Price Point Distributors Inc. d/b/a Price Point NY – FDA Warning Letter, Sep 8, 2020

The FDA's Center for Tobacco Products reviewed the website pricepointny.com and determined that electronic nicotine delivery system (ENDS) products, including specific brands like JUUL Pod Fruit and Eonsmoke Grape, are offered for sale or distribution to U.S. customers. These products are classified as 'new tobacco products' under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The firm is in violation for offering these ENDS products without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). The FDA requires the firm to promptly correct these violations, discontinue the violative sale, distribution, labeling, and advertising of these products, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in further regulatory action, including detention and refusal of admission for imported products.