Is Nd Labs, Inc. Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 01, 2017
Executive Summary
The FDA issued a warning letter to Nd Labs, Inc. on September 01, 2017 citing labeling violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by New York District Office.
Detailed Analysis
False Claims and Regulatory Violations
“Helps to relieve chronic constipation, bowel irregularity,irritable bowel syndrome, and diverticulitis …Helps lower cholesterol levels and stabilize blood sugars…and prevent diarrhea…”
Your LPS Cherry, Liquid Fiber Flow, and Nana Flakes product labels include the disclaimer statement “These statements have not been evaluated by the FDA…” This disclaimer applies to the label or labeling of dietary supplements that bear a claim under section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6) and 21 CFR 101.93(b). As your products are not dietary supplements, such statement should not be used on the label or labeling of conventional foods.
Potential Health Risks
Your LPS Cherry product is manufactured with Whey Hydrolysate which is made from the allergen, milk. To declare this allergenic ingredient you may either list it parenthetically immediately after the ingredient or in a “Contains” statement immediately following the ingredient statement. Your use of an asterisk linking to a separate statement is not provided for in section 403(w) of the Act.
Regulatory Context
The Nana Flakes bears a Supplement Facts panel which is only appropriate for those products which have the statement of identity as a dietary supplement. (21 CFR 101.9)
The Calories listing for the Liquid Fiber Flow and LPS Cherry are incorrectly calculated at 5 and 100, respectively. (21 CFR 101.9(c)(1)(i)(B)).
The LPS Cherry and Liquid Fiber Flow labels fail to contain the footnote. (21 CFR 101.9(d)(9)).
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Nd Labs, Inc.?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are Nd Labs, Inc. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.
- What should I do if I've used Nd Labs, Inc. products?
- If you have used products from Nd Labs, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter