FDA Classification of Ichthammol and Azelaic Acid for Cosmetic Registration
Question
I am interested in making a cream with active ingredients Ichthammol and Azelaic Acid for acne treatment, but I have some issues:
1. Assuming I want to register this product with the Thai FDA for use in cosmetics, are these substances classified as drugs or cosmetics? Are there any prohibitions for registration? For example, Azelaic Acid is typically listed as a drug, but Azeloil diglycinate can be used instead, which is a bit confusing.
2. How can I check whether a substance is classified as a drug or a cosmetic ingredient? Is there a website to check this information, or do I have to call the FDA for each specific substance, such as Tar?
Answer
Guidance on Registering Cosmetics Containing Ichthammol and Azelaic Acid in Thailand
Hello, I understand you are interested in developing an acne treatment cream containing Ichthammol and Azelaic Acid and have questions regarding registration with the Thai Food and Drug Administration (FDA).
Here are the points explained:
Classification of Ichthammol and Azelaic Acid for FDA Registration
- Generally, the classification of a substance as a "drug" or "cosmetic ingredient" depends on its intended use, concentration, and the claims made on the product label, according to Thai FDA law.
- Azelaic Acid: This substance is often classified as a drug when used at high concentrations with specific indications for acne treatment. Products containing it under these conditions must undergo drug registration, not cosmetic notification. However, derivatives of Azelaic Acid, such as Azeloil diglycinate, may have a different legal status and might be permissible for use in cosmetics, depending on the specific derivative and its usage as per FDA announcements and restrictions.
- Ichthammol: This substance also has a history of use in both pharmaceuticals and cosmetics, depending on the concentration and intended use. Whether it can be used in cosmetics and under what restrictions must be verified directly with FDA announcements.
- Registration Prohibitions: If a substance is classified as a drug or is listed as a prohibited substance in cosmetics according to the FDA announcements, it cannot be notified as a cosmetic product.
How to Check if a Substance is Classified as a Drug or Cosmetic Ingredient
- The most accurate and reliable method to check the status of substances like Ichthammol, Azelaic Acid, Azeloil diglycinate, or Tar (some types of Tar are also regulated in cosmetics) is to refer directly to the official announcements and regulations of the Thai Food and Drug Administration (FDA).
- Sources:
- FDA Thailand Website: Check the database of laws, announcements, or cosmetic notification guidelines, which list controlled substances, prohibited substances, and substances allowed under specific conditions (e.g., maximum concentration limits).
- Contact the FDA Directly: If you are unsure about the status or requirements for any substance, the best approach is to contact the FDA directly for the most accurate and up-to-date advice.
- There is no single public website that provides comprehensive and official information equivalent to that from the FDA. Interpretation of regulations must be done carefully based on the latest announcements.
In summary, using Ichthammol and Azelaic Acid in your product for cosmetic notification can be complex because these substances are often regulated as drugs at certain concentrations or for specific indications. It is highly recommended to check with FDA announcements or consult directly with a cosmetic regulatory expert to ensure your formulation complies with the requirements and can be properly notified.