Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488185.htm
Timestamp: 2018-11-18 21:31:12
Document Index: 499887156

Matched Legal Cases: ['§ 355', '§ 352', '§ 321', '§ 321', '§ 321', '§ 353', '§ 352', '§ 201', '§ 201', '§ 352', '§ 321', '§ 352', '§343', '§ 321']

Sharim Distributing Co Inc 2/11/16
CMS # 482681
Sharim Distributing Co., Inc.
1115 W. Hayward Avenue
The United States Food and Drug Administration (FDA) conducted an inspection of your warehouse and distribution facility located at 1115 W. Hayward Avenue, Independence, Missouri, on June 23 – 30, 2015. During this inspection, FDA investigators collected samples of seven products at your facility. FDA investigators conducted a second inspection of your facility at 1115 W. Hayward Avenue on August 24 – September 10, 2015.
FDA has determined that certain products you distribute, including but not limited to, “(b)(4) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)].
FDA confirmed through laboratory analysis that “(b)(4)” contain the following undeclared phosphodiesterase type-5 (PDE-5) inhibitors:
Undeclared Pharmaceutical Ingredient
Sildenafil is the active pharmaceutical ingredient in Viagra™, an FDA-approved prescription drug used to treat erectile dysfunction (ED). Dithiodesmethylcarbodenafil is a PDE-5 inhibitor and an analogue of sildenafil.
Your firm markets “(b)(4)” and “(b)(4)” as dietary supplements. However, according to section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)], a dietary supplement may not contain an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Viagra™ (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. Given that sildenafil was not marketed as a dietary supplement or as a food before this date, “(b)(4)” and “(b)(4),” which both contain sildenafil, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the FD&C Act.
All three of the products, “(b)(4),” and “(b)(4)” are intended to affect the structure or function of the body and, thus, are drugs as defined in section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)].[1] Labeling statements for “(b)(4),” and “(b)(4)” documenting these intended uses include, but are not limited to, the following:
The claims on your products’ labels, and the presence of PDE-5 inhibitors, including sildenafil and dithiodesmethylcarbodenafil in the above-listed products, indicate that these products are intended to affect the structure or function of the body or for use as a treatment for ED.
Moreover, “(b)(4),” and “(b)(4)” are new drugs as defined under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because these products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the FD&C Act, 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 “(b)(4)” without such approved applications violates these provisions of the FD&C Act.
“(b)(4),” and “(b)(4)” each contains a PDE-5 inhibitor. 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 such drugs. Therefore, “(b)(4) and “(b)(4)” are “prescription drugs” as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitionerlicensed by law to administer them.
As such, “(b)(4),” and “(b)(4)” are each a misbranded drug under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fail to bear adequate directions for their intended use(s). “Adequate directions for use” means directions under which a layman can use the 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. “(b)(4)” and “(b)(4)” are not exempt from the requirements that their labeling bear adequate directions for use by a layperson [21 U.S.C. §§ 201.100(c)(2) and 201.115] because there is no FDA-approved application in effect for any of these products. For these reasons, the above-mentioned products are misbranded under section 502(f)(1) of the FD&C Act.
Additionally, under section 502(a) of the FD&C 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 FD&C 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 failure to disclose the presence of sildenafil (a PDE-5 inhibitor) renders the labeling of “(b)(4)” and “(b)(4)” misbranded under section 502(a) of the FD&C Act. Similarly, the failure to disclose the presence of dithiodesmethylcarbodenafil (a PDE-5 inhibitor) in “(b)(4)” renders the labeling of “(b)(4)” misbranded under section 502(a) of the FD&C Act. The presence of undeclared PDE-5 inhibitors contained in your products may pose serious health risks because consumers with underlying medical issues may take these products without knowing that they 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. Those consumers who have been advised against taking PDE-5 inhibitors because of comorbidities or potential drug interactions may seek products like “(b)(4),” and “(b)(4)” because they are marketed as dietary supplements.
The undeclared PDE-5 inhibitors in “(b)(4),” and “(b)(4)” also cause these products to be misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] in that the products’ labeling lacks adequate warnings for the protection of users. As previously noted, there is the potential for adverse events associated with PDE-5 inhibitors, particularly since anyone who takes these products would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events.
Introduction or delivery for introduction into interstate commerce of misbranded drugs is prohibited under section 301(a) of the FD&C Act.
The violations and issues cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations, and to ensure that all products you manufacture or distribute are in compliance with the FD&C Act and all of its implementing regulations and all other requirements of federal law.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action of violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, please 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 all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections. If you no longer distribute these products, please indicate this in your response, including the reasons and the dates on which you ceased to distribute them.
If you have any questions regarding any issue in this letter, please contact Amy E. Devine, Compliance Officer, at (913) 495-5147, or at the above letterhead address.
[1] Under section 201(g)(1) of the FD&C Act (last sentence), the structure/functions claims permitted for dietary supplements must be made in accordance with section 403(r)(6) of the FD&C Act [21 U.S.C. §343(r)(6)]. However, the structure/function claims made for “(b)(4)” do not conform to section 403(r)(6). Therefore, this 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. The male enhancement structure/function claims made for “(b)(4)” do not describe the effects of a nutrient or dietary ingredient in the product. Rather, the structure/function claims made for the product relates to its dithiodesmethylcarbodenafil content. Dithiodesmethylcarbodenafil is not a nutrient or dietary ingredient, as defined in section 201(ff)(1) of the FD&C Act [21 U.S.C. § 321(ff)(1)], but is a synthetic active pharmaceutical ingredient. For these reasons, “(b)(4)” is a drug within the meaning of section 201(g)(1) of the FD&C Act.