Inspections, Compliance, Enforcement, and Criminal Investigations
Can-X Products, Inc. 18-Aug-05
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
RETURN RECEIPT REOUESTED
Our Reference: 3005043351
August 18, 2005
Linda E. Van Rigteren
Can-X Products, Inc.
505 Vail Drive
Dayton, NV 89403
Dear Ms. Rigteren:
This letter concerns "Can-X, Black Salve" marketed by your firm. Can-X Black Salve is labeled for topical use, and during an inspection of your business conducted by the Food and Drug Administration (FDA) on March 4 and 11, 2005, you informed our investigator that this product is used to remove warts. The "instruction pamphlet" accompanying the product states that it is for "EXTERNAL USE."
Although the label on the immediate container bears the statement "An Herbal Food Supplement," Can-X Black Salve cannot be a dietary supplement because it is not intended for ingestion. The Federal Food, Drug, and Cosmetic Act (the Act) defines "dietary supplement" in Section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is "intended for ingestion . . . ." Accordingly, topical products intended to enter the body directly through the skin are not "dietary supplements:"
The intended uses of Can-X Black Salve are conveyed on the instruction pamphlet shipped with the product. These include statements such as:
"NOT a gentle healer . In many cases it is a relentless substance which hunts down and penetrates all abnormal tissue."
"Pain, swelling, redness around the area, and sometimes fever is associated during use."
"More than half the people who have used "BLACK SALVE" have reported that they end up with a moderate or heavy sear when they used it externally of (sic] their skin."
"Use the smallest dose possible and increase only if it seems necessary More will extend the healing period much longer than necessary."
"Apply . . . "BLACK SALVE" to cover the affected area. . . . You will feel a burning sensation and a dark pus scab will begin to form."
"If the salve has penetrated the skin, you will see a red ring around the area and a grayish-white coloring will have appeared with a degree of swelling indicating the salve is at work."
"Five to seven days, could even be up to two (2) weeks, depending on how deep the infection is in the body."
"After the core comes out you will have a hole in your flesh . . ."
Based on the claims noted in the labeling, Can-X Black Salve is a "drug" as defined by Section 201(g) of the Act, 21 U.S.C. 321(g), because it is intended to affect the structure or function of the body or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, Can-X Black Salve is a "new drug" as defined by Section 201(p) of the Act, 21 U.S .C. 321(p), because there is no evidence that it is generally recognized as safe and effective for its intended uses. Under Section 505(a) of the Act, 21 U.S.C. 355(a), a "new drug" may not be introduced or delivered for introduction into interstate commerce unless an approved FDA application is in effect for it. The continued distribution of this product without an approved FDA application violates Sections 301(d) and 505 of the Act, 21 U.S.C. 331(d) and 355.
Additionally, Can-X Black Salve fails to comply with the Final Monograph for Over-the-Counter Wart Remover Drug Products, Title 21 of the Code of Federal Regulations, Part 358, Subpart B (21 CFR 358.101 to 358.150). This likewise causes the product to be a new drug that may not be distributed without an FDA approved application.
Can-X Black Salve is also misbranded under Section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1), because its labeling fails to bear adequate directions for the uses for which it is offered and it is not exempt from this requirement under 21 CFR 201.115. The product is further misbranded under Section 502(o) of the Act, 21 U.S.C. 352(o), because you manufacture, prepare, propagate, or process it in an establishment not duly registered under Section 510 of the Act, 21 U.S.C. 360, and the drug is not listed as required by Section 510(j) of the Act, 21 U.S.C. 360(j).
The violations described above are not intended to be an all-inclusive list of your firm's deficiencies. It is your responsibility to ensure that all drug products manufactured and distributed by your firm are in compliance with federal laws and regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
You must promptly correct these violations. Failure to do so may result in regulatory action without further notice. Possible actions include seizure and/or injunction. You must notify this office in writing within 15 days of receipt of this letter as to the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made.
Your response should be directed to Paul A. Peterson, Compliance Officer, Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, CA 94502, phone (510) 337-6856.
Barbara J. Cassens
San Francisco District