borderline between cosmetics and medicine maximising profit by regulatory knowledge and expertise ...

Borderline Cosmetics / Medicine –

Maximising Profit by Regulatory Knowledge and Expertise

Peter Lassoff, Pharm.D.Practice Leader, Pharma Regulatory & Quality

Europe

Borderline: Cosmetics / Drugs

• Understanding the meaning

of the Terms Cosmetic and

Cosmeceutical

• Learning what ingredients

are permitted in European

Cosmetics

Objectives of the Presentation

Borderline: Cosmetics / Drugs

• Learning what Claims can

be made for a Cosmetic

• Understanding the

Registration Opportunities

and Threats

Objectives of the Presentation (Continued)

Borderline: Cosmetics / Drugs

• Any Substance or Preparation intended to be placed in contact with the Various External Parts of the Human Body . . . With a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition

• There is no ‘Positive List’ for ingredients in Europe

Cosmetics – European Law

Borderline: Cosmetics / Drugs

Cosmetics Directive

• New Cosmetics Directive in place in 2010

• Objectives were reducing administration costs, strengthening the self-assessment and responsibility of individual manufacturers, maintaining a high level of safety in cosmetics without unnecessary red tape

• “Focus must be on reducing legislation and administrative costs considerably, but making it at the same time more efficient, without effecting public health and safety” - Commission VP G Verheugen

• Industry-driven

Borderline: Cosmetics / Drugs

New, Amended Cosmetics Directive (EC Press Release)

• Clarifies minimum requirements for the safety assessment of cosmetic products thus strengthening further the safety of cosmetic products placed on the EU market

• Clarifies minimum requirements for safety assessment

• Simplifies notification requirements which cut administrative costs for cosmetic companies

• Scratching of national laws and regs by introducing a single EU-law for reporting of undesirable effects, product withdrawal, and coordination of enforcement among Member States

• Rules for reporting of undesirable effects to be in place by 2010

Borderline: Cosmetics / Drugs

Cosmeceuticals

• No formal legal / regulatory definition

• To categorise more active skin care products with substantiated efficacy data

• Has now been commandeered by the supplements industry to describe ‘beauty foods’

• Huge market, high growth (baby boomers and working women driving growth)

Borderline: Cosmetics / Drugs

Cosmeceuticals (Continued)

• The total European and US market for cosmeceuticals stands at US$8.2 billion. The US is the largest cosmeceutical market reaching $9.4 billion in 2012 after strong annual growth of 7.2% per year, with Europe growing at about 5% per year

• The rapid growth of the cosmeceutical market will continue to be based on a combination of science and astute marketing, driven by a stream of new and technologically advanced product introductions offering age-defying and other appearance-enhancing benefits for an aging population

• Producers to focus on unique active ingredients to differentiate offerings

Borderline: Cosmetics / Drugs

Claims

• Main“Visibly Reduce Lines and Wrinkles by 70%” (Cosmetic) Versus:

• “For the Treatment of Photodamaged Skin” (Drug)

• “Functional Use” vs. Medicinal Claim

Borderline: Cosmetics / Drugs

Claims (Continued)

• ‘Forbidden’ Terms: Remedies, Eliminates, Restores, Stops, Heals, Clears, Removes, Avoids, Protects, Avoids and Prevents

• UK Regulations, Quite Stringent (‘Duck’)

• Primary Purpose: Cosmetic, but Secondary Preventative Benefit Is Allowed (e.g. Anti-dandruff Shampoos)

Borderline: Cosmetics / Drugs

• Difference in Interpretation of Cosmetics and Pharmaceutical Regulations

• “Medicated Shampoo” - Cosmetic in UK, Drug in France

EU National Differences

Borderline: Cosmetics / Drugs

• Ingredient Differences – Europe

• Harmonised now, but France had a different list from that used in the EU Cosmetics Directive

• Cosmetic Surgery – Some MSs Regulate, Some Do Not (UK – New Proposals)

• [With Great Respect ] Don’t Ask the Drug Authorities for Advice, Try the Trade Associations First

EU National Differences

Borderline: Cosmetics / Drugs

International Harmonisation

• International Cooperation on Cosmetic Regulation (ICCR)

• Last meeting was Sept 2009, taking over from “Cosmetics Harmonisation and International Co-operation Meeting” (CHIC)

• Europe (Commission), US, Japan and Canada

• Focus on Alternative Test Methods, GMP (will implement ISO Standard 22716 in all regions), Safety of Ingredients / Authorised Substances Lists, Nanotechnology, Cosmetics Labelling and Sunscreens

Borderline: Cosmetics / Drugs

European Harmonisation

European Commission Workshop on Borderline Products with Pharmaceuticals – Conclusion

The European Commission has issued a Communication addressing the issues of Borderline Products and the need to establish a Borderline Committee, whose task is amongst other to establish Guidelines

• The Committee will be sub-divided as follows:• Medicinal Products Vs. Cosmetics (and Possibly Biocides)• Medicinal Products Vs. Medical Devices• Medicinal Devices Vs. Cosmetics

• EMEA and the EFSA should be involved in the discussion, especially on the location of the Committee

Borderline: Cosmetics / Drugs

Risk to Innovation

New classes of cosmetics products can prove challenging for regulators but it is important that regulation does not starve innovation, says UK trade association CTPA’s Chris Flower.

Examples:

• Eyelash treatment with bimatoprost said to increase eyelash length (originally a glaucoma treatment from Allergan)

• Tooth whitener products (“illegal cosmetics”)

"We shouldn't use regulation to constrain innovation," said Flower. "If the market wants it and the product is safe and efficacious then we should work on the regulation to see how the product can reach the EU market as either a cosmetic or a medicine."

Borderline: Cosmetics / Drugs

Shampoos

• Switching Primary Versus Secondary Purpose (Cosmetic and Preventative)

• Ingredients, e.g. Coal Tar, Tea Tree Oil, Menthol, Anti-fungals

Borderline: Cosmetics / Drugs

Shampoos – Antifungal Example

Borderline: Cosmetics / Drugs

Creams

• OTC Eczema Versus Moisturiser

• Antimicrobial Activity Versus Preservation

• Ceramides, Vitamin C, Nanosomes, Alpha Hydroxy Acids -- Cosmetic Ingredients

Borderline: Cosmetics / Drugs

Creams (Continued)

Companion products for Topical Drugs, e.g. Corticosteroid Vehicles as Moisturisers, Cream to help Roaccutane Patients, Ointment for Topical 5-FU Patients

Borderline: Cosmetics / Drugs

Creams – Companion Claims

• “Emollients are recommended by Dermatologists for use in Eczema and Dermatitis” - Medicinal Product Claim. “Removes, Restores, Repairs” – Generally Proscribed

• “Brand is suitable for use after treatment for Eczema / Dermatitis / Psoriasis with Medicinal Products” – Cosmetic Claim (UK)

Borderline: Cosmetics / Drugs

Acne• Camouflage

Cosmetics Versus Healing Drugs

• ‘Blemishes’ OK, ‘Spots / Acne,’ NO! Seemingly Arbitrary Rules, Different in Each Member State

Borderline: Cosmetics / Drugs

Wrinkles (Anti-Ageing Products)

• Largest Cosmeceutical Segment, 15% Growth Rate

• Retinol - Vitamin A Derivative, Similar to Tretinoin

• Teratogenicity Maybe a Concern for Retinoids

Borderline: Cosmetics / Drugs

Anti-Ageing Ingredient Trends

•Trends• “Natural” Ingredients• Less Skin Irritation• More UV Protection• Greater Efficacy

• Potential New Actives• Copper Peptides (very

popular!)• Hyaluronic Acid and

Hyaluronidase• Lactobionic Acid• Herbs, Vitamins, Minerals, etc

Borderline: Cosmetics / Drugs

• User Testing Versus Clinical Studies - reduced time to market for Cosmetics

• Alpha Hydroxy Acids - widely used as both Drug Active ingredients and in Cosmetics

• Recent FDA Studies - Decrease in MED, Increase in number of ‘Sunburn’ Cells

Borderline: Cosmetics / Drugs

AHA Labelling in the US

FDA Warning

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Borderline: Cosmetics / Drugs

Anti-Ageing Products, Examples

Borderline: Cosmetics / Drugs

Anti-Ageing Products, Examples

TopicalTretinoinResults

Borderline: Cosmetics / Drugs

“Puffery” – Examples of Claims

• Restoring Tri-Regenerating Cream - “Association of Pure Oxygen, Negative Ions, Vitamins and Anti-Free Radicals”

• “Face Lift without Surgery”

• “Containing ingredients essential for the Life and Preservation of Healthy Skin”

• “Reinforces waning Metabolic Functions of the Skin”

Borderline: Cosmetics / Drugs

Recent Product Trends

• Sirtuins – will “revolutionise cosmetics” by slowing ageing (Clinique)

• Stem Cells – incorporated into skincare products along with peptides that stimulate the skin (La Prairie)

• Genomics – DNA sequencing, epigenetics and single-cell analysis techniques will lead to personalised skincare (P&G)

• Rigorous Clinicals – randomised clinical studies etc

• Specific Protein Barcoding – associated with gene expression of young and aged skin to ‘recover younger characteristics’ of skin (L’Oreal)

Borderline: Cosmetics / Drugs

The Face Bra – a facelift without Surgery

The Face Bra uses light a light non-latex fabric impregnated with natural minerals that lift, firm and tighten the skin after only a few treatments.

Any Questions?

Thank you!

Peter.Lassoff@Quintiles.com