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Unauthorized skin lightening health products may pose serious health risks

Last updated: 02-09-2020

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Unauthorized skin lightening health products may pose serious health risks

Health Canada is warning Canadians that skin lightening health products — such as creams or gels — that are not authorized for sale in Canada may pose serious health risks. Health Canada has seized several products from retailers and is concerned that similar unauthorized products continue to be sold to Canadians despite their risks.

Health Canada is encouraging Canadians to read the labels of products that claim to lighten, whiten, fade or bleach skin. Look for an eight-digit Natural Product Number (NPN) or Drug Identification Number (DIN) on the label, which indicates the product has been assessed by Health Canada for safety, efficacy and quality, and has been authorized for sale.

Health products that have not been authorized for sale by Health Canada may contain high-risk ingredients, such as prescription drugs, that may or may not be listed on the product label. Prescription drugs should be used only under the advice and supervision of a healthcare professional because they are used to treat specific conditions and may cause serious side effects.

It is illegal to sell unauthorized health products in Canada. Health Canada has seized and warned Canadians about several unauthorized skin lightening health products whose labels show they contain prescription drugs (e.g., betamethasone dipropionate, clobetasol propionate, or hydroquinone at concentrations greater than 2%). These products may pose health risks, such as blisters, scarring, skin weakening or deterioration, bone loss, decreased ability to fight infection, and, in the case of hydroquinone at concentrations greater than 2%, possibly cancer. The Department strongly encourages Canadians to not use these products and to report to Health Canada if they see the products for sale, so that the Department can take appropriate action.

Unauthorized skin lightening products may also contain unacceptable levels of mercury, a heavy metal. Mercury poisoning can cause serious harm, particularly to children, pregnant women and women who are breastfeeding. The Department has implemented measures to reduce the amount of heavy metals to which Canadians are exposed, including establishing strict limits for health products and cosmetics.

Health Canada will continue to take action against companies selling unauthorized skin lightening health products online or in stores in Canada. The Department encourages Canadians to report any information regarding the sale of these products to Health Canada. The Department will work with the Canada Border Services Agency to help prevent the import of any unauthorized skin lightening health products. Health Canada will continue to warn Canadians about these products when they are found in the marketplace.

Health Canada has seized unauthorized skin lightening health products whose labels show they contain the following prescription drugs. Unauthorized products may also contain unacceptable levels of mercury: 

Betamethasone dipropionate and clobetasol propionate are highly potent corticosteroid prescription drugs that are applied to the skin to treat inflammatory skin conditions. Side effects include skin irritation and, with prolonged use, skin weakening or deterioration. Adverse effects from using too much include decreased ability to fight infection, symptoms of adrenal gland suppression (i.e., low blood pressure, low blood sugar, weight loss, muscle pain, gastrointestinal problems and severe fatigue) or Cushing's syndrome (i.e., high blood pressure, high blood sugar, weight gain, muscle weakness, bone loss and severe fatigue) depending on how much has been absorbed. These drugs should not be used by pregnant or nursing women.

Hydroquinone is a prescription drug when it is greater than a 2% concentration and for topical use (applied to the skin). It is used to lighten areas of darkened skin caused by different conditions (e.g., sun exposure, skin damage, pregnancy, medications or age). It should not be used by people who are allergic to hydroquinone or who are taking medicines that make their skin more sensitive to light. Hydroquinone is not recommended for pregnant or breastfeeding women, or children. It should be used with caution in those who have previously had cancer. Side effects include skin reactions such as redness, dryness, cracked skin, burning, stinging, peeling, itching, increased sensitivity to sunlight, sunburn, blisters and scarring. It may cause skin discolouration (i.e., blue or black discolouration or white patches or spots) that, in some cases, can be disfiguring. In laboratory animals, it has been associated with cancer after long-term exposure. As of June 30, 2019, products containing hydroquinone greater than 2% for topical use require a prescription from a healthcare practitioner to be sold in Canada. Several products with more than 2% hydroquinone that were previously sold over the counter have been recalled in Canada.

Mercury is a heavy metal that poses serious health risks. Skin exposure to mercury may result in skin rashes, skin discolouration and scarring, and reduction in the skin’s resistance to bacterial and fungal infections. Absorbing too much mercury through the skin may result in an accumulation of the metal in vital organs of the body. Children, pregnant and breastfeeding women are most susceptible to the toxic effects of heavy metals. The toxic effects of mercury include irritability, tremors, memory loss, insomnia, concentration problems, and kidney and brain damage.

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