| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human ServicesApril 18, 2011
WARNING LETTER NO. 2011-NOL-12
UNITED PARCEL SERVICE
Delivery Signature Requested
R. Parker LeCorgne, President
Dr. G.H. Tichenor Antiseptic Co.
4200 Poche Court West
New Orleans, LA 70129-2222
Dear Mr. LeCorgne:
On August 24, 2010, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your liquid and ointment pharmaceutical manufacturing facility, located at 4200 Poche Court West, New Orleans, Louisiana. During the inspection, labeling of your “DR. TICHENOR’S ANTISEPTIC GEL,” “Bruise Relief,” and “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic,” products were collected. Based on a review of each of the products’ labeling, which includes your website at www.drtichenor.com, your products are drugs as defined in Section 201(g) of the Federal Food Drug and Cosmetic Act (the Act) [21 United States Code § 321(g)] (21 USC 321), because they are intended for use in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. Furthermore, as presently formulated, labeled and promoted, these over-the-counter (OTC) products violate provisions of the Act.
Below is an analysis of the regulatory status of “DR. TICHENOR’S ANTISEPTIC GEL,” “Bruise Relief,” and “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic,” which includes excerpts of the violative labeling and the specific new drug and misbranding charges. Please note, this is not an all inclusive description of all violative labeling [violations] for your OTC drug products.
“DR. TICHENOR’S ANTISEPTIC GEL”
The package labeling and your Internet website (www.drtichenor.com), includes the following “drug” claims for this product:
“KILLS MOST GERMS ON CONTACT”
“SOOTHING, COOLING RELIEF FROM INSECT BITES, MINOR BURNS AND OTHER SKIN IRRITATIONS”
“HAND SANITIZER”
“KILLS STAPH & MRSA”
“Uses . . . For topical antimicrobial use . . . First aid use for minor cuts and scrapes . . . Dries the oozing of: Poison ivy, Poison oak, Poison sumac . . . Temporarily protects minor: Cuts, Scrapes, Burns . . . Temporarily protects and helps relieve minor skin irritation and itching due to rashes and eczema . . . Temporarily helps relieve minor skin irritation and itching due to insect bites . . . Hand sanitizer to help reduce bacteria on the skin”
“KILLS MOST GERMS ON CONTACT SOOTHING, COOLING RELIEF FROM INSECT BITES, MINOR BURNS AND OTHER SKIN IRRITATIONS HAND SANITIZER DR. TICHENOR’S ANTISEPTIC GEL KILLS STAPH & MRSA.”
“Please note, in particular, Dr. Tichenor's Antiseptic Gel was successful against Staphylococcus A, especially the antibiotic resistant MRSA strain. Given the nationwide concern over these infections, we think we belong on your shelf, as your number one germ fighter.”
“DR. TICHENOR’S ANTISEPTIC GEL” is a drug as defined by Section 201(g)(1) of the Act [21 USC 321(g)(1)], because it is an article intended for use in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man.
Based on the OTC skin protectant drug claims noted above, “DR. TICHENOR’S ANTISEPTIC GEL” is subject to the Final Monograph for OTC Skin Protectant Drug Products Title 21, Code of Federal Regulations, Part 347 (21 CFR 347). However, for the reasons set forth in the following paragraphs, “DR. TICHENOR’S ANTISEPTIC GEL” does not meet this final monograph.
Your product’s “Drug Facts” label identifies as the “Active ingredients … Purpose” “Alcohol 70% … Antimicrobial/Skin Protectant” and “Peppermint Oil 3% … Skin Protectant.” However, this product is neither formulated nor labeled in accordance with that monograph. Peppermint Oil and Alcohol 70% are not recognized as skin protectant active ingredients in 21 CFR 347.10. Furthermore, the Agency determined there is inadequate data to establish general recognition of the safety and effectiveness of alcohol and peppermint oil for use as an insect bite and sting drug product under this monograph [21 CFR 310.545(a)(18)(v)(A)].
“DR. TICHENOR’S ANTISEPTIC GEL” is a four-way combination of a skin protectant, an external analgesic, a first-aid antiseptic, and a healthcare antiseptic. FDA has considered the Final Monograph for OTC Skin Protectant Drug Products (21 CFR 347) in evaluating the regulatory status of “DR. TICHENOR’S ANTISEPTIC GEL.” The final monograph for OTC Skin Protectant Drug Products permits the two-way combination of a generally recognized safe and effective (GRAS/E) skin protectant active ingredient with either a GRAS/E first-aid antiseptic active ingredient or a GRAS/E external analgesic active ingredient, provided the combination complies with the conditions outlined in 21 CFR 347.20. Because “DR. TICHENOR’S ANTISEPTIC GEL” is a four-way combination of a skin protectant, an external analgesic, a first-aid antiseptic, and a healthcare antiseptic, it does not meet this final monograph.
Also, we considered whether “DR. TICHENOR’S ANTISEPTIC GEL” is formulated and labeled in compliance with the Tentative Final Monograph (TFM) for OTC healthcare antiseptics and OTC first aid antiseptics. Although one of the active ingredients in “DR. TICHENOR’S ANTISEPTIC GEL” (alcohol) is covered by these ongoing rulemakings (OTC healthcare antiseptics and OTC first aid antiseptics) for certain topical antimicrobial uses, the combination of alcohol and peppermint oil is not. In addition, the consumer-directed claims for effectiveness against specific microorganisms, such as Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) are not covered by these ongoing rulemakings. Therefore, this product is not formulated and labeled in accordance with the TFMs.
Pending a final monograph for OTC topical antimicrobials, FDA would not object to the marketing of an OTC healthcare antiseptic or OTC first aid antiseptic which meets the provision of the TFM. For your information and guidance, OTC topical antimicrobials, which include OTC healthcare antiseptics and OTC first aid antiseptics, are being evaluated under FDA's OTC Drug Review. TFMs for these products were published in the Federal Register of 59 Fed. Reg. 31402 (June 17, 1994) and 56 Fed. Reg. 33644 (July 22, 1991). These TFMs are available on FDA’s Internet website at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm070821.htm.
We considered whether “DR. TICHENOR’S ANTISEPTIC GEL” is formulated and labeled in compliance with the TFM for external analgesics, because it claims to provide a “soothing, cooling relief from insect bites, minor burns and other skin irritations,” “helps relieve minor skin irritation and itching due to rashes and eczema,” and “helps relieve minor skin irritation and itching due to insect bites.” For your information and guidance, OTC external analgesics is being evaluated under FDA’s OTC Drug Review (See http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm155846.htm#). The TFM for OTC External Analgesic Drug Products permits the two-way combination of a GRAS/E external analgesic active ingredient with either a GRAS/E skin protectant active ingredient or a GRAS/E Topical Antimicrobial active ingredient [Federal Register of 48 Fed. Reg. 5868 (February 8, 1983)]. This product does not conform to this TFM because, while alcohol 70% is an acceptable First-Aid Antiseptic ingredient, peppermint oil is not a recognized skin protectant ingredient nor is it a recognized External Analgesic ingredient. Therefore, this product is neither formulated nor labeled in accordance with this TFM.
Thus, “DR. TICHENOR’S ANTISEPTIC GEL,” as formulated and labeled, does not comply with the final monograph for OTC Skin Protectant Drug Products at 21 CFR 347, nor does it conform to the TFMs for OTC Health Care Antiseptic Drug Products; OTC First-Aid Antiseptic Drug Products; and, OTC External Analgesics Drug Products, nor to any other final or tentative final monograph under the OTC Drug Review. Further, we are not aware of sufficient evidence to show “DR. TICHENOR’S ANTISEPTIC GEL,” as formulated and labeled, is generally recognized as safe and effective. As noted above, we are also not aware of any marketing of a product formulated and labeled like “DR. TICHENOR’S ANTISEPTIC GEL” on or before the inception of the OTC Drug Review. As a result, the product is not deferred to the OTC Drug Review for such indications. Therefore, “DR. TICHENOR’S ANTISEPTIC GEL” is a “new drug” under Section 201(p) of the Act [21 USC 321(p)]. Because “DR. TICHENOR’S ANTISEPTIC GEL” is a “new drug” under Section 201(p) of the Act [21 USC 321(p)], under Sections 301(d) and 505(a) of the Act [21 USC 331(d) and 355(a)], it may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.
“Bruise Relief”
According to the package labeling, this product is intended for the reduction and/or elimination of bruises from surgery and cosmetic procedures, dark circles, and skin discolorations. Statements on the respective package labeling that demonstrate these intended uses include the following:
“Bruise Relief”
“Safe & effective for use immediately following cosmetic & dermatologic procedures”
“Reduces bruising & the appearance of dark circles”
“Use for: Bruising, Dark Circles, Skin Discolorations”
“Virtually Eliminates Bruising . . . Bruises on the Body & Face . . . Dark Circles Under Eyes . . .
Post Cosmetic Procedures . . .”
Based on the labeling described above, “Bruise Relief” is a “drug” as defined by Section 201(g)(1) of the Act [21 USC 321(g)(1)] because it is intended to affect the structure or any function of the body of man.
However, we are not aware of sufficient evidence which shows “Bruise Relief” is generally recognized as safe and effective for the uses noted above. In particular, we are not aware of evidence that this product is safe and effective in eliminating and/or reducing bruising following cosmetic and dermatologic procedures, dark circles, or skin discolorations.
FDA initiated the OTC Drug Review to evaluate the safety and efficacy of OTC drugs marketed in the United States at the inception of this review. We are not aware of any evidence a product so formulated and labeled was marketed in the United States on or before the inception of the OTC Drug Review. As such, “Bruise Relief” does not qualify for evaluation under the OTC Drug Review. Therefore, “Bruise Relief” is a “new drug” under Section 201(p) of the Act [21 USC 321(p)] and may not be legally marketed in the United States without an approved application under Section 505(a) of the Act [21 USC 355(a)].
“DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic”
Based on labeling obtained from your firm on August 24, 2010; the package labeling includes the following “drug” claims for this product:
“Uses . . . For topical antimicrobial use . . . For first aid use to decrease germs in minor cuts and scrapes . . . Dries the oozing of: Poison ivy, Poison oak, Poison sumac . . . Temporarily protects minor: Cuts, Scrapes, Burns . . . Temporarily protects and helps relieve minor skin irritation and itching due to rashes and eczema.”
“First Aid Antiseptic”
“DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic” is a drug as defined by Section 201(g)(1) of the Act [21 USC 321(g)(1)], because it is intended for use in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man.
Your product’s “Drug Facts” label identifies as the “Active ingredients … Purpose” “Alcohol 70% … Antimicrobial/Skin Protectant” and “Peppermint Oil 1% … Skin Protectant.” Based on the OTC skin protectant drug claims noted above, “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic ” is subject to the final monograph for OTC Skin Protectant Drug Products (21 CFR 347). However, this product is neither formulated nor labeled in accordance with that monograph. Peppermint oil and alcohol 70% are not recognized as skin protectant active ingredients in 21 CFR 347.10. Furthermore, the Agency determined there is inadequate data to establish general recognition of the safety and effectiveness of alcohol for use as a Poison ivy, Poison oak, Poison sumac drug product under this monograph [21 CFR 310.545(a)(18)(vi)(A)].
“DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic” is a two-way combination of a skin protectant and first-aid antiseptic. FDA has considered the Final Monograph for OTC Skin Protectant Drug Products (21 CFR 347) in evaluating the regulatory status of “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic.” The final monograph for OTC Skin Protectant Drug Products permits the two-way combination of a GRAS/E skin protectant active ingredient with either a GRAS/E first-aid antiseptic active ingredient or a GRAS/E external analgesic active ingredient provided the combination complies with the conditions outlined in 21 CFR 347.20. “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic” does not meet this final monograph. The TFM for OTC First-Aid Antiseptic Drug Products permits the two-way combination of a GRAS/E skin protectant active ingredient with a GRAS/E first-aid antiseptic active ingredient [56 Fed. Reg. 33644 (July 22, 1991)]. This product does not conform to that TFM because, while alcohol 70% is an acceptable First-Aid Antiseptic ingredient, peppermint oil is not a recognized skin protectant ingredient nor is it a recognized First-Aid Antiseptic ingredient.
Thus, “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic,” as formulated and labeled, does not comply with the final monograph for OTC Skin Protectant Drug Products in 21 CFR 347 nor does it conform to the TFM for OTC First-Aid Antiseptic Drug Products. Further, we are not aware of sufficient evidence to show “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic,” as formulated and labeled, is generally recognized as safe and effective. We are not aware of any marketing of a product formulated and labeled like “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic” on or before the inception of the OTC Drug Review. As a result, the product is not deferred to the OTC Drug Review for such indications. Therefore, “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic” is a “new drug” under Section 201(p) of the Act [21 USC 321(p)]. Because “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic” is not the subject of an FDA-approved application, under Sections 301(d) and 505(a) of the Act [21 USC 321(d); 355(a)] it may not be introduced or delivered for introduction into interstate commerce.
As previously explained above, for your information and guidance, OTC topical antimicrobials, which include OTC healthcare antiseptics and OTC first aid antiseptics, are being evaluated under FDA's OTC Drug Review. TFMs for these products were published in the Federal Register of 59 Fed. Reg. 31402 (June 17, 1994) and 56 Fed. Reg. 33644 (July 22, 1991).
Additionally, according to Section 510 of the Act (21 USC 360), manufacturers, repackers, and relabelers who engage in the manufacture, preparation, propagation, compounding, or processing of human drugs must register their establishment(s) and submit to FDA a listing of every product in commercial distribution. Because you have not registered your firm, nor have you listed your drug products, you are in violation of Section 510 of the Act, and your products are misbranded under Section 502(o) of the Act [21 USC 352(o)].
We note an inconsistency with your product label in that “DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic” describes the following: Uses: “topical;” Warnings: “For external use only;” Directions: “Apply to skin directly and as often as necessary.” The principal display panel describes this product as a mouthwash as well as the heading above the Drug Facts panel. The uses, warnings, directions, as well as “purpose” of the product are not consistent with the use of the term “mouthwash.”
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure your firm complies 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.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions can not be completed within fifteen (15) working days, state the reason for delay and the time within which corrections will be completed.
Your response should be sent to Mr. Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/s/
Laurie C. Farmer
Acting District Director
New Orleans District
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