FDA WARNING_LETTER - CAW Industries, Inc.

The FDA issued a Warning Letter to CAW Industries, Inc. for misbranded Dr. Willard's Water® CLEAR Concentrate, DARK XXX® Concentrate, and ULTIMATE Concentrate products. The violations were identified through a review of product labels and websites (www.dr-willardswater.com and www.drwillard.com).

Key violations include: 1. **Unauthorized Nutrient Content Claims:** The claim "very powerful antioxidant" on www.drwillard.com is an unauthorized nutrient content claim under 21 U.S.C. § 343(r)(1)(A) and 21 CFR 101.54(g), as it does not comply with requirements for antioxidant claims, including naming the specific nutrients. 2. **Unauthorized Implied Nutrient Content Claims:** Statements on www.drwillard.com regarding "19 trace minerals... essential to maintaining optimum health" constitute implied nutrient content claims under 21 CFR 101.13(b)(2)(ii) but fail to meet the "health" claim requirements of 21 CFR 101.65(d)(2), such as being low in fat, saturated fat, and containing at least 10% DV of specific nutrients. 3. **Failure to List Sub-Ingredients:** Products are misbranded under 21 U.S.C. § 343(