Inspections, Compliance, Enforcement, and Criminal Investigations
US Lab Research, Inc. 1/06/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Cincinnati District Office
6751 Steger Drive
Cincinnati, 0H 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
Via Federal Express
January 6, 2009
Mr. Timothy J. Parr, President
US Lab Research, Inc.
7409 Kingston Court
Mentor, Ohio 44060
Dear Mr. Parr:
This letter concerns your firm's marketing of the products "10 mg Melanotan ONE - American Lab", "10 mg Melanotan ONE - Chinese Lab", "50 Mg Kit Melanotan ONE - Chinese Lab", "50 Mg Kit Melanotan ONE - American", "10 MG MT 2 -American Lab", "10 mg MT 2 -Chinese Lab", "50 MG Kit MT 2 -American", and "50 mg Kit MT 2 -Chinese Lab" on your website, www.uslabresearch.com. According to information on your website, you market injectable products intended to prevent, treat, or cure disease conditions in humans or to affect the structure or function of the human body.
Melanotan ONE and MT 2 Products
Statements on your website, www.uslabresearch.com, that document the intended uses include, but are not limited to, the following:
• "What side effects have been noted for Melanotan and Melanotan 2? Hyper pigmentation including new freckles/spots or darkening of existing ones. Darkening, enlarging or new moles. Darkening of hair, and color changes in places where melanin normally concentrates (i.e. genital region, and on rare occasions lips). Some have mentioned white spots that do not tan (some of these resolved themselves, but not all). For Melanotan 2, some have had an undesired increase in libido and erections with a rare report of priapism . Reports of new moles are more common with Melanotan 2 than with Melanotan. Some have claimed a link between Melanotan 2 and serious eye and heart problems."
Furthermore, your website provides the link "News/Articles". This link takes consumers to the page http://www.melanotan.org. Statements on this website further demonstrate your MT 2 products are intended to prevent, treat, or cure disease conditions in humans or to affect the structure or function of the human body. The following are statements that document these intended uses:
• "Both Melanotan and Melanotan II have sunless tanning capabilities but because Melanotan II had libido enhancement and spontaneous erections as side effects, it is now being developed as a sexual and erectile dysfunction drug."
• "Supplier - US Lab Research (Chinese Peptide) / Mgs into cycle -18.8, .6mgs per day / Opinion -great potency, great results, minimal side effects - I am / getting spontaneous erections and moles though."
•"Uslabresearch (American Peptide) / Mgs into cycle: 6.5mg / dose: .5mg ED before bed / results / sides: so far im amazed at how tan i already am from only 3 tanning sessions ... very impressed with product."
Your website's "News/Articles" page also takes consumers to the following webpage, http://www.drnase.com/rosacea_hot_topics.htm#mel, which makes additional statements that demonstrate that your Melanotan and MT 2 products are intended to prevent, treat, or cure disease and conditions in humans or to affect the structure or function of the human body, in this case as a treatment for rosacea. The following are statements that document these intended uses:
• "One of the most interesting findings demonstrated that after 3 months of treatment with Melanotan I, epidermal thickness increased significantly in all subjects .... In rosacea sufferers the epidermis can be half that of normal subjects; thus doubling or tripling the thickness of the epidermis should be extremely beneficial to rosacea sufferers."
• "Melanotan II: All Studies Show that this Polypeptide will benefit Rosacea Patients"
• "Rosacea is known to involve an inflammatory response via neutrophilic action. Rosacea also causes fibrosis in the dermis. Both of these negative actions are reversed while on Melanotan II."
Your website's "News/Articles" page also takes consumers to http://www.museletalk.co.uk/article-melanotan.aspx, a bodybuilding article, which makes additional statements that demonstrate that your products are intended to prevent, treat, or cure disease conditions in humans or to affect the structure or function of the human body. The following are statements which document these intended uses:
• "Along with other melanocortins, they are responsible for various internal human functions including skin and hair pigmentation, appetite, libido and physical sexual arousal. Whilst these effects have been observed in both sexes, it is worth noting that increases in libido and sexual function are exclusive to MT-II"
• "Both Melanotan and Melanotan II have been shown in the clinical setting to increase pigmentation without exposure to UV ...."
In addition to the claims cited above, the name of the product is "Melanotan." "Melanotan" is a combination of the words "melanin," meaning pigments responsible for the dark color of the skin and hair in man and other animals, and "tan," meaning a brown color imparted to the skin. These words imply that this product is intended to affect the structure or function of the human body, namely the darkening of skin color. As such, listing the ingredient "Melanotan" on the labeling causes your Melanotan products to be drugs under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1).
For these reasons, "10 mg Melanotan ONE - American Lab", "10 mg Melanotan ONE - Chinese Lab", "50 Mg Kit Melanotan ONE - Chinese Lab", "50 Mg Kit Melanotan ONE - American", "10 MG MT 2 - American Lab", "10 mg MT 2 - Chinese Lab", "50 MG Kit MT 2 - American", and "50 mg Kit MT 2 Chinese Lab" are drugs, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. Section 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. Moreover, these products are new drugs, as defined by Section 201(p) of the Act [21 U.S.C. Section 321(p)], because they are not generally recognized as safe and effective for its labeled uses. Under Sections 301(d) and 505(a) of the Act [21 U.S.C. Sections 331(d) and 355(a) respectively], 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 these products without approved applications violates these provisions of the Act.
Because "10 mg Melanotan ONE - American Lab", "10 mg Melanotan ONE - Chinese Lab", "50 Mg Kit Melanotan ONE - Chinese Lab", "50 Mg Kit Melanotan ONE - American", "10 MG MT 2 - American Lab", "10 mg MT 2 - Chinese Lab", "50 MG Kit MT 2 - American", and "50 mg Kit MT 2 - Chinese Lab" are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use them safely for their intended uses. Thus, your products' labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
You have attempted to disclaim some of the statements on your site that indicate that the products are intended to prevent, treat, or cure disease conditions in humans or to affect the structure or function of the human body. For example, your site includes the following regarding your products:
"We seek to avoid any buyers planning experimentation on humans outside of a controlled FDA regulated study through use of our disclaimer which reads as follows: `Product is legally sold for non-human experimental purposes only. Buyer warrants that the product will not be used in any other manner and assumes any and all responsibility for misuse. Buyer further warrants that they are of legal age and that the purchase of this item is legal where this is being shipped to or used and assumes responsibility for any legal infractions ...'
We further avoid improper sales and seek to conform to US laws by not including any claims or educational information regarding the peptides we sell on our site. Even mention of published results and studies have been removed to avoid any interpretation that these may be product claims that would encourage human use. Our FAQ page specifically states that we will not answer any questions related to human use of any of our products."
However, untrue or misleading information in one part of your site will not be mitigated by inclusion of such a "disclaimer." per 21 C.F.R. 202.1(e)(3)(i). Regardless of your statement, "for non-human experimental purposes only," the circumstances surrounding the promotion of your products demonstrate that your disclaimer is ineffectual and your products are, in fact, intended for human use.
In addition to the cited claims, you market accessories at www.uslabresearch.com that include needles for injections, saline water, and alcohol prep pads. Your website also links to www.melanotan.ora, a website that provides a discussion forum with topics that include dosing, mixing, and injecting both Melanotan and Melanotan II. Furthermore, FDA purchased from your website a sample of your products and received a 10mg vial of MT 2, syringes with needles for injection, alcohol pads, and bacteriostatic water.
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations which exist in connection with your product(s). You are responsible for investigation 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 the products you manufacture or distribute comply with all requirements of federal law and FDA regulations.
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 and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps 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. If you no longer market your violative products, your response should so indicate, including the reasons, and the date on which you ceased distribution.
Your written response should be sent to Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Parmon at 513-679-2700 Ext. 162.
Teresa C. Thompson