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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Professional Hair Institute, Inc. 13-Oct-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Baltimore District Office
6000 Metro Drive, Ste 101
Baltimore, MD 21215
Telephone: (410) 779-5454

FEI: [redacted]

VL 05-200834

WARNING LETTER

October 13, 2005

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Mr. Dennis R. Jones
President
Professional Hair Institute, Inc.
1025 Executive Blvd ., Suite 112
Chesapeake, VA 23320

Dear Mr. Jones:

This letter concerns Sonacaine Topical Anesthetic Gel (Sonacaine) and Zcaine Fast Acting Anesthetic Gel (Zcaine), distributed by your firm. Based on these products' labeling, they are intended for topical over-the-counter (OTC) use as an anesthetic to control discomfort and soothe the skin when applied before laser treatment. These intended uses cause these product to be drugs under Section 201(g) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. 321(g).

The labeling for Sonacaine includes the following claims: "Rapidly effective to control discomfort and soothe the skin when applied topically prior to laser treatment . . . ." And "Cover [treated area] with clear plastic wrap and wait 45 minutes to 1 hour for numbness to develop . . . ." The labeling for Zcaine includes the following claims: "works immediately on contact to control discomfort and soothe skin when applied prior to laser treatment . . . ." And "For optimal results cover with occlusive dressing ." Additional labeling on your firm's website, www.creativeinc.biz, provides, "Occlusion, or covering the application with plastic wrap, speeds up absorption of Zcaine into the skin . . . .[and although] occlusion is not necessary for Zcaine's numbing benefits it can be used to maximize pain relief and is recommended for optimal absorption and results . . . ." As noted above these claimed uses cause Sonacaine and Zcaine to be drugs as defined by the Act.

As a condition for marketing Sonacaine and Zcaine under FDA's OTC Drug Review, there must be a precedent OTC product containing 4% lidocaine, marketed in the United States on or before December 4, 1975, with the indications found in your products' labeling. We are unaware of any such products, and Sonacaine and Zcaine therefore are not extended to the OTC Drug Review. Further, the Tentative Final Monograph (TFM) for External Analgesics (48 Fed. Reg. 5852, February 8, 1983) does not permit indications such as controlling discomfort during laser treatment.

Because they fall outside the OTC Drug Review, Sonacaine and Zcaine are not generally recognized as safe and effective for their labeled indications. We are not aware of any data establishing that Sonacaine or Zcaine are generally recognized as safe and effective for those indications. Accordingly, these products are new drugs as defined by Section 201(p) of the Act [21 U.S.C. 321(p)]. Under Section 505(a) of the Act [21 U.S.C. 355(a)], a new drug must be the subject of an approved application to be legally marketed in the United States. Sonacaine and Zcaine lack approved applications and their marketing in this country violates Sections 505(a) and 301(d) of the Act [21 U.S.C. 355(a) and 331(d)].

Furthermore, Sonacaine is misbranded under Section 502(a) of the Act [21 U.S.C. 352(a)] because its label identifies Professional Hair Institute, Inc. as the manufacturer of the product. It was determined during the inspection of your firm that, [redacted] manufactures Sonacaine.

Your products are also misbranded under Section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because their directions for use are inadequate for the products' intended uses as represented in their labeling. Be advised that occlusion of topically applied anesthetics containing lidocaine has been associated with recent deaths. Such directions may pose a serious safety risk.

The violations described above are not meant to be all-inclusive. It is your responsibility to ensure that all drug products manufactured or distributed by your firm comply with the Act. 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 request that you take action immediately to correct these violations. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.

Please send a written response to this office within fifteen working days of receipt of this letter. Your response should describe the specific actions that you will take, or that you have taken, to correct the violations described in this letter. Your response should also include an explanation of each step being taken to prevent recurrence of similar violations. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which corrections will be completed. Please direct your response to Kirk D. Sooter, Compliance Branch Director, at the address and telephone number above.

Sincerely,

/S/

Michael W. Roosevelt
Acting District Director