June/ July 2015
www.fda.gov/womens
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.
Marsha Henderson
Assistant Commissioner for Women’s Health
FDA WOMEN'S HEALTH HIGHLIGHTS
Essure
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.
Public Meeting
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.
New Essure Webpage
FDA is committed to keeping patients and health care providers informed by sharing information as it becomes available. FDA updated its Essure Web Pageto include information for patients and health care providers.
Learn more about Essure Permanent Birth Control
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
Learn 2 ways to report a problem with a cosmetic to FDA
Get helpful tips on safely using cosmetics
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.
Get other Sun Safety Tips for Infants
Learn the ABCs of Sun Protection
HIV Testing Resources
June 27th is National HIV Testing Day. FDA has resources that you can use at your events to help educate women about HIV testing, prevention, and treatment.
Download a Women and HIV fact sheet
Learn more about FDA’s role in HIV Testing
Find a free and confidential HIV testing site near you
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.
Read a Consumer Article on Trans Fats
FDA Meetings
Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee
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 Calendar
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:
YWCA, June 4-6 – Washington, DC
American Association of Nurse Practitioners, June 9-12 – New Orleans, LA
American Library Association*, June 25-30 – San Francisco, CA
American College of Nurse-Midwives, June 28—National Harbor, MD
Teratology Society, June 27-July 1 – Montreal, Canada
National Association of Hispanic Nurses*, July 7-10 – Anaheim, CA
National Council of La Raza*, July 11-14 – Kansas City, MO
American Association of Colleges of Pharmacy, July 11-15 – National Harbor, MD
National Area Agencies on Aging*, July 11-15 – Philadelphia, PA
Delta Sigma Theta National Public Service Convention, July 23-29 – Houston, TX
National Black Nurses Association*, July 29- August2 – Atlanta, GA
*Come meet the local FDA Public Affairs Staff who support our women’s health field outreach.
FDA Office of Women's Health
10903 New Hampshire Avenue
WO32 - Room 2333
Silver Spring, MD 20993*0002
301-796-9440
Report a Problem with a Medical Product