, may not be used in a way which exploits public ignorance or encourages popular misconceptions, or in any other way which might confuse or mislead viewers.

8.6.6 Self Diagnosis
Advertising must not contain any descriptions or case histories which could lead to a wrong self-diagnosis.

8.6.7 Appeals to Fear
Advertisements should not appeal to fear, nor encourage viewers to believe they are suffering, or may without treatment suffer, from any ailment, illness or disease.

8.6.8 'Necessary'
It should not be suggested that a medicine or treatment is 'necessary' or that it is needed by people in general, e.g. 'in winter time everyone needs their daily X'.

8.6.9 Indiscriminate and Prophylactic Use
Advertisements should not encourage people to take remedies indiscriminately or as a means of forestalling the onset of certain conditions, such as headaches or indigestion, except in the case of products for which such prophylactic use is authorised by the Marketing Authorisation.

8.6.10 Trivialisation
While advertising can use humour it should not be used in a way which trivialises a medical condition or encourages a frivolous attitude to the use of medical products. Jingles are allowable but must not contain any medical claims.

8.6.11 Disparagement
No advertisement is acceptable which, directly or by implication, disparages other products or treatments, or the advertising for them, or established medical practice. It should be noted that this prohibition is not limited to unfair disparagement, but applies irrespective of whether or not the advertised product is able to demonstrate superiority.

8.6.12 Tonic
Except in the case of products whose Marketing Authorisation expressly authorises its use, the word 'tonic' is not acceptable in advertisements for products making health claims and no product may be advertised in a way which implies that it has tonic properties.

8.6.13 Refunds and Special Promotions
Advertisements for medicines or treatments, or which make health claims, may not offer to refund money to dissatisfied users, nor feature guarantees, competitions, premium offers, samples or any other promotional method. This restriction does not apply to vitamin or food supplements.

8.6.14 Professional Endorsement
Advertisements must not state, suggest or imply that a medical product is recommended by or used by health professionals (including Vets.) Claims or impressions of medical or other professional support for a product or its ingredients are not acceptable.

8.6.15 Infectious Situations
Advertisements should avoid showing situations where there is a significant risk of cross-infection.

8.6.16 Serious Conditions
Care must be taken with creative treatments to avoid the portrayal of serious conditions unless these are in line with the Marketing Authorisation.

8.6.17 Distasteful Presentations
Visual representations of germs or infected areas should not be distasteful.

8.6.18 Vitamins
No advertisement may claim or imply that vitamins have any value in the treatment or prevention of colds or influenza in the absence of convincing evidence. No reference to the inclusion of vitamins in products for the treatment of colds and 'flu is acceptable other than in shots of the label or pack which give no undue prominence to such a reference.

8.6.19 Correct Dosage
When products are shown being prepared or taken, it is important to avoid any impression of overdosing.

8.7 Types of Claim and Presentation
8.7.1 'New', 'Improved', 'Breakthrough', etc.
Products may not continue to be described as 'new', 'improved', etc., after a period has elapsed which makes such a claim unjustified. As a general rule, such claims cease to be acceptable after the product has been on the market for 12 months. Words such as “breakthrough” “revolutionary” or similar will only be acceptable where there is compelling evidence to support their use.

8.7.2 Medical Efficacy and Sales Claims
No advertisement may confuse high sales of a product with its medical efficacy. Sales claims must be unambiguously presented as such, and advertisements should not suggest or imply that a product which outsells others is therefore medically superior.

8.7.3 Comparative Claims for Medical Products
8.7.3.1 Naming Competitors
Advertisements which name or otherwise identify a competitive product are forbidden by Medicines (Advertising) Regulations.

8.7.3.2 Comparative Claims
These should be based on clinical research evidence acceptable to Clearcast's medical advisers. Such evidence should either have been accepted for publication in a reputable professional journal operating on the 'peer-review' principle, or be of comparable quality:

(i) where comparative claims are made against more than one product or a whole category of products, clinical evidence will need to establish beyond doubt that the claims are valid against all products in that category. It is not sufficient, for example, to produce evidence of comparative tests against the best-selling product in a particular category, since sales are not necessarily an indication of superior efficacy;
(ii) clinical evidence should be based on tests conducted on patients suffering from the actual ailment for which the product is indicated, not on subjects in whom symptoms have been artificially produced by means unrelated to the clinical condition;
(iii) the basis of the comparison must be established in clear and unambiguous terms, so that there is no likelihood of viewers being misled or confused about the type of product with which the advertised product is being compared. Comparisons with vague definitions such as 'conventional analgesics' or 'ordinary cough remedies' are acceptable only in circumstances where claims can be demonstrated to be valid against any product which viewers might reasonably suppose to fall within such a definition;
(iv) because of differing individual responses to the same remedy, absolute and unqualified claims of superiority, speed of action, etc., are unlikely to be acceptable. However, qualified claims, e.g. 'most people find that X works faster or 'in the majority of cases Y lasts longer' are normally acceptable, provided they are substantiated.

8.7.4 Presenters
Where there might otherwise be any doubt about their status, presenters must be positively established as not being professionally qualified. Ambiguous terms such as 'research director' or 'spokesman' are not acceptable. Presenters may not appear wearing white coats, stethoscopes, etc.

The script should indicate (if necessary with a storyboard) exactly how the presenter's identity will be established.

No identification is necessary if the presenter does not appear on screen, e.g. if only his hands are seen accompanied by a voice-over. In such cases, however, no medical, laboratory or other scientific equipment or accessories should be visible and neither the presenter's words nor the setting should suggest that he is a doctor, dentist, scientist, etc.

White-coated laboratory staff (or actors representing them) may appear in the advertisement provided that they are not presenters and there is no ambiguity about their status.

Label or pack illustrations of nurses or chemists are normally acceptable provided they are a true representation of the actual pack design and receive no undue emphasis in the advertisement.

Professional journals should not be named or quoted without permission and references to such journals should avoid any impression of their professional endorsement of a medicine or treatment.

8.7.5 Consulting a Doctor
Where for safety reasons it is necessary for advertisements to advise viewers to consult their doctor before taking a product, the wording used may not suggest that doctors would be likely to recommend or prescribe it.

8.7.6 Testimonials
In addition to the general requirements concerning testimonials the following requirements apply to advertisements for medicines and treatments:

(i) in order that celebrity status is not used to encourage consumers to use a medicine, no person well-known in public life, sport, entertainment, etc., may present an advertisement or give a testimonial.

This restriction does not extend to commercials for foods or beverages, even when they contain nutritional claims, or to aids to slimming;
(ii) testimonials are acceptable only from genuine users of an established product, or those who have taken part in clinical trials for a new product.

Testimonials are only acceptable if they reflect the degree of change or benefit that an average user can reasonably expect. Advertisers must be able to substantiate the claims that are made or implied in the testimonials. All claims must be in line with the product’s Marketing Authorisation.

8.8 Safety
8.8.1 Natural Products
Advertisements may not suggest that the safety or efficacy of a medical product is due to the fact that it is natural.

8.8.2 Unqualified Claims
Unqualified claims that a product is 'safe' are not acceptable. No advertisement may suggest that a product's use is entirely unaccompanied by side-effects. The absence of individual side-effects may be mentioned, however.

8.8.3 Unsafe Situations
Advertisements for products which carry a pack warning that they may cause drowsiness must not show them being used in situations where they could be dangerous.

8.9 Particular Conditions, Products and Services
8.9.1 Clinics for the Treatment of Hair and Scalp
Advertising for clinics offering treatment for the hair and scalp can be accepted provided that they are registered or licensed as may be required by national or local authority regulations. Clearcast will require evidence that such clinics are run by properly qualified staff and this evidence will be assessed by the Clearcast’s Medical consultant.

No exaggeration of likely results is permitted. Visual treatments featuring shots of the head before and after treatment must give an accurate indication of the typical results likely to be achieved. Photographic evidence of the before and after shots may be required for assessment prior to production of the advertisement.

8.9.1.1 Baldness
Claims to cure baldness or restore the growth of hair are only acceptable where the advertised product has been granted a Marketing Authorisation which specifically permits such claims in the case of medicines. Any other treatment or device that purports to promote hair growth will have to have been the subject of good quality clinical trials. This does not preclude the advertising of cosmetic products whose function is to bulk and thicken the existing hair, but this function must be clearly explained in the advertisement and there must be no suggestion that lost hair will be restored or growth promoted.

8.9.2 Colds and Influenza
8.9.2.1 Relief, Not Cure
Advertisements may indicate that the product can help to relieve particular symptoms. They should not, however, claim to prevent, cure or shorten the duration of the cold or influenza itself unless this is stated on the product’s Marketing Authorisation. Thus, words such as 'checks' or 'fights' should relate to the symptoms only. No reference should be made to frequent recurrence of colds, a condition which may require medical attention.

8.9.2.2 Serious Conditions
Care must be taken with the creative treatment to avoid the portrayal of serious conditions, e.g. a high fever unless these are in line with the Marketing Authorisation.

8.9.2.3 Portrayal of Symptoms, Treatment or Recovery
When the advertisement refers to influenza, a 'shivery cold', a temperature or any other condition normally requiring some time to be spent in bed, care is needed to avoid suggesting that the product will promote or hasten recovery without the need for bed rest. Scenes in which sufferers appear to be fully recovered after taking the product are likely to give this impression and should be avoided. There is, however, no objection to sequences showing the patient in a convalescent situation, provided an appropriate passage of time after taking the product is indicated.

Ordinary colds do not usually require treatment in bed, and advertisements referring to them are not normally subject to this requirement - even if the advertisement also contains a brief reference to the product's suitability for treating ‘flu.

8.9.2.4 Vitamins
No advertisement may claim or imply that vitamins have any value in the treatment or prevention of colds or influenza in the absence of convincing evidence. No reference to the inclusion of vitamins in products for the treatment of colds and 'flu is acceptable other than in shots of the label or pack which give no undue prominence to such a reference.

8.9.2.5 Infectious Situations
Advertisements should avoid showing situations where there is a significant risk of cross-infection, e.g. someone with a cold kissing someone else.

8.9.3 Coughs, Catarrh, Sore Throat, etc.
Advertisements should feature only mild and temporary forms of cough, catarrh and sore throat, which cause irritation and inconvenience, rather than pain and illness unless the Marketing Authorisation states that the product can be used for more severe symptoms. In general, advertisements for cough treatments, throat lozenges and pastilles, vapour rubs, etc., should be based on their soothing effect, although products which act on the central nervous system to suppress the coughing mechanism may indicate this. The following points should be specially noted.

8.9.3.1 Pain
References to 'pain' are not acceptable in this connection unless specified in the Marketing Authorisation.

8.9.3.2 Cures
Claims to get rid of coughs are not acceptable. However, if the advertisement clearly refers to an isolated coughing attack and not to the cough condition as a whole, expressions such as 'checks coughs' or 'stop that cough' may be acceptable.

8.9.3.3 References to Germs
No reference should be made to germs or bacteria unless there is sufficient antiseptic or antibiotic in the product to have a significant effect on them.

8.9.3.4 Congestion
There may be no reference to 'bronchitis', 'whooping cough' or any serious bronchial congestion. Expressions such as 'wheezing' or 'difficult breathing' must be avoided, since they imply a potentially serious condition unless such claims are in line with the product’s Marketing Authorisation.

8.9.3.5 Gargles
Antiseptic gargles may not be presented as cough treatments having any relaxing or suppressant effect on coughing attacks.

8.9.4 Analgesics
8.9.4.1 Headaches and Minor Conditions
(i) Chronic and Serious Conditions
Advertisements must be directed towards the relief of occasional headaches only; there must be no suggestion of frequent, recurring or regular attacks unless such claims are in line with the product’s Marketing Authorisation. The term 'headache sufferer' is unacceptable. Any suggestion that a headache should be anticipated by medication is unacceptable. Claims for long-lasting relief are not acceptable, except in the case of products whose Market Authorisation allows such claims.
(ii) Courses of Treatment
No product may be advertised as a course of treatment for headaches and accompanying symptoms.
(iii) Continuous Use
No advertisement may advocate the use of analgesics on a continuous basis.
(iv) Taste
Advertisements may not claim that analgesics are positively enjoyable to take, but this does not preclude a factual statement that a product tastes pleasant, where this is the case.
(v) Headache Pain
Care must be taken in referring to or illustrating headache pain, by whatever means, to avoid impressions of pain for which the product advertised not is suitable.
(vi) Other Symptoms, Depression, Tiredness, etc.
The advertising of unlicensed stimulants for the relief of fatigue and drowsiness is unacceptable, and no advertisement may make any reference to depression. Care must be taken to avoid undue emphasis on irritability, tiredness, tension and 'nerviness' accompanying headaches. While it may be justified to refer to minor indispositions of this kind associated with the headache pain and likely to disappear when the headache itself is relieved, they must not be presented as conditions in themselves for which the product can offer treatment.
(vii) Period Pains
A reference to the relief of period pains is permissible, but where a commercial is wholly or mainly devoted to it, a timing restriction may be required.
(viii) Symptoms of Over-Indulgence and Hangovers
General purpose analgesics should not be advertised for the relief of hangovers. However, products specifically designed for the relief of the symptoms of mild overindulgence in food and drink may be advertised for that purpose, provided that:

(a) the product is not seen to be taken in anticipation of discomfort, e.g. before going to a party;
(b) there is no suggestion that over-indulgence in food or drink is in order provided the product is taken, or that a hangover is a regular or commonplace occurrence;
(c) only the results of unintentional and mild over-indulgence are shown: there must be no suggestion of deliberate or gross excess.
(ix) Comparative Speed of Action
While there is no conclusive medical evidence that soluble analgesics invariably relieve pain faster than solid tablets, it is accepted that they can be absorbed into the system more quickly. This fact may be indicated, although care should be taken not to make categorical statements about speed of pain relief unless robust evidence is provided. Comparison between the time taken by soluble tablets to dissolve in the glass and non-soluble tablets to dissolve in the stomach is permissible.
(x) Occupational Causes of Headache
No advertisement may refer to a headache supposedly caused by the peculiar working conditions of some particular occupation, e.g. use of video screens, etc.

8.9.4.2 Arthritis Rheumatic and Allied Pains
No advertisement may refer to any medicine, product, appliance or device in terms likely to lead to its use for the treatment of any form of arthritis, or for chronic or persistent rheumatism, except to the extent that the Marketing Authorisation specifically authorises such use.

8.9.5 Indigestion
References to indigestion must be used carefully, to refer only to relatively minor discomforts such as heartburn, flatulence, hyperacid dyspepsia, 'nervous dyspepsia', reactions to certain foods and the effects of eating too much too quickly.

Claims attributing the speed of action of an antacid product to its greater strength are not acceptable - the two properties are not necessarily related. Most antacids act quickly, and claims for quick relief are acceptable. A brief time-lapse for the product to take effect should be indicated, but precise time in which relief may be expected should not be suggested since this will vary from one individual to another.

8.9.5.1 Intestinal Disorders
Claims that 'holiday tummy' or 'holiday diarrhoea' may be prevented by taking the advertised product before or during a holiday are not acceptable. Such products must be advertised only for relief in the event of an attack of diarrhoea, and must not claim to be invariably effective.

Advertisements should not refer to 'food poisoning' or 'gastro-enteritis', since these are conditions which should receive medical attention.

8.9.6 Skin Ailments and Treatments
8.9.6.1 'Spots'
Unqualified references to 'spots' are not acceptable unless the product concerned is effective in the treatment of acne.

8.9.6.2 Suntan Lotions
In advertising suntan lotions, care must be taken not to encourage the risk of sunburn or over-exposure. Advertisements must not suggest that a suntan is 'healthy' or that a pale skin is less attractive than a suntan.

Claims to provide protection against sunburn are acceptable only in the case of products which can be demonstrated to provide significant screening from ultraviolet rays. There should be no suggestion that use of the product provides complete protection from sunburn.

Colouring products, which act upon the dead outer layer of the epidermis to produce a cosmetic effect similar to suntan, should not be advertised as 'suntanning' preparations.

8.9.6.3 Mildness Claims for Detergents
Advertisements for soaps and detergents (e.g. washing-up liquids) claiming to have a mild effect on the skin should not imply a positive cosmetic or therapeutic benefit (e.g. alleviation of chapped, rough or sore skin). Claims for 'mildness' should be related to a comparative lack of harshness and avoiding roughening the skin, rather than to positive improvement such as might be expected from the use of a hand lotion.

8.9.6.4 Cosmetics Claims and the Effects of Ageing
Advertising for cosmetic products might sometimes make claims which to the uninformed appear to be of a medical nature. It is extremely important that cosmetic products which are designed to improve appearance are not confused with those products which have a physiological effect and thus be considered as a medical treatment.

Any claims to delay the effects of ageing must be supported by clinical data acceptable to the Clearcast’s medical advisers. Self assessment surveys in isolation are unlikely to be sufficient to support claims of a physiological nature.

Cosmetic products which have no physiological effect must only refer to the appearance of the skin. Claims of the effectiveness of such products must always be qualified in order to make this clear. Thus claims like ‘reduces the appearance of fine lines’ etc. would be acceptable while claims like ‘visibly reduces fine lines’ etc. would not.

Particular care should be taken with product names in the voice-over lest an unjustifiable physiological effect be implied.

8.9.6.5 Penetration Claims
In advertisements for products used for the treatment of the skin, no claim may be made for more than superficial penetration.

8.9.7 Antiperspirants
Since their effects vary widely between individual users, antiperspirants should not claim to keep skin dry either absolutely or for a specific period unless there is good evidence for such claims. Comparative claims in this area are acceptable only if based on tests carried out according to Clearcast's own protocol, which is set out in Appendix 7 of these Notes.

8.9.8 Products for the Treatment of Sleeplessness
These types of products should only be advertised in the context of temporary sleeplessness and should not imply that they can be of benefit to those suffering chronic insomnia, a condition that requires medical advice and treatment.

8.9.9 Diets
8.9.9.1 Very Low Calorie Diets (VLCDs)
In the light of the COMA Report on 'The Use of Very Low Calorie Diets In Obesity', the following guidelines have been prepared in consultation with Clearcast's medical advisers:

(a) in order to be acceptable for broadcast advertising VLCDs must comply with the recommendations outlined in the COMA Report on VLCDs and be approved by Clearcast's medical advisers;
(b) if VLCDs are misused the results may be serious; they should therefore only be used after medical clearance and under the supervision of a qualified person. All advertisements must therefore include a clear injunction to 'Consult your Doctor';
(c) no advertisement may claim, either directly or by implication, that a VLCD preparation is appropriate for infants, growing children, adolescents, women who are pregnant or lactating, or the elderly;
(d) VLCDs are recommended only as a short term measure to induce high initial weight loss. This loss includes considerable amounts of fluid and non-fat tissue and its rate is not sustained. Testimonial advertising is therefore inappropriate for VLCDs;
(e) advertising for VLCDs must make clear the limited time period recommended for their use and the need to use them in accordance with the manufacturer's advice;
(f) there is at present no evidence that VLCDs are more likely to achieve enduring weight loss than conventional weight-reducing diets, and consequently no advertisement may suggest this either directly or by implication.

In the event of the Department of Health recommending a Voluntary Code of Practice on VLCDs these guidelines may be reviewed.

8.9.9.2 Substitutes for Main Meals
Advertisements for confectionery and snack foods must not suggest that these products may be substituted for main meals. Such products should not be shown being eaten shortly before meals and suggestions that they will not interfere with normal meals or spoil the appetite are acceptable only if the situation depicted is a reasonable one.

8.9.9.3 Vitamins and Slimming
Possible benefits of vitamin supplements for those on restricted dietary regimens will only be considered on receipt of sound scientific evidence acceptable to our medical advisers in respect of the class of people identified in the advertising.

8.9.9.4 Mechanical Devices
Devices which encourage or assist physical exercise may make suitable claims to trim and shape the figure as a result of strengthening stomach muscles, etc. It has not been demonstrated that weight loss can be achieved other than by or in conjunction with controlling calorie intake. Any claim on behalf of any device, topically applied product or garment etc must be supported by evidence of efficacy beyond what might be expected of any accompanying diet programme.

8.9.10 Vitamins and Minerals
The Food Labelling Regulations list those vitamins and minerals whose presence in food may be referred to in advertisements. Subject to those requirements, advertisements may refer to the fact that the product contains vitamins.

In this country, however, there is no evidence of any general vitamin deficiency though sub-optimal intakes have been demonstrated among some groups. Advertisements must not therefore suggest that specific health benefits can be derived from vitamin supplements, e.g. 'makes your hair glossy', nor imply that ordinary healthy adults need to supplement their diet with extra vitamins or are likely to derive any benefit from doing so.

Only certain groups of people have been shown potentially to benefit from particular vitamin or mineral supplements. Such groups might include people on restricted dietary regimens or those eating unsupplemented, low food-energy diets, women of child-bearing age (particularly if they are planning to have a baby, are pregnant or lactating), growing children and some individuals over the age of 50.

Claims in this category must be substantiated with sound scientific evidence acceptable to Clearcast’s medical advisers and advertisements must establish clearly which groups are likely to benefit from a particular form of supplementation.

Claims or implications that vitamins are beneficial in preventing or treating colds, 'flu, etc., are not acceptable in the absence of convincing evidence. No advertisement may suggest that vitamins are a source of physical energy.

8.9.11 Eating and Dental Health
For reasons of dental hygiene, advertisements must not suggest or imply that sweets can be eaten frequently throughout the day or at bedtime. Children, in particular, should not be encouraged to eat or drink shortly before going to bed and such scenes should be avoided.

8.10 Toothpastes and Other Oral Hygiene Products
Advertising for these products will be assessed by Clearcast’s Dental Consultant. Some toothpastes may hold a Marketing Authorisation from MHRA and are permitted to make claims within the parameters set out in the Marketing Authorisation. All of the rules regarding medicines advertising apply to licensed toothpastes including the prohibition on health professional endorsement.

8.10.1 Plaque Removal
Plaque build up is a major cause of gum disorders and may eventually lead to loss of teeth. Advertising may claim no more than that regular brushing reduces build up of plaque unless the toothpaste holds a Marketing Authorisation which allows otherwise. No toothpaste may claim complete removal of plaque since this normally requires dental treatment. Depictions of plaque may only show a reduction rather than complete removal and any statistics for percentage plaque reduction must be accurately stated and be incapable of misleading.

8.10.2 Prevention of Decay
8.10.2.1 Tested Fluoride Toothpastes
Certain toothpaste formulations containing fluoride have been shown by independent clinical studies to reduce the prevalence of tooth decay in children. It is permissible to claim that clinical trials have proved that such a toothpaste reduces decay in regular use, but there must be no implication that decay will be eliminated.

8.10.2.2 Other Toothpastes
Formulations which contain fluoride but which have not been independently tested, may claim no more than that regular brushing with the toothpaste helps fight tooth decay. Claims based on the inclusion of a special ingredient, e.g. for the reduction or inhibition of plaque, are acceptable if justified by satisfactory evidence. Claims for a reduction in gingivitis require adequate clinical trial evidence.

8.10.3 Bad Breath
Claims that a dentifrice or other product will eliminate the cause of mouth odour or provide long-lasting freedom from mouth odour are not acceptable. In advertisements for such products it must be made clear that the odour results from poor oral hygiene or is purely temporary, e.g. as a result of eating garlic, since bad breath may be due to a chronic disorder requiring the advice of a doctor or dentist.

8.10.4 Impressions of Professional Support
In addition to the prohibition on dentists, dental nurses and other medically qualified people, whether genuine or played by actors, are not acceptable as presenters in toothpaste advertisements.

8.11 Antiseptics and Disinfectants
Please refer also to the testing protocols contained in Appendix 6 of these Notes.

Advertisements should not suggest that the use of disinfectants can offer complete protection against disease, or, conversely, that disease is an inevitable or likely alternative to their use. Medical names of particular viruses or bacteria should not normally be used.

8.12 Smoking Deterrents
The indispensable factor in giving up smoking is willpower. All advertisements, and any literature which accompanies products, must make this clear. Products can claim to be an aid in breaking the habit, but there must be no implication that success is certain. Advertisements may not claim that the risk to health is reduced while the habit is being given up.

Every product and advertisement must be approved by Clearcast's medical advisers. Products which seem to them to offer no genuine assistance in breaking the habit will not be accepted.

8.13 Pregnancy Testing Services and Kits
8.13.1 Pregnancy Testing Services
Television advertising for pregnancy testing services is prohibited.

8.13.2 Pregnancy Testing Kits
Pregnancy testing kits intended for home use and available over the counter in pharmacies, may be advertised subject to approval by Clearcast's medical advisers. Commercials must include the words 'Always read the label/leaflet' or equally unambiguous advice to follow the instructions, irrespective of whether or not the kit has a Product Licence. Claims that results are invariably accurate are not acceptable, whether made directly or by implication.

Advertisements must not suggest that the use of a pregnancy-testing kit makes it unnecessary to consult a doctor or is a suitable alternative to such a consultation.

8.14 Opticians
Advertising by opticians which deals with ophthalmic matters such as sight-testing, examination of the eyes for optical problems, prescribing lenses, etc., is regarded as falling into the category of medical advertising. However, advertisements which simply feature the retail side of an optician's business, e.g. the range of spectacle frames available, the repairing of frames or the making up of prescriptions, are not normally regarded as falling into the medical category.

8.15 Contact Lenses
Contact lenses are acceptable for broadcast advertising subject to approval by Clearcast's medical advisers.

8.16 Homeopathic Medicines and Treatments
Advertisements for homeopathic medicines and treatments are subject to all relevant requirements of EC Directive 92/73/EEC.

Advertising can be accepted only for homeopathic medicinal products registered in the United Kingdom. Full details, including the Certificate of Registration, must be submitted to Clearcast. It should be noted that the only product information which can be mentioned in the advertisement is that which appears on the product labelling. Medicinal or therapeutic claims of any description, whether express or implied, are not permitted (including any suggested by product names), nor may advertisements suggest a particular ailment.

8.17 Medicines and Children
8.17.1 Symptoms
In advertising any product for the relief of children's ailments, care must be taken to ensure that any symptoms indicated in the advertisement are of a minor or common nature and cannot be confused with symptoms which need medical attention.

8.17.2 Medicines Suitable for Children
Advertisements should not show medicines and treatments being administered to a child unless the product is suitable for children. Except in the case of medicines specially formulated for children, the correct children's dose should be clearly indicated.

8.17.3 Restrictions on Times of Transmission
(i) Advertisements for medical products and vitamin supplements may not be transmitted during children's programmes, or in the advertisement break immediately before or after them.
(ii) The following categories of advertisement will not be transmitted before 2100h - advertisements in which any medicine or dietary supplement is shown being administered to a child; - advertisements for medicines, vitamins or other dietary supplements which use techniques likely to appeal particularly to children, e.g. cartoons – though adult style cartoons may be considered, toys or characters of special interest to children. N.B. Relaxations of this rule are likely to be granted only in the case of products such as those for oral hygiene, skin preparations, including treatments for acne, and externally-applied decongestants.

8.17.4 Confusion with Sweets
Where medicines have been specially prepared to be palatable or easily administered (e.g. orange flavoured tablets), care must be taken not to give the impression that they may be eaten like sweets. Vitamin supplements may not be advertised in such a way as to risk children confusing them, or medicines which they may resemble, with sweets. No advertisement for vitamin supplements may be specifically addressed to children.

8.17.5 References to Pain, etc.
In the case of children, references to pain or other symptoms which might indicate a serious condition should be avoided; abdominal pain, in particular, must not be mentioned, since it may be caused by appendicitis or some other serious condition. In advertising indigestion treatments for children, phrases which clearly refer to mild indigestion must be used, e.g. 'a slight tummy-upset'.

Children should not be portrayed running a very high temperature or in a distressed state.

8.17.6 Children as Presenters
Children may not be used to present any medicine, treatment or dietary supplement.

8.17.7 Child Safety
Medicines should not be shown left within reach of children and nothing in any advertisement may suggest or imply that it is acceptable for children to take any medicine or vitamin supplement without adult supervision.

Products which are packaged in so-called 'child-proof' containers should not be shown being opened in such a way as to demonstrate to children how it is done.

8.17.8 Claims to Enhance Performance
Claims that preparations enhance physical or mental performance in children are not acceptable in the absence of strong evidence.

8.17.9 Health Education
Where appropriate, suitable health education information (provided it is accepted as valid by the Medical Advisory Panel) can be included in advertisements. Such references may not suggest that the product advertised can contribute to achieving these health education aims unless this can be demonstrated to be the case.

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