Description
FDA has considered evidence that suggests that topically applied cosmetic products containing alpha hydroxy acids (AHAs) as ingredients may increase the sensitivity of skin to the sun while the products are used and for up to a week after use is stopped, and that this increased skin sensitivity to the sun may increase the possibility of sunburn. The purpose of this guidance is to educate consumers about the potential for increased skin sensitivity to the sun from the topical use of cosmetics containing AHAs as ingredients and to educate manufacturers to help ensure that their labeling for cosmetic products containing AHAs as ingredients is not false or misleading. As an interim measure, while FDA continues to review the data on AHAs to address the potential for this increased skin sensitivity to the sun, FDA is recommending that the labeling of a cosmetic product that contains an AHA as an ingredient and that is topically applied to the skin or mucous membrane bear a statement that conveys the following information. The information in the AHA labeling statement is consistent with FDA's current thinking on sun protection.
Scope & Applicability
Product Classes
2The primary product category addressed in the guidance; Safety of nanomaterials in cosmetic products; safety assessment of cosmetic products using nanomaterials; Subject of EU Directive 2003/15/EC and Council Directive 76/768/EEC
Preparation of cosmetic ingredients for use in a finished product; Products subject to registration and listing requirements under the FD&C Act; Products subject to registration and listing requirements under MoCRA.
Stakeholders
3MAHs are expected to follow-up all pregnancy reports from consumers
manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws
Entity responsible for submitting NDINs
Regulatory Context
Attributes
2Environmental factor that interacts with AHA-treated skin.
Intrinsic characteristic affecting the growth of L. monocytogenes; intrinsic characteristic used as a process control; parameter to monitor for control; Process control parameters such as pH; Used to define listeristatic formulations
Identified Hazards
Hazards
1exposure to UV radiation after application of AHAs
Related CFR Sections (2)
- 21CFR1.21§ 1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, cosmetic, or tobacco product shall be deemed to be misleading if it fails to reveal facts that are:Read full regulation →
- 21CFR701.3§ 701.3 Designation of ingredients.
(a) The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance, except that fragrance or flavor may be listed as fragrance or flavor. An ingredient which is both fragrance and flavor shall be designated by each of the functionsRead full regulation →
See Also (4)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry (Status: Final)
- Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration (Status: Final)
- Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide: Guidance for Industry (Status: Final)