Inspections, Compliance, Enforcement, and Criminal Investigations
Melanocorp, Inc. 30-Aug-07
Department of Health and Human Services
Public Health Service
New Orleans District
August 30, 2007
WARNING LETTER NO. 2007-NOL-15
133 Trail East Drive
Hendersonville, Tennessee 37215
Dear Mr. Manookian:
This letter concerns your firm's marketing of the product Melanotan II on your Internet website, www.melanocorp.com. According to information on your website, Melanotan II is an injectable product intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. Statements on your website which document these intended uses include, but are not limited to, the following:
"Melanotan II is an analog of the peptide hormone alpha-melanocyte stimulating hormone that induces skin tanning. The drug was developed at the University of Arizona. Researchers there knew that one of the best defenses against skin cancer was a natural tan which has been slowly developed over weeks. They hypothesized that an effective way to reduce skin cancer rates in people would be to induce the body's natural tanning system to produce a protective tan prior to UV exposure."
"Melanotan II . . . The hormones stimulate the body's own melanin production to give users a deep and natural tan without an orangish [sic] hue or uneven color."
"As a long time sufferer of rosacea I can't begin to tell you how much your service means to me. A (very) pale redeheaded [sic] friend of mine turned me on to your site, and I thought, hey what could it hurt. Well, two months later my red splotches have completely transformed into a deep brown tan. Thank you so much! Barbara, USA"
Furthermore, your website provides the link "Melanotan II in the News." This link takes consumers to the pages http://www.newswise.com/articles/view/506095/ and http://www.abc.net.au/news/newsitems/200407/s1158519.htm. Statements on these web pages further demonstrate Melanotan II is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. The following are examples of statements which document these intended uses:
"Hormone shots help tanning, cut sun damage: study."
"Drug Can Induce Tanning"
Based on this information and these types of statements on your website, Melanotan II is a drug, 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 it is 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, this product is a new drug, as defined by Section 201(p) of the Act, 21 U.S.C. Section 321(p), because it is 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), 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 Melanotan II without an approved application violates these provisions of the Act.
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 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 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. Other Federal agencies may take this warning letter into account when considering the award of contracts.
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 manufacture or market Melanotan II, your response should so indicate, including the reasons, and the date on which you ceased production.
Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Please direct your response to the U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, TN 37217-1003, Attention: Kari L. Batey, Compliance Officer.
A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
H. Tyler Thornburg
New Orleans District