Warning letter · FDA Warning Letters

Latro Inc.: FDA Warning Letter 698196 (Mar 25, 2025)

Agency action: Mar 25, 2025Record ID: fda_warning_-96f5d5195976c641
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What happened

Original notice title

Latro Inc. MARCS-CMS 698196, March 25, 2025

From the archived source record

FDA has determined that your Dozo D9 Smashers Peach Mango Delta-8 product is adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(2)(C)(i), because it bears or contains an unsafe food additive. It is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the Act, 21 U.S.C. 331(a). FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has expressed serious concerns about products containing Delta-8 THC. Our concerns include: 1)Delta-8 THC products have not been evaluated or approved by FDA for safe use and may bemarketed in ways that put the public health at risk; 2) FDA has received adverse event reportsinvolving Delta-8 THC-containing products, including for your product specifically; 3) Delta-8THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes usedto create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA isconcerned about Delta-8 THC products that may be consumed by children, as some packagingand labeling may appeal to children. This letter is to inform you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers. Adulterated Human Foods According to your product labeling, your Dozo D9 Smashers Peach Mango Delta-8 product is a food to which Delta-8 THC has been added. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the Act (21 U.S.C. 348(a)) and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. 331(a).

What the official notice says to do

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Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
3375d83a6d97

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
CMS 698196; Delta-8 THC-containing products; Dozo D9 Smashers Peach Mango Delta-8 product
Company
Latro Inc.
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.