Inspections, Compliance, Enforcement, and Criminal Investigations
Kramer Laboratories Inc. 22-Nov-05
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Suite 200
RETURNED RECEIPT REQUESTED
November 22, 2005
Gloria M . Rodriquez, President
Kramer Laboratories Incorporated
8778 S.W. 8th Street
Miami, FL 33174
Dear Ms. Rodriquez:
This letter pertains to the marketing and distribution of your products, FUNGI-NAIL BRAND Anti-Fungal Solution (Fungi-Nail) and FUNGI-NAIL BRAND ANTI-FUNGAL TREATMENT SYSTEM (System Kit). We have also reviewed the labeling of your products and statements about them at the following Internet websites: http://www.funqinail.com and www.kramerlabs.com.
As explained below, our review shows that Fungi-Nail and the System Kit are drugs as defined by section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g), and that they are new drugs as defined by section 201(p) of the Act, 21 U.S .C. § 321(p). Because these products are not the subject of FDA- approved drug applications, they are marketed in violation of sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a). The products are also misbranded under sections 502(a) and (f)(1) of the Act, 21 U.S.C. §§ 352(a) and (f)(1).
Our review included the following labeling statements about your products:
"Preliminary Treatment and Control of Nail Fungus . . . Fungus Infections of the Nails . . . Follow these simple instructions to treat your nail infections . . . . Apply FungiNail®Brand Anti-fungal Solution twice a day (morning and night) to all infected nails . . . ." [instruction book accompanying kit]
"Use FungiNail Brand Anti-fungal Solution as effective treatment for and prevention of jock itch, athlete's foot and ringworm infections-as well as nail infections ." [instruction book accompanying kit]
- " The Kit's outer carton displays a circled picture of a diseased nail and states,
"A COMPLETE SYSTEM FOR THE SELF-TREATMENT OF FUNGUS WITHOUT A PRESCRIPTION . . . ."
"THE ORIGINAL FUNGI-NAIL BRAND . . . Anti-fungal Treatment that is Safe and Effective . . . Fingernails and Toenails . . . Fungal Infections of the Nails . . . Signs and Symptoms . . . Fungus spores may attach themselves to the dense bed of keratin cells that make up your nails . The resulting infection, called onychomycosis (tinea of the nails) may persist indefinitely . . . . For many years, physicians and pharmacists have recommended Fungi-Nail Brand for treating infections of the nails . . . ." [product insert]
"Fungi-Nail Brand Anti-Fungal Treatment System. A complete system for the self treatment of nail fungus . . . ... [product insert]
Moreover, your labeling for both Fungi-Nail and the System Kit directs readers to your websites http//www.kramerlabs.com and www.funginail.com. These websites further establish the products' intended uses. Statements on www.krameriabs.com include, "Fungi-Nail Brand is the strongest topical anti-fungal medication available without a prescription." The website also includes information under the section "Fungus Infection" that states, "Athlete's foot, jock itch and ringworm of skin and scalp are fungus caused by mold-like fungi called dermatophytes. These fungi thrive on the dead tissues of your hair, finger and toenails and the outer layer of your skin. Poor hygiene, continually moist skin and minor skin and nail injuries increase your chances of developing a fungal infection."
The above statements, and the names of the products themselves, Fungi-Nail Brand Anti-Fungal Treatment and Fungi-Nail Brand Anti-Fungal Solution, demonstrate that your products are intended for the treatment of fungal nail infections, despite their disclaimers stating they are not effectiveness on the scalp or nails.
Based on the claims and representations made in the products' labeling and evidence of the products' intended uses, Fungi-Nail and the System Kit are drugs as defined by section 201(g) of the Act, 21 U.S.C. § 321(g), and are subject to the final regulations covering topical antifungal OTC drug products, codified at Title 21, Code of Federal Regulations (CFR), Part 333, Subpart C. The only indications for use permitted by those regulations are athlete's foot, jock itch, and ringworm.
Fungi-Nail and the System Kit are also subject to final regulations covering OTC drug products containing certain active ingredients and offered OTC for use on nails. These regulations, set forth at 21 CFR § 310.545(a)(22)(iii), provide that there are no active ingredients recognized for OTC use to treat fungal infections of the scalp and nails. Therefore, Fungi-Nail and the System Kit are not generally recognized as safe and effective for these indications, causing them to be "new drugs" as defined by section 201(p) of the Act, 21 U.S.C. § 321(p). Because these products are new drugs, their marketing without approved applications causes them to violate sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d), 355(a).
The products are also misbranded under section 502(a) of the Act because, while their packaging disclaims use for nail fungus treatment, the materials accompanying the products and the promotional statements about them clearly demonstrate that they are intended for this purpose. The discrepancy between the disclaimer and the promotional statements causes the products' labeling to be false and misleading.
Fungi-Nail and the System Kit are further misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S .C. § 352(f)(1), because their labeling lacks adequate directions for use, as defined by 21 CFR § 201.5. The conditions for which the products are offered are not amenable to self diagnosis and treatment by the laity; therefore, adequate directions for use cannot be written under which laymen can use these products safely and effectively for their intended uses. Further, the products are not exempt from this requirement under 21 CFR § 201.115 because they are new drugs that lack approved applications.
This letter is not an all-inclusive review of your products or your product labeling. You must ensure that all products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against the manufacturers and distributors of those products. Federal agencies are advised of the issuance of all Warning Letters pertaining to drugs and devices so that they may take this information into account when considering the award of contracts.
We sent you a Warning Letter on March 4, 1996, regarding the Fungi-Nail product. As explained in this Warning Letter, since that time, you have added additional promotional material and labeling claims that further cause your products to violate the Act. You must take prompt action to correct the violations identified in this letter. Failure to do so may result in enforcement action without further notice.
Please advise this office, in writing and within fifteen working days of receipt of this letter, as to the specific steps that you have taken to correct any violations and to assure that similar violations do not occur. If corrective action cannot be completed with fifteen working days, state the reason for the delay and the time within which the corrections will be made.
Your reply should be sent to the attention of Compliance Officer Shari Shambaugh at 555 Winderiey Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms. Shambaugh at (407) 475-4730.
Emma R. Singleton
Director, Florida District