Is BrainAlert, LLC Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 14, 2017
Executive Summary
The FDA issued a warning letter to BrainAlert, LLC on December 14, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Seattle District Office.
Detailed Analysis
False Claims and Regulatory Violations
“Traditionally, gotu kola has been used to treat anxiety …”
“Salvioli G, Neri M. L-acetylcarnitine treatment of mental decline in the elderly. Drugs Exp Clin Res 1994;20(4):169-76.”
“Soja AM, Mortensen SA. Treatment of chronic cardiac insufficiency with coenzyme Q10, results of meta-analysis in controlled clinical trials. Ugeskr Laeger 1997;159:7302”
Potential Health Risks
“Huperzine A … be more effective and selective than tacrine, a pharmaceutical drug, at inhibiting cholinesterase.”
“Schonheit K, Gille L, Nohl H, Institute of Pharmacology and Toxicology, Veterinary University of Vienna, Austria. Effect of alpha-lipoic acid and dihydrolipoic acid on ischemia/reperfusion injury of the heart and heart mitochondria. Biochim Biophys Acta 1995 Jun 9;1271(2-3):335-42.”
“Ved HS, Koenig ML, Dave JR, et al. Huperzine A, a potential therapeutic agent for dementia, reduces neuronal cell death caused by glutamate. Neuroreport. 1997;8:963-968.”
Regulatory Context
“Polo V, Saibene A, Pontiroli AE. Nicotinamide improves insulin secretion and metabolic control in lean type 2 diabetic patients with secondary failure to sulphonylureas. Acta Diabetol. 1998;35:61-64.”
“Anand JC. Osteoarthritis and pantothenic acid. Journal of the College of General Practice 5:136-7, 1963.”
YourBrainAlert product incorrectly lists in the Supplement Facts label thiamin and riboflavin in relation to the synonyms for these dietary ingredients. The synonyms should be placed in parentheses immediately following the name of the dietary ingredient per 21 CFR 101.9(c)(8)(v) and 21 CFR 101.36(b)(2).
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with BrainAlert, LLC?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are BrainAlert, LLC 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 BrainAlert, LLC products?
- If you have used products from BrainAlert, LLC 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