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  5. HIS Enterprise Inc dba Adam’s Secret USA, LLC - 646494 - 01/10/2023
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WARNING LETTER

HIS Enterprise Inc dba Adam’s Secret USA, LLC MARCS-CMS 646494 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Kwang Pyo Lee
HIS Enterprise Inc dba Adam’s Secret USA, LLC

460 Bergen Blvd., #222
Palisades Park, NJ 07650
United States

adamssecretusa@gmail.com
info@adamssecret.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

WARNING LETTER

January 10, 2023

PO Box 281
Palisades Park, NJ 07650

RE: 646494

Dear Mr. Lee:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.adamssecret.com, in May 2022 and again in December 2022, where you take orders for “Adam’s Secret Extra Strength 3000 Platinum,” “Adam’s Secret Extra Strength Blue,” “Adam’s Secret Extra Strength Purple,” “Adam's Secret Extra Strength Amazing Black,” “Adam’s Secret Extra Strength 2000,” (hereinafter referred to as your “Adam’s Secret” products) and “Dr. Reade Slim Sense.” We also reviewed your social media websites at www.instagram.com/adamssecretus and www.facebook.com/AdamsSecretUSA, where you direct consumers to your website, www.adamssecret.com, to purchase your products. In addition, FDA has obtained samples and labeling of your Adam’s Secret and “Dr. Reade Slim Sense” 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 Adam’s Secret and “Dr. Reade Slim Sense” 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 samples of your Adam’s Secret and “Dr. Slim Sense” products contain undeclared pharmaceutical ingredients.1 Specifically, samples of your “Adam’s Secret Extra Strength 3000 Platinum,” “Adam’s Secret Extra Strength Blue,” and “Adam's Secret Extra Strength Amazing Black,” products contain tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor. In addition, samples of your “Adam’s Secret Extra Strength Purple” and “Adam’s Secret Extra Strength 2000” products contain tadalafil and sildenafil. Tadalafil is a phosphodiesterase type-5 (PDE-5) inhibitor and the active ingredient in the FDA-approved prescription drug Cialis used to treat erectile dysfunction (ED). Sildenafil is a PDE-5 inhibitor and the active ingredient in the FDA-approved prescription drug Viagra also used to treat ED. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease, often take nitrates. Additionally, FDA confirmed through laboratory analysis that a sample of your “Dr. Reade Slim Sense” product contains lorcaserin, a controlled substance and the active ingredient in the withdrawn prescription drug Belviq, formerly used for chronic weight management in some overweight or obese adults. Lorcaserin may cause psychiatric disturbances and impairments in attention or memory. Further, this hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events. Belviq was withdrawn from the market on September 2020 after FDA requested that the manufacturer voluntarily withdraw the drug because of a safety clinical trial that showed an increased occurrence of cancer.

Information on the labels and/or labeling of your Adam’s Secret and “Dr. Reade Slim Sense” products demonstrate that they 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 Cialis (containing tadalafil as the active ingredient) as a new drug on November 21, 2003, and approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. Given that tadalafil and sildenafil were not marketed as dietary supplements or as food before Cialis and Viagra were approved, your Adam’s Secret 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).

Similarly, “Dr. Reade Slim Sense,” which contains lorcaserin, is also excluded from the definition of a dietary supplement. According to section 201(ff)(3)(B)(ii) of the FD&C Act, 21 U.S.C. 321 (ff)(3)(B)(ii), the definition of a dietary supplement does not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public unless the article was marketed as a dietary supplement or food before its authorization for investigation as a new drug. Lorcaserin has been authorized for investigation as a new drug under an investigational new drug (IND) application. When Belviq was approved for marketing as a new drug in the United States, the existence of substantial completed clinical investigations of lorcaserin became public. Based on the information available to FDA, lorcaserin was not marketed as a dietary supplement or as a food before it was authorized for investigation as a new drug. Therefore, “Dr. Reade Slim Sense,” which contains lorcaserin, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act, 21 U.S.C. 321 (ff)(3)(B)(ii).

Unapproved New Drugs

Your Adam’s Secret and your “Dr. Reade Slim Sense” 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 prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Examples of claims observed on your website and social media websites that establish the intended use of your Adam’s Secret and “Dr. Reade Slim Sense” products as drugs include, but are not limited to, the following:

Adam’s Secret Products

From your product page for your Adam’s Secret products, on your website www.adamssecret.com:

  • “Take 45~60 minutes before sexual activity to produce harder, bigger and longer erections. One capsule will be effective for up to 4 days and always under your control. Get hard when you want. This pill is all you need to enhance your blood flow and testosterone level whenever there’s sexual activity.”
  • “Many customers consume this enhancement pill on a weekly basis to revive their sexual confidence, as well as erections and stamina. Adam’s Secret can also help men with erectile dysfunction, premature ejaculation, and weak prostate.”
  • Your Adam’s Secret products include “Tags: Erectile Dysfunction” under their product description.

From your website www.adamssecret.com/pages/about:

  • “Adams Secret is a holistic alternative to big pharma and is comparable to popular prescription drugs.”
  • Under “Adams Secret 100% Natural Ingredients”

    o “Native to the Peruvian Andes mountain range, Maca is known to help enhance libido, increase sperm count, plus improve mood and energy.”
    o “Ginkgo biloba is a tree native to China. The extract is made from the tree’s fan-shaped leaves. Its purpose in their formula is to increase blood flow and circulation.”
    o “Saw Palmetto . . . In Adams Secret, it is a great natural ingredient to help naturally boost testosterone.”
    o “Epimedium Sagitatum . . . It is sometimes referred to as a ‘natural viagra’ because it similarly increases blood flow to the penis, just like Viagra, without the potential side effects.”
    o “Stinging nettle is most commonly used for diabetes and osteoarthritis. It is also sometimes used for urinary tract infections (UTIs), kidney stones, enlarged prostate, hay fever, and other conditions.”
    o “Cnidium is most commonly used for increasing sexual performance and sex drive, erectile dysfunction (ED).”
    o “Tongkat Ali . . . It’s often used to treat a variety of ailments, including fevers, erectile dysfunction, and bacterial infections.”
    o “Forskolin works on muscles in the heart and in the walls of the blood vessels. It produces a more powerful heartbeat and widening of the blood vessels, which lowers blood pressure.”

From your website www.adamssecret.com, clicking on “Read More” directs to an article titled “Just Take It Adams Secret” at www.inlovemag.com/just-take-it/, which includes many of the claims listed under the previous sub bullets, including but not limited to:

  • “Native to the Peruvian Andes mountain range, Maca is known to help enhance libido, increase sperm count, plus improve mood and energy.”
  • “Ginkgo biloba is a tree native to China. The extract is made from the tree’s fan-shaped leaves. Its purpose in their formula is to increase blood flow and circulation.”

From your social media pages, at www.instagram.com/adamssecretus and www.facebook.com/AdamsSecretUSA, you posted the following on November 15, 2022:

  • A post that links to your website www.adamssecret.com and includes the following hashtags: “#adamssecret,” “#erectiledysfunction,” “#erectiledysfunctiontreatment”

“Dr. Reade Slim Sense”

From your website www.adamssecret.com/products/slim-sense-10-capsules:

  • “Clinically Proven Fat Binder 10 Day Plan (10 Capsules: Effective Weight Loss of 8-12 lbs/month Boosts Energy & Supports Metabolism”
  • An image of the product’s label on your website states: “Clinically proven fat burner for healthy and safe weight loss.”

Your Adam’s Secret and “Dr. Reade Slim Sense” products are not generally recognized as safe and effective for their above referenced uses and, therefore, they 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 is no FDA-approved application in effect for your Adam’s Secret or “Dr. Reade Slim Sense” products. Introduction or delivery for introduction of these product 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 Adam’s Secret and “Dr. Reade Slim Sense” 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 fail 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 (21 CFR 201.5). 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 Adam’s Secret products, which contain undeclared sildenafil and/or tadalafil, and your “Dr. Reade Slim Sense” product, which contains undeclared lorcaserin, are prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of their toxicity or potential for harmful effects, methods of use, or collateral measures necessary for their use. Prescription drugs 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 prescription drugs, including your Adam’s Secret and “Dr. Reade Slim Sense” products. Your Adam’s Secret and “Dr. Reade Slim Sense” products are not exempt from the requirements that their labeling bear adequate directions for use by a layperson, 21 CFR 201.100(c)(2) and 201.115, because there is no FDA approved application in effect for these products. For these reasons, your Adam’s Secret and “Dr. Reade Slim Sense” products are misbranded under section 502(f)(1) of the FD&C Act.

Additionally, your Adam’s Secret and “Dr. Reade Slim Sense” 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 Adam’s Secret and “Dr. Reade Slim Sense” products do not declare that the products contain a PDE-5 inhibitor or lorcacerin. The use of PDE-5 inhibitors can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE-5 inhibitors in your Adam’s Secret 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. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. The presence of undeclared lorcaserin in your “Dr. Reade Slim Sense” product may cause psychiatric disturbances and impairments in attention or memory. Further, this hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events. The failure to disclose these ingredients in the products’ labeling renders your Adam’s Secret and “Dr. Reade Slim Sense” products misbranded under section 502(a) of the FD&C Act.

The undeclared active pharmaceutical ingredients in your products also cause these products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because their labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with the use of PDE-5 inhibitors and/or lorcaserin. Consumers who use your Adam’s Secret and/or your “Dr. Reade Slim Sense” products would be unaware of the presence of the undeclared drug ingredients and placed at risk for their 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).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. 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 submit a written response to this letter within fifteen working days from the date of receipt, explaining 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 believe that the product you distribute is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within fifteen working days from the date of receipt of this letter.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/

CAPT Tina Smith
Acting Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

__________________________

1 FDA has issued warnings to consumers not to use your Adam’s Secret and “Dr. Reade Slim Sense” products. See: Public Notification: Adam’s Secret Extra Strength Amazing Black contains hidden drug ingredient https://www.fda.gov/drugs/medication-health-fraud/public-notification-adams-secret-extra-strength-amazing-black-contains-hidden-drug-ingredient, Public Notification: Dr. Reade Slim Sense contains hidden drug ingredient https://www.fda.gov/drugs/medication-health-fraud/public-notification-dr-reade-slim-sense-contains-hidden-drug-ingredient, Public Notification: Adam’s Secret Extra Strength 3000 Platinum (White Packaging) contains hidden drug ingredient https://www.fda.gov/drugs/medication-health-fraud/public-notification-adams-secret-extra-strength-3000-platinum-white-packaging-contains-hidden-drug, Public Notification: Adam’s Secret Extra Strength Blue contains hidden drug ingredient https://www.fda.gov/drugs/medication-health-fraud/public-notification-adams-secret-extra-strength-blue-contains-hidden-drug-ingredient, Public Notification: Adam’s Secret Extra Strength 2000 contains hidden drug ingredients https://www.fda.gov/drugs/medication-health-fraud/public-notification-adams-secret-extra-strength-2000-contains-hidden-drug-ingredients#:~:text=FDA%20laboratory%20analysis%20confirmed%20that,a%20licensed%20health%20care%20professional. and Public Notification: Adam’s Secret Extra Strength Purple contains hidden drug ingredients https://www.fda.gov/drugs/medication-health-fraud/public-notification-adams-secret-extra-strength-purple-contains-hidden-drug-ingredients.

 
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