Test Shows Sex Product is Again Contaminated

MAITLAND, Fla.Intelli Health Products was again reprimanded by FDA for its Duro Extend sexual health product, this time for marketing claims as well as adulteration. Marketing claims, especially for sexual function, weight loss and bodybuilding, are under increasing scrutiny from FDA as well as consumers due to the governments continuing action against violators.

In an April 27, 2011, warning letter to Stacy N. Sujanani, president, and Sanjay Sujanani, manager, Intelli Health Products LLC, FDA Florida District Director, Emma R. Singleton said marketing and distribution positions Duro Extend as an unapproved new drug in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §§ 355(a) and 331(d)], and the product is misbranded in violation of sections 502(f) and 502(a) [21 U.S.C. §§ 352(f) and 352(a)] of the act.

On Oct. 27, 2010, Intelli Health Products conducted a voluntary recall of specific lots of "Duro Extend" after FDA found the product contained sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of erectile dysfunction (ED). On Dec. 2, 2010, it expanded its voluntary recall to include all lots of Duro Extend. Read about that here.

FDA said recent lab tests found it again contained sulfoaildenafil and/or aildenafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafil, the active pharmaceutical ingredient in Viagra.

Further, label claims for Duro Extend say is intended to prevent, treat or cure disease conditions, or to affect the structure or function of the body. FDA noted the claims Male Enhancer" and Herbal dietary supplement for men, Duro may help increase pleasure and performance" describe the product as a drug under section 201(g)(1) of the act because it is intended to affect the structure or function of the body.

FDA noted section 403(r)(6) act of 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," the letter reported.  

Because FDA declared Duro Extend as a new drug, the agency said it is in further violation because it is not GRAS (generally recognized as safe) and effective for use under the conditions prescribed, recommended or suggested in its labeling. FDA also noted as a drug, Duro Extend is not safe for use except under the supervision of a practitioner licensed by law to administer them, and adequate directions for use are not provided.  Additionally, FDA said Duro Extend, as a drug is misbranded because its labeling is false or misleading in the sense that it fails to 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 potential drug interactions may seek products like Duro Extend because they are marketed as not containing the active ingredients in approved ED drugs.

Because Duro Extend does not declare the potential negative health effects, FDA said Duro Extend is also misbranded per 502(f)(2) of the act.