FDA WARNING_LETTER - dipammo.com - April 29, 2025

On April 3, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to the entity operating dipammo.com, identifying that nicotine pouch products, specifically "Ammo, Wintergreen Standard" and "Ammo, Blue Razz Standard," are being manufactured and offered for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. 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, unless it has a substantial equivalence order or an exemption. Since the listed products lack FDA marketing authorization and are not otherwise exempt, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuation of violative