Muscle Sports Products, LLC
FDA issued a warning letter to Muscle Sports Products, LLC (CEO Jason R. Mancuso) after reviewing multiple company websites and social media in May and September 2022. The agency found that numerous products — including CardioBurn For Her Powder, Rhino Rampage Capsules, Joint Revolution Capsules, IMMUNITY+ Powder, THERMX, HYPEX, RECOMP Capsules, and others — bore claims establishing drug intent (cure, mitigation, treatment, or prevention of disease) without FDA approval, rendering them unapproved new drugs and misbranded drugs under the FD&C Act. Several products also made COVID-19 mitigation and prevention claims. FDA warned that failure to address violations may result in seizure and injunction, and required a written response within 15 working days.
Flagged claims (32)
ECHINACEA-250MG Helps accelerate recovery at the first sign of sickness. Helps reduce the duration of sickness. May help fight pathogens by stimulating macrophage production.
MSM – Assists with . . . reducing joint stiffness and swelling.
Decreases swelling and inflammatory cytokines in soft tissue and joints
Bromelain – Decreases swelling and inflammation in soft tissue and joint disorders. Also, the combination of bromelain and glucosamine provides relief from joint stiffness.
Fenugreek [an ingredient in the product] helps . . . manage blood sugar
Berberine [an ingredient in the product] . . . Potent blood glucose, cholesterol . . . reducing abilities
Glucosamine with the combination of chondroitin has shown to assist with pain relief in association with arthritis.
Blond et al. discovered in 20 men without diabetes but with dyslipidemia, 2g niacin supplementation over the course of eight weeks promoted a reduction in triglycerides (28%) and VLDL (68%) while increasing HDL cholesterol (17%).
ZINC-50MG . . . Reduces duration & severity of common cold symptoms.
Citrulline Malate . . . converts to nitric oxide. Nitric oxide is a vasodilator that can help to lower blood pressure . . . .
Green coffee extract . . . is a concentrated source of chlorogenic acid, a compound that may be able to reduce blood sugar and have an anti-diabetic effect. Green coffee bean extract may also be a potent . . .anti-obesity supplement.
Chondroitin may help joint pain, improve joint stiffness, and decrease the symptoms of osteoarthritis.
OLIVE LEAF EXTRACT – 400MG Possesses antiviral effects May be antibacterial against Staph infections.
Supplementing with 550mg of apple cider vinegar may help kill bacteria, lower blood sugar levels . . . .
Arginine . . . has been studied for healing wounds . . . and preventing tissue degradation in people with critical illnesses.
Reductions in glycine receptor stimulation or function . . . promote REM sleep behavior disorder.
May alleviate joint pain, reduce joint stiffness, and decrease the symptoms of common joint conditions
Chromium is an essential mineral with a role in insulin regulation and glucose management. It affects chromodulin, which improves its ability to enhance insulin receptor activity.
Chondroitin Sulfate – May help with relieving joint pain, stiffness, and other joint symptoms.
Added choline & inositol . . . help with regulating insulin levels
Niacin has long been used to increase high-density lipoprotein (HDL), or the 'good,' cholesterol. HDL cholesterol helps sweep up low-density lipoprotein (LDL), or the 'bad,' cholesterol, in your bloodstream.
CORONAVIRUS OUTBREAK SUPPLEMENTING WITH IMMUNITY+ . . . Supplementing with Immunity+ can help you strengthen your immune system, speed up illness recovery, &decrease the risk of infection. Stay protected, and choose a supplement that actually works.
Kanna . . . Inhibits phosphodiesterase 4 in the amygdala to exert anti depressive effects. Has been noted to have powerful reductions in anxiety.
Hyaluronic Acid . . . may also help decrease symptoms of osteoarthritis.
VITAMIN C – 1,000MG . . . Reduces upper respiratory tract infection
ELDERBERRY – 750MG . . . relieves symptoms of influenza an average of 4 days faster than placebo. Helps fight bacteria.
Boost your immune system to reduce your chances of getting infected during the cold and flu season. Did you know that elderberry prevents virus' [sic] from being able to enter human cells thus preventing infection. With all the concern about the #coronavirus make sure your immune system is #optituned with Immunity + by Optitune! . . . #coldandfluseason
L-LYSINE-300MG Shown promise in combatting certain types of infections. . . . May be effective at reducing the severity of herpes flare ups.
Fenugreek . . . Decreases blood glucose
The combination of bromelain and glucosamine provides relief from joint stiffness. Studies have shown that bromelain may decrease swelling and inflammation in soft tissue and joint disorders. It has been used as an alternative treatment to NSAIDs for osteoarthritis.
Rauwolfia Vomitoria is a plant found in Africa that has been used in traditional medicine for heart, cancer, and brain ailments. May reduce blood pressure and blood sugar. Has been noted to reduce psychosis
Glucosamine Sulfate . . . may also assist with the slowing down of joint damage.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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