WARNING LETTER
Centura Pharmaceuticals Inc
MARCS-CMS 684733 —
November 15, 2024
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Rahul Patel
Recipient Title
President
Centura Pharmaceuticals Inc
24718 State Road 54C
Lutz
,
FL
33559
United States
centurapharma@gmail.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
November 15, 2024
Re: 684733
Dear Mr. Patel:
This letter is to advise you that in April 2024, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet addresses www.centurapharma.com and centurabltcream.com, where your “BLT 1-2-3 Cream” drug product is available for purchase in the United States without a prescription.
“BLT 1-2-3 Cream” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) and 301(d) of the Federal Food, Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
FDA has safety concerns about your external analgesic drug product because it is intended to be used before certain cosmetic procedures that could lead to increased absorption of the drug product through the skin. FDA is aware that use of this product before and/or during a cosmetic procedure may not always be supervised by trained health professionals. Without this supervision, large amounts of topical analgesics may be applied to a person’s skin. FDA has specifically warned in a recent press announcement
1
and multiple public health advisories
2
about the use of similar lidocaine and other “-caine” type ingredient products when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when used in conjunction with methods that increase skin temperature such as warming the skin before application and/or covering the skin after application. These uses increase the amount of active ingredient that passes into the bloodstream and, if used improperly, may cause serious injury.
Unapproved New Drug and Misbranded Drug Violations
“BLT 1-2-3 Cream” is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.
Examples from the “BLT 1-2-3 Cream” product labeling, including the websites listed above, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:
“
DRUG FACTS Active Ingredient:
Benzocaine 20% Topical Anesthetic…For the temporary relief of pain and itching.” [from your product label]
“
DRUG FACTS Active Ingredient:
Lidocaine HCL 4% Topical Anesthetic…For the temporary relief of pain and itching.” [from your product label]
“
DRUG FACTS Active Ingredient:
Tetracaine 2%...Topical Anesthetic…For the temporary relief of pain and itching.” [from your product label]
“BLT numbing creams are topical anesthetics consisting of benzocaine, lidocaine, and tetracaine as local analgesics for mild pain control. In cosmetic settings, topical anesthetics are widely used to alleviate pain and minimize discomfort associated with procedures like filler injectables, laser hair removal, skin resurfacing with laser and light-based devices.…BLT numbing cream packets provide the best over-the-counter numbing cream for minimizing pain and discomfort associated with cosmetic and esthetic procedures. [from your “BLT 1-2-3 Cream” product website]
“
How Centura BLT Numbing Creams Work?
…When mixed before use, BLT numbing creams provide a maximum analgesic effect on the skin by keeping it numb for up to 30 minutes.” [from your “BLT 1-2-3 Cream” product website]
“
Potential Applications
…The Centura Pharmaceuticals BLT Cream is potentially useful for a wide range of cosmetic and esthetic procedures, including: ∙ Dermal fillers used on small areas of skin such as hyaluronic acid (Juvederm, Restylane, Belotero Balance, Revanesse Versa) ∙ Injectable toxins (Botox, Dysport, and Xeomin injections) ∙ Esthetic facial treatments (chemical peels, laser hair removal, collagen induction therapy, eyebrow microblading, and tattoo removal).” [from your “BLT 1-2-3 Cream” product website]
“Centura Pharma’s packaging separates each medication into its own sachet. Each sachet is 5gm in size, and is mixed just prior to application. Specifically formulated for minimally invasive surgeries such as microneedling Minimizes the pain of many procedures for patients.” [from your “BLT 1-2-3 Cream” product website]
Unapproved New Drug Violations
Based on the above labeling, “BLT 1-2-3 Cream” is intended for use as an external analgesic drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug product identified above.
Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as, “BLT 1-2-3 Cream,” in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph(s), here Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesic monograph”).
3
However, your “BLT 1-2-3 Cream” product does not conform to the conditions specified in M017 for the reasons described below.
Your “BLT 1-2-3 Cream” is distributed as a combination of three packets containing benzocaine 20%, lidocaine HCl 4%, and tetracaine 2%, respectively. Your website states, “Empty the contents of each sachet gradually and mix them thoroughly to ensure even distribution of the pack contents” and includes a video instructing users to mix the three packets together prior to use as well. While benzocaine at a concentration range of 5% to 20%, lidocaine HCl from 0.5% to 4%, and tetracaine from 1% to 2% are permitted active ingredients in M017, the monograph does not permit a combination of more than one “-caine” type active ingredient in a single drug product.
Furthermore, labeling for your “BLT 1-2-3 Cream” includes indications that are not consistent with the permitted indications for an external analgesic drug product in M017. For example, claims on your product identified above describe its use for sensitive cosmetic procedures, such as laser hair removal and tattoo removal treatments, go beyond merely describing the general intended uses for an external analgesic drug product as set forth in M017.50(b).
Thus, your “BLT 1-2-3 Cream” drug product does not comply with the applicable conditions specified in M017 and has not otherwise been found GRASE.
4
Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no evident basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug.
The introduction or delivery for introduction of this unapproved new drug into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
Misbranded Drug Violations
Your “BLT 1- 2-3 Cream” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. 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. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
____________________________
1
Refer to FDA Press announcement FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects.
2
Refer to public health advisories Life-Threatening Side Effects with the Use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures, Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions, and Improper Use of Skin Numbing Products Can Be Deadly.
3
M017 reflects the conditions as set forth in the relevant final order(s) established and in effect under section 505G; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA [https://dps.fda.gov/omuf].
4
FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “BLT Cream” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.
Content current as of:
11/26/2024
Regulated Product(s)
Drugs
Over-the-Counter Drugs