Canada proposes rules requiring sunscreens with anti-aging ingredients to bear strong warning label advising consumers that product could increase sun sensitivity, sunburn for up to a week after they use it

, May 23, 2013 (press release) – Health Canada is pleased to announce the release of the revised Sunburn Protectants Monograph for stakeholder consultation. The document is now titled "Guidance Document Sunscreen Monograph", to reflect the common Canadian term for this category of drugs.

This draft Monograph is intended to replace the existing Sunburn Protectants Monograph of October 12, 2006. The proposed Monograph applies to drugs subject to the Food and Drug Regulations administered by the Therapeutic Products Directorate (TPD) and natural health products subject to the Natural Health Product Regulations administered by the Natural Health Products Directorate (NHPD). It identifies the permitted ingredients, doses, directions and indications for use for these products, which will be required to appear on the product labels as well as the recommended supporting test methods.

The development of this Monograph is the result of a thorough survey of existing regulations, guidance documents, policies and current practices within Health Canada and other leading regulatory agencies.

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

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