| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Denver District Office |
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
December 02, 2010
Prolatis’ (aka Hyper Interactive Media, LLC and Crush, LLC)
11778 Election Road, Suite 140
Draper, UT 84020
Ref: # DEN-11-03-WL
Dear Mr. Brailow:
This letter concerns your firm’s distribution and marketing of the product “ProLatis’.” As described below, “ProLatis’” is an unapproved new drug 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)] and is misbranded in violation of sections 502(f) and 502(a) [21 U.S.C. §§ 352(f) and 352(a)] of the Act.
On August 5, 2010, investigators from the Food and Drug Administration (FDA) obtained two samples of “ProLatis’” from (b)(4). Each sample was from a unique lot and obtained from a different (b)(4) location. “ProLatis’” is labeled as a dietary supplement. However, as you were informed, laboratory analyses conducted by the FDA concluded that “ProLatis’” contains sulfoaildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED). According to statements on the label of “ProLatis’”, it is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. These statements include, but are not limited to, the following:
- “All-Natural Male Performance Pill”
- “This time you will be ready!”
- “Take 1-2 capsules 2 hours before sexual activity.”
These statements make clear that “ProLatis’” is a drug under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)] because it is intended to affect the structure or function of the human body. Under section 201(g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)], or the 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. However, the structure/function claims quoted above for “ProLatis’” do not describe the effects of nutrients or dietary ingredients in the product. Rather, the claims are made for the product as a whole and relate to its sulfoaildenafil content. Since sulfoaildenafil is not a nutrient or dietary ingredient, as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], but a synthetic active pharmaceutical ingredient, claims about improvement of sexual function do not conform to section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)]. Accordingly, “ProLatis’” is a drug within the meaning of section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)].
Moreover, “ProLatis’” 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 distribution or sale of “ProLatis’” without an approved application violates these provisions of the Act.
“ProLatis’” is a “prescription drug” as defined at 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 FDA approvals of PDE5 inhibitors are limited 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 drugs that bear their FDA-approved labeling are exempt from the requirement that they 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 for your firm’s “ProLatis’,” 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)].
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 “ProLatis’” does not declare that it contains sulfoaildenafil. Because it is an analogue of sildenafil, it likely exhibits similar pharmacological action to sildenafil. The use of PDE5 inhibitors, like sildenafil, can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE5 inhibitor in “ProLatis’” may pose a serious health risk 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, PDE5 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, patients who have been advised against taking PDE5 inhibitors because of comorbidities or potential drug interactions may seek products like “ProLatis’” because it is marketed as not containing the active ingredients in approved ED drugs. The failure to disclose the presence of sulfoaildenafil renders your product’s labeling false and misleading. “ProLatis’” is therefore misbranded under Section 502(a) of the Act [21 U.S.C. § 352(a)].
“ProLatis’” 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 “ProLatis’”, particularly since someone who takes it would be unaware of the presence of sulfoaildenafil. For example, because sulfoaildenafil is an analogue of sildenafil and is a PDE5 inhibitor, patients who take nitrates and consume “ProLatis’” may be at risk of life-threatening hypotension.
The introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301 of the Act (21 U.S.C. § 331).
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 product. 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 assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to ensure that you have knowledge of the ingredients in your products before you offer them for sale.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. 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 corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be sent to the Food & Drug Administration, Denver District Office, P.O. Box 25087, Denver, CO 80225-0087, to the attention of Thomas R. Berry, Compliance Officer. If you have any questions regarding the content of this letter, please contact Mr. Berry at (303) 236 -3028.
H. Thomas Warwick, Jr.
Denver District Director
Mr. Joseph Fortunato
Director and Chief Executive Officer
General Nutrition Centers, Inc.
300 6th Ave. Pittsburgh, PA 15222