Recall Alert: Health Canada Warns of Unsafe Cosmetics

On October 6, 2023, Health Canada issued a public health advisory regarding unapproved skin-lightening and skin treatment creams sold as cosmetics. These products were found to contain hazardous components that pose serious health risks. The list of recalled products, along with specific details, can be accessed here. These products either contain unsuitable cosmetic ingredients or fail to disclose certain components on their product labels.

Some of the ingredients posing a health risk that were found in the above-mentioned products include: 

  • Aminocaproic acid – Ingredient not suitable for use in cosmetics as it is listed in the Prescription Drug List. The use of this ingredient in products requires a drug identification number (DIN) and sufficient safety assessment prior to market entry. It is important to note that an improper use of this ingredient can lead to severe side-effects including, but not limited to, nausea, vomiting, muscle weakness, and skin rash.

  • Betamethasone valerate – Belongs to an adrenocortical hormone (and salt derivatives) family and is not suitable for use in cosmetics as it is listed in the Prescription Drug List. The use of this ingredient in products requires a drug identification number (DIN) and sufficient safety assessment prior to market entry.

  • Clobetasol propionate – This is ingredient is a corticosteroid and is a potent prescription drug used to treat skin condition. This ingredient is listed in the Prescription Drug List and is not suitable for use in cosmetics. The use of this ingredient in topical products requires a drug identification number (DIN) and must undergo proper safety assessment prior to market entry. Improper use of products with this ingredient can cause sever side-effects including skin irritation, weaking, or deterioration. Absorption through skin can also lead to adrenal suppression or Cushing’s syndrome.

  • Dexamethasone – This ingredient is a corticosteroid and used in prescription medicine to treat inflammatory condition or to suppress the immune system. It is listed in the Prescription Drug List and is not suitable for use in cosmetics. As with the above-mentioned ingredients, products containing dexamethasone require a drug identification number (DIN) and must be assessed prior to market entry to ensure safety. Improper use of the ingredient can lead to serious adverse effects, including skin atrophy, skin colour changes, swelling, rashes, and others.

Other ingredients that appear in these products include erythromycin, hydroquinone, ketoconazole, penicillin potassium, tretinoin, and others. It is important to note that these ingredients are not suitable for use in cosmetics and need further safety evaluation. Health Canada strongly advises all consumers to discontinue the use of these products and seek guidance from a healthcare professional if they have used them in the past.

Follow us on LinkedIn

Karolina Zarichna, BSc, Regulatory Affairs Specialist | Business Development and Marketing Lead

With over 3 years of experience in regulatory affairs, Karolina helps natural health product (NHP) brands navigate Canada's complex regulatory landscape and achieve compliance with Health Canada's standards. As a Regulatory Affairs Specialist at Natural Products Consulting Corp. (NPC), she manages product licence applications, scientific research, label reviews, and client communications for NHPs, cosmetics, and food products.

Previous
Previous

Guideline Update: Simulated Meat and Simulated Poultry

Next
Next

Natural Health Product (NHP) Licensing Fees - Update