Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Seattle District |
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
January 13, 2016
In reply refer to Warning Letter SEA 16-07
David K. Humphrey
Chief Executive Officer and President
Kirkman Laboratories, Inc.
10639 Professional Circle
Reno, Nevada 89521
Dear Mr. Humphrey:
The United States Food and Drug Administration (FDA) conducted an inspection of your drug manufacturing facility, Kirkman Laboratories, Inc., located at 6400 Rosewood St., Lake Oswego, Oregon on June 3, 2015, through June 24, 2015. This inspection revealed that your firm is marketing the following unapproved new drugs: Kirkman Laboratories, Inc. Flura-Drops ® Sodium Fluoride drops, 2.21 mg; Perry Medical Fluorabon Drops USP; Kirkman Laboratories, Inc. 1.1 mg Cherry Dye-Free Sodium Fluoride Tablets; and Kirkman Laboratories, Inc. 2.21 mg Cherry Dye-Free Sodium Fluoride Tablets, in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(a)]. Additionally, FDA has determined that these products are misbranded drugs in violation of section 502 and 503 of the Act [21 U.S.C. §§ 352 and 353], as detailed below.
A. Unapproved New Drug Violations
Based on the information collected during the recent inspection, you manufacture and/or distribute unapproved new drugs in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)].
The unapproved new drugs include, but are not limited to:
- Kirkman Laboratories, Inc. Flura-Drops® Sodium Fluoride Drops, 2.21 mg (NDC 58223-517), which is labeled “for once daily, self-administered, systemic use as a dental caries preventive in pediatric patients”;
- Perry Medical Fluorabon Drops USP, 0.25mg (NDC 11763-524), which is labeled “as an aid in the prevention of dental caries”;
- Kirkman Laboratories, Inc. 1.1 mg Cherry Dye-Free Sodium Fluoride Tablets (NDC 58223-678), which is labeled “as an aid in the prevention of dental caries”; and
- Kirkman Laboratories, Inc. 2.21 mg Cherry Dye-Free Sodium Fluoride Tablets (NDC 58223-679), which is labeled “as an aid in the prevention of dental caries.”
The above products are drugs within the meaning of section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans. Further, as labeled, these drugs are “new drugs” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the drug. There are no FDA-approved applications on file for the drugs listed above. The marketing of these drugs, or other new drugs, without an approved application constitutes a violation of the Act.
B. Misbranding Violations
The above products also are “prescription drugs” as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or potential for harmful effects, or the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them.1
Because these prescription drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use them safely for their intended uses. Consequently, the labeling of your firm’s unapproved prescription drug products fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(l) of the Act [21 U.S.C. § 352(f)(1)]. Because your drugs lack required approved applications, they are not exempt under 21 CFR 201.115 from the requirements of section 502(f)(1) of the Act. The above products also are misbranded under section 503(b)(4)(A) of the Act [21 U.S.C. § 353(b)(4)(A)], because the labels fail to bear the symbol “Rx Only.” The introduction or delivery for introduction into interstate commerce of these drugs therefore violates sections 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. 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. It is your responsibility to ensure that 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 actions 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. You should discontinue marketing all of the unapproved prescription drugs manufactured at your facility immediately. Additionally, FDA may withhold approval of requests for export certificates or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected. A re-inspection may be necessary to verify corrective actions have been completed.
FDA requests that you contact CDER’s Drug Shortages Staff immediately at email@example.com so that we can work with you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture, as required under 21 U.S.C. § 356c(a), and to allow FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.
Please notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If the corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any documentation demonstrating that corrections have been made. If you no longer manufacture or market your fluoride products, your response should indicate, including the reasons that, and the date on which, you ceased production.
Your reply should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021 to the attention of Maria P. Kelly-Doggett, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Compliance Officer Maria Kelly-Doggett by telephone at 425-302-0427.
Miriam R. Burbach
cc: Lawrence A. Newman
Chief Operating Officer Technical & Regulatory Affairs
Kirkman Laboratories, Inc.
6400 Rosewood St.
Lake Oswego, Oregon 97035
1 Over-the-Counter (OTC) fluoride dentifrice drug products are subject to the final rule for Anticaries Drug Products for OTC Human use found in 21 CFR 355. As described in 21 CFR 355.60, the professional labeling allows for anticaries fluoride treatment rinses that are specifically formulated so they may be swallowed (fluoride supplements) and are provided to health professionals (but not to the general public) to contain additional dosage information. This additional information cannot be directed to consumers and the product must be in accordance with 21 CFR 355.60. The Flura-Drops® Sodium Fluoride Drops, 2.21 mg (NDC 58223-517), Fluorabon Drops USP, 0.25mg (NDC 11763-524), 1.1 mg Cherry Dye-Free Sodium Fluoride Tablets (NDC 58223-678), and 2.21 mg Cherry Dye-Free Sodium Fluoride Tablets (NDC 58223-679) labels and labeling do feature additional dosage information (i.e., professional labeling information) and as such, the information is inappropriately directed to consumers. Additionally, 21 CFR 355.60 only allows additional dosage information for children 3 to under 14 years of age. These products all indicate for use down to age 6 months. Furthermore, a fluoride tablet is not a dosage form permissible under the final rule.