Product Assessment Against Criteria: Medicated Skin Care Products

Classification: Drug
Date of Decision: Spring 2009

Summary of Classification:

Medicated skin care products are indicated for the mitigation of damage done to the skin due to disease or injury, and to help prevent further damage while the skin heals. These products are recognized to be used on an abnormal state of the skin requiring therapeutic intervention, and as such, are classified as drugs. Medicated skin care products do not include the indication for the relief of dry, chapped skin, as these are considered to be cosmetic claims

Evaluation Against Criteria

Representation:

Is the product represented in a manner suggesting it is used for treating, diagnosing, preventing, or curing disease or restoring, correcting or modifying organic functions in human beings?

Medicated skin care products are those intended for the relief of a variety of skin conditions such as eczema, rashes, hives, rosacea, dermatitis, insect bites and minor burns, cuts and scrapes. Therapeutic emollients for medical conditions, such as diabetes, also fall into this category.

The stratum corneum is composed of 25 to 30 layers of flattened dead keratinocytes, which are continuously shed and replaced from below. These dead cells are interlaid with lipids secreted by the stratum granulosum just underneath, which help to make this layer of the skin a waterproof barrier. The stratum corneum's function is to reduce water loss, repel water, protect deeper layers of the skin from injury and to repel microbial invasion of the skin. When damaged, the stratum corneum's innate defense mechanisms are not able to perform optimally, and further harm can ensue. Medicated skin care products are intended to mitigate the damage done to the skin due to disease or injury, and to help protect the skin during the healing process.

Prior to April 2007, medicated skin care products traditionally included those intended for the treatment of dry skin, chapped skin and lips. A review of the claims for this product category concluded that moisturization or hydration of the outer layer of the stratum corneum to mitigate dry, chapped skin was for comfort and aesthetic purposes only, which meets the definition of "cosmetic". The Medicated Skin Care monograph was revised to remove the claims which fall under the jurisdiction of the Cosmetic Regulations. Drug or natural health product submissions solely making such claims are now redirected to notify as cosmetics.

Subcategories of this class are barrier creams and ointments. These products are primarily composed of ingredients such as petrolatum or mineral oils, and form a solid layer over the top of the stratum corneum to repel external moisture and prevent cell dehydration. These creams are frequently used in situations stressful to skin, for example harsh environmental working or leisure conditions such as fishing, skiing, construction, etc. In a similar fashion to the "dry skin" claims, barrier creams claiming protection against the elements would be considered cosmetic as they are for the maintenance of the integrity of the skin. However, if a barrier cream is represented as protecting or treating a skin condition resulting from a disease, an immune condition, or otherwise compromised skin, then such a therapeutic emollient would meet the definition of a drug under the Food & Drugs Act.

The April 2007 Medicated Skin Care monograph was revised to clearly link the product to the treatment or mitigation of a disease-related and/or immune-related skin condition.

The following table outlines what was maintained in the Medicated Skin Care monograph and what was deemed to be cosmetic. These classification decisions continue to hold true using the principled criteria. Further, to add clarity around the therapeutic classification related to a medicated skin care product, additional examples of therapeutic claims outside of this monograph have been provided:

Table 1. Medicated Skin Care Product Claim Classification

Claim	Classification
Relief, soothing, prevention or treatment of dry skin	Cosmetic
Relief, soothing, prevention or treatment of chapped skin	Cosmetic
Relief, soothing, prevention or treatment of irritated skin	Therapeutic
Therapeutic emollient for skin condition	Therapeutic
Relief of minor irritation and itching due to rashes, eczema, poison ivy, poison oak, poison sumac and/or insect bites	Therapeutic
Temporary protection of minor cuts, scrapes and burns	Therapeutic
Relief, soothing, or prevention of psoriasis, eczema, rosacea	Therapeutic

Is the product likely to be understood by consumers to have characteristics of a drug?

It was determined that the claims for normal dry, chapped skin meet the definition of "cosmetic" in that such products are represented as improving and/or maintaining the appearance of the skin. These are perceived in the marketplace as cosmetics.

Medicated skin care products, including therapeutic emollients, claiming relief or prevention of diseases, abnormal skin states, and compromised skin are likely to be understood by the consumer to be drugs.

Composition:

Does the product's composition suggest it is an agent for treating, diagnosing, preventing, or curing disease or restoring correcting or modifying organic functions in human beings?

Medicated skin care products contain ingredients frequently used in cosmetic as colourants or humectants (e.g. zinc oxide, allantoin, petrolatum, etc.) The ingredients in the products are not necessarily therapeutic until applied at appropriate concentrations and/or with the intent to treat or prevent an abnormal skin state such as a wound, eczema, poison ivy or other medical condition.

Level of action:

Does the product exert solely a superficial effect?

Ingredients which would achieve the intended result do not exhibit any pharmacological activity, nor do they affect the biochemistry of skin. The ingredients are superficial in action as they are intended to act on the epidermis, and there is no maximum frequency of dosing to ensure safety.

The product is applied topically with no evidence of percutaneous absorption. The effect of the product is to treat and remove an abnormal and irritated skin condition, so its effect cannot be considered transient.

Other considerations:

In the United States, medicated skin care products are classified as drugs. The US also classifies the claim "for dry, chapped lips" as a drug claim.

In the European Union, products for the relief of dry skin are cosmetics while those claiming relief of an irritated skin condition are classified as drugs. In Australia and New Zealand, medicated skin care products are regulated in a similar fashion to this proposed approach.

Conclusion:

The primary purpose of medicated skin care products is to treat and prevent an abnormal skin condition. As such, medicated skin care products meet the definition of 'drug' under the Food and Drugs Act, and are regulated under the Natural Health Product Regulations or Food and Drug Regulations depending on ingredient. For more information, consult the TPD/NHPD Medicated Skin Care Product monograph, however note that the document may not capture all product types within this category.

References:

• Canadian Pharmaceutical Association . Self-Medication: Reference for Health Professionals Vol.1, 4^th Edition. Ottawa: Canadian Pharmaceutical Association, 1992.
• EMEA. Borderline Between Directive 98/8/EC Concerning the Placing on the market of Biocidal Product and Directive 76/768/EEC Concerning Cosmetic Products. May 24, 2004.
• FDA. Is It a Cosmetic, Drug, or Both (Or Is It Soap?). Washington: USA Department of Health and Human Services, July 8, 2002.
• FDA. Skin Protectant Products for Over-the-Counter Human Use, Final Monograph 21 CFR Part 347. Washington: USA Department of Health and Human Services, 2003.
• Friel JB, ed. Dorland's Illustrated Medical Dictionary 26^th edition. Toronto: WB Saunders, 1985.
• Health Canada. Category IV Monograph: Medicated Skin Care Products. September 11, 1995.
• Health Canada. Medicated Skin Care Products. Ottawa: Therapeutic Products Directorate and Natural Health Products Directorate, April 19, 2007.
• Hoggarth A, Waring M, Alexander J, Greenwood A, and Callaghan T. 2005. A controlled, three-part trial to investigate the barrier function and skin hydration properties of six skin protectants. Ostomy Wound-Management. Dec 51(12): 30-42.
• MHRA. A Guide to What is a Medicinal Product, MHRA Guidance Note No. 8. London: MHRA, amended April 2003.
• MHRA. Borderline Products. London: MHRA, modified June 5, 2006
• NICNAS. Regulation of Cosmetic Chemicals: Final Report and Recommendation. Australia: Commonwealth of Australia, November 2005.
• Sweetman SC, editor. Martindale: The Complete Drug Reference 33^rd edition. Grayslake (IL): Pharmaceutical Press, 2002.
• TGA. Draft Review of the Regulation of Products at the Interface Between Cosmetics and Therapeutic Goods. Australia: Commonwealth of Australia, January 16, 2005.
• TGA. The National Coordinating Committee on Therapeutic Goods Australia "Cosmetic Claims Guidelines" 3^rd Ed. Australia: Commonwealth of Australia, May 1997.