FDA Office of Women's Health Update Archive
The Office of Women's Health e-Update highlights women's health initiatives, meetings, and regulatory safety information from the U.S. Food and Drug Administration (FDA). The e-Update is disseminated via email to the public.
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Message from the Director
Throughout the summer, FDA is busy working to keep you safe. In this update, we highlight some of the Agency’s ongoing efforts to monitor the safety of products used by women including birth control and cosmetics. There are also links to FDA resources on HIV, sun safety, and nutrition. Whether you are on vacation or at the office, I encourage you to look to FDA for the health information that can help both you and your family.
Essure is a permanent birth control method for women (female sterilization). FDA takes reports of problems with Essure very seriously. The agency is actively evaluating postmarket experiences with this device.
FDA plans to convene a public meeting of the Obstetrics and Gynecology Devices Panel on September 24, 2015 to discuss scientific data regarding Essure’s safety and effectiveness. At this meeting, the FDA invites feedback from presenters, panel members and the public to inform recommendations and next steps about Essure.
FDA is committed to keeping patients and health care providers informed by sharing information as it becomes available. FDA updated its Essure Web Page to include information for patients and health care providers.
FDA Guidance on Pregnancy, Lactation, and Reproductive Potential Labeling
This guidance is intended to help small businesses better understand and comply with the new content and format requirements of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products.
Read the Guidance (PDF 164KB).
How to Report a Problem with Cosmetics
Cosmetic products range from lipstick and nail polish to deodorant and hairspray. While many people don’t have any problems after using cosmetics, reactions sometimes occur. FDA wants to know if you’ve had a reaction to a cosmetic product. You can report any reaction related to a cosmetic, from a minor rash or headache to an illness that put you in the hospital. You can even report something that didn’t cause a reaction, but alerted you to a problem with the product, such as a bad smell or other sign of contamination. A consumer, a health care provider, or a salon professional can report a problem. It helps if only one person files a report on each incident.
Should You Put Sunscreen on Infants? Not Usually
Babies' skin is less mature compared to adults, and infants have a higher surface-area to body-weight ratio compared to older children and adults. Both these factors mean that an infant's exposure to the chemicals in sunscreens may be much greater, increasing the risk of side effects from the sunscreen. The best protection is to keep your baby in the shade, if possible.
HIV Testing Resources
FDA Cuts Trans Fat in Processed Foods
FDA finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.
July 7-8, 2015
FDA White Oak Campus, Silver Spring, MD
The committees will discuss the results of post marketing studies evaluating the misuse and/or abuse of reformulated OXYCONTIN (oxycodone hydrochloride) extended-release tablets, supplemental new drug application.
OWH Conference Exhibits
The Office of Women’s Health exhibits and presents at conferences across the country to increase awareness of FDA’s women’s health resources and programs. Check out an OWH exhibit booth or presentation at one of these conferences:
*Come meet the local FDA Public Affairs Staff who support our women’s health field outreach.