Metaugus Inc – FDA Warning Letter, Oct 10, 2012

On October 10, 2012, the FDA inspected a dietary supplement facility at 3570 Lees Chapel Road, Cedartown, GA, regarding the product (b)(4) BIOTIN 3,000 mcg. The product was found to be misbranded under the Federal Food, Drug and Cosmetic Act.

Violations include: 1. **Misleading Labeling (Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]):** The label declared 3000 mcg (3 mg) of biotin per serving, but FDA laboratory analysis found only 0.168 mg/serving (5.6% of declared) and 0.15 mg/serving (4.99% of declared) in repeat analysis. This violates 21 CFR 101.9(g)(4)(i), which requires the nutrient content to be at least equal to the declared value. 2. **Failure to Name Dietary Ingredients (Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]):** The label failed to list the name of each dietary ingredient. 3. **Failure to Include Quantity of Dietary Ingredients (Section 403(q)(5)(F) [21