Source: https://www.fda.gov/iceci/enforcementactions/warningletters/ucm619568.htm
Timestamp: 2019-04-19 16:57:56+00:00

Document:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed http://www.hellocig.com and determined that the e-liquid products listed there are offered for sale or distribution to consumers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that statements or representations made on the website http://www.hellocig.com regarding certain e-liquids violates section 301(tt) of the FD&C Act (21 U.S.C. 331(tt)) because they are directed to consumers and conveys, misleads, or would mislead consumers into believing that the tobacco products are approved by FDA.
Additionally, FDA has determined that the products E-Rimonabant HelloCig E-Liquid and E-Cialis HelloCig E-Liquid are unapproved new drugs in violation of section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded under sections 502(a), (f)(1), and (f)(2) of the FD&C Act (21 U.S.C. §§ 352(a), (f)(1), and (f)(2)).
Specifically, certain e-liquid products are sold or distributed on the website to consumers in the United States with the statements: “99.9% pure nicotine is FDA approved product with FDA,” and “The 100% pure nicotine is FDA approved product with FDA”: DIY Pure Nicotine 5mL, DIY Pure Nicotine 10mL, DIY Pure Nicotine 30mL, DIY Pure Nicotine 60mL, DIY Pure Nicotine 250mL, and DIY Pure Nicotine 1L. Because these statements or representations on the website are directed to consumers and convey, mislead, or would mislead consumers into believing that the tobacco products are approved by FDA, they are in violation of section 301(tt) of the FD&C Act.
FDA has also determined that certain e-liquid products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). Section 903(a)(1) of the FD&C Act provides that a tobacco product is misbranded if its “labeling is false or misleading in any particular.” Section 903(a)(7) of the FD&C Act provides that a tobacco product distributed or offered for sale in any State is misbranded if its “advertising is false or misleading in any particular.” These e-liquid products are misbranded under section 903(a)(1) of the FD&C Act and/or section 903(a)(7)(A) of the FD&C Act as their labeling or advertising is false or misleading because it makes the statement or representation that the products are FDA approved.
“E-Cialis HelloCig E-Liquid” with an image of a Cialis bottle and tablets.
“E-Rimonabant HelloCig E-Liquid” with an image of an Acomplia container and tablets.
“E-Cialis HelloCig E-Liquid” and “E-Rimonobant HelloCig E-Liquid” are sold on the website under the “HC Healthcare Flavor” category.
Cialis is the tradename of the FDA-approved prescription drug product used to treat erectile dysfunction. Using the tradename of the drug product Cialis and including an image of a Cialis bottle and tablets next to the product on your website suggests that this product is intended to improve sexual capacity for men who suffer from erectile dysfunction. Similarly, Acomplia is the tradename of the anti-obesity drug product in Europe. Using the tradename of the drug product Acomplia and including an image of the Acomplia container and tablets next to the product on your website suggests that the product is intended to treat obesity.
Additionally, we confirmed through laboratory analysis that your E-Rimonabant HelloCig E-Liquid contained undeclared sildenafil and your E-Cialis HelloCig E-Liquid contained undeclared sildenafil and tadalafil. Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and is the active pharmaceutical ingredient in Viagra™, an FDA-approved prescription drug used to treat erectile dysfunction (ED). Tadalafil is also a PDE-5 inhibitor and is the active ingredient in Cialis™, another FDA-approved prescription drug used to treat ED. The presence of undeclared PDE-5 inhibitors in these products is further evidence that these products are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under because they are intended to affect the structure or any function of the body.
These products are “new drugs” within the meaning of section 201(p) of the FD&C Act (21 U.S.C § 321(p)) because they are not generally recognized among scientific experts as safe and effective for their labeled uses. As new drugs, E-Rimonabant HelloCig E-Liquid or E-Cialis HelloCig E-Liquid may not be legally marketed in the United States absent approval of an application filed in accordance with section 505(a) of the FD&C Act (21 U.S.C § 355(a)). E-Rimonabant HelloCig E-Liquid or E-Cialis HelloCig E-Liquid are not the subject of FDA-approved applications, and therefore, the current marketing of these products violates section 505(a) of the FD&C Act (21 U.S.C § 355(a)). Introduction of such products into interstate commerce is prohibited under Section 301(d) of the FD&C Act (21 U.S.C. § 331(d)).
As described above, we confirmed through laboratory analysis that your E-Rimonabant HelloCig E-Liquid contained undeclared sildenafil and your E-Cialis HelloCig E-Liquid contained undeclared sildenafil and tadalafil.
Under section 502(a) of the FD&C Act (21 U.S.C. § 352(a)), a drug is misbranded if its labeling is false or misleading in any particular. According to section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether the labeling or advertising “is misleading, there shall be taken into account (among other things) not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations . . ..” The labeling for your E-Cialis HelloCig E-Liquid and E-Rimonabant HelloCig E-Liquid fail to declare that the products contain the PDE-5 inhibitors listed above. The use of PDE-5 inhibitors can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE-5 inhibitors in your products may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. The failure to disclose the presence of the PDE-5 inhibitors renders your products’ labeling false or misleading. Therefore, E-Cialis HelloCig E-Liquid and E-Rimonabant HelloCig E-Liquid are misbranded drugs under section 502(a) of the FD&C Act (21 U.S.C. § 352(a)).
E-Cialis HelloCig E-Liquid and E-Rimonabant HelloCig E-Liquid contain one or more PDE-5 inhibitors. All PDE-5 inhibitors that have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a licensed practitioner to administer such drugs. Therefore, E-Cialis HelloCig E-Liquid and E-Rimonabant HelloCig E-Liquid are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. § 353(b)(1)(A)), because, in light of their toxicity or potential for harmful effects, the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs.
Therefore, E-Cialis HelloCig E-Liquid and E-Rimonabant HelloCig E-Liquid are misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. § 352(f)(1)), because their labeling fails to bear adequate directions for their intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended, 21 CFR 201.5. Because, by definition, prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner, section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)A)], adequate directions for use cannot be written so that a layperson can use them safely for their intended uses. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson (21 CFR 201.100(c)(2) and 201.115). Because no FDA-approved applications are in effect for your products, they are not exempt from the requirements of section 502(f)(1) of the FD&C Act. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. § 352(f)(1)).
The undeclared PDE-5 inhibitors in E-Cialis HelloCig E-Liquid and E-Rimonabant HelloCig E-Liquid also cause these products to be misbranded under section 502(f)(2) of the FD&C Act (21 U.S.C. § 352(f)(2)) in that the products’ labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with the use of PDE-5 inhibitors. Consumers who use E-Cialis HelloCig E-Liquid and E-Rimonabant HelloCig E-Liquid would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events.
Your E-Rimonabant HelloCig E-Liquid and E-Cialis HelloCig E-Liquid products are misbranded for all of the before-stated reasons. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)).
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco and drug products into compliance with the FD&C Act.
It is your responsibility to ensure that your tobacco and drug products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

References: § 321
 § 387
 § 355
 § 387
 § 387
 § 321
 § 355
 § 355
 § 331
 § 352
 § 321
 § 352
 § 353
 § 352
 § 353
 § 352
 § 352
 § 331