Letter to Avitar Inc.

DEPARTMENT OF HEALTH & HUMAN SERVICES
	Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 1 2003

Mr. Peter Phildius
Chairman and CEO
Avitar Inc.
65 Dan Road
Canton, MA 02021

Dear Mr. Phildius:

We are writing to you because the Food and Drug Administration (FDA) has reviewed information revealing a possible regulatory problem with the sample collection system offered for sale by Avitar, Inc. (Avitar), as part of the company's HAIRscreen™ drugs of abuse test (see <http://www.avitarinc.com/hairscreen.html>). Based on promotional material on your website, it appears that you offer for sale collection systems intended for use in collecting hair samples, which are then sent to you to test for the presence of drugs of abuse.

Under the Federal Food, Drug, and Cosmetic Act (the Act), an over-the-counter (OTC) test sample collection system for drugs of abuse testing is a device because it is intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease (section 201(h)(2) of the Act). FDA regulations establish certain requirements for OTC sample collection systems used to collect biological samples, such as hair, urine, saliva, sweat, or other matrices, that are then tested for drugs of abuse (Title 21 Code of Federal Regulations (21 CFR) 809.40, 864.3260). These regulations require that, among other things, the screening test used on the collected samples be approved, cleared, or otherwise recognized by FDA as accurate and reliable. Failure to adhere to this requirement would render the OTC test sample collection system misbranded under section 502(q)(2) of the Act.

Our records indicate that the drugs of abuse screening tests you are performing on hair samples obtained using your sample collection system have not been cleared, approved, or otherwise recognized as accurate and reliable by FDA. We also note that several pages of your website contain the following statement at the bottom of the screen: "HAIRscreen [other names omitted]: For Forensic Use Only. Not for consumer or Clinical Use." The regulations cited above do not apply to sample collection systems used to develop evidence for law enforcement purposes. See 21 CFR 864.3260(a). The materials on your website, however, do not consistently indicate that the HAIRscreen test is limited to this use. For example, your HAIRscreen product brochure, available at <http://www.avitarinc.com/HAIRscreen.pdf>, states that "[w]ith HAIRscreen, anyone can collect a qualified sample – anywhere, anytime."

There are many FDA requirements pertaining to the manufacture, distribution, and marketing of devices. You may obtain general information about these requirements by contacting our Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at 1-800-638-2041 or through the Internet at http://www.fda.gov.

You may provide information or direct any questions you may have to Steven Gutman, M.D., Director, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, 2098 Gaither Road, Rockville, Maryland 20850, (301) 594-3084.

Sincerely yours,

/S/

Steven I. Gutman, M.D., M.B.A.
Office Director
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health