FDA WARNING_LETTER - Hot Podz d/b/a Buy Pods Now - August 25, 2020

On August 14, 2020, the FDA's Center for Tobacco Products issued a Warning Letter to buypodsnow.com after reviewing their website and determining they offer Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation identified is the sale of "new tobacco products" without required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. Examples of unauthorized ENDS products cited include Myle Pods – Sweet Mango, Lava 2 Pods (5 Pack) - Vanilla Cream, Sol Pods – Strawberry Lychee, STLTH Pods – Berry Blast, and SOL FEELM Pods (5 Pack) – Watermelon.

These products are deemed adulterated under section 902(6)(A) of the FD&C Act because they lack FDA marketing authorization orders or exemptions. Furthermore, they are misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

The FDA requires buypodsnow.com to submit a written response within 1