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  5. Empire Distributors, Inc. - 575029 - 04/10/2019
  1. Warning Letters

WARNING LETTER

Empire Distributors, Inc. MARCS-CMS 575029 —

Product:
Drugs
Inactive Ingredient
Misbranding
Recipient:
Recipient Name
Mr. Devendra R. Patel
Recipient Title
Owner
Empire Distributors, Inc.

242 James St.
Bensenville, IL 60106-3319
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

300 River Place, Suite 5900
Detroit, MI 48207
United States

April 10, 2019

 

WARNING LETTER

 

Case# 575029

 

UPS NEXT DAY

SIGNATURE REQUIRED 

 

Empire Distributors, Inc.

Attn: Mr. Devendra R. Patel, Owner

242 James St.

Bensenville, IL 60106-3319 

 

Dear Mr. Patel:

This letter concerns products that your firm distributes to consumers via your website, http://empiredistributor.com and your storefront, The Merchandise Guru, on Amazon.com: https://www.amazon.com/s?me=AIMRSOC1JQGKL&marketplaceID=ATVPDKIKX0DER. The United States Food and Drug Administration (FDA) has obtained a sample and labeling of the product, “Rhino Black 5K Plus.” As described below, this product is an unapproved new drug sold 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)]. Furthermore, the product is a misbranded drug under section 502 of the Act [21 U.S.C. § 352] and sold in violation of section 301(a) of the Act [21 U.S.C. § 331(a)]. 

FDA confirmed through laboratory analysis that a sample of your “Rhino Black 5K Plus” contains the undeclared active pharmaceutical ingredients sildenafil and tadalafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors. Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

You market “Rhino Black 5K Plus” as a dietary supplement.  However, under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)], a dietary supplement may not include an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27, 1998.  FDA approved Cialis™ (containing tadalafil as the active ingredient) as a new drug on November 21, 2003. Given that sildenafil or tadalafil was not marketed as a dietary supplement or as a food before Viagra or Cialis was approved, “Rhino Black 5K Plus,” which contains sildenafil and tadalafil, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the Act.

Unapproved New Drug

“Rhino Black 5K Plus” is a drug as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Label statements documenting the intended uses of “Rhino Black 5K Plus” include, but are not limited to, the following:

  • “IMMEDIATE ENERGY”
  • “INCREASED STAMINA”

Your “Rhino Black 5K Plus” is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)], because it 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 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 “Rhino Black 5K Plus” without an approved application violates these provisions of the Act.

Misbranded Drug

Your “Rhino Black 5K Plus” also is misbranded under section 502(f)(1) of the Act [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].  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. 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. “Rhino Black 5K Plus” is not exempt from the requirements that its labeling bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115] because there is no FDA-approved application in effect for this product. For these reasons, “Rhino Black 5K Plus” is misbranded under section 502(f)(1) of the Act.

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 for “Rhino Black 5K Plus” does not declare that it contains sildenafil and tadalafil. The failure to disclose the presence of sildenafil and tadalafil in the product’s labeling renders “Rhino Black 5K Plus” misbranded under section 502(a) of the Act. The presence of undeclared PDE-5 inhibitors contained in your product 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 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 “Rhino Black 5K Plus” because it is marketed as a dietary supplement.

The undeclared sildenafil and tadalafil in “Rhino Black 5K Plus” also cause this product to be 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. As previously noted, there is potential for adverse events associated with the use of PDE-5 inhibitors. Consumers who use “Rhino Black 5K Plus” would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events. 

The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the Act [21 U.S.C. §331(a)].

FDA has also reviewed your website at www.empiredistributor.com and documented that you offer the products, “BLACK MAMBA PREMIUM” “Blue Diamond” “libigirl” “Libigrow” “Night Bullet” “Triple MiracleZEN” “Triple PowerZEN” “RHINO 7” “RHINO 25K” “Rhino 69” “S.W.A.G.” and “Stamina-Rx” for sale to consumers in the United States. Previous FDA laboratory analyses of these products from other distributors found that this product contains the undeclared ingredients, including sildenafil or tadalafil or substances similar in structure to sildenafil and tadalafil.

While the Agency has not tested and sampled these products from your inventory to date, this letter is to express our serious concern about the safety of this product and emphasize that it is your legal responsibility under federal law to ensure that it does not contain any undeclared and potentially harmful ingredients.  

A full list of all tainted products discovered by FDA can be found at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder.

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 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 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. 

Please send your electronic reply to: ORAPHARM3_RESPONSES@fda.hhs.gov.

Attn:    Russell K. Riley

Compliance Officer

U. S. Food and Drug Administration

Division of Pharmaceutical Quality Operations III

 

Refer to the Unique Identification Number (Case# 575029) when replying. If you have questions regarding the contents of this letter, please contact Mr. Riley, Compliance Officer, at (630) 323-2763 ext. 101.

 

Sincerely,

/S/

Nicholas F. Lyons

Compliance Director

Division of Pharmaceutical Quality Operations III

 

On behalf of

     

Art O. Czabaniuk

Program Division Director

Division of Pharmaceutical Quality Operations III

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