Information about advertising medicinal products and cosmetics
Can advertising or product names make a product "medicinal"?
Yes. Ask Mornflake Oats, who in 1993 were successfully prosecuted for claims in Mornflake Oats ads that "research has proved that oats can help reduce cholesterol levels when eaten as part of a low fat diet, thereby cutting down the risk of heart disease." The offence was in essence the making of medicinal claims in respect of a product that was not a licensed drug.
The golden rule to remember is that if a product is advertised for use "wholly or mainly" for treating, preventing or diagnosing disease (for these purposes "disease" is defined widely as including "any adverse condition of body or mind" for example stress or depression, a stuffed-up nose or nappy rash) or otherwise preventing or interfering with a normal physiological function, it will be regarded as "medicinal". If it is so regarded it will be a criminal offence to sell or advertise it in the UK unless it is a licensed drug.
Are there any products which might on the face of it seem to qualify as licensable medicinal products but are exempted?
Yes. Principally these are plasters, bandages or other non-medicated dressings. These will not in any circumstances be regarded as "medicinal products." "Cosmetics" on the other hand are exempted in a different way: they may classify as "medicinal products" but are specially exempted from the need to obtain a product licence. They are defined as including any substance to be applied to various surfaces of the body for perfuming, cleansing, protecting, caring for or keeping them in condition, modifying their appearance or combating body odour or normal body perspiration. It should be noted however that this special exemption will be automatically lost if any "curative or remedial" claim is made in cosmetic advertising or packaging.
How do I avoid the "medicinal product" bind?
Steer clear of "curative or remedial" claims in packaging or advertising. If the product is not a cosmetic, then if it is advertised as useable "wholly or mainly" for non-medicinal purposes the "medicinal product" problem should be avoided. Take care however, since the issue will be resolved by looking at the balance of the medicinal and non-medicinal uses mentioned in the labelling or advertising and not by reference to the likelihood of sales being made for one use or another.
Are there any particular words I should avoid to escape the "medicinal" trap?
Yes. Problematic terms include "heals", "helps to heal", "restores", "remedies", "eliminates", "controls", "counteracts", "combats", "treats", "alleviates", "clears", "relieves", "stops", "removes" or "cures", if any of these are used in relation to a specific adverse bodily or mental condition. If the advertisement is for a cosmetic then to avoid the licensing requirement emphasis should be placed on the preventive, protective or hygienic uses of the product rather than curative or remedial claims, which will be fatal to the product's exemption from the licensing requirements.
There certainly are. Principally there are the Medicines (Advertising) Regulations 1994. These create a criminal offence of advertising a medicinal product in respect of which there is no product licence or certificate of registration. They also prohibit advertisements for the treatment, prevention or diagnosis of particular diseases such as cancer, epilepsy, cataracts and diabetes. The regulations also prohibit misleading advertisements for medicinal products and prohibit various methods of advertising them such as:
- giving the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by post, fax or telephone;
- suggesting that health can be enhanced by taking the product;
- referring to recommendations by scientists, health professionals or persons who are neither scientists nor health professionals but who because of their celebrity could encourage the consumption of the product;
- use of improper, alarming or misleading terms or pictorial representations of changes in the human body caused by disease or injury.
T he regulations also prohibit direct to consumer advertising of prescription-only drugs. There is also a raft of requirements in the Committee of Advertising Practice's British Advertising Code and it should also be borne in mind that in relation to non prescription licensed drugs available over the counter the industry operates its own pre vetting system under the Code of Advertising Standards and Practice of the Proprietary Association of Great Britain. Separately the British Pharmaceutical Industry operates a self regulatory Code of Practice governing promotions aimed at the medical and dental profession.
So what about these new "Disease Awareness" campaigns sponsored by particular drug manufacturers?
They have been given the go ahead by the Medicines Control Agency on the basis that the advertising is not permitting any particular "medicinal product" but really heightening awareness of particular diseases and the availability of treatment for them. The logo of the sponsoring drug company appears in the advertising, but so far as the MCA are concerned, so long as the logo is not identified with any particular "medicinal product" but only with the corporation as a whole, there should be no difficulty. Some consider this to be the thin end of the wedge towards direct to consumer advertising of prescription drugs. Others say that if this is the case then it would be a jolly good thing. Look at the American experience, they say, where after a 2 year trial, during which there has not been the expected gadarene rush to GP's with demands for all manner of obscure drugs "as seen on TV," direct-to-consumer prescription drug advertising has now been given a general green light though subject to certain constraints.
The Medicines Control Agency is clearly an important player in this field. Do they have any particular role or service that I should be aware of?
The MCA are, or certainly have in our experience in the past been very helpful in advising on labelling and advertising copy so as to ensure that the "medicinal product" problem is avoided. Advertisers must always ask themselves, however, whether they wish to put their heads in the lion's mouth. It should also be remembered that following the recent EU directive, the MCA has been given still greater powers in relation to the regulation of medicinal product advertising. This includes the power to insist on the pre-vetting of specified medicinal products, in addition to the self-regulatory vetting which occurs pursuant to the code of the Proprietary Association of Great Britain.
What about health foods?
Generally, health foods are not regarded as "medicinal" products, provided that they are not promoted as such – by avoiding any claims that they are intended to be used "wholly or mainly" for treatment, prevention or diagnosis of disease. Certain herbal and low-concentration homeopathic remedies are also not regarded as medicinal products, even though on the face of it they are potentially for the treatment of physiological conditions. But these products will be regarded as licensable if identified through advertising or labelling as "medicinal" – in that they advertised as usable "wholly or mainly" for treating, prevention or diagnosis of disease.
So, health food manufacturers and their marketing agencies have two hurdles to overcome if herbal products are to remain "non-medicinal". First, to establish that they are in the exempt categories under MCA regulation, and secondly, to ensure that products are promoted as non-medicinal. As many herbal products are not easily defined within the scope of the regulations it is advisable to clear these types of products on an individual basis – whether the product is a herbal tea or a herbal chewing gum.
Are the guidelines on "nutraceuticals" likely to change?
Yes – partly as a result of EU initiatives, there is increasing interest in regulating borderline areas between medical products and non-medical vitamin and mineral supplements (products sometimes referred to as "nutraceuticals"). A second tier of product licensing – less strict than full medical product licensing – has been proposed by the EU Commission, following concern that over the counter unlicensed herbal products are competing unfairly with licensed products. This is likely to affect the promotion of these types of product – we will keep you informed.
