WARNING LETTER
Elite Supplement Center LLC and Elite Training Facility LLC
MARCS-CMS 627498 —
July 06, 2022
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Mathew Chaffee
Elite Supplement Center LLC and Elite Training Facility LLC
1055 Hamburg Tpke
Wayne
,
NJ
07470
United States
elitesupplementcenter@gmail.com
elitetrainingfacilitynj@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
July 6, 2022
Elite Training Facility LLC
215 Wanaque Ave
Pompton Lakes NJ 07442
RE: CMS# 627498
Dear Matthew Chaffee:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.elitesupplementcenter.com/ in June 2022 and has observed that you take orders there for “Ostarine MK-2866,” “Ligandrol LGD 4033,” “Ibutamoren MK-677,” “Testolone Rad140,” and “Cardarine GW501516” and that these products are marketed on your product labels as selective androgen receptor modulators (SARMs, hereinafter referred to as “your SARMs products” or “products”). As described below, your SARMs products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 301(d).
FDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke. Despite statements on your product labels marketing your SARMs products for “RESEARCH ONLY” and “Not for Human Consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Examples of claims observed on your website that establish the intended use of your SARMs products as drugs intended for human use include, but may not be limited to, the following:
“
Ostarine MK-2866
delivers a full dose of premium Ostarine commonly considered the world's most anabolic and popular SARM. Ostarine is known for producing excellent lean muscle gains while helping bone and joint health as well as muscle recovery. This makes it a great choice for body recomposition.”
“
Ligandrol LGD 4033
SARM LGD-4033 also known as Ligandrol. This non-steroidal supplement helps prevent muscle wasting and keeps the you[sic] highly anabolic; that is, it helps you build muscle faster and delivers much of the same benefits of testosterone without the possible negative side effects. Brawn, due to its highly anabolic nature as well as its great aid in recovery, is so versatile that it may be used with excellent results in bulking, recomp, and cutting!”
“
Ibutamoren MK-677
Known as MK-677 and Ibutamoren, is a highly potent growth hormone secretagogue as it mimics ghrelin, the hormone that signals the release of GH. It can also help boost IGF-1 with affecting cortisol levels. Overall, it can help users build lean muscle mass and bone mineral density as well as help you lose fat.”
“
Testolone Rad140
RAD140 has been noted 90:1 anabolic/androgenic ratio. This means serious muscle building power without the possible negative side effects associated with anabolic steroids. Use it as a bulking agent to help put on solid lean muscle mass as well as keep mass in between cycles.”
“
Cardarine GW501516
GW501516 and Cardarine, has become known as incredible fat loss and endurance agent over the past couple of years. Shred can help stimulate fatty acid oxidation in skeletal muscle tissue.”
You market these products as “Muscle Builders” on your webpage at https://www.elitesupplementcenter.com/backpacks?page=2.
Unapproved New Drugs
Your SARMs products are not generally recognized as safe and effective for the above referenced uses and, therefore are “new drugs” under section 201(p) of the FD&C 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 FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
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.
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 FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
07/12/2022
Regulated Product(s)
Drugs