Cosmetics are prevalent in our daily lives, from make-up to shaving cream to baby powder. It is estimated that sales of cosmetics in Canada total over $5.3 billion annually. On average, North American adults use seven different cosmetic products a day (Regulatory Impact Statement, Regulations Amending the Cosmetic Regulations, Canada Gazette Part I, March 27, 2004).
In order to ensure the health and safety of Canadian consumers, a regulatory framework has been developed. Central to this framework are the Food and Drugs Act and the Cosmetic Regulations.
Overview of the Regulatory Scheme
Unlike the sale of drugs to consumers, Health Canada does not approve cosmetics for sale in Canada. Only notification of sale or importation is required.
Notification is a relatively simple procedure, consisting essentially of:
- information on the name and address of the manufacturer(s) and Canadian distributor;
- the cosmetic trade name;
- the purpose of the cosmetic;
- the form of the cosmetic;
- a list of ingredients and concentrations; and
- indication of whether the cosmetic is intended for human and/or animal use.
Although there is no approval process, there are minimum safety requirements imposed by the Food and Drugs Act and the Cosmetic Regulations. A manufacturer may have to prove product safety, upon request, and the Act and Regulations also allow for random inspection and sampling for compliance. Penalties may be imposed for failure to comply.
Consumers must be provided with a certain amount of information about the product at the time of sale, such as the product identity or function, net amount of product, name and address of manufacturer, and, for some products, avoidable hazards and cautions regarding use. Interestingly, there is no requirement to provide consumers with a list of ingredients, although regulatory changes have been proposed to make this a mandatory requirement within the next few years.
Some of the more interesting questions concerning the regulatory scheme, however, arise at a very fundamental level. To what products do the Cosmetic Regulations and related provisions in the Food and Drugs Act apply? The answer to this question is not as simple as one might expect.
What is a cosmetic?
Under the Food and Drugs Act, a cosmetic is defined in terms of a substance’s use in “cleansing, improving or altering the complexion, skin, hair or teeth.” Deodorants and perfumes are specifically included in the definition.
Many “cosmetics” available on the market today, however, make other or additional claims than simply “cleansing, improving or altering the complexion, skin, hair or teeth.” Products known as “cosmeceuticals”, cosmetics having drug-like properties, are becoming more popular. For instance, some cosmetics claim to treat a medical condition, such as dandruff. Others claim to modify a body function, such as aging. Many include medicinal ingredients, such as sodium fluoride to prevent tooth decay. Are these products regulated as cosmetics?
Cosmetic vs. Drug
The answer is no -- these products are regulated as drugs. Most consumers would probably be surprised to find that many of their personal care products carry a DIN (“drug identification number”), and are considered drugs, rather than “cosmetics.”
In general, where a product makes a therapeutic claim or claims to modify a body function that product is no longer considered a cosmetic, but is classified as a drug. For example, while deodorant is considered a cosmetic, acting to control odour in perspiration on the skin’s surface, an antiperspirant is considered a drug, because antiperspirants suppress the flow of perspiration to the skin’s surface. A deodorant does not alter or modify a body function, but an antiperspirant does.
A product cannot be both a drug and a cosmetic, and Health Canada indicates on its web-site that the regulations pertaining to drugs take precedence over those pertaining to cosmetics.
The regulations pertaining to drugs are generally more stringent than those pertaining to cosmetics. As previously indicated, before most drugs can be sold in Canada, they must be approved for use, unlike cosmetics. Moreover, there are other specific regulatory provisions, such as those governing the formulation and labelling of drugs, which do not apply to cosmetics. In view of the more complex regulatory regime, it may be desirable to have a product classified as a cosmetic rather than a drug.
It is primarily the claimed utility of the product that is used to determine whether a product is a cosmetic or a drug. As a starting point, Advertising Standards Canada, the Canadian Cosmetic, Toiletry and Fragrance Association and Health Canada have published “Guidelines for Cosmetic Advertising and Labelling Claims.” These guidelines provide a list of generally accepted criteria for acceptable and unacceptable claims, and specific examples.
Claims for beauty products
| Product | Acceptable Claim | Unacceptable Claim |
| exfoliant | “younger looking skin” | “reduces aging” |
| skin cleansers/astringents/toners | “antibacterial cleanser” | “kills germs” |
| mouthwash/breath freshener | “fights bad breath” | “kills odour-causing germs” |
| cosmetic suncare products | “enhances tan” | “accelerates suntan” |
Drug-type claims remove the product from the Cosmetic Regulations, engaging the more complex drug regulations.
Of course product claims are not the only criteria used in determining whether a product is a cosmetic. Product composition is also considered -- specifying both the ingredients and the amount of each ingredient.
Manufacturers do have some leeway in making cosmetic claims. While misleading advertising is not allowed, a claim that a cosmetic “increases attractiveness” or “increases masculinity” is generally allowed. Since these claims can only be judged subjectively, it is difficult to say that they are misleading.
Other regulatory schemes
There are also a number of other pieces of legislation that may apply in place of or in conjunction with the cosmetic and drug regulations. Central among these are the Natural Health Products Regulations that recently came into force and effect. Under these regulations, some products previously classified as drugs will now be classified as natural health products, depending on the ingredients. For instance, an anti-aging cream containing an amino acid falls within the new regulations as a natural health product.
With the rise of cosmeceuticals, the Food and Drug Regulations and Natural Health Products Regulations are becoming increasingly relevant to the cosmetic industry. In a recent article in Chemical & Engineering News (May 3, 2004) entitled “Beauty Before Age,” the rise of anti-aging cosmeceuticals in the skincare industry in the U.S. is described. The author quotes a 14 percent increase in sales of anti-aging products in 2003, compared to a 5 percent increase in 2001 and 2002. If we see the same increase in Canada, then Canadian consumers will probably see more and more products on the market, and in their medicine cabinets, that are drugs or natural health products.
This article was originally published in ACCN Canadian Chemical News July/Aug 2004 Vol. 56, No. 7 pg. 26-27
Acknowledgement: The author wishes to thank Nessim Abu-Zahra for his assistance in preparing this article.