Regulation: Cosmeceutical confusion continues

The fact nutricosmetic claim-making exists in a large grey zone can be viewed as a factor of its relative youth even though the sector has grown to be worth about $2bn, according to industry estimates.

Beauty foods, drinks and supplements simply haven’t been around very long and so the science backing them remains formative and in many cases regulators are still working out how to classify the science and the products themselves.

Given the protacted struggle to recognize dietary supplements as a drugs-foods straddling regulatory category in their own right in the US (the 1994 Dietary Supplements and Health Education Act (DSHEA)), Canada (the 2004 Natural Health Products Directorate) and the European Union (the 2002 Food Supplements Directive), it’s no surprise ambiguity remains in the sector.

Are cosmeceuticals half way between drugs and cosmetics, or between cosmetics and foods or food supplements? Will the type of claim determine whether a product is a food supplement or a drug? Or is that down to the ingredients used and their dosage? Or both?

Are claims promising better hair, skin and nails health claims or beauty claims? If your product helps prevent the onset of eczema, is that a health, drug or cosmetic claim?

It is these complex questions regulators have been grappling with to ensure products are backed by science and making claims that are not misleading.

The cosmeceutical science-regulation nexus​

With so much uncertainty, most spheres are tackling the industry’s product development and marketing efforts on a case-by-case basis. In the US, such policing is shared between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), and Health Canada north of the border.

Most of the policing that has gone on has tended to be against small players making unsubstantiated claims such as ‘skin darkening or lightening’.

The more serious firms such as the high-profile joint venture between L’Oreal and Nestlé – Innéov – are more cautious as is demonstrated by Innéov very gingerly entering the US market (its English-language website remains under construction).

EFSA says no​

Cross the Atlantic to Europe and the predicament of Innéov – probably the world’s highest profile cosmeceutical – goes to the very heart of the complexity of cosmeceuticals.

Just last year, Innéov’s international director of regulatory affairs and product safety, Michel Donat, PhD, was calling on the EU to clarify how his company’s skin health claims would be treated in the EU legislature.

“It is very important to know how the legislator is going to consider these kind of claims,”​ he said.

“We are in the field of beauty claims, of products that affect the skin and the hair, and in some cases this may fall under the health claims legislation… We would like these kinds of things clarified at the European level.”​

That clarification came this year and may have made Innéov ponder the axiom: be careful what you wish for.

Its submission to the European Food Safety Authority (EFSA) – the agency charged by the European Commission with evaluating the scientific merit of nutrient-health claim associations in the EU – drew a negative opinion.

Innéov proposed that the he product that contains blackcurrant seed oil, fish oil, lycopene, vitamin C, and vitamin E, ‘Helps to improve dry skin condition.’ ​EFSA said no.

Innéov, obviously sensitive to interpretation of claims, also submitted alternate wordings:

• Helps to improve skin dryness.
• Helps to improve dry skin aspect.
• Helps to improve skin comfort.
• Helps to improve skin soothing.
• Helps to improve skin ageing signs.
• Helps to act against skin dryness.

EFSA also rejected these mainly due to the fact the science submitted was conducted on individual ingredients, not the Innéov product itself, or because the trials did not demonstrate significant changes in skin dryness and other measures.

Innéov’s reaction to that opinion can be found here.

Japan remains the biggest market for cosmeceuticals with a plethora of beauty drinks and supplements, but the FOSHU (Foods for Specified Health Uses) rules remain relatively strict, and many products name only active ingredients such as lycopene, collagen or coenzyme Q10 in lieu of any specific skin, nail or health claims.

Typical claimed benefits include: (for skin) repair and prevention; sun protection; firmness; pigmentation; whitening; and slimming; (for hair) retention and growth; restoration; nourishment; and volumizing; (for nails) strengthening.

 Beauty From Within 2010​

 CosmeticsDesign-Europe.com and NutraIngredients.com have combined resources to bring you the Beauty From Within 2010 conference. Taking place in Paris on 11th October this one day event aims to help companies harness the potential of the category.

 The conference program will look at the science behind the ingredients and the important issue of marketing claims, as well as exploring how to bring successful products to a highly competitive market.