WARNING LETTER
Hua Da Trading, Inc.
MARCS-CMS 664359 —
December 20, 2023
Product:
Drugs
Recipient:
Recipient Name
Daniel Zeng
Hua Da Trading, Inc.
PO Box 40517
Brooklyn
,
NY
11204
United States
support@eshoponlineusa.com
Eshoponlineusa@gmail.com
Wefun2022@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
WARNING LETTER
December 20, 2023
RE: 664359
Dear Daniel Zeng:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address, https://www.eshoponlineusa.com, from July to December 2023, where you take orders for “WeFun.”
1
In addition, FDA has obtained a sample and labeling of your “WeFun” product. As described below, this product is an unapproved new drug 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 “WeFun” is a misbranded drug 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 “WeFun” product contains the undeclared pharmaceutical ingredient 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. Men with diabetes, high blood pressure, high cholesterol, or heart disease, often take nitrates.
Information on the label and labeling of your “WeFun” product demonstrates that this product is marketed as a dietary supplement. 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 “WeFun” product is 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 “WeFun” product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because it is 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 product labels that establish the intended use of your “WeFun” product as a drug include, but are not limited to, the following:
On the “WeFun” label:
“ENERGY”
“PERFORMANCE”
On your webpage, https://eshoponlineusa.com/collections/frontpage/products/we-fun-natural-make-energy-supplement-amplifier-for-strength-performance-energy-and-endurance-fast-acting-10-gold-capsules:
“WeFun Natural Male Energy Supplement, Amplifier for Strength, Performance, Energy, and Endurance”
Your “WeFun” product is not generally recognized as safe and effective for its above referenced uses and, therefore, is a “new drug” 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 “WeFun.” Introduction or delivery of this 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 Drug
Your “WeFun” product is also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its 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 “WeFun” product, which contains undeclared sildenafil, is a prescription drug 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 “WeFun” product such that a layperson can use the drug safely for its intended uses. “WeFun” is not exempt from the requirements that its labeling bears 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 this product. For these reasons, your “WeFun” product is misbranded under section 502(f)(1) of the FD&C Act.
Additionally, your “WeFun” product is 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 “We Fun” does not declare that the product contains a PDE-5 inhibitor. The use of PDE-5 inhibitors can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE-5 inhibitor in your “WeFun” product may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it 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 failure to disclose this ingredient in the product labeling renders your “WeFun” product misbranded under section 502(a) of the FD&C Act.
The undeclared active pharmaceutical ingredient in your product also causes this product 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 this product, particularly since anyone who takes your “WeFun” product would be unaware of the presence of the undeclared drug ingredient and placed at risk for its associated adverse events.
The introduction or delivery for introduction into interstate commerce of this misbranded drug product 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.eshoponlineusa.com/, offers for sale variations of “BLACK ANT KING,” “BIGGER LONGER,” “Germany Black Gorilla” and/or various Rhino products for sale to consumers in the United States. Previous FDA lab analyses of products similarly named to those sold on your websites revealed these products contained the undeclared ingredients sildenafil and/or tadalafil.
2
We also note that you offer for sale the product “Royal Honey” on your website. A variation of this product with the same name has been the subject of previous FDA warnings after FDA analysis confirmed the presence of an undeclared PDE-5 inhibitor.
3
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
The violations cited in this letter are not intended to be an all-inclusive statement of 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/
Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
____________________
1
FDA issued a warning to consumers not to use your “WeFun” product (see: https://www.fda.gov/drugs/medication-health-fraud/wefun-contains-hidden-drug-ingredient). Further, we acknowledge that you recalled 300 boxes of your “WeFun,” lot numbers 18520168 and 09/30/2026, due to presence of undeclared sildenafil in August 2023 (see: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hua-da-trading-inc-dba-wefun-inc-issues-voluntary-nationwide-recall-wefun-capsules-due-presence).
2
Tadalafil 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). For example, you offer for sale “Black Ant King,” “Bigger Longer,” and “Germany Black Gorilla” on https://www.eshoponlineusa.com/ that appear similar to products that have been the subject of previous FDA warnings (see: https://www.fda.gov/drugs/medication-health-fraud/public-notification-black-ant-king-contains-hidden-drug-ingredient, https://www.fda.gov/drugs/medication-health-fraud/public-notification-bigger-longer-more-time-more-sperms-sic-contains-hidden-drug-ingredient-0 and https://www.fda.gov/drugs/medication-health-fraud/public-notification-germany-black-gorilla-contains-hidden-drug-ingredient). Additionally, you offer various Rhino products for sale on your website https://www.eshoponlineusa.com/. FDA warned consumers to avoid Rhino products in 2018 (see: https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-rhino-male-enhancement-products-found-retailers-because-undeclared-and).
3
See: https://www.fda.gov/drugs/medication-health-fraud/public-notification-royal-honey-contains-hidden-drug-ingredient and https://www.fda.gov/consumers/health-fraud-scams/tainted-honey-based-products-hidden-active-drug-ingredients.
Content current as of:
12/26/2023
Regulated Product(s)
Drugs