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U.S. Department of Health and Human Services

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Enforcement Actions

Health Care Products 7/15/13

  

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

Public Health Service
Food and Drug Administration
 New York District Office
158-15 Liberty Avenue
Jamaica, NY 11433-1034 

 

July 15, 2013
 
 
WARNING LETTER NYK 2013-23
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
                                                                                                                       
Gary April, President
Health Care Products, Diabetes Care Division
Hi-Tech Pharmacal Co., Inc.
369 Bayview Avenue
Amityville, NY 11701
 
Dear Mr. April:
 
This letter is in reference to your firm’s marketing and distribution of ZOSTRIX Diabetic Foot Pain Relief Cream, ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream and Diabeti-Derm Antifungal Cream, all of which are sold over-the-counter (OTC).
 
As presently formulated, labeled, and promoted, these products are unapproved drugs in violation of Section 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act) [21 U.S.C. § 355(a)].  Introduction of such products into interstate commerce is prohibited under § 301(d) of the FD&C Act [21 U.S.C. § 331(d)]. Furthermore, the Diabeti-Derm Antifungal Cream is misbranded under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)].  Introduction of such products into interstate commerce is prohibited under § 301(a) of the FD&C Act [21 U.S.C. § 331(a)].  These violations are described in more detail below.  Please note that this is not inclusive of all the products your firm manufactures and/or distributes and may not represent all product violations.
 
ZOSTRIX Diabetic Foot Pain Relief Cream and ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream
 
FDA reviewed labeling claims on the product labels, outer containers, package inserts, and your website www.zostrix.com, for your products ZOSTRIX Diabetic Foot Pain Relief Cream and ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream. While both products have stated purposes as “Topical Analgesics” the products also include labeling claims that demonstrate intended uses, including uses targeted specifically to diabetic patients, that cause the products to be unapproved new drugs under Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. Labeling claims for such intended uses include, but are not limited to, the following:
 
ZOSTRIX Diabetic Foot Pain Relief Cream
 
Claims Found on Outer Carton:
 
 “For Relief Of Diabetic Foot Pain”
 
Claims Found on Package Insert:
 
 References to studies as well as study summaries that discuss topical capsaicin (the active ingredient of the product) used to treat pain associated with diabetic neuropathy
 
Claims Found on Internet Website, www.zostrix.com:
 
 “The effectiveness of treating diabetic foot pain is one reason why Doctors and Pharmacists recommend Zostrix.”
 
Product name:
 
 “ZOSTRIX Diabetic Foot Pain Relief Cream”
 
ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream
 
Claims found on Outer Carton:
 
“Stimulates circulation – Important for Diabetics!
 
Claims Found on Internet Website, www.zostrix.com:
 
• “Zostrix Diabetic Joint and Arthritis Pain Relief Cream not only attacks arthritis pain with the same powerful ingredient as Zostrix HP Arthritis Pain Relief Cream, but this special formula for people with diabetes also has an important ingredient to stimulate circulation.”
 
Product name:
 
 “ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream”
 
Based on labeling claims, ZOSTRIX Diabetic Foot Pain Relief Cream and ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)], because they are intended for 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 they are intended to affect the structure or any function of the body of man.
 
Although both products are labeled as topical analgesics and the stated “Uses” are for temporary relief of minor aches and pains of the muscle joints associated with strains, sprains bruises and arthritis; both products, as demonstrated by the above referenced claims, are also specifically intended for diabetic patients and are identified in their product names as diabetic creams.
 
Drug products intended for topical (external) analgesic indications, such as the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains are covered under the Tentative Final Monograph (TFM) for OTC External Analgesics (48 FR 5852, February 8, 1983).  However, products that are specifically intended for diabetic patients and for the uses described above, including for diabetic foot pain, diabetic joint and arthritis pain, pain associated with diabetic neuropathy, and stimulating circulation are not included in any part of the OTC Drug Review nor are we aware of a similar OTC product that was available in the U.S. market at the inception of the OTC Drug Review.
 
Therefore, as drugs, ZOSTRIX Diabetic Foot Pain Relief Cream and ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream, require an approved application in order to be legally marketed in the United States. Specifically, as formulated and labeled, these products are not covered under any OTC monograph that sets forth conditions for general recognition of safety and effectiveness, nor are we aware of products intended specifically for diabetic foot health, or products that are labeled for diabetics, and/or otherwise being considered under FDA’s OTC Drug Review.  Furthermore, we are not aware of evidence to show that ZOSTRIX Diabetic Foot Pain Relief Cream and ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream are generally recognized as safe and effective for their labeled uses.  Therefore, ZOSTRIX Diabetic Foot Pain Relief Cream and ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream are new drugs within the meaning of Section 201(p) of the FD&C Act [21 U.S.C. § 321(p)].  In addition, we are not aware of ZOSTRIX Diabetic Foot Pain Relief Cream and ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream being the subjects of approved applications.  As new drugs without approved applications, the current marketing of ZOSTRIX Diabetic Foot Pain Relief Cream and ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream violate Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)].  Introduction of such products into interstate commerce is prohibited under § 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
 
Diabeti-Derm Antifungal Cream
 
FDA reviewed labeling claims on the product label, outer container, and your website www.zostrix.com, for Diabeti-Derm Antifungal Cream. While the product has a stated purpose as an “Antifungal”, the product also includes labeling claims that demonstrate intended uses that cause the products to be an unapproved new drug under Sections 505(a) of the FD&C Act [21 U.S.C. § 355(a)].  Introduction of such products into interstate commerce is prohibited under § 301(d) of the FD&C Act [21 U.S.C. § 331(d)].  Labeling claims for such intended uses include, but are not limited to, the following:
 
Diabeti-Derm Antifungal Cream
 
Claims Found on Outer Carton:
 
 “KILLS TOENAIL & FOOT FUNGUS”
 “WHY L-ARGININE? . . . Diabetes can cause poor circulation as well as a compromised immune system which makes a person more susceptible to fungal infections. Diabeti-Derm is the only anti-fungal to contain L-Arginine to help stimulate healthy blood flow to promote healing.”
 
Claims Found on Internet Website, www.diabeticproducts.com identified on your products outer carton and immediate container:
 
 “Prevents fungus form (sic) growing on the skin and around the nails (sic) Podiatrists often recommend using around nails daily to prevent recurrence.”
 “Diabeti-Derm is the only antifungal product to contain L-Arginine plus an effective fungal treatment to help meet the special needs of people with diabetes.”
 
Product name:
 
 “Diabeti-Derm Antifungal Cream”
 
Based on labeling claims, Diabeti-Derm Antifungal 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 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 of man.
 
Drug products intended as an antifungal are subject to the final monograph for Topical Antifungal OTC Drug Products at 21 CFR Part 333, Subpart C Topical Antifungal Drug Products. However, in addition to being an antifungal, Diabeti-Derm Antifungal Cream is targeted for diabetics, with claims to stimulate healthy blood flow to promote healing, and treating nail fungus, as described above.  These uses are not consistent with the final monograph for Topical Antifungal OTC Drug Products at 21 CFR Part 333, Subpart C Topical Antifungal Drug Products. Moreover, 21 CFR § 310.545(a)(22)(iii) indicates that no OTC antifungal drug marketed without an NDA may make any claims for use on the nails.
 
Therefore, Diabeti-Derm Antifungal Cream is a new drug within the meaning of Section 201(p) of the FD&C Act [21 U.S.C. § 321(p)]. In addition, we are not aware of Diabeti-Derm Antifungal Cream being the subject of an approved application.  As a new drug without an approved application, the current marketing of Diabeti-Derm Antifungal Cream violates Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)].  Introduction of such products into interstate commerce is prohibited under § 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
 
Furthermore, Diabeti-Derm is also misbranded under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)] because it is misleading in that the Drug Facts lists Undecylenic Acid 10% as the active ingredient; however, labeling describes “L-Arginine,” a labeled inactive ingredient, in a role greater than its inactive purpose [See 21 CFR § 201.10(c)(4)]. In fact, based on the labeling, “L-Arginine” is intended as an active ingredient (see 21 CFR § 201.66(b)(2)) and the inclusion of “L-Arginine” as an active ingredient causes the product to be an unapproved new drug.  Introduction of such products into interstate commerce is prohibited under § 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above, and for preventing their recurrence and the occurrence of other violations. We advise you review all the information on your websites, social media websites (e.g., Facebook and Twitter), product labels, and other labeling and promotional materials for your products to ensure the claims you make are not in violation of the FD&C Act. It is your responsibility to assure compliance 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. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.

We also remind you that it is your responsibility to ensure all your products are legally marketed under the FD&C Act. For example, we note that ZOXTRIX Foot Pain Cream on its website, www.zostrix.com, includes a violative diabetes-related claim (“[t]his powerful topical pain medication provides warming, soothing relief for feet affected by . . . diabetes”) that is not covered under the OTC monograph rulemaking.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute any of the drug products manufactured at this facility, and provide the date(s) and reason(s) you ceased production.
 
You should send your reply to: Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, NY 14202. If you have questions regarding any issues in this letter, please contact Ms. Clark at 716-846-6236.
 
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District