Anastasia Marie Laboratories, Inc. 7/15/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
July 15, 2013
UNITED PARCEL SERVICE
Anastasia M. Chehak, President and CEO
Anastasia Marie Laboratories, Inc.
6520 North Western Ave., Suite 100
Oklahoma City, OK 73116
Dear Ms. Chehak:
This letter is in reference to your firm’s marketing and distribution of Anastasia Diapedic Foot & Leg Treatment, which is sold over-the-counter (OTC) and is available for purchase from your website www.amlab.com. Package labeling for this product was obtained during a Food and Drug Administration (FDA) (b)(4) inspection performed at your manufacturer, (b)(4).
As presently formulated, labeled, and promoted, this product is an unapproved and misbranded drug in violation of Sections 505(a) and 502(a) of the Federal Food, Drug & Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 352(a)]. Introduction of this product into interstate commerce is prohibited under Sections 301(d) and 301(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 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.
FDA reviewed labeling claims on the product label, outer container, and your website for your product, Anastasia Diapedic Foot & Leg Treatment. While the product has stated its purpose as a “Topical Analgesic,” the product also includes labeling claims that demonstrate intended uses, including uses targeted specifically to diabetic patients, that cause the product to be an unapproved new drug 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:
Claims Found on Outer Carton:
· “Temporarily relieves pain of: diabetic neuropathy”
· “High performance treatment penetrates to cellular level to soothe the effects of diabetic neuropathy and alleviate pain. Ideal for diabetic or non-diabetic use.”
Claims Found on Product Label:
· “Diapedic Foot & Leg Treatment penetrates to cellular level to relieve diabetic neuropathy and promote circulation.”
· “Naturally anti-fungal.”
Claims Found on Internet Website, www.amlab.com identified on your product's immediate container:
· “Clinically superior Diapedic® Foot & Leg Treatment is an FDA-approved therapy to relieve diabetic foot and leg pain (neuropathy) and arthritis as it stimulates peripheral circulation.”
· “Natural anti-fungal formula fights infections, athlete’s foot and nail fungus.”
· “Natural anti-inflammatory properties”
· “FDA approved-OTC topical pain reliever”
· “Diapedic Testimonials . . . This Diapedic Foot Treatment has not only stopped the progression of the neuropathy but actually reversed it to some extent. This was more than I expected when I first tried it ....”
Based on labeling claims, Anastasia Diapedic Foot & Leg Treatment 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.
Although Anastasia Diapedic Foot & Leg Treatment is labeled as a topical analgesic and some of its stated “Uses” are for arthritis and minor aches, the product, as demonstrated by the above referenced claims, is also labeled for use as an antifungal and is specifically intended for diabetic patients.
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 and leg pain, 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.
In addition, Anastasia Diapedic Foot & Leg Treatment also includes claims as described above that demonstrate it is intended as an antifungal. 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, Anastasia Diapedic Foot & Leg Treatment is marketed as a topical analgesic and is targeted for diabetics, with claims to stimulate peripheral circulation to relieve diabetic foot and leg pain 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. As formulated and labeled, this product is not covered under any OTC monograph that sets forth conditions for general recognition of safety and effectiveness; nor are we aware of a product intended specifically for diabetic foot pain or a product that is labeled for diabetics otherwise being considered under FDA’s OTC Drug Review. Furthermore, we are not aware of evidence to show that Anastasia Diapedic Foot & Leg Treatment is generally recognized as safe and effective for its labeled uses.
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, which your product does. In light of the foregoing, Anastasia Diapedic Foot & Leg Treatment is a new drug within the meaning of Section 201(p) of the FD&C Act [21 U.S.C. § 321(p)]. We are not aware of Anastasia Diapedic Foot & Leg Treatment being the subject of an approved application. As a new drug without an approved application, the current marketing of Anastasia Diapedic Foot & Leg Treatment violates Sections 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. Introduction of such product into interstate commerce is prohibited under § 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
Lastly, Anastasia Diapedic Foot & Leg Treatment is misbranded under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)] because its labeling includes the statement “FDA Approved.” Your product is not the subject of a FDA-approved application and therefore connoting FDA approval is a false statement that misbrands your product. Introduction of such product 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, including testimonials, 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.
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 of distribute any of the drug products manufactured at this facility, and provide the date(s) and reason(s) you ceased production.
Your firm’s response should be sent to: Dallas District Office, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions about the contents of this letter, please contact: Jeff Wooley, Compliance Officer, at 214-253-5251.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
John A. Foust, Pharm. D., D.Ph, Executive Director
Oklahoma State Board of Pharmacy
4545 Lincoln Blvd, Suite 112
Oklahoma City, OK 73105