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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P06-159
October 6, 2006

Media Inquiries:
Catherine McDermott, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

Permanent Injunction of Dental Products Manufacturer Furthers FDA Efforts Against Marketed Unapproved Drugs

The U.S. Food and Drug Administration (FDA) today announced the entry of a Consent Decree of Permanent Injunction barring C. R. Canfield Co., Inc. (Canfield) and Garry R. Persons, Canfield's owner and president, from manufacturing and distributing unapproved drugs and drugs that do not satisfy current good manufacturing practice (cGMP) requirements. Canfield and Persons are further barred from manufacturing and distributing drugs until they correct Canfield's manufacturing problems and obtain necessary approval.

The products in question are all used in the practice of dentistry and FDA is advising dental professionals and consumers to stop using and discard any product from this manufacturer. Consumers who have used this firm's products and have concerns or questions should contact their dental practitioner.

FDA obtained evidence that Canfield manufactured and distributed adulterated (i.e., not manufactured according to cGMP) and unapproved drugs, including D.S. Dressing (20% Eugenol), D.S. Mini-Dressing (20% Eugenol), D.S. Syringe (20% Eugenol), and D.S. Ointment (20% Eugenol). Canfield promoted these products for the treatment of "dry socket," a condition in which the socket does not heal properly following the extraction of a tooth. The products were available nationwide through dental practices for use by dentists and consumers.

FDA's CPG on Marketed Unapproved Drugs warns that the agency may focus its enforcement on firms whose products, in addition to lacking required approval, violate other parts of the Federal Food, Drug, and Cosmetic Act. Canfield has not corrected its cGMP violations -- which include releasing products for distribution without proper testing and failing to conduct studies to determine appropriate product expiration dates -- despite repeated FDA inspections, efforts, and warnings by the agency advising the firm of significant compliance deviations that require prompt corrective action.

"Unapproved drugs and drugs that do not meet cGMP requirements are a public health concern because they may not satisfy quality standards, or standards for safety, effectiveness, and labeling," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "Confronting these issues through enforcement actions and other strategies is a key part of FDA's comprehensive drug safety efforts."

This action supports FDA's focus on unapproved drugs, as explained in the agency's June, 2006, guidance: "Marketed Unapproved Drugs -- Compliance Policy Guide (CPG)." This guidance makes clear that firms marketing drugs that require FDA approval must submit applications showing that those products are safe and effective before marketing them. Information on FDA's ongoing efforts regarding marketed unapproved drugs can be found at: http://www.fda.gov/cder/drug/unapproved_drugs/default.htm.

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