May 2022 Office of Women's Health e-Update
Message from the Associate Commissioner
This year, National Women’s Health Week (NWHW) begins on Mother's Day, May 8th, and our focus is maternal health.
On Monday, May 9, in partnership with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation, we will host a virtual workshop on Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation. I encourage you to learn more about this virtual workshop and invite you to register here.
In addition, on Wednesday, May 11, we are pleased to bring you a continuing education webinar in collaboration with FDA’s Division of Pediatric and Maternal Health on Pregnancy and Lactation Medication Information for the Healthcare Provider. This webinar will assist healthcare providers in understanding how prescription drug labeling can be used to inform prescribing in pregnancy and lactation. I hope you will register for this educational webinar here.
Our theme for this year is #KNOWHmore to Optimize Your Maternal Health. Throughout NWHW, we will highlight our pregnancy resources via our social media platforms and encourage you to view our toolkit. Please visit this month’s OWH blog and share our maternal health print resources with your communities.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Below are links to specific COVID-19 topics and the latest vaccine fact sheets, with a full list of the latest COVID-19 information from the FDA here.
- FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines
- At-Home OTC COVID-19 Diagnostic Tests - Information to Help Consumers Find Current Expiration Date for FDA-Authorized At-Home OTC Diagnostic Tests
- FDA Approves First COVID-19 Treatment for Young Children
- FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
CALL TO ACTION
This Mental Health Awareness Month, take time to raise awareness and understanding of mental health and access to care for women. Mental disorders can affect women and men differently. It includes emotional, psychological, and social well-being. It affects how you think, feel, act, make choices, and relate to others. Mental health is more than the absence of a mental illness—it’s essential to your overall health and quality of life. Self-care can play a role in maintaining your mental health and help support your treatment and recovery if you have a mental illness.
Learn more about women and mental health and women and depression, including FDA-approved medicines to treat depression. Learn how to talk about mental health or how to get help for yourself or someone you care about, as your mental health truly matters.
WOMEN'S HEALTH HIGHLIGHTS
FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products
The U.S. Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products.
FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death
The U.S. Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the number of smokers that quit.
FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused Medication
The U.S. Food and Drug Administration announced it is seeking public comment on a potential change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes and that pharmacists provide patient education on safe disposal of opioids. This potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy would provide a convenient, additional disposal option for patients beyond those already available such as flushing, commercially available in-home disposal products, collection kiosks and takeback events.
Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication
The U.S. Food and Drug Administration is warning patients and healthcare providers about the risks of false results with genetic non-invasive prenatal screening (NIPS) tests, sometimes called noninvasive prenatal testing or tests (NIPT). Results from NIPS tests can provide information about the possibility of a fetus having certain genetic abnormalities that could result in a child being born with a serious health condition.
FDA Works to Protect Consumers from Potentially Harmful OTC Skin Lightening Products
FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing hydroquinone that do not meet the requirements to be legally sold as OTC drugs. The warning letters explain that these OTC skin lightening products containing the active drug ingredient hydroquinone are unapproved drugs and are not generally recognized as safe and effective (not GRASE).
FDA has received reports of serious side effects including skin rashes, facial swelling, and ochronosis (discoloration of skin) from the use of skin lightening products containing hydroquinone. FDA advises consumers not to use these products due to the potential harm they may cause, including ochronosis which may be permanent. Consumers should talk to their healthcare professional about treatment options for certain skin conditions including aged or dark spots.
FDA Releases Final Rule for Added Fluoride Levels in Bottled Water
The U.S. Food and Drug Administration issued its final rule for added fluoride levels in bottled water titled Beverages: Bottled Water. This final rule amends the allowable level for fluoride in domestically packaged and imported bottled water to which fluoride is added to 0.7 milligrams per liter (mg/L). The proposed rule published in April 2019.
FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens
The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the U.S (non-listed food allergens).
Currently, the major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans, though more than 160 foods are known to cause food allergic reactions. Sesame becomes the ninth major food allergen, effective Jan. 1, 2023.
FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials
The U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding on the agency’s previous guidances for industry to improve clinical trial diversity.
FDA and DEA Warn Online Pharmacies Illegally Selling Adderall to Consumers
The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration recently issued joint warning letters to operators of two websites illegally selling Schedule II stimulants, including amphetamine drug products marketed as Adderall. These websites sell Adderall online without a prescription, which places consumers at risk.
Adderall is an FDA-approved prescription drug that has a high potential for abuse and addiction and should only be used under the supervision of a licensed health care professional. This joint action demonstrates the federal government’s ongoing commitment to reduce the public health danger posed by drugs illegally sold online.
Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.
Learn more about pregnancy registries today!
Participate in Upcoming FDA Meetings
- Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP, May 16-May 17, 2022
- FDA Oncology Center of Excellence, Conversations on Cancer Program: A Global Dialogue on Ovarian Cancer, May 20, 2022
- Development Considerations of Antimicrobial Drugs for the Treatment of Uncomplicated Urinary Tract Infections (UTI), June 6, 2022
- Conversations on Cancer: "National Black Family Cancer Awareness Week: Engaging the Generations”, June 16, 2022
- FDA Workshop: 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop, June 29, 2022
- FDA Patient Engagement Advisory Committee Meeting: Augmented Reality (AR) and Virtual Reality (VR) Medical Devices, July 12-13, 2022
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.