- R Thomas Marketing, LLC
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
July 31, 2015
WARNING LETTER NYK-2015-45
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
R Thomas Marketing
710 East 217 Street
Bronx, NY 10467
20 Passaic Street
Trenton, NJ 08618
Dear Mr. Thomas and Mr. Hackett:
The United States Food and Drug Administration (FDA) recently reviewed your websites at www.herbviagra.com
. Based on our review, FDA has determined that you offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, FDA has determined that certain products you offer for sale, including but not limited to “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)], as detailed below.
Unapproved New Drugs
FDA confirmed through laboratory analysis that your products identified below contain the following undeclared active pharmaceutical ingredient(s):
Undeclared Active Pharmaceutical Ingredient(s)
Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and is the active pharmaceutical ingredient in Viagra™, an FDA-approved prescription drug used to treat erectile dysfunction (ED).
According to section 201(ff)(3)(B)(i) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(i)], a dietary supplement cannot contain an article that is approved as a new drug under section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] unless that article was marketed as a dietary supplement or food prior to FDA approval of such 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 a food before Viagra was approved, “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill”, which all contain sildenafil, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.
Moreover, these 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. Labeling statements documenting the intended uses of “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” include, but are not limited to the following:
On the Black Ant package insert:
- “[M]ale hormone active (sic), albumen assimilation and stimulating marrow making blood function effects (sic) can accelerate blood corpuscle growth and producing sperm (sic). It can effectively activate adrenal gland PDA sound ause (sic) factor, dilute and supplement sperms (sic), reach several ejaculation and many times orgasm (sic)”
- “Promote Harder Erections and Longer Lasting Sex.”
- “Prevent Premature Ejaculation.”
- “Produce Longer and Stronger Orgasms.”
- “Increased blood flow to genitals”
- “Increased sexual function”
- “Increased sperm count”
- “Increased ejaculation time”
- “Gives instant erection results within 15 to 20 minutes.”
On your website, http:// herbsviagra.com:
- “[S]tart up the manufacture of the natural hormone of the human body, increase secretion of the andrusol to enlarge the length and perimeter of the penis with great effect to male’s impotence”
On your website, http:// herbsviagra.com:
- “Stree Overlord accelerates blood flow to the penis, increasing the size and strength . . . it stimulates the parasympathetic nerve providing a prolongation of the erection.”
- “STREEOVERLORD . . . has a marked male hormone activity with albumen assimilation and stimulate marrow hemopoiesis, accelerate blood cell grow (sic) and sperm producing . . . This product is fit for those with functionality (sic) sexual impotence and prostatitis . . . it can also treat those (sic) sexual impotence caused by diabetes, etc.”
These products are also new drugs under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the FD&C Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the FD&C Act [21 U.S.C. § 355(b) or (j)] is in effect for it. There is no FDA-approved application on file for “Black Ant,” “Herb Viagra,” “Stree Overlord,” or “Real Skill.”
The distribution or sale of these products without approved applications violates these provisions of the FD& C Act.
Your “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” contain PDE-5 inhibitors. All PDE-5 inhibitors that have been approved for marketing by FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drugs. Therefore, “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” are prescription drugs as defined in section 503(b)(1)(A) of the FDCA [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or potentiality for harmful effect, the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs.
As such, “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], because their labeling fails to bear adequate directions for their intended uses. “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]. Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115]. Because no FDA-approved applications are in effect for your products, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C Act.
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. According to section 201(n) of the FD&C Act [21 U.S.C. § 321(n)], in determining whether the labeling or advertising “is misleading, there shall be taken into account (among other things) not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations ....” The labeling for your “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” fail to declare that the products contain the PDE-5 inhibitor, sildenafil. The use of PDE-5 inhibitors can be associated with significant safety issues and the risk of serious adverse events. The undeclared sildenafil in your 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 failure to disclose the presence of sildenafil renders your products’ labeling false or misleading. Therefore, “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” are misbranded under section 502(a) of the FD&C Act.
The undeclared sildenafil in “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” also cause these products to be misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] in that the products’ 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. Consumers who use “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” would be unaware of the presence of the undeclared drug ingredient and placed at risk for its associated adverse events.
Accordingly, the introduction or delivery for introduction into interstate commerce of the misbranded drug products mentioned above violates section 301(a) of the FD&C Act.
We also documented that you offer the products “African Superman,” “Bigger Longer More Time More Sperms,” “Black Ant King,” “Black Storm,” “Germany Niubian,” “Happy Passengers,” “Plant Vigra,” “Hard Ten Days,” “Man King,” “Mojo Risen,” “Night Man,” “Tiger King,” “Samurai-X,” “Superhard,” and “Zhen Gong Fu” for sale to consumers in the United States. FDA lab analysis revealed that these products contain the undeclared ingredients sildenafil, tadalafil and/or noracetildenafil (see http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsing Medicine Safely/Medication HealthFraud/ucm234539.htm
). While the Agency has not tested and sampled these products from your inventory to date, this letter is to express our serious concern about their safety and emphasize that it is your legal responsibility under federal law to ensure they do not contain any undeclared and potentially harmful ingredients.
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 and FDA regulations, and to ensure that all products you manufacture or distribute are in compliance with the FDCA and all of its implementing regulations and all other requirements of federal law. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action of violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, please 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 all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections.
Please send your written response to Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or Email at Lillian.Aveta@fda.hhs.gov
Ronald M. Pace
New York District
Table of Websites:
 In addition to the websites, www.herbviagra.com and www.herbsviagra.com, we note you own numerous other websites, identified below, where you offer “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill” for sale to consumers in the United States. In addition to these products, your websites offer many other products for sale that appear to be the same products that FDA had previously collected from other distributors and confirmed by FDA laboratory analysis to contain undeclared active pharmaceutical ingredients.