WARNING LETTER
Muscle Sports Products, LLC
MARCS-CMS 625731 —
September 23, 2022
Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Jason R. Mancuso
Recipient Title
CEO
Muscle Sports Products, LLC
101 Dominion Blvd.
Ronkonkoma
,
NY
11779
United States
jmancuso@customnutra.fit
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
WARNING LETTER
CMS # 625731
Dear Mr. Mancuso:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.musclesport.com, www.purgesports.com, www.musclemilitia.com, www.kodiaksupps.com, and your social media website at https://www. facebook.com/OptituneNutrition/ in May 2022 and September 2022. Based on our review, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act through links on FDA’s website at
https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
and the FDA regulations at
https://www.ecfr.gov/current/title-21
.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your website at www.musclesport.com in May 2022 and September 2022 and has determined that you take orders there for the products CardioBurn For Her Powder, Rhino Rampage Capsules™, Joint Revolution™ Capsules, STRESS B-COMPLEX, IMMUNITY + Powder, and Apple Cider Vinegar Capsules. The claims on this website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. In addition, we observed that your product IMMUNITY + Powder is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
1
in people. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
On the product webpage for CardioBurn For Her Powder, a product containing green coffee extract (https://musclesport.com/collections/her-series/products/cardioburn-for-her):
“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.”
On the product webpage for Rhino Rampage PUMPED Capsules™, a product containing niacin (https://musclesport.com/products/rhino-rampage-pumped-capsules):
“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.”
“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%).”
On the product webpage for Joint Revolution™ Capsules (https://musclesport.com/products/joint-revolution):
“May alleviate joint pain, reduce joint stiffness, and decrease the symptoms of common joint conditions”
“Decreases swelling and inflammatory cytokines in soft tissue and joints”
Claims about ingredients in the product
o “Glucosamine Sulfate . . . may also assist with the slowing down of joint damage.”
o “Chondroitin Sulfate – May help with relieving joint pain, stiffness, and other joint symptoms.”
o “MSM – Assists with . . . reducing joint stiffness and swelling.”
o “Bromelain – Decreases swelling and inflammation in soft tissue and joint disorders. Also, the combination of bromelain and glucosamine provides relief from joint stiffness.”
o “Glucosamine with the combination of chondroitin has shown to assist with pain relief in association with arthritis.”
o “Chondroitin may help joint pain, improve joint stiffness, and decrease the symptoms of osteoarthritis.”
o “Hyaluronic Acid . . . may also help decrease symptoms of osteoarthritis.”
o “MSM . . . A recent study in Japan on rats . . . in an accepted human osteoarthritis model showed decreased degeneration of cartilage at the joint surface in the knee joints”
o Under the heading “ANTI-INFLAMMATORY COMPLEX”:
▪“Quercetin . . . possesses anti-inflammatory . . . properties.”
▪“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.”
On the product webpage for STRESS B-COMPLEX Capsules (https://musclesport.com/products/stress-b-complex):
“Added choline & inositol . . . help with regulating insulin levels”
On your social media site at https://www.facebook.com/OptituneNutrition/, which directs consumers to your website www.musclesport.com to purchase your products:
2
IMMUNITY + Powder:
From a post dated March 7, 2020 –
o “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”
o “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.”
From a post dated May 20, 2020 describing ingredients in the product –“VITAMIN C – 1,000MG . . .
o Reduces upper respiratory tract infection”
“VITAMIN D – 2,000IU
o Improves macrophage (cells which ‘eat’ pathogens …)
o Reduces symptoms of autoimmune dysfunction”
“ZINC-50MG . . .
o Reduces duration & severity of common cold symptoms.”
“ELDERBERRY – 750MG . . .
o relieves symptoms of influenza an average of 4 days faster than placebo.
o Helps fight bacteria.”
“OLIVE LEAF EXTRACT – 400MG
o Possesses antiviral effects
o May be antibacterial against Staph infections.”
“L-LYSINE-300MG
o Shown promise in combatting certain types of infections. . . .
o May be effective at reducing the severity of herpes flare ups.”
“ECHINACEA-250MG
o Helps accelerate recovery at the first sign of sickness.
o Helps reduce the duration of sickness.
o May help fight pathogens by stimulating macrophage production.”
Apple Cider Vinegar Capsules:
From a post dated April 28, 2020 – “Supplementing with 550mg of apple cider vinegar may help kill bacteria, lower blood sugar levels . . . .”
FDA reviewed your website at www.purgesports.com in May 2022 and September 2022 and has determined that you take orders there for the products THERMX™ Powder and HYPEX Powder. The claims on this website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
On the product webpage for THERMX™ Powder, a product containing chromium (https://purgesports.com/collections/purge-products/products/thermx#ingredients):
“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.”
On the product webpage for HYPEX Powder under “Ingredient Profile” (https://purgesports.com/collections/purge-products/products/hypex#ingredient-profile):
“Citrulline Malate . . . converts to nitric oxide. Nitric oxide is a vasodilator that can help to lower blood pressure . . . .”
“Kanna . . .
o Inhibits phosphodiesterase 4 in the amygdala to exert anti depressive effects.
o Has been noted to have powerful reductions in anxiety.”
“Rauwolfia Vomitoria is a plant found in Africa that has been used in traditional medicine for heart, cancer, and brain ailments.
o May reduce blood pressure and blood sugar.
o Has been noted to reduce psychosis”
FDA reviewed your website at https://www.musclemilitia.com/ in May 2022 and September 2022 and has determined that you take orders there for the product RECOMP Capsules. The claims on this website establish that the product is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
On the product webpage for RECOMP Capsules (https://www.musclemilitia.com/products/recomp):
“Fenugreek [an ingredient in the product] helps . . . manage blood sugar”
“Fenugreek . . .
o Decreases blood glucose”
“Berberine [an ingredient in the product] . . .
o Potent blood glucose, cholesterol . . . reducing abilities”
FDA reviewed your website at www.kodiaksupps.com, which redirects to https://musclesport.com/collections/alpha-series, in May 2022 and September 2022 and has determined that you take orders there for the products Attack™ Pre-Workout Powder and Coma™ Sleep & Recovery Activator Lemon Drop Powder. The claims on this website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
On the product webpage for Attack™ Pre-Workout Powder under “Ingredient Profile” (https://musclesport.com/collections/alpha-series/products/attack-pre-workout):
“Citrulline Malate . . . converts to nitric oxide. Nitric oxide is a vasodilator that can help to lower blood pressure . . . .”
“Arginine . . . has been studied for healing wounds . . . and preventing tissue degradation in people with critical illnesses.”
On the product webpage for Coma™ Sleep & Recovery Activator Lemon Drop Powder under “Ingredient Profile” (https://musclesport.com/products/coma-sleep-aid):
“Reductions in glycine receptor stimulation or function . . . promote REM sleep behavior disorder.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products CardioBurn For Her Powder, IMMUNITY + Powder, and HYPEX Powder are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, CardioBurn For Her Powder, IMMUNITY + Powder, and HYPEX Powder fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We also offer the following comment:
The Supplement Facts panel of your product RECOMP Capsules declares Bitter Orange Extract (Citrus aurantium) (see musclemilitia.com/products/recomp under Supplement Facts tab), and your product webpage for the RECOMP Capsules states, “Bitter orange extract contains neuroactive agents, synephrine, hordenine, and octopamine” (musclemilitia.com/products/recomp under “Ingredients” tab). Your website does not provide enough information for us to determine whether hordenine and octopamine have been added to RECOMP Capsules as ingredients or are present in trace amounts as components of Bitter Orange Extract. We also do not know whether these compounds are present in their original biogenic form or as synthetically produced salts (e.g., hordenine HCl).
FDA recently sent warning letters to several firms selling dietary supplements containing hordenine, hordenine HCl, or octopamine as ingredients. See “FDA Sends Warning Letters to Multiple Companies for Illegally Selling Adulterated Dietary Supplements” and May 4, 2022 warning letters to, e.g., Ironmag Labs (hordenine) and Max Muscle (hordenine HCl and octopamine). Although FDA does not have enough information at present about the composition of RECOMP Capsules to take a position on whether the product is adulterated because of the presence of hordenine and octopamine, it is your responsibility to take any action necessary to ensure that your distribution and sale of RECOMP Capsules does not violate the Act, including evaluating whether the product contains any substances that render it adulterated.
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. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433 or via email at Lillian.aveta@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or email atLillian.aveta@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
______________________________
1
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described in the body of this letter, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 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.
2
The Facebook page refers consumers to the Internet address www.optitunenutrition.com, which redirects to https://musclesport.com/collections/general-health.
Content current as of:
09/27/2022
Regulated Product(s)
Drugs
Food & Beverages