| Public Health Service Food and Drug Administration |
| New York District 158-15 Liberty Ave. Jamaica, NY 11433 |
Department of Health and Human Services
August 23, 2010
WARNING LETTER NYK 2010-27
VIA UPS
Peter Erlikh
Vice President
INZ Distributors, Inc.
2713 Coney Island Avenue
Brooklyn, NY 11235-5054
Dear Mr. Erlikh:
This letter concerns your firm's marketing and distribution of the product "Magic Power Coffee." As described below, "Magic Power Coffee" is an unapproved new drug in violation of sections 505(a) and 301(d) of the Food, Drug and Cosmetic Act (the Act) (21 U.S.C. §§ 355(a) and 331 (d)) and a misbranded drug in violation of sections 502(f) and 502(a) (21 U.S.C. §§ 352(f) and 352(a)). Furthermore, if "Magic Power Coffee" were a food, which it is not, it would be adulterated under section 402(a)(2)(C) of the Act (21 U.S.C. § 342(a)(2)(C)).
Unapproved and Misbranded Prescription Drug
Your product, "Magic Power Coffee," is intended to prevent, treat or cure disease conditions or to affect the structure or function of the body. Laboratory analysis conducted by the Food and Drug Administration (FDA) concluded that "Magic Power Coffee" contains hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analogue of sildenafil, the active ingredient in Viagra, which is an FDA-approved drug for the treatment of erectile dysfunction (ED). Both are phosphodiesterase type 5 inhibitors (PDE 5 inhibitors). PDE 5 inhibitors (which also include tadalafil and vardenafil) are well known to have an effect on the structure or function of the body. The intended use of "Magic Power Coffee" is further demonstrated by the statement "Serving Passion One Cup at a Time" and the directions "for best results use approximately 30-45 minutes prior to engaging in sexual intercourse."
Magic Power Coffee" is a drug under sections 201(g)(1)(B)&(C) of the Act (21 U.S.C. §§ 321(g)(1)(B)&(C)) because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or an article (other than food) intended to affect the structure or function of the body. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution, 21 C.F.R. § 201.128. The presence of hydroxythiohomosildenafil, a PDE 5 inhibitor, in your coffee product, and the claims on your product label indicate that "Magic Power Coffee" is intended to affect the structure or function of the body and for use as a treatment for ED. Accordingly, "Magic Power Coffee" is a drug as defined by sections 201 (g)(1)(B)&(C) of the Act (21 U.S.C. §§ 321(g)(1)(B)&(C))1.
Moreover, "Magic Power Coffee" 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 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 sale of "Magic Power Coffee" without such an approved application violates these provisions of the Act.
"Magic Power Coffee" is a prescription drug as defined in section 503(b)(1)(A) of the Act (21 U.S.C. § 353(b)(1)(A)), because, in light of its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. Indeed, all PDE 5 inhibitors which have been approved for marketing by the 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 C.F.R. § 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. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 C.F.R. §§ 201.100(c)(2) and 201.115). Because there is no FDA-approved application for your Firm's "Magic Power Coffee," its labeling fails to bear adequate directions for its intended use, causing it to be misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)). The introduction or delivery for introduction into interstate commerce of this misbranded products violates section 301(a) of the Act (21 U.S.C. § 331(a)).
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 a drug'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 "Magic Power Coffee" does not declare that the product contains hydroxythiohomosildenafil. Because it is an analogue of sildenafil, it likely exhibits similar pharmacological action to sildenafil. The use of PDE 5 inhibitors, like sildenafil, can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE 5 inhibitors in "Magic Power Coffee" may pose serious health risks because patients 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. The failure to disclose the presence of hydroxythiohomosildenafil renders your product's labeling false and misleading. "Magic Power Coffee" is therefore misbranded under Section 502(a) of the Act (21 U.S.C. § 352(a). The introduction or delivery for introduction into interstate commerce of your misbranded product violates section 301(a) of the Act (21 U.S.C. § 331(a)).
"Magic Power Coffee" is also misbranded under Section 502(f)(2) of the Act, (21 U.S.C. § 352(f)(2)) in that its labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of "Magic Power Coffee" particularly since someone who takes one of these products would be unaware of the presence of hydroxythiohomosildenafil. For example, because hydroxythiohomosildenafil is an analogue of sildenafil and is a PDE5 inhibitor, patients who take nitrates and consume "Magic Power Coffee" may be at risk of life-threatening hypotension. 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)).
Adulterated Food
Even if "Magic Power Coffee" were a food, which it is not, the product could not be lawfully marketed because it would be adulterated within the meaning of section 402(a)(2)(C) of the Act (21 U.S.C. 342(a)(2)(C)). Any substance intentionally added to a conventional food must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction, or is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of intended use, or is otherwise exempt from the food additive definition in section 201(s) of the Act (21 U.S.C. §321(s)). Hydroxythiohomosildenafil is neither GRAS nor the subject of a prior sanction. It is therefore a food additive for which FDA has not adopted a regulation authorizing its use. Thus, even if Magic Power Coffee were a food, it would be adulterated under section 402(a)(2)(C) of the Act and could not be legally marketed in the United States.
The violations described above are not intended to be an all-inclusive list of violations that exist in connection with your products. FDA is continuing to evaluate your products and activities. It is your responsibility to ensure that any products manufactured or distributed by you meet all of the requirements of federal law and FDA regulations. In addition, please note that products are misbranded under section 502(j) of the Act (21 U.S.C. § 352(j)) if they are dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the product's labeling. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing within 15 working days of receipt of this letter as to the specific steps that you have taken to correct the violations noted above and to ensure that similar violations will not recur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections. 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 Compliance Branch, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433 Attention: Melaine D. Small, Compliance Officer.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
___________________________________________________________________
1 Your product does not fit within the "other than food" exception to the definition of "drug" in Section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)). Notwithstanding your use of the term "Dietary Supplement" to describe the product, a dietary supplement does not include a product represented for use as a conventional food. 21 U.S.C. § 321(ff)(2)(B). "Magic Power Coffee" is represented as a conventional food within the meaning of section 201(f) of the Act (21 U.S.C. § 321(f). For example, the product is labeled as coffee, and the label includes images of a cup of coffee and coffee beans, and a "Nutrition Facts" panel. Due to the presence of the synthetic active pharmaceutical ingredient, hydroxythiohomosildenafil, and the above-mentioned label claims, Magic Power Coffee is not consumed primarily for its taste, aroma, or nutritive value. It is therefore a drug within the meaning of the Act. See Nutrilab v. Schweiker, 713 F.2d 335 (7th Cir. 1983).
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