Inspections, Compliance, Enforcement, and Criminal Investigations
Sargent, Robert 11-Jul-06
Department of Health and Human Services
Public Health Service
New York District
WARNING LETTER NYK 2006-22
July 11, 2006
16 Valley View Drive
Batavia, NY 14020
Dear Mr. Sargent:
This letter concerns your firm's marketing of the product Vigor-25 on your website, www.screennictures com. A laboratory analysis conducted by the Food and Drug Administration (FDA) concluded that. your product contains piperidenafil, an analogue of vardenafil. Vardenafil is the active pharmaceutical ingredient in Levitra, an FDA-approved drug that is used to treat erectile dysfunction. Statements on your website describe the intended use of Vigor-25. These statements include, but are not limited to, the following:
"Vigor-25(Vigor25) Male Potency is an herbal supplement developed to help boost your sexual pleasure and improve your sexual performance."
"Vigor-25 is a complete herbal supplement and works in as quickly as 25 minutes."'
"It's fast result lets oil be read whenever you want and enjoy pleasure of sex and life."
"Vigor25 gives you the stamina and energy you need when You need it."
"Rhoiola..[Your website states that Rhodiola is an ingredient in Vigor-25] Other Studies have shown benefits in such varied areas as . . . erectile dysfunction . . . ."
"Poria...[Your website states that Poria is an ingredient in Vigor-25] Traditional and modern studies have shown that Poria has tranquilizing, diuretic, cardiotonic, and anti-bacterial, immunotonic, and anti-cancer effects, and can also lower blood sugar levels."
These claims are further supplemented by a metatag that you use to bring consumers to your website. This metatag includes the words "herbal sex enhancement.".
These statements make clear that Vigor-25 is intended for use in 'the diagnosis, cure, mitigation, treatment, or prevention of disease (e.g., erectile dysfunction). Accordingly, Vigor-25 is a drug, as defined by Section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. § 321(g)(1)(B).
These statements make clear Vigor-25 is also 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. Under section 201(g)(1) (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 characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. In the case of Vigor-25, 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 piperidenafil content. Since piperidenafil is not a nutrient or dietary ingredient but a synthetic analogue of vardenafil, your claims about improvement of sexual function do not conform with 403(r)(6). Accordingly, Vigor-25 is a drug within the meaning of section 201(g)(1)(C).
Moreover, this product 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 Vigor-25 without such an approved application violates these provisions of the Act.
Additionally, the product .labeling does not declare that your product contains piperidenafil . Further, your website states that Vigor-25 is "Side-effect free" even though piperidenafil likely exhibits similar pharmacological action to vardenafil. This statement 'falsely asserts that the product does not have the potential to cause side effects. This statement and the failure to disclose the presence of piperidenafil renders your product's labeling. false and misleading. Vigor-25 is therefore misbranded under Section 502(a) of the Act, 21 U.S.C. § 352(a).
Furthermore, because your product 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, Vigor- 25's 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). Finally, the product 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 Vigor-25, particularly since someone who takes Vigor-25 would be unaware of the presence of a vardenafil analogue. For example, patients who take nitrates and consume Vigor-25 are at risk of life-threatening hypotension.
The violations described above are not intended to be an . all-inclusive list of your product's deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.
You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
If your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, 300 Pearl Street, Buffalo, NY 14202 Attention: Patricia A. Clark, Compliance Officer.
A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (FFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
Acting Director, New York District