October 11, 2018
“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, M.D. “This action is part of FDA’s broader effort to regulate the safety of vaping products, and crack down on misleading claims and illegal and dangerous e-liquids that may entice youth or put consumers at risk.”
The U.S. Food and Drug Administration announced today it has issued a warning letter to HelloCig Electronic Technology Co. Ltd 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. These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally. 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.
Laboratory analysis conducted by the FDA confirmed “E-Cialis HelloCig E-Liquid” contains the undeclared drugs sildenafil and tadalafil, and “E-Rimonabant HelloCig E-Liquid” contains the undeclared drug sildenafil. These undeclared ingredients are phosphodiesterase type-5 (PDE-5) inhibitors. These ingredients can be associated with significant safety issues and the risk of serious adverse events. For example, they may interact with nitrates found in some prescription drugs used to treat, high blood pressure or heart disease, and can lower blood pressure to dangerous levels. Further, the “E-Cialis HelloCig E-Liquid” is marketed with an image of a Cialis bottle and tablets. Cialis (tadalafil) is the trade name of an FDA-approved prescription drug. “E-Rimonabant HelloCig E-Liquid” is marketed with an image of an Acomplia container and tablets. Acomplia is the trade name of an anti-obesity drug product that is not FDA-approved for sale in the U.S. Use of these trade names and images of the drug products next to the e-liquid products on HelloCig’s website suggests that the products are intended to treat the same conditions as the drug itself. Therefore, these products are unapproved new drugs and misbranded under federal law because they are not generally recognized among scientific experts as safe and effective for their labeled uses and require FDA review and approval before they can be sold.
The FDA has requested that the company respond within 15 working days on how it intends to address the agency’s concerns. Failure to correct violations may result in further action such as seizure or injunction.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.