FDA WARNING_LETTER - Heaven Gifts International Limited d/b/a Heaven Gifts - January 07, 2020

The FDA Center for Tobacco Products issued a Warning Letter to HEAVEN GIFTS INTERNATIONAL LIMITED (heavengifts.com) on December 20, 2019, following a review of their website. The FDA determined that the company's electronic nicotine delivery system (ENDS) and e-liquid products, which are considered tobacco products under the FD&C Act, are misbranded. The primary violation identified is the failure of advertising for several ENDS and e-liquid products to include the required nicotine warning statement, as mandated by 21 C.F.R. § 1143.3(b). This non-compliance renders the products misbranded under two sections of the FD&C Act: 903(a)(7)(B) for violating regulations prescribed under section 906(d), and 903(a)(7)(A) because the advertising is considered misleading due to the omission of material facts. The FDA requires immediate corrective actions, including discontinuing violative advertising, sale, and distribution, and ensuring all tobacco products and related advertising comply with the FD&C Act and implementing regulations. The company must submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may lead to severe consequences, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.