FDA WARNING_LETTER - Tws Marketing Group Inc.

The FDA issued a Warning Letter to Tws Marketing Group Inc. after reviewing the label for their HomeMaker Premium 100% Pure Florida Squeezed Orange Juice, concluding it is misbranded under the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101. The product's label is false and misleading under section 403(a)(1) due to inaccurate statements like "Made With Not From Concentrate Juice" and "100% Pure Florida Squeezed," as it contains orange juice concentrate and water. The label also presents conflicting information and fails to reveal the material fact that it's partly from concentrate, violating section 201(n). Furthermore, the product is misbranded under section 403(i)(1) for not bearing the common or usual name, specifically omitting "From Concentrate" as required by 21 CFR 102.33(g). Under section 403(i)(2), the label fails to declare the common or usual name of each ingredient (21 CFR 101.4(a)(1)) and includes extraneous modifiers in the ingredient list (21 CFR 101.2(e)). A percent juice declaration is also missing from the information panel, violating 21 CFR 101.30(b)(1). Lastly, the label bears unauthorized implied health claims under section 403(r)(1)(B), associating folate, vitamin C, and calcium with reduced risk of high blood pressure and stroke through text and heart symbols. The company must take prompt corrective action and respond within 15 working days, detailing steps taken and providing documentation to avoid further regulatory action, including seizure or injunction.