Alpha-Hydroxy Acids and Acid Peel Products: Canadian Hotlist Confusion

by | Aug 1, 2018 | Canadian Regulatory, Cosmetics | 0 comments

Acid peel products have become increasingly popular in Canada. Acid peel products typically contain the Canadian Hotlist ingredients Alpha-Hydroxy-Acids (AHA’s). These peel products are intended for topical application only, are usually applied to the face, and can either be used at home (consumer use) or by skin-care professionals (professional use). Acid peel products with AHA’s can either be classified as a cosmetic or as a prescription drug – depending on the concentration of the AHA’s and also the pH of the product.

 

For consumer use – at home peels – the maximum concentration of AHA’s that is allowed within the product is 10% and pH of equal to or greater than 3.5. AHA concentrations below 3% do not require a warning statement to be present on the product’s label, but concentrations above 3% (no matter if for consumer use of professional use) do.

 

For professional use – peels to be used by skin-care professionals only – the maximum concentration of AHA’s that is allowed within the product is “30% or a pH of 3-3.5”, as per the Hotlist. The controversial aspect of this restriction is the “or” statement, which tends to confuse most companies as this statement could be interpreted to mean for example, an AHA concentration of 30% and a pH of 2, or AHA concentration of 40% and pH of 3.0 are both acceptable. This interpretation is incorrect. Health Canada classifies products with either pH of lower than 3, or AHA concentration higher than 30% as prescription drugs. Therefore, in order to be acceptable for professional use but not be classified as a prescription drug, the total AHA concentration within a peel must be lower than 30% and also a pH equal to or higher than 3.0.

 

The following examples demonstrate the difference between cosmetic consumer-use acid peel products versus cosmetic professional use acid peels versus prescription drug acid peels:

  • Cosmetic Consumer Use:
    • Restriction: Total AHA concentration of 0-10% and pH of 3.5 or greater
    • Example:
      • A product with 5% AHAs with pH 3.7 would be consumer use
      • A product with 9% AHAs with pH 4.0 would be consumer use
      • A product with 1% AHAs with pH 5.0 would be consumer use
    • Cosmetic Professional Use:
      • Restriction: Total AHA concentration of 10-30% and pH of 3-3.5
      • Example:
        • A product with 5% AHAs with pH 3.2 would be professional use
        • A product with 25% AHAs with pH 4.0 would be professional use
        • A product with 30% AHAs with pH 3.2 would be professional use
      • Prescription Drug:
        • Restriction: Total AHA concentration greater than 30% and pH lower than 3
        • Example:
          • A product with 35% AHAs with pH 4.0 would be a prescription drug
          • A product with 25% AHAs with pH 2.5 would be a prescription drug
          • A product with 40% AHAs with pH 1.5 would be a prescription drug

Health Canada has acknowledged that the Hotlist listing is confusing and have therefore noted that they will be making changes to the Hotlist to make these important restrictions clearer to everyone.

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading North American regulatory consultants.