WARNING LETTER
Supercore Products Group, Inc.
MARCS-CMS 690510 —
September 26, 2024
Product:
Drugs
Recipient:
Recipient Name
Christopher Ingram
Supercore Products Group, Inc.
230 Peachtree Street Ste 2200
Atlanta
,
GA
30303
United States
customersupport@hardsteelusa.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
September 26, 2024
RE: 690510
Dear Christopher Ingram:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address, https://www.hardsteelusa.com which redirects to https://supercoreintl.com/ from May to September 2024, where you take orders for “Hard Steel”
1
and “Gold Hard Steel Plus.”
2
In addition, FDA has obtained a sample and labeling of your “Hard Steel” and “Gold Hard Steel Plus” products. As described below, these 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 331(d). Furthermore, your “Hard Steel” and “Gold Hard Steel Plus” products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
FDA confirmed through laboratory analysis that a sample of your “Hard Steel” product contains the undeclared pharmaceutical ingredients sildenafil and acetaminophen and your “Gold Hard Steel Plus” product contains undeclared sildenafil. Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and the active ingredient in the FDA-approved prescription drug Viagra used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease, often take nitrates. Acetaminophen is a medicine used to reduced pain and fever that is found in many prescriptions, and over-the-counter (OTC) drug products. Use of the product “Hard Steel” poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. Victims of unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters.
Information on the label and labeling of your “Hard Steel” and “Gold Hard Steel Plus” products demonstrate that these products are marketed as dietary supplements. However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. Given that sildenafil was not marketed as a dietary supplement or as food before Viagra was approved, your “Hard Steel” and “Gold Hard Steel Plus” products are excluded from the definition of dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).
Unapproved New Drugs
Your “Hard Steel” and “Gold Hard Steel Plus” products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended to for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples of claims observed on your website and from the labeling, including the outer packaging, that provide evidence of the intended use of these products as drugs include, but may not be limited to the following:
Hard Steel
On your webpages https://hardsteelusa.com/hard-steel-20-count-capsules and https://supercoreintl.com/hard-steel-20-count-capsules/:
“Best Possible Treatment of Erectile Dysfunction”
“Hard Steel male enhancement is the most powerful all-natural treatment to combat erectile dysfunction.”
Gold Hard Steel Plus
On the product label:
“NO MORE Premature Ejaculation”
“Better Ejaculation Control, NO limits”
“Amazing Increase in Thickness”
“Maximize Length, Width and Stamina”
“Experience Rock Hard Erections”
On your webpages, https://hardsteelusa.com/hard-steel-gold-plus-liquid/ and https://supercoreintl.com/hard-steel-gold-plus-liquid/:
“Best Possible Treatment of Erectile Dysfunction, Extra Strength”
“Hard Steel wins against erectile dysfunction”
Your “Hard Steel” and “Gold Hard Steel Plus” products are not generally recognized as safe and effective for their 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, a new drug may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for either of your “Hard Steel” or “Gold Hard Steel Plus” products. Introduction or delivery of either of these products into interstate commerce without an approved application violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drugs
Your “Hard Steel” and “Gold Hard Steel Plus” products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “Hard Steel” and “Gold Hard Steel Plus” products do not declare that the products contain a PDE-5 inhibitor or acetaminophen. The use of PDE-5 inhibitors can be associated with significant safety issues and the risk of serious adverse events. As previously mentioned, the undeclared ingredients in your “Hard Steel” and “Gold Hard Steel Plus” products may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose these ingredients in the product labeling renders your “Hard Steel” and “Gold Hard Steel Plus” products misbranded under section 502(a) of the FD&C Act.
Your “Hard Steel” and “Gold Hard Steel Plus” products are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1), include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. All PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer such drugs. Your “Hard Steel” and “Gold Hard Steel Plus” products, which contain undeclared sildenafil, are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), and as such, can be used safely only at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for your “Hard Steel” and “Gold Hard Steel Plus” products such that a layperson can use the drug safely for its intended uses. “Hard Steel” and “Gold Hard Steel Plus” products are not exempt from the requirements that their labeling bears adequate directions for use by a layperson, 21 CFR 201.100(c)(2) and 201.115, because there are no FDA approved applications in effect for these products. For these reasons, your “Hard Steel” and “Gold Hard Steel Plus” products are misbranded under section 502(f)(1) of the FD&C Act.
The undeclared active pharmaceutical ingredients in your products also causes these products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because its labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for serious health risks associated with these products, particularly since anyone who takes your “Hard Steel” and “Gold Hard Steel Plus” products would be unaware of the presence of the undeclared drug ingredient(s) and placed at risk for its associated adverse events.
The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
We also documented that your website, https://www.hardsteelusa.com, offers for sale variations of “Pink Pussycat”
3
and “HoneyGizer”
4
for sale to consumers in the United States. Previous FDA lab analyses of “Pink Pussycat” and “HoneyGizer” products similarly named to those sold on your websites revealed these products contained the undeclared ingredients sildenafil. While the Agency has not sampled and tested these product variations from your inventory to date, this letter is to express our serious concern about the safety of these products and emphasize that it is your legal responsibility under federal law to ensure that they do not contain any undeclared and potentially harmful ingredients.
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/or injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 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/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
___________________________
1
FDA issued a warning to consumers not to use your “Hard Steel” product (see: https://www.fda.gov/drugs/medication-health-fraud/hard-steel-contains-hidden-drug-ingredients). Further, we acknowledge that you recalled your “Hard Steel” product in July 2024 due to the presence of undeclared sildenafil and acetaminophen (see: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/supercore-products-group-inc-issues-voluntary-worldwide-recall-hard-steel-capsules-gold-hard-steel).
2
FDA issued a warning to consumers not to use your “Gold Hard Steel Plus” product (see: https://www.fda.gov/drugs/medication-health-fraud/gold-hard-steel-plus-contains-hidden-drug-ingredient. Further, we acknowledge that you recalled your “Gold Hard Steel Plus” product in July 2024 due to the presence of undeclared sildenafil (see: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/supercore-products-group-inc-issues-voluntary-worldwide-recall-hard-steel-capsules-gold-hard-steel).
3
See: https://www.fda.gov/drugs/medication-health-fraud/public-notification-pink-pussycat-contains-hidden-drug-ingredient
4
See: https://www.fda.gov/drugs/medication-health-fraud/public-notification-honeygizertm-contains-hidden-drug-ingredient
Content current as of:
10/01/2024
Regulated Product(s)
Drugs