FDA Wants Black Box Warning on Breast Implants, Greater Transparency Regarding Risks
On Wednesday, the FDA issued draft guidance for improving communication to patients regarding the potential risks of breast implants, including the FDA’s strongest consumer warning, a product label black box. The black box would state that implants are not lifetime devices, that the risk of complications increases over time and may require additional surgeries, and that implants have been associated with systemic symptoms such as fatigue and joint pain as well as with cancer.
Other recommendations include patient information booklets, a patient decision checklist, and greater transparency regarding breast implant ingredients such as chemicals and heavy metals that may be released into the body. The FDA developed this guidance in response to testimony from dozens of women who shared their breast implant stories at a March advisory panel hearing. The FDA has been under increasing pressure over breast implant safety concerns, including from an International Consortium of Investigative Journalists report released during the hearings revealing that the agency had withheld more than 350,000 breast implant incidents from the public.
Public comments on the draft guidance can be submitted through December 23 at www.regulations.gov under docket number FDA-2019-D-4467.
Four Major Retailers Pull Johnson & Johnson Baby Powder Over Asbestos Concerns
Target, Walmart, CVS and Rite Aid are removing all Johnson & Johnson Baby Powder from their stores over concerns the product may be contaminated with asbestos, a known carcinogen.
After being notified by the FDA that sub-trace levels of asbestos had been found in a single baby powder bottle from lot #22318RB, which was manufactured in 2018, Johnson & Johnson issued a recall of the 33,000 bottles from that particular lot on October 18. The lot number is located on the back neck of the bottle. Consumers can contact the Consumer Care Center at www.johnsonsbaby.com or call 1-866-565-2229 for baby powder refund information.
Latest Vaping News: Lung Disease, FDA Action, New Research
On Tuesday the Centers for Disease Control (CDC) reported 125 new cases of vaping-related lung disease since the previous week, bringing the total number of cases across 49 states (excluding Alaska), the District of Columbia and the U.S. Virgin Islands to 1,604. On Thursday the CDC reported 34 vaping-related deaths of individuals ages 17 to 75 years across 24 states. The chemical responsible for the disease outbreak remains unknown as health officials continue to investigate.
On Thursday the FDA took action, notifying vaping manufacturer Eonsmoke that it’s illegally marketing nearly 100 flavored nicotine e-liquids without the market authorization for new tobacco products required by the federal Food, Drug and Cosmetic Act. The company’s e-liquids are used in vaping devices such as JUULs.
This is the second letter to Eonsmoke from the FDA regarding the matter. The FDA further rebuked Eonsmoke for making unauthorized label claims that their products do not contain the same “harmful additives and chemicals often found in tobacco cigarettes,” and for failing to include warning labels that their products contain nicotine.
And finally, new research published Wednesday found that young people who start their tobacco use with flavored nicotine products, including flavored cigarettes, e-cigarettes and hookahs, are at higher risk of using tobacco products later on than those who start out with a non-flavored product.
Trans Fat Consumption Linked to 74 Percent Increased Dementia Risk
Those who consume the greatest amounts of trans fats have a 74% higher risk of developing Alzheimer’s disease and dementia from all causes in later life. Published Wednesday, the study from Japan of 1,628 individuals age 60 and over relied on blood levels of elaidic acid, an objective biomarker of industrially-produced trans fats, lending greater scientific validity to the findings compared with studies traditionally based on less-reliable dietary self-reports.
While trans fats occur naturally in small amounts in some dairy products and meats, by far the greatest sources are manufactured hydrogenated (solidified) vegetable oils. Trans fats are cheap to produce, enhance the flavor and texture of foods and extend product shelf life. However, due to their negative cholesterol health impacts, trans fats were banned in 2015 with the final extensions ending January 1, 2020. Concerned consumers should be aware that the FDA does not require disclosure of trans fats in products containing less than .5 grams trans fat per serving.