Dynamic Technical Formulations FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 13, 2017
Executive Summary
The FDA issued a warning letter to Dynamic Technical Formulations on December 13, 2017 citing regulatory violations. The letter was issued by Atlanta District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Dynamic Technical Formulations's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Dynamic Technical Formulations.
Regulatory Context
For your ClaFuel product label, calories must be expressed to the nearest 5-calorie increment up to and including 50 calories. In addition, a statement of the number of grams of total fat per serving must be expressed to the nearest .5 gram increment below 5 grams, as required by 21 CFR 101.9(c)(1).
Your DHEAFuel product label lists 50 mg of Free Testosterone Accelerator along with 3,4-divanillytetrahydrofuran 95%. However, this declaration implies there are either other ingredients in the Accelerator mixture or the 95% declaration is referring to an extract from some other source. The nutrition information should accurately inform the consumer.
For your OMEGAFuel product label, a symbol that links to “Daily Value not Established” must be placed in the column %DV and lateral to the amount of polyunsaturated fat declared, as required by 21 CFR 110.36(b)(3)(iv).
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Dynamic Technical Formulations?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Dynamic Technical Formulations 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 Dynamic Technical Formulations products?
- If you have used products from Dynamic Technical Formulations 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