Optimum Bioenergy International Corp. FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 21, 2017
Executive Summary
The FDA issued a warning letter to Optimum Bioenergy International Corp. on December 21, 2017 citing regulatory violations. The letter was issued by San Francisco District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Optimum Bioenergy International Corp.'s operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Optimum Bioenergy International Corp..
Regulatory Context
Your Youth Life Collagen, Youth Life Calcium, and EssenceLife Bee Propolis product labels bear the Supplement Facts on the panel located to the left of the principal display panel. This information belongs in the information panel located to the right of the principal display panel.
Your Youth Life Collagen product label refers to “Inactive Ingredient.” The correct term is “ingredients” or “other ingredients” per 21 CFR 101.4(g).
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Optimum Bioenergy International Corp.?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Optimum Bioenergy International Corp. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
- What should I do if I've used Optimum Bioenergy International Corp. products?
- If you have used products from Optimum Bioenergy International Corp. 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