Is it really "clinically proven"?

Don't be hoodwinked by ads spruiking the benefits of scientific-sounding, "clinically proven" ingredients
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  • Updated:30 Apr 2009

03.Regulating claims in ads and marketing

It’s not just cosmetics that use science to sell – complementary medicines also like to play up their scientific credentials. It seems “natural” and, by implication, “healthy” and “safe” just don’t cut it as selling points anymore. However, these companies are on a tighter rein than cosmetics when it comes to advertising claims.

There is an excellent Therapeutic Goods Advertising Code that spells out the kinds of claims that can be made about therapeutic goods, such as drugs, medical devices and herbal and complementary medicines. There are also various industry self-regulatory codes. Anybody who believes an ad or marketing material (including information on the internet, but not on product packaging) breaches the code can lodge a complaint with the Complaints Resolution Panel (CRP).

In Australia, anything claiming to have a therapeutic effect must be either listed or registered with the Therapeutic Goods Administration (TGA).

  • Listed products have to demonstrate they are relatively safe to use and produced according to good manufacturing practices.
  • Registered products must meet the above criteria and also have substantial proof they work.

Most herbal and complementary medicines prefer to go the way of listing rather than registering: it’s a lot cheaper, they don’t have to undergo the scrutiny of rigorous clinical trials and in some cases they can rely on clever marketing to convince consumers of their effectiveness. Some companies do undertake clinical trials, although all too often they’re small and short-term, and not necessarily of good quality.

"Clinically proven"

One of the CRP’s bugbears is the use of the term “clinically proven” in ads for listed complementary medicines (to use the term, a product must be registered). After many complaints about the use of “clinically proven” in the marketing material for one such product, the CRP felt compelled to point out that the use of the term in advertising “should not even be contemplated unless unequivocally supported by robustly designed, published, peer-reviewed clinical trials which have been conducted upon the product being advertised or an identical formulation”.

It went on to explain that the claims must also take into account all evidence for a particular product, not just one or two trials – so, if a majority of trials show something has no effect, the advertiser can’t highlight the few that did. The Complementary Healthcare Council, the leading industry association for companies that sell complementary medicines, duly reported this to its members in September 2008. We await the outcome with interest.

Cosmetics companies aren’t bound by the advertising regulations for therapeutic products because they’re not considered therapeutic. A therapeutic product is defined in several ways, including that it’s used in “influencing, inhibiting or modifying a physiological process in persons…”

However, the line between cosmetics and therapeutics has become increasingly blurred with the popularisation of the concept of “cosmeceuticals” to describe cosmetics that have more than just a temporary cosmetic effect. Anti-ageing creams and lotions often fall into this category.

The trouble is, once they start claiming to have more than a cosmetic effect they run the risk of meeting the definition of a therapeutic good, and fall under the jurisdiction of the TGA. So in ads and marketing, they imply, rather than clearly state, that the effect is more than just cosmetic.

A few have gone too far, and therapeutic claims have been brought to the attention of the CRP. Obviously, it’s easier for the company to modify its claims, rather than go through the process of listing or registering the product, and most agree to do this. In any case, the original ad exposure probably boosted sales, so the damage or the benefit, depending on your point of view, has already been done.




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