WARNING LETTER
Supplement Science Corp. d/b/a Condemned Labz
MARCS-CMS 613165 —
September 22, 2021
Delivery Method:
United Parcel Service
Product:
Drugs
Recipient:
Recipient Name
Mr.Vincent Miletti
Recipient Title
General Counsel
Supplement Science Corp. d/b/a Condemned Labz
2139 East 3rd Street
Brooklyn
,
NY
11223
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
WARNING LETTER
CMS# 613165
September 22, 2021
Dear Mr. Miletti:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://condemnedlabz.com/ and your social media website at https://www.facebook.com/condemnedl abzofficial/ in June, July and September 2021. Based on our review, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your website at https://condemnedlabz.com/ in June, July and September 2021 and has determined that you take orders there for the products Arsyn, ConvictStim, Humaslin, Thyrogenic, and DNA Dispatch. We also reviewed your social media website https://www.facebook.com/condemnedlabzofficial/, which directs consumers to your website https://condemnedlabz.com/ to purchase your products. The claims on your websites 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 your website https://condemnedlabz.com/:
On the product webpage for DNA Dispatch:
• “Increases tolerance to pain”
On the product webpage for Humaslin:
• “Reduces blood sugar levels”
• “Optimizes insulin sensitivity”
In the blog “Nutrition” post titled, “Maximizing Insulin Sensitivity For Superior Muscle Growth,” dated September 6, 2021, which discusses your Humaslin:
• At the top of the blog post, you display an image of a needle inserted into a glass vial.
• “Having insulin resistance is a tell-tale sign that you’re experiencing difficulty metabolising glucose, and is often a warning sign of future health complications including high blood pressure, heart disease, heart failure, obesity, type 2 diabetes and even cancer. . . . The good news, is that just because you may have poor insulin sensitivity right now, you’re not doomed to be that way forever. . . . And, if you need some extra help getting insulin under control, Condemned Labz has created the ultimate glucose disposal agent / insulin mimetic in HumaSlin!”
• “Make insulin work for you with Humaslin!”
In the blog “Supplements” post titled, “Pre Workout Stimulants 101,” dated August 25, 2021, regarding your Arsyn and ConvictStim:
• “[H]igenamine [an ingredient in your ConvictStim] also acts as a bronchodilator…”
• “Originally developed as a nasal decongestant for the treatment of bronchitis, 2-aminoisoheptane has emerged as a powerhouse pre workout simulant …” [your blog post discusses 2-aminoisoheptane in the context of your Arsyn and ConvictStim, which are labeled to contain 2-aminoisoheptane HCl]
On the product webpage for Thyrogenic, which describes the product as a “powerful thyroid complex”:
• “An underactive thyroid can bring about a host of complications including depression… What’s more, an estimated 20 million Americans have some form of thyroid disorder, with as many as 60% of those affected are unaware of their condition.”
On your social media site https://www.facebook.com/condemnedlabzofficial/:
References to Humaslin:
• A post dated November 25, 2016 –
o “FORMULATED BY A Type 1 DIABETIC NATIONAL LEVEL COMPETITOR WHOS [sic] KNOWN FOR CONDITIONING… HumaSlin is Condemned Labz advanced Insulin…manipulating formula.”
o “TESTIMONIAL FROM . . . NATIONAL LEVEL TYPE 1 DIABETIC BODYBUILDER…For years I have used these individual ingredients to help me balance blood sugar and take less insulin…The combination of this formula played a major role in …controlling my diabetes.” [this testimonial appears next to an image of your HumaSlin product]
• A post dated January 13, 2018 - “What are the benefits of Humaslin?... Insulin Mimicking…Blood Sugar Regulation…”
• A post dated July 5, 2018 - “It’s effective for regulating blood sugar levels, due to its high saponin content, and it’s also shown to control blood glucose levels…”
• A post dated November 14, 2018 - “Brief backstory: the owner of #CondemnedLabz, Michael J., is a Type 1 Diabetic. HumaSlin was his attempt to reduce the need for exogenous insulin via natural insulin mimetics…”
• A post dated November 25, 2019 - “Humalsim is an advanced insulin- . . . manipulating formula … regulating blood sugar levels…”
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 Arsyn, ConvictStim, Humaslin, Thyrogenic, and DNA Dispatch are intended for treatment of one or more diseases that, with certain exceptions not applicable here, 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, Arsyn, ConvictStim, Humaslin, Thyrogenic, and DNA Dispatch 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)].
Adulterated Dietary Supplements
Your products Arsyn and ConvictStim are labeled as dietary supplements. Even if your products Arsyn and ConvictStim did not have therapeutic claims that make these products unapproved new drugs and misbranded drugs, they would be adulterated dietary supplements.
The Supplement Facts panel on your product ConvictStim declares higenamine as a dietary ingredient in the product. Higenamine is a dietary ingredient under section 201(ff)(1) of the Act [21 U.S.C. 321(ff)(1)]. Further, as a dietary ingredient that was not marketed in the United States before October 15, 1994, higenamine is a “new dietary ingredient” under section 413(d) of the Act [21 U.S.C. 350b(d)].
Under section 413(a) of the Act [21 U.S.C. 350b(a)], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. 342(f)] unless it meets one of two requirements:
1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
To the best of FDA’s knowledge, there is no information demonstrating that higenamine was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. As such, higenamine is subject to the notification requirement in section 413(a)(2) of the Act [21 U.S.C. 350b(a)(2)] and 21 CFR 190.6. Products for which the manufacturer or distributor is required to submit a new dietary ingredient notification under section 413(a)(2) and 21 CFR 190.6, but for which the required notification has not been submitted, are adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. 342(f) and 350b(a)]. Introduction of such products into interstate commerce is prohibited under sections 301(a) and (v) of the Act [21 U.S.C. 331(a) and (v)].
Moreover, based on our evaluation of the relevant safety evidence, there is no history of use or other evidence of safety establishing that higenamine will reasonably be expected to be safe when used as a dietary ingredient. Therefore, even if a new dietary ingredient notification had been submitted, dietary supplements containing higenamine would be adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. 342(f) and 350b(a)]. In fact, the available evidence underscores higenamine’s potential for serious cardiotoxic effects. In the absence of adequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, dietary supplements containing higenamine are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. 342(f)(1)(B].
Further, your Arsyn and ConvictStim product labels declare 2-aminoisoheptane hydrochloride (HCl) as an ingredient in each of the products and your Arsyn product label also declares hordenine HCl and higenamine HCl as an ingredient in your Arsyn product. Your Arsyn product is adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because 2-aminoisoheptane HCl, hordenine HCl, and higenamine HCl are unsafe food additives under section 409(a) of the Act [21 U.S.C. 348(a)]. Your ConvictStim product is adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because 2-aminoisoheptane HCl is an unsafe food additive under section 409(a) of the Act [21 U.S.C. 348(a)].
If a substance added to food is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive.
1
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(C)(i)].
The definition of “food additive” in section 201(s) of the Act [21 U.S.C 321(s)] does not include dietary ingredients used in dietary supplements as defined in section 201(ff)(1) of the Act [21 U.S.C 321(ff)(1)] or substances that are GRAS under the conditions of intended use. The ingredients 2-aminoisoheptane HCl, hordenine HCl, and higenamine HCl do not qualify as dietary ingredients under section 201(ff)(1) of the Act [21 U.S.C. 321(ff)(1)] because they are not a vitamin, mineral, amino acid, herb or other botanical, dietary substance for use by man to supplement the diet by increasing the total dietary intake, or concentrate, metabolite, constituent, extract, or combination of any of the preceding dietary ingredient types. Neither are 2-aminoisoheptane HCl, hordenine HCl, and higenamine HCl GRAS under their conditions of use in your dietary supplement products. Because 2-aminoisoheptane HCl, hordenine HCl, and higenamine HCl do not qualify as dietary ingredients and are not GRAS or otherwise exempt from the food additive definition, your Arsyn and ConvictStim products are adulterated under section 402(a)(2)(C)(i) of the Act because they contain one or more unsafe food additives. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under 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.
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 at Lillian.aveta@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1
cc:
Michael Jirovec
Founder & CEO
Supplement Science Corp.
d/b/a Condemned Labz
351 Majestic Eagle Drive
Ponte Vedra, FL 32081-0671
________________________
1
Under section 201(s) of the Act [21 U.S.C. 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement.
Content current as of:
09/28/2021
Regulated Product(s)
Drugs