Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
RETURN RECEIPT REQUESTED
July 27, 2009
Mr. David Cyrus Pourmand, President
2222 Avenue of Stars, #702E
Century City, CA 90067
Dear Mr. Pourmand:
This letter concerns your firm's marketing and distribution of the product Zencore Plus on your website, www.zencoreplus.com. on other websites, and via retail stores. You market Zencore Plus as a dietary supplement. Laboratory analyses conducted by the Food and Drug administration (FDA) concluded that five lots of this product contain benzamidenafil, a novel Phosphodiesterase Type 5 (PDE5) inhibitor. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the phosphodiesterase type 5 (PDE5) inhibitors, sildenafil, tadalafil, and vardenafil, which are FDA-approved for the treatment of erectile dysfunction (ED). According to statements in your labeling and on your website, your Zencore Plus product is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body.(1) These statements include, but are not limited to, the following:
• "Zencore Plus contains a combination of powerful natural herbs that supports long lasting, hard and firm erections ..."
• "Zencore Plus ... stimulates the production of nitric oxide, leading to the production of cyclic GMP (cGMP). It is the cGMP which ultimately affects smooth muscle relaxation, allowing the penile arteries to expand and fill with blood."
• "Zencore Plus utilizes xanthoparmelia scabrosa, a natural source of Pyrazolo pyrimidinone and 4- methyl piperazine, both of which help inhibit PDE-5. This component of the Zencore Plus formula serves to effectively inhibit PDE-5 activity, allowing the body to sustain an erection!"
• "Zencore Plus does not allow the penis to break down. Instead, it builds up and lets the arteries in the penis fully dilate. His penis inflates with blood, and the man gets a full erection."
• "Lately I was avoiding any opportunity for sexual intercourse. When the time came, I either could not have an erection or it was not hard enough to do the job. Zencore Plus has turned my love life around."
These statements make clear that Zencore Plus is a drug under Section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C), because it is intended to affect the structure or function of the human body and/or prevent, treat, or cure disease conditions. Under section 201(g)1l) (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with Section 403(r)(6) of the Act, 21 U.S.C. § 343(r)(6), or the product is subject to regulation as a drug. Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. In the case of Zencore Plus, however, the sexual performance structure/function claims quoted above do not describe the effects of nutrients or dietary ingredients in the product. Rather, these claims are made for the product as a whole and relate to its benzamidenafil content. Since benzamidenafil is not a nutrient or dietary ingredient but a synthetic active pharmaceutical ingredient, claims about improvement of sexual function do not conform to Section 403(r)(6). Accordingly, Zencore Plus is a drug within the meaning of Section 201(g)(1)(C).
Moreover, Zencore Plus is a new drug, as defined by Section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses.
Under Sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Zencore Plus without such an approved application violates these provisions of the Act.
Additionally, under section 502(a) of the FDCA, a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FDCA [21 U.S.C. § 321(n)] provides that, in determining whether a drug'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 ...." Zencore Plus labeling does not declare that it contains benzamidenafil. Also, your website, www.zencoreplus.com. claims: "You are worried about the adverse side effects of prescription drugs" and "You are looking for a safe and effective natural alternative." These statements falsely assert that the product does not have the potential to cause side effects; however, the use of your product has the potential to cause side effects, such as a sudden, profound and life threatening drop of blood pressure in individuals who take organic nitrates. These statements and the failure to disclose the presence of benzamidenafil render your product's labeling false and misleading. Zencore Plus is therefore misbranded under Section 502(a) of the Act, 21 U.S.C. § 352(a).
Furthermore, because Zencore Plus is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use this product safely for its intended uses. Thus, Zencore Plus' labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), and it is not exempt from the requirement pursuant to 21 C.F.R. § 201.115.
Zencore Plus is also misbranded under Section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), in that its labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of Zencore Plus, particularly since someone who takes Zencore Plus would be unaware of the presence of benzamidenafil. For example, patients who take nitrates and consume Zencore Plus may be at risk of life-threatening hypotension.
The violations described above are not intended to be an all-inclusive list of violations that exist in connection with your products. FDA is continuing to evaluate your products and activities. In this regard, please note that the Agency is concerned that you are demonstrating a continuing pattern and practice of marketing violative products.(2) It is your responsibility to ensure that any drug or dietary supplement products manufactured or distributed by you meet all of the requirements of federal law and FDA regulations. In addition, please note that products are misbranded under section 502(j) of the Act, 21 U.S.C. § 352(j), if they are dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the product's labeling. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing within 15 working days of receipt of this letter as to the specific steps that you have taken to correct the violations noted above and to ensure that similar violations will not recur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections. You can find guidance and information for the regulated industry regarding regulations for drug products through links at FDA's website at http://www.fda.gov/oc/industry.
Please direct your reply to the U.S. Food and Drug Administration, 222 West 6th Street, Suite 700, San Pedro, CA 90731, Attention: Dr. James Lin, Compliance Officer. If you have questions regarding any issue in this letter, please contact Dr. Lin at 310-971-2312.
Director, Los Angeles District
Jeff Farrar, DVM, PhD, MPH
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413
1 In March 2009, your firm conducted a voluntary recall of Zencore Plus after FDA found that the product contained benzamidenafil. According to your press release announcing the March 2009 recall, your firm was marketing and distributing Zencore Plus up until the time of the recall. See http://www.fda.gov/SafetylRecalls/ArchiveRecalls/2009/ucmI28422.htm. In addition, since March 2009, your firm has continued to promote Zencore Plus on www.zencoreplus.com.
2 In August 2007 and November 2007 your firm had also conducted voluntarily recalls on two other purported dietary supplement products, "Zencore Tabs" and "Encore Tabs," after FDA found that they contained active pharmaceutical ingredients or their analogues. The product
"Zencore Tabs" was found by FDA to contain in some cases aminotadalafil, an analogue of tadalafil which is the active pharmaceutical ingredient in an FDA-approved drug for ED treatment; or sildenafil, the active ingredient of another FDA-approved drug for ED treatment, as
well as sulfosildenafil and sulfohomosildenafil, both analognes of sildenafil. In addition, the product "Encore Tabs" was found by FDA to contain aminotadalafil.