REPORTING
ABOUT ADVERSE EVENTS (USA)
ADVERSE EVENT REPORTING (USA)
IMPORTANT: This page is aimed exclusively at our customers in the USA.
Your safety is important to us!
At Anakena, we take the safety of our products very seriously. We carefully test all our cosmetic products to ensure safe use. We use the most rigorous testing methods to ensure that our products meet all safety standards required by the FDA and European authorities under Regulation (EC) No 1223/2009. If you experience an adverse event associated with the use of our products - that you have acquired in the USA in particular - please let us know immediately. Your feedback is crucial for our efforts to ensure product safety, product improvement and, of course, customer safety.
What are adverse events?
Adverse events are negative reactions or problems that can occur after using a cosmetic product. These include, among others:
- Skin irritations
- Allergic reactions
- More serious health disorders
Definition of serious adverse events
According to the FDA, a serious adverse event is one of the following:
A)
- Death or a life-threatening situation
- Hospitalization
- Persistent or significant disability or incapacity
- Congenital anomalies or birth defects
- Infections
- Serious incidents (including severe and persistent rashes, second or third degree burns, significant hair loss, or persistent or significant change in appearance) that does not occur as intended under the usual conditions of use; or
B)
requires medical or surgical intervention, based on appropriate medical judgment, to prevent an outcome described in (A).
If such events occur, they must be reported by us within 15 working days to the FDA be reported in the USA.
Reporting of undesirable events
If you have detected an adverse event, please send an e-mail immediately to info@anakena.de. Please attach the completed FDA MedWatch Form 3500A which you can download here:
This form allows you to provide detailed information about the adverse event. You can also find instructions for completing the form here: Instructions for using the FDA MedWatch form.
Our steps after your report
As soon as we have received your notification, we will take the following measures:
1. verification of the message: We will carefully review your information and track and analyze the details of the adverse event.
2nd documentation: In compliance with all current FDA requirements, we document all relevant information in our system.
3. notification to the FDA: If the adverse event is classified as serious, we are required to report it to the FDA within 15 business days.
4. follow-up: Depending on the severity of the incident, we may request additional information from you or provide you with feedback on the results of our investigation.
Confidentiality and data protection
All reports will be treated confidentially and used exclusively to improve our products. We undertake to comply with all applicable data protection lawsincluding the General Data Protection Regulation (GDPR). These regulations ensure that your information is processed securely and responsibly, and we are required by the FDA to document and report adverse events. This obligation is part of the Federal Food, Drug, and Cosmetic Actwhich ensures that consumer information on product safety is taken seriously.
Why is your message important?
Reporting adverse events helps us to improve the safety of our products and to identify and minimize potential risks for other consumers. Everyone reacts differently to cosmetic products. Although our products are rigorously tested for safety, allergic reactions can occur. We therefore recommend a "patch test" before using our products. Thank you for your support and trust in Anakena - Natural Cosmetics!
CONTACT US
If you have any questions or wish to report undesirable events, please do not hesitate to contact us. Please contact us at:
Phone: +49 (0)89 32309601
Mobile: +49 176 28040383
Mail: info@anakena.de
