Herbal Science International, Inc. FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 23, 2017
Executive Summary
The FDA issued a warning letter to Herbal Science International, Inc. on January 23, 2017 citing labeling violations. The letter was issued by Los Angeles District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Herbal Science International, Inc.'s operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Herbal Science International, Inc..
Regulatory Context
The identity of equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(b);
The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or cross references to such records, such as individual equipment logs, where this information is retained, as required by 21 CFR 111.260(c);
A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f);Documentation, at the time of performance, of the manufacture of the batch, including the initials of the person performing each step, including:
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Herbal Science International, Inc.?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are Herbal Science International, 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 Herbal Science International, Inc. products?
- If you have used products from Herbal Science International, 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