The U.S. Food and Drug Administration has issued a warning letter to HelloCig Electronic Technology Co. for various violations of the Federal Food, Drug, and Cosmetic Act, including selling two e-liquids that contain the prescription drugs tadalafil and/or sildenafil, leading the FDA to determine that the products are unapproved new drugs.
Sildenafil and tadalafil are the active pharmaceutical ingredients in FDA-approved prescription drugs used to treat erectile dysfunction, according to the FDA. These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally, according to the FDA. In addition, the company is marketing other e-liquids used in e-cigarettes in ways that convey and mislead consumers into believing that the FDA has approved these tobacco products, when it has not.
“There are no e-liquid products approved to contain prescription drugs or any other medications that require a doctor’s supervision. Prescription drugs are carefully evaluated and labeled to reflect the risks of the medications and their potential interactions with other medicines, and vaping active drug ingredients is an ineffective route of delivery and can be dangerous. There are no e-liquids that contain prescription drugs that have been proven safe or effective through this route of administration,” said FDA Commissioner Scott Gottlieb.