Marketing Myths and Magic - A Cosmetic or a Drug

Advertisers do have to be careful  aout the claims they make  or they may find that their products  become regulated as drugs. In the USA, cosmetics and drugs are clearly defined  by the FDA and a product may be classified  as a cosmetic, as a drug or as a cosmetic which is also a drug. A cosmetic is something that when applied results in a temporary, superficial change. Cosmetics that make a medical claim  - such as a shampoo that treats dandruff, toothpaste that reduces cavities , sunscreens that prevent sunburn, or preparations that reduce wrinkles  - are classified as cosmetics that are also drugs.

In this case, the product must be proved to be safe and must comply with the regulations for cosmetics, or drugs, or both, to be freely sold as a cosmetic or as an over-the-counter drug. In order to avoid the product being classified  a drug, advertisers will often use vague terms such as " reveals smoother, fresher skin.

Claims to be Natural and Hypoallergenic some terms like "natural" and "hypoallergenic" are used liberally by advertisers and, unfortunately, there are no legal, scientific, or accepted dictionary definitions of these terms as they apply to cosmetics. Despite the lack of a definition, it is generally accepted that a hypoallergenic product is formulated to cause fewer allergic responses than a similar, non-hypoallergenic product.

The consumer, however, usually believes that hypoallergenic products are much superior to normal products because they have been scientifically formulated to be especially kind to sensitive skin, and that natural products contain mostly natural ingredients ( usually extracted from plants), and are free from, or only contain small amounts of artificial chemical additives. This belief is often reinforced by the higher cost of hypoallergenic products and products that claim to be natural.

In the  USA, the FDA tried to control the use of "hypoallergenic" and "natural" when used to describe toiletries and cosmetics, so that consumers would not be misled by the manufacturers. It wanted some guarantee that hypoallergenic products had been tested  and had been shown to cause fewer allergies, or to be less irritating than standard products. it also wanted a "natural" product to contain substantial quantities of natural ingredients and fewer synthetic chemicals.

But the cosmetic manufacturers challenged the FDA through the courts, and the FDA eventually lost the case on the grounds that it had no authority  to regulate the way products are advertised. The net result is that, in the USA at least, these words are completely meaningless and misleading. Words like " allergy tested" "non-irritating," "dermatologically tested," and so on,carry no guarantee that the products will not cause skin irritation or allergic reactions. in fact, in the USA, manufacturers can use these words, without any supporting evidence whatsoever.

The situation in the UK is much less clear. The British Advertising Standards Authority has no specific regulations regarding these terms, and manufacturers  and importers of cosmetics have no common code of practice governing their usage. A recent study carried out by Rohm and Haas, a chemical manufacturer concluded that, in the EU the term "hypoallergenic " has no scientific definition and no regulatory guide lines... it appears that claims such as "for sensitive skin,"hypoallergenic." and "high tolerance formula" should be strictly regulated if not discouraged.

In a recent circular issued by the UK Local Authorities Co-ordinating Body on Food and Trading Standards (LACOTS), it stated that it failed to find " either a legal or accepted dictionary definition" on the term "hypoallergenic" and that, "consultation with representative trade bodies has shown there to be differences in industry understanding and usage" of this term.

There are two pieces of relevant legislation though. The Department of Trade and Industry's Guide to Cosmetic Products (Safety) Regulations states  each product that is manufactured in , or imported into the EU should have a product information package (PIP), which is not usually available to the general public, should contain all of the information about the product that a "competent authority" (i.e., Trading Standards Officers in the UK, or the District Council in Northern Ireland) may require. The PIP should contain evidence for any claims that are made for the product.

For example, If a sunscreen is claimed to have a sun Protection factor (SFP) of 15 and to protect against both UV-A and UV-B ultra-violet rays, then there should be some laboratory measurements recorded in the PIP to show that these claims are correct, and a product that claims to be hypoallegenic  must show that it causes fewer allergies  than a comparable, standard product.

The second piece of legislation is in the 1968 Trade Descriptions Act, which prohibits manufacturers from making false or misleading claims about their products. If a manufacturer  or advertising agency does make such a claim , the Director General of Fair Trading (DGFT) normally asks for a voluntary undertaking to cease these advertisements. The courts only become involved if the false or misleading claims continue to be made. However, manufacturers often make claims that stretch the law to its absolute limit and it may be difficult to show that these claims are misleading .

Take the claim by some toothpaste manufacturers that their products can make your teeth whiter. Whiter than what? To show that this statement is misleading, it would have to be proved that it is likely to deceive consumers, and as a result of deceiving them, to affect their behaviour. The average consumer may well buy the product believing it would make their teeth whiter but it is unlikely that sufficient numbers of consumers would, after scientifically testing the product  on themselves, complain to the DGFT that the product was not working as claimed.

Most dissatisfied customers are likely instead to to complain to the manufacturer and be happy with a refund and an apologetic letter, or simply buy another brand next time.The law may well be there  to protect the consumer but it is often difficult to enforce. In conclusion, the meaning of terms such as "hypoallergenic " and "natural" are a point of confusion and the evidence must speak for itself. Products on British shelves that claim to be natural sometimes contain less than one percent  of natural ingredients. We have found that many hypoallergenic products are not substantially different  to the standard version of the same product (other than being much more expensive, of course), and that often they have the exact same ingredients except they contain fewer colorants and fragrances.

However, since these ingredients are the most common cause of irritation and allergies, the mere fact that fewer of them have been used  may be sufficient to prove the product is hypoallegenic. From a consumer's point of view, a product that contains fewer colorants and fragrances may well be kinder to their skin, but it should not cost more than a comparable, alternative product.

Other terms that often cause confusion are "unscented", "fragrant free" dermatologically tested," and "allergy" "tested." There are no legal definitions of these terms  and they are often used without explaination as to their meaning  or the outcome of any tests  which have ben carried out. many products  labelled as being "unscented" do in fact contain small quantities of fragrance chemicals, added by the manufacturer  to cover  up the unpleasant , natural odors of other ingredients. If you want to avoid fragrance chemicals, ignore the banner on the front and check the list of ingredients on the back of the product for terms that may include "Fragrance," "Flavor," "Parfum," or "Aroma."

Reference: Dr Stephen and Gina Antczak