Is MusclMasster, LLC Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on August 30, 2017
Executive Summary
The FDA issued a warning letter to MusclMasster, LLC on August 30, 2017 citing labeling violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Denver District Office.
Detailed Analysis
False Claims and Regulatory Violations
“[M]ay slow the progression of Alzheimeris [sic] disease…beneficial for asthma, dementia, depression, eczema, headaches, heart and kidney disorders, and tinnitus (ringing of ears)”
The(b)(4)and(b)(4)products make structure function claims, but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). Under section 403(r)(6) of the Act, a dietary supplement may bear certain claims, generally called "structure/function claims," on its label or in its labeling provided that the firm has substantiation that the claim is truthful and not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim; and the claim includes the required disclaimer.
Your Nu-Woman, Nu Man Plus, Vir-L IV, and the(b)(4)Capsule product labels do not bear a symbol next to all structure/function claims linking the claims to the FDA disclaimer.
Potential Health Risks
Consumers should be aware of potential risks associated with products from MusclMasster, LLC.
Regulatory Context
“Mullien Leaf … aids in healing respiratory ailments, asthma, bronchitis, diarrhea, sinus congestion; soothing to any inflammation and relieves pain; acts to relieve spasms & clears the lungs; Mullein is a soothing demulcent for respiratory ailments; it clears congestion and aids in getting rid of warts; useful for asthma, bronchitis, difficulty breathing, earache, hay fever and swollen glands”
“Echinacea Angustifolia Root … stimulates the body to fight bacterial and viral infection…reduces inflammation”
A complete list of components to be used [21 CFR 111.210(b)]. Your(b)(4)Capsule, batch(b)(4)and(b)(4), do not include(b)(4)and Vitamin B-5 as ingredients in the MMR; however, both these ingredients are listed on the product label;
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with MusclMasster, LLC?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are MusclMasster, LLC 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 MusclMasster, LLC products?
- If you have used products from MusclMasster, 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