Inspections, Compliance, Enforcement, and Criminal Investigations

221 Enterprises, LLC. 8/7/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707 

 

WARNING LETTER
CMS# 428388
 
August 7, 2014
 
Via UPS
 
Mr. Baronne F. Fleming, Owner
221 Enterprises, LLC
3351 Baker Street NE
Washington, DC 20019-1324
 
Dear Mr. Fleming:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at www.sexwithagrudge.com in April 2014, and has determined that "S.W.A.G" (also known as "Sex With A Grudge") is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a) and 331(d)] and a misbranded drug sold in violation of sections 502, 503, and 301(a) of the FDCA [21 U.S.C. §§ 352, 353, and 331(a)], as detailed below.
 
Unapproved New Drug
 
FDA confirmed through laboratory analyses that "S.W.A.G" contains undeclared sildenafil. Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and is the active pharmaceutical ingredient in Viagra, an FDA-approved drug for the treatment of erectile dysfunction (ED).
 
"S.W.A.G" is marketed as a dietary supplement. Under section 201(ff)(3)(B) of the FDCA [21 U.S.C. § 321(ff)(3)(B)], dietary supplements may not include an article that is approved as a new drug under section 505 of the FDCA unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Viagra on March 27, 1998 and sildenafil was not marketed as a dietary supplement or as a food before this date. As such, "S.W.A.G" is excluded from the definition of a dietary supplement.
 
Moreover, "S.W.A.G" is a drug as defined by section 201(g)(1) of the FDCA [21 U.S.C. § 321 (g)(1)] because it is intended to affect the structure or function of the human body. Labeling statements for "S.W.A.G" documenting these intended uses include, but are not limited to, the following:
 
S.W.A.G
 
• "[T]ake 1 white capsule and 1 black pill (together) ... 45 minutes before sexual activity."
• "TAKE YOUR SEXUAL PERFORMANCE TO THE NEXT LEVEL!!!"
• "S.W.A.G helps to improve blood flow to the penis and increases testosterone levels .... "
• "Quite a few of our clients are on blood pressure related meds and they swear by S.W.A.G. (sic) because unlike ED drugs like Viagra, Cialis, and Levitra there is no interaction."
 
Under the Testimonials section of your website, www.sexwithagrudge.com, statements include:
 
• "[T]his product has no side effects. I have high blood pressure and can't take Viagra. S.W.A.G is the only thing that I've ever been able to take that doesn't bother me at all."
 
"S.W.A.G" is also a new drug under section 201 (p) of the FDCA [21 U.S.C. § 321 (p)] because this product is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the FDCA [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. No approved application is in effect for this product. Therefore, the distribution or sale of "S.W.A.G" violates these provisions of the FDCA.
 
Misbranded Drug
 
"S.W.A.G" contains one or more PDE-5 inhibitors. All PDE-5 inhibitors that 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. Therefore, "S.W.A.G" is a "prescription drug" as defined under section 503(b)(1)(A) of the FDCA [21 U.S.C. § 353(b)(1)(A)], because, in light of its toxicity or other potentiality for harmful effects, the methods of its use, or the collateral measures necessary for its use, your product is not safe for use except under the supervision of a practitioner licensed by law to administer it.
 
As such, "S.W.A.G" is misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)], in that the labeling for this drug fails to bear adequate directions for use. "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. "S.W.A.G" 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 it. For these reasons, "S.W.A.G" is misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)].
 
Additionally, "S.W.A.G" is misbranded under section 502(a) of the FDCA [21 U.S.C. § 352(a)], which states a drug is misbranded if its labeling is false or misleading in any particular. Section 201 (n) of the FDCA [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 renders the labeling of "S. W.A.G" misbranded under section 502(a) of the FDCA [21 U.S.C. § 352(a)]. The undeclared drugs in "S.W.A.G" may pose serious health risks because consumers with underlying medical issues may take this product without knowing that it can cause serious harm or interact in dangerous ways with other drugs the consumers may be taking. For example, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers who have been advised against taking PDE-5 inhibitors because of comorbidities or the potential drug interactions may seek products like "S.W.A.G" because it is marketed as a dietary supplement. This product is, therefore, misbranded under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)].
 
The undeclared PDE-5 inhibitor in "S.W.A.G" also causes this product to be misbranded under section 502(f)(2) of the FDCA [21 U.S.C. § 352(f)(2)], because its labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with the use of PDE-5 inhibitors. Consumers who use "S.W.A.G" would be unaware of the presence of the undeclared drug ingredients and placed at risk for its associated adverse events.
 
"S.W.A.G" is misbranded for all of the before-stated reasons. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the FDCA [21 U.S.C. § 331(a)].
 
A full list of all tainted products discovered by FDA can be found at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfim?sd=tainted_supplements_cder.
 
The violations cited in this letter are not meant to be an all-inclusive list of violations in connection with your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the FDCA and its implementing regulations. In particular, it is your responsibility under the FDCA to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law and regulations. We also advise you to review your website, your products, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the FDCA.
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The FDCA authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products under sections 304 and 302 of the FDCA [21 U.S. C. §§ 334 and 332].
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Additionally, if another firm manufactures these products identified within this letter, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name and address of your supplier in addition to the manufacturer information. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak by phone at 410-779-5715 or by email at ernest.bizjak@fda.hhs.gov.
 
Sincerely yours,
/S/
Evelyn Bonnin
District Director
Baltimore District Office

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