Regulatory clarity for nutricosmetics proves elusive

The first hurdle is to get everyone to agree on what products are, and therefore which regulation should be applied.

Earlier this week a nutritional supplements company was told that using the word ‘spot’ placed its product into the world of medicines; replacing spot with blemish turned that medicine back into a food.

It is becoming abundantly clear, therefore, that the lack of understanding of what a product is, and therefore the regulations that govern it, needs to be cleared up before this sector can take off.

Regulatory uncertainty holds back innovation​

After a number of informative presentations and fruitful discussions that were had earlier this week at the Beauty From Within 2010 conference, the power of regulatory uncertainty to hold back innovation became abundantly clear.

Presentations on promising ingredients backed up by strong science were in abundance during the conference, but product positioning, marketing and regulation were definitely playing on delegates’ minds.

Europe is the most tightly regulated region in the world. While, this in itself is not a bad thing, it can be extremely damaging to the growth of a market if not everyone is on the same page.

And, as can be expected for a young sector dealing with a new regulatory creation (in the form of EFSA’s health claims regulation), the players are far from being on the same page.

When attempting to navigate this unexplored regulatory territory, the first step, is to decide what the product is, and even this first step does not appear to be clear for everyone.

Food, cosmetic or medicine?​

In all likelihood a nutricosmetic product is a food product. It cannot be a cosmetic, even though it makes cosmetics claims, as it is not topical. However, it could be deemed a medicine.

A medicine is something that can treat or prevent human disease, or can ‘restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action’, according to the EU Council Directive. In this respect a nutritional supplement that makes claims about health could be seen to be positioning itself as a medicine.

This is best avoided; as, although EFSA’s regulation for health claims may seem problematic, medicinal regulation is a different story entirely.

Claims deemed medicinal ​

Earlier this week a UK nutritional supplement manufacturer was asked to alter its product claims and advertisements as the UK’s advertising watchdog the ASA deemed its claims to be medicinal in nature.

The lactoferrin-based acne supplement, produced by Works With Water Nutraceuticals, claimed to "help: get the better of spots with milk protein"​. The ASA said changing the word spot to blemish would take this product out of the medicinal domain and into the world of food supplements.

This was a costly manoeuvre for the company, as product packaging and advertisements had to be changed, and will eventually leave its claims less specific.

Of course once in the world of food supplements, the product will be subject to food regulation, including both the specific health claims regulation but also more general rules that help protect the consumer from being misled.

This is by no means simple, and is itself characterised by grey areas such as what is a health claim and how to go about getting one.

But of real primary concern is the lack of understanding between regulators, bodies that implement regulation, and the industry as to which regulation is relevant for which products.

If the ASA can deem a product to be medicinal because it uses the word spots rather than blemishes, this has huge ramifications for how anti-acne and other skin improving supplements can be positioned.

Significant steps need to be made to get everyone on the same page, or at least the same chapter, if this product sector is to succeed.