Solace International, Inc. - 07/03/2014
- Solace International, Inc.
- Issuing Office:
- San Francisco District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502
Tel. (510) 337-6700
RETURN RECEIPT REQUESTED
July 3, 2014
Solace International, Inc.
80 W. 1st Street, Suite C
Reno, NV 89501
Dear Mr. Lilly:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed the information on your website www.dermatend.com. The FDA had determined that your firm's marketing of the products, "Derma Tend Original Mole, Wart, Skin Tag Remover" and "Derma Tend Ultra Mole, Wart, Skin Tag Remover," which are offered for sale on your website, violates the Federal Food, Drug, and Cosmetic Act (the Act). As formulated, labeled, and promoted, both Derma Tend Original and DermaTend Ultra are unapproved drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 355(a)] and are misbranded under sections 502 and 502(f)(1) of the Act [21 U.S.C §§ 352 and 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these products is prohibited under sections 301 (a) and (d) of the Act [21 U.S.C. §§ 331 (a) and (d)].
Labeling claims for your products make clear that your product is intended to be used as a drug. The statements include, but are not limited to, the following:
• The product names, "Derma Tend original mole, wart, skin tag remover" and "Derma Tend ultra mole, skin tag remover"
• Statements on the dermatend.com website:
o "Removes moles and skin tags"
o "Safely remove unwanted moles, imperfections, and skin tags at home"
o "Derma Tend™ gives you the freedom to remove all your moles or skin tags in the comfort of your own home. No more doctors, no more surgery or insurance hassles."
o "When you apply Derma Tend™ to the blemish the active ingredients will penetrate to the root and alert your immune system. This immune response will send white blood cells to the blemish and start the removal and healing process
Based on these claims, both Derma Tend products are drugs, as defined by section 201(g)(1) of the Act [21 U.S.C. § 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.
Your Derma Tend products are new drugs, as defined by section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their 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. Your sale of Derma Tend Original and Derma Tend Ultra without an approved application violates these provisions of the Act.
Furthermore, Derma Tend Original and Derma Tend Ultra are offered for conditions, which are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, 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)]. These products are not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that labeling bear adequate directions for use because these products lack approved applications. Section 301(a) of the Act [21 U.S.C. § 331(a)], prohibits the introduction of a misbranded drugs into interstate commerce. Accordingly, the sale of the above--listed products violates these provisions of the Act.
We note that wart removal is among the uses your products are intended for and that there is a Final Monograph for OTC Wart Remover Products, 21 C.F.R § 358 Subpart B. In order to be lawfully marketed under the final common and plantar wart remover monograph, a: product must meet the requirements of the final monograph. However, neither Derma Tend Original nor Derma Tend Ultra conforms to the final monograph.
For example, the only active ingredient permitted under the monograph is salicylic acid and mole and skin tag removal are not uses addressed by this monograph. 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 review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
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 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. If you no longer manufacture or market the aforementioned products, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures these products, identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Please address your reply to William V. Millar, Compliance Officer, U.S. Food and Drug Administration, San Francisco District Office, 1431 Harbor Bay Parkway, Alameda, CA 94502.
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, 10903 New Hampshire Ave., WO51-2201, Silver Spring, MD 20993.
Kathleen M. Lewis, J.D.
San Francisco District Director
 We note that your website also references Derma Tend ultra as a mole, wart, and skin tag remover. For purposes of this letter, we consider the three products to raise similar concerns.
cc: Jessica Rich, Director, Bureau of Consumer Protection, Federal Trade Commission.