What This Means for You
- Food Safety: The FDA has launched a new review of the food preservative BHA to determine whether it remains safe under current uses.
- Women’s Health: Risk statements related to cardiovascular disease, breast cancer, and probable dementia have been removed from the boxed warnings on certain menopausal hormone therapy products.
- Cancer Treatment: A first-of-its-kind, wearable device for locally advanced pancreatic cancer has been approved through the FDA’s most rigorous review process.
WASHINGTON, D.C. — Federal health regulators are reassessing a long-used food preservative, updating safety warnings on hormone replacement therapies, and approving a new medical device for pancreatic cancer in a series of actions announced this week by the U.S. Food and Drug Administration.
On February 10, the FDA announced it is conducting a comprehensive post-market reassessment of butylated hydroxyanisole, or BHA, a chemical preservative used to prevent spoilage of fats and oils in food products. BHA is commonly found in items such as frozen meals, breakfast cereals, cookies, candy, ice cream, and certain meat products.
BHA was classified by the FDA as “Generally Recognized as Safe,” or GRAS, in 1958 — a designation that allows substances to be used in food without premarket approval if qualified experts consider them safe under intended conditions of use. The agency formally approved BHA as a food additive in 1961.
The new review will evaluate whether BHA remains safe under its current conditions of use in both food and food-contact substances, based on the latest scientific evidence. As part of the reassessment, the FDA issued a Request for Information seeking updated data on BHA’s use and safety. Additional details are available at https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review.
The National Toxicology Program has listed BHA as “reasonably anticipated to be a human carcinogen” based on animal studies. FDA officials said the reassessment is part of a broader initiative launched in May 2025 to strengthen oversight of chemicals already in the food supply.
The agency also noted it has advanced draft rulemaking to reform the GRAS framework to increase transparency and oversight of independent safety determinations for food additives.
Two days later, on February 12, the FDA approved labeling changes to six menopausal hormone therapy products — also known as hormone replacement therapy, or HRT — removing certain risk statements from the boxed warning, the agency’s most prominent safety-related warning on prescription drugs.
The removed boxed warning language concerned risks related to cardiovascular disease, breast cancer, and probable dementia. The FDA initiated the labeling review in November 2025 after conducting a comprehensive review of scientific literature.
Twenty-nine drug manufacturers submitted proposed labeling updates at the FDA’s request. The six products with approved changes include therapies across four categories: systemic combination estrogen and progestogen therapy; systemic estrogen-alone therapy; systemic progestogen-alone therapy for women with a uterus using systemic estrogen; and topical vaginal estrogen therapy.
Menopause is a normal life stage but can cause symptoms that significantly affect quality of life, including hot flashes and night sweats — known as vasomotor symptoms — vaginal and urinary tract changes related to lower estrogen levels, and osteoporosis, or thinning of bones that increases fracture risk.
The FDA has approved hormone therapies to treat moderate-to-severe vasomotor symptoms, vaginal dryness and discomfort, and to prevent bone loss. Randomized studies cited by the agency show that women who begin HRT within 10 years of menopause onset, generally before age 60, may experience reductions in all-cause mortality and fracture risk.
In 2020, approximately 41 million U.S. women were between ages 45 and 64, yet only about 2 million women ages 46 to 65 received a hormone therapy prescription, according to FDA data.
Updated prescribing information for menopausal hormone therapies is available at https://www.fda.gov/drugs/drug-safety-and-availability/menopausal-hormone-therapies-updated-prescribing-information.
Also on February 12, the FDA approved Optune Pax, a first-of-its-kind device designed to treat adults with locally advanced pancreatic cancer. The device, developed by Novocure, delivers tumor treating fields, or TTFields — low-intensity, alternating electrical fields that disrupt cancer cell division — through adhesive patches placed on the abdomen.
The therapy is non-invasive and portable. Patients wear the device with a generator carried in a specially designed bag, allowing for continuous treatment during daily activities. Device settings are preset by the manufacturer and cannot be adjusted by patients or physicians.
Pancreatic cancer is among the most lethal cancers. According to the National Cancer Institute, an estimated 67,440 new cases and 51,980 deaths were expected in the United States in 2025. Although pancreatic cancer accounts for roughly 3.3% of new cancer diagnoses, it represents a disproportionately high share of cancer deaths due to late detection and limited treatment options.
Optune Pax was approved through the FDA’s premarket approval pathway, the agency’s most stringent review process for medical devices. Approval was based on data from a randomized, controlled clinical study conducted under an Investigational Device Exemption. The study followed patients for up to five years and found that adding TTFields therapy to standard chemotherapy drugs gemcitabine and nab-paclitaxel improved overall survival by approximately two months compared to chemotherapy alone.
Localized skin reactions were the most common device-related side effect observed in the study.
The device previously received Breakthrough Device designation in December 2024, a program intended to expedite development and review of technologies that may provide more effective treatment for life-threatening or irreversibly debilitating conditions.
Together, the agency’s actions this week reflect ongoing reviews of food safety standards, prescription drug labeling, and emerging medical technologies, each with direct implications for consumers, patients, and public health.
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