Health Highlights: Aug. 8, 2019
Warning Letters Sent to Companies Illegally Selling E-Liquid, Hookah Products: FDA Medicare to Cover Breakthrough Gene Therapy for Leukemia, Lymphoma
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Warning Letters Sent to Companies Illegally Selling E-Liquid, Hookah Products: FDA
Warning letters about 44 flavored e-liquid and hookah tobacco products being sold illegally in the United States have been sent to four companies, the Food and Drug Administration says.
The companies are selling the products without required marketing authorization, according to the FDA.
The warning letters were sent Aug. 8 to the following companies:
- Mighty Vapors LLC doing business as Ovo Manufacturing & Distributing for: Hulk Tears NicSalts, Frozen Hulk Tears NicSalts, Majestic Mango NicSalts, Frozen Majestic Mango NicSalts, Mystery Pop NicSalts and Frozen Mystery Pop NicSalts
- Liquid Labs USA LLC doing business as Likido Labs USA for: Vape SZNS Salty SZN Pom Berry Salts, Vape SZNS Salty SZN Kapital Grape Salts and Vape SZNS Salty SZN Neon Sours Salts
- V8P Juice International LLC for: V8P Saltz Blonde Bombshell, V8P Saltz Mami Merengue, V8P Saltz Port Master, V8P Saltz Last Samurai, V8P Saltz Cowboy Killer and V8P Saltz Caribbean Don
- Hookah Imports Inc. for: ROR Tobacco products including flavors such as Yummy Gummy, Sexy Senorita and Raspberry Lemonade.
The companies were given 15 working days to respond to the FDA about how they intend to correct the violations. Failure to do so may lead to further measures such as seizure or injunction.
The FDA said the letters were sent as part of its efforts against illegally marketed tobacco products that have played a role in the epidemic of youth e-cigarette use.
"Today's actions make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found. Our work in this area has already resulted in a number of companies removing products from the market," Acting FDA Commissioner Dr. Ned Sharpless said in an agency news release.
"The marketing of illegal tobacco products is particularly concerning given the epidemic of youth vaping that we're facing, which we know has resulted in part from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing of these products," Sharpless said.
Medicare to Cover Breakthrough Gene Therapy for Leukemia, Lymphoma
A breakthrough gene therapy will be covered for certain types of lymphoma and leukemia, Medicare says.
The therapy, called CAR-T, boosts a patient's own immune cells to fight cancer and can cost hundreds of thousands of dollars, the Associated Press reported.
Studies have shown that CAR-T is effective against certain types of cancers, but can cause severe side effects. The use of the gene therapy to treat certain types of leukemia and lymphoma is approved by the U.S. Food and Drug Administration.
Medicare considered the matter for months before it announced its decision on Wednesday. The agency's policies on coverage can influence private insurance, the AP reported.