Your firm also manufactures "Sexual Virility Max" for the own-label distributor, (b)(4) (dba, (b)(4), Inc.). FDA confirmed through laboratory analysis that "Sexual Virility Max" (Lot 10090571) contained sulfoaildenaftl and sulfosildenaftl, both of which are phosphodiesterase type-5 (PDE-5) inhihitors and are synthetic chemical compounds that are structural analogs of sildenaftl. Sildenaftl citrate is an active pharmaceutical ingredient found in Viagra, an FDA-approved drug product intended to treat erectile dysfunction (ED). Neither sulfoaildenaftl or sulfosildenaftl was declared on the product label for "Sexual Virility Max."
The name of the product, "Sexual Virility Max" makes clear that your product is intended to affect the structure or any function of the body of man or other animals. Under Section 201(g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must he 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. However, the structure/function claim quoted above for "Sexual Virility Max" does not describe the effects of nutrients or dietary ingredients in the product. Rather, the claim is made for the product as a whole and relates to its sulfoaildenaftl and/or sulfosildenaftl content. Since sulfoaildenaftl and sulfosildenaftl are not nutrients or dietary ingredients as defined in Section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], but instead are analogues of an active pharmaceutical ingredient, the claim about sexual virility does not conform to Section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)]. Therefore, "Sexual Virility Max" is a drug under Section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)].
Moreover, "Sexual Virility Max" is a new drug within the meaning of Section 201(p) of the Act [21 U.S.C. § 321(P)], because it is not generally recognized as safe and effective for its intended use. 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 "Sexual Virility Max" without an approved application violates these provisions of the Act because it is not the subject of an approved new drug application.
Furthermore, "Sexual Virility Max" is a prescription drug as defined in Section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of its toxicity or potentiality for harmful effect, the method or its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. "Sexual Virility Max" is a prescription drug because it contains several PDE-5 inhibitors; 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 them.
In addition to the unapproved new drug charges, your "Sexual Virility Max" is misbranded under Section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)]. According to Section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). "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 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. 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 there is no FDA-approved application for your firm's "Sexual Virility Max," its labeling fails to bear adequate directions for its intended use, causing it to be misbranded under Section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)].
"Sexual Virility Max" is also misbranded under Section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] in that the product's labeling lacks adequate warnings for the protection of users. There is a potential for adverse events associated with this product, particularly since someone who takes it would be unaware of the presence of sulfoaildenafil or sulfosildenafil in your "Sexual Virility Max" product. The undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Under Section 502(a) of the 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 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 ...." Your product, "Sexual Virility Max" is misbranded under Section 502(a) of the Act because its labeling makes false and misleading statements regarding safety and fails to reveal material facts with respect to consequences that may result from the use of this product. Sulfoaildenafil and sulfosildenatil, contained in your "Sexual Virility Max," may pose serious health risks to consumers, which are only compounded by the fact that these ingredients are not declared on the product's label.
