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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ESBA Laboratories, Inc. 09-Nov-05

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

Public Health Service
Food and Drug Administration

 

555 Winderley PI ., Ste. 200
Maitland, FL 32751



CERTIFIED MAIL
RETURN RECEIPT REOUESTED

WARNING LETTER

FLA-06-04

November 9, 2005

Estela Basso, President
ESBA Laboratories, Inc.
1001 Jupiter Park Drive
Suite 112
Jupiter, FL 33458

Dear Mrs. Basso:

This letter concerns Topicaine® and Topicaine 5®, topical anesthetic gel products marketed by your firm. These products contain 4% and 5% lidocaine, respectively. As evidenced by their labeling and promotional materials, these products are intended for over-the-counter (OTC) use as topical anesthetics to temporarily prevent and relieve pain caused by laser hair removal, laser acne treatments, and various other procedures such as dermal filler, botox injections, permanent make-up, port-wine stain treatments, tattoo removal, acid peels, and hair transplants.

Your labeling, promotional material, and website, www.tonicaine.com, include the following statements:

Topicaine brochure that is included with shipments of both the 4% and 5% formulations:

"For the PREVENTION of pain: [from] . . . Collagen injections . . . Botox . . . Acid Peels . . . Permanent Make-Up . . . Electrolysis . . . Tattooing . . . Laser or IPL Hair Removal . .

Brochure testimonial:

"Topicaine gave me exceptional relief from the discomfort of the laser . . . . I am now approaching my final laser hair removal treatment and I attribute my staying power and my ability to receive treatments at a higher than typical setting to the fact I trusted [Topicaine]."

Topicaine flyer promoting both 4% and 5% formulations:

"TOPICAINE Topical Anesthetic Gel: Lidocaine 4% or 5% . . . . LASER HAIR REMOVAL DERMAL FILLER/BOTOX INJECTIONS PERMANENT MAKE-UP PORT-WINE STAIN TREATMENT LASER/IDL/PDT ACNE TREATMENT . . . FAST AND CLINICALLY PROVEN . . . ."

Topicaine label:

"TOPICAINE . . . PREVENTS PAIN caused by: Laser treatments : hair removal, veins, port wine stains, skin resurfacing. Electrolysis . . . . For best results: Apply a thick layer- Optionally: cover with plastic film . . . . For the PREVENTION of pain such as before hair removal: apply 30-60 min in advance."

Topicaine 5 label:

"For best results: Apply a thick layer. Allow time for penetration. Onset of numbness is 5 min, with efficacy increasing with application time 30 min. to 60 min. recommended covering area with plastic film accelerate penetration."

www.topicaine.com promoting both the 4% o and 5% formulations:

"Topicaine gel is a topical anesthetic used daily by more than 5,000 doctors and laser centers worldwide."

"Initially developed for electrolysis, it has been found useful for: . . . laser hair removal, laser skin surfacing..."

"Topicaine should be applied 30-60 minutes prior to the application of the laser, preferably under occlusion."

These claims are evidence of the products' intended uses and cause them to be drugs pursuant to section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g).

As a condition for marketing Topicaine and Topicaine 5 as OTC topical analgesic products under FDA's OTC Drug Review, there must be precedent products containing 4% lidocaine (for Topicaine) and 5% lidocaine (for Topicaine 5), marketed in the United States on or before December 4, 1975, with the indications found in these products' labeling. We are unaware of any such products; therefore, they are not eligible for inclusion in the OTC Drug Review. Further, the Tentative Final Monograph for External Analgesics (48 FR 5852, February 8, 1983) and the conditions of use in the Final Monograph for OTC Anorectal products (55 FR 31776, August 3, 1990) do not include indications such as prevention and relief of pain from laser hair removal, waxing, electrolysis, tattooing, and your products' other labeled indications.

Because Topicaine and Topicaine 5 fall outside the OTC Drug Review, they are not generally recognized as safe and effective for their labeled indications. Accordingly, these products are new drugs as defined by 21 U.S.C. § 321(p). Under 21 U.S.C. § 355(a), a new drug must be the subject of an approved application as a condition of marketing in the United States. Topicaine and Topicaine 5 lack approved applications and their marketing in this country violates 21 U.S.C. §§ 355(a) and 331(d).

Topicaine and Topicaine 5 are intended and labeled for use by the general public for the indications described in this letter. These indications require the supervision of a physician or other learned intermediary. Thus, adequate directions for use, as described by 21 CFR § 201.5, cannot be written for these uses. Pursuant to 21 U.S.C. § 352(f)(1), Topicaine and Topicaine 5 therefore are misbranded. Be advised that occlusion of topically applied anesthetics containing lidocaine has been associated with recent deaths. Accordingly, directions regarding occlusion may pose a serious safety risk.

In addition, statements in your labeling imply that Topicaine is a safe and effective, FDA approved product. For example, your Topicaine flyer states that Topicaine, referencing both the 4% and 5% lidocaine products, "is a safe OTC product," and directs treatment facilities not to risk liability with a "non-FDA-approved" compounded product. This labeling is false and misleading because it suggests that there is evidence that your products are safe, effective, and approved by FDA for their intended uses. Such evidence has not been established and your products therefore, are misbranded under 21 U.S.C. § 352(a).

The violations described above are not meant to be all-inclusive. It is your responsibility to ensure that all drug products manufactured and 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. You must 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 have taken, to correct the violations described in this letter. Your response should also include an explanation of each step 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.

Your reply should be addressed to Shari H. Shambaugh, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District