| Public Health Service Food and Drug Administration |
Florida District |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-11-25
April 27, 2011
Mrs. Stacy N. Sujanani, President
Mr. Sanjay Sujanani, Manager
Intelli Health Products, LLC
12809 Killarney Court
Odessa, FL 33556-5420
Dear Mr. and Mrs. Sujanani:
This letter concerns your firm’s marketing and distribution of the product “Duro Extend.” “Duro Extend” is labeled as a dietary supplement. As described below, “Duro Extend” is an unapproved new drug in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 355(a) and 331(d)] and is misbranded in violation of sections 502(f) and 502(a) [21 U.S.C. §§ 352(f) and 352(a)] of the Act.
Laboratory analyses conducted by the U.S. Food and Drug Administration (FDA) concluded that multiple lots of “Duro Extend” contain sulfoaildenafil and/or aildenafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafil.1 Sildenafil is the active pharmaceutical ingredient in Viagra, an FDA-approved drug for the treatment of erectile dysfunction (ED). According to statements on the label of “Duro Extend,” it is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. These statements include, but are not limited to, the following:
• “Male Enhancer.”
• “Herbal dietary supplement for men, Duro™ may help increase pleasure and performance.”
These statements make clear that “Duro Extend” is a drug under section 201(g)(1) of the Act [21 U.S.C. §§ 321(g)(1)] because it is intended to affect the structure or function of the body. Under section 201(g)(1) of the Act (last sentence), the structure/functions claims made for dietary supplements must be made in accordance with section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)], and if such claims do not conform to section 403(r)(6), 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 male enhancement structure/function claim made for “Duro Extend” does not describe the effects of nutrients or dietary ingredients in the product. Rather, the structure/function claim is clearly made for the product as it relates to its sulfoaildenafil and/or aildenafil content. Since sulfoaildenafil and aildenafil are not nutrients or dietary ingredients, as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], but synthetic active pharmaceutical ingredients, claims about improvement of sexual function do not conform to section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)]. Accordingly, “Duro Extend” is a drug within the meaning of section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)].
Moreover, “Duro Extend” 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 use under the conditions prescribed, recommended, or suggested in their labeling. 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 marketing and distribution of “Duro Extend” without such an approved application violates these provisions of the Act.
Furthermore, “Duro Extend” is a “prescription drug” as defined at section 503(b)(1)(A) of the Act [21 U.S.C. § 503(b)(1)(A)], in that their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Indeed, all PDE 5 inhibitors which 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.
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 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. As such, the labeling of “Duro Extend” fails to bear adequate directions for its intended use. “Duro Extend” is not exempt from the requirement that its labeling bear adequate directions for use under 21 CFR §§ 201.100(c)(2) and 201.115 because no FDA-approved application is in effect for “Duro Extend.” For these reasons, “Duro Extend” is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
Additionally, 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 . . ..” The labeling of “Duro Extend” does not declare that it contains the PDE-5 inhibitors, sulfoaildenafil and/or aildenafil. The undeclared PDE-5 inhibitors in “Duro Extend” 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, high cholesterol, or heart disease often take nitrates. Further, consumers who have been advised against taking PDE-5 inhibitors because of comorbidities or potential drug interactions may seek products like “Duro Extend” because they are marketed as not containing the active ingredients in approved ED drugs. The failure to disclose the presence of sulfoaildenafil and/or aildenafil renders your product’s labeling false and misleading. “Duro Extend” is therefore misbranded under Section 502(a) of the Act [21 U.S.C. § 352(a)].
The undeclared PDE-5 inhibitors contained in “Duro Extend” also cause it to be misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)], because the labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of “Duro Extend,” particularly since someone who takes it would be unaware of the presence of sulfoaildenafil and/or aildenafil. For example, because sulfoaildenafil and aildenafil are analogues of sildenafil and are PDE-5 inhibitors, patients who take nitrates and consume “Duro Extend” may be at risk of life-threatening hypotension. Consequently, your product, “Duro Extend,” is misbranded under sections 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)].
The introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the Act [21 U.S.C. § 331(a)].
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 product. 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. We advise you to ensure that you have knowledge of the ingredients in your products before you offer them for sale. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. 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 corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 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.
Your reply should be sent to the Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751, to the attention of Salvatore N. Randazzo, Compliance Officer. If you have any questions regarding the content of this letter, please contact Mr. Randazzo at (407) 475-4712.
Sincerely,
/s/
Emma R. Singleton
Director, Florida District
C: (b)(4)
1 In October 27, 2010, your firm conducted a voluntary recall of specific lots of "Duro Extend" after FDA found that the product contained sulfoaildenafil. In December 2, 2010, your firm expanded your voluntary recall to include all lots of"Duro Extend.
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