WARNING LETTER
Ironmag Labs
MARCS-CMS 622504 —
May 04, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Recipient:
Recipient Name
Robert DiMaggio
Ironmag Labs
1860 Whitney Mesa Dr.
Ste 120
Henderson
,
NV
89014
United States
cs@ironmaglabs.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. DiMaggio:
This letter concerns your products CBD Gummies, Ephedra Stack, Lean Fuel V2 and Stimulate, which are labeled as dietary supplements.
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the products are adulterated dietary supplements.
Based on our review of your website https://ironmaglabs.com and other relevant evidence, CBD Gummies, Ephedra Stack, Lean Fuel V2, and Stimulate are unapproved new drugs sold in violation of section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. Furthermore, your CBD-containing product is a misbranded drug under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. As explained further below, introducing or delivering these unapproved and misbranded drugs for introduction into interstate commerce violates the FD&C Act. You can find the FD&C 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.
Adulterated Dietary Supplements: New Dietary Ingredients
The label of your Ephedra Stack product declares higenamine as a dietary ingredient. The label of your Stimulate and Lean Fuel V2 products declare hordenine as a dietary ingredient. Higenamine is a “dietary ingredient” under section 201(ff)(1)(F) of the FD&C Act [21 U.S.C. § 321(ff)(1)(F)] because it is a constituent of aconite, asarum, lotus, and other botanicals. Hordenine is a “dietary ingredient” under section 201(ff)(1)(F) of the FD&C Act [21 U.S.C. § 321(ff)(1)(F)] because it is a constituent of barley and other botanicals.
As explained below, higenamine and hordenine are also “new dietary ingredients” (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) under section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)].
Under section 413(a) of the FD&C 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 FD&C 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 hordenine or higenamine were lawfully marketed as dietary ingredients in the United States before October 15, 1994, nor is there information demonstrating that hordenine or higenamine have been present in the food supply as articles used for human food in a form in which the food has not been chemically altered. Therefore, hordenine and higenamine are subject to the premarket new dietary ingredient notification requirement in section 413(a)(2) of the FD&C Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. FDA has not received any NDI notifications pertaining to the use of hordenine or higenamine in dietary supplements. 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 FD&C Act [21 U.S.C. §§ 342(f) and 350b(a)].
Moreover, based on our evaluation of the relevant safety evidence, there is no history of use or other evidence of safety establishing that hordenine or higenamine will reasonably be expected to be safe when used as dietary ingredients. Therefore, even if a new dietary ingredient notification had been submitted, dietary supplements containing hordenine or higenamine would still be adulterated under sections 402(f) and 413(a) of the FD&C Act [21 U.S.C. §§ 342(f) and 350b(a)]. In the absence of adequate information to provide reasonable assurance that hordenine and higenamine do not present a significant or unreasonable risk of illness or injury, dietary supplements containing hordenine or higenamine are adulterated under section 402(f)(1)(B) of the FD&C Act [21 U.S.C. § 342(f)(1)(B)]. The introduction into interstate commerce of dietary supplements that are adulterated under sections 402(f) and 413(a) of the FD&C Act is prohibited under sections 301(a) and (v) of the FD&C Act [21 U.S.C. § 331(a) and (v)].
Dietary Supplement Labeling
Information on your website at https://www.ironmaglabs.com/product/cbd-gummies/ indicates that you intend to market your CBD Gummies product as a dietary supplement. For example, your CBD Gummies product contains a Supplements Facts panel, as well as a statement of identity identifying it as a dietary supplement. However, your CBD Gummies product cannot be a dietary supplement because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), but you may present FDA with any evidence bearing on this issue.
Unapproved New Drugs
FDA reviewed your website at https://ironmaglabs.com in January 2022 and has determined that you take orders there for the products CBD Gummies, Ephedra Stack, Lean Fuel V2, and Stimulate. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the FD&C 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 FD&C Act.
Examples of some of the website claims that provide evidence that your products are intended for use as a drug include the following:
Ephedra Stack
(https://www.ironmaglabs.com/product/ephedra-stack/))
• “White Willow Bark is an herbal form of aspirin and is a natural pain reliever.”
Lean Fuel V2
(https://www.ironmaglabs.com/product/leanfuel-v2/)
• Under the heading The Power Behind LeanFuel V2: “anti-inflammatory compounds”
• “D-phenylalanine is also used as a pain reliever…”
• “Uva Ursi … possesses an anti-inflammatory properties. The benefits if reducing systemic inflammation are too numerous to mention here, as this process is related to just about every degenerative disease experienced by modern society”
• “Uva Ursi helps correct this imbalance by reducing inflammation…”
Stimulate
(https://www.ironmaglabs.com/product/stimulate)
• “White Willow Bark has the ability to naturally minimize pain and inflammation.”
CBD Gummies
(https://www.ironmaglabs.com/product/cbd-gummies/)
• “Pain … Relief”
• “Decreases Anxiety & Depression”
• “Lower blood pressure”
• “Lower intestinal inflammation”
• “Relieve depression”
• “Help with alcohol and nicotine addiction”
• “Neurodegenerative diseases”
• “Reduce chronic pain”
• “Reduce Inflammation”
Your Ephedra Stack, Lean Fuel V2, Stimulate and CBD Gummies 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 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), 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 FD&C 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 product CBD Gummies is 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 product safely for its intended purposes. Accordingly, the CBD Gummies fail to bear adequate directions for their intended use and, therefore, the product is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the FD&C 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.
Within fifteen working days of receipt of this letter, please notify this office in writing 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 fifteen 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 written reply should be directed to Aaron Dotson, Compliance Officer, via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Sincerely,
/S/
Ann Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
05/09/2022
Regulated Product(s)
Dietary Supplements