FDA — OMEGA Letter: Request for Correction (RFC)

The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Food and Drug Administration (FDA)
Office of the Ombudsman
Food and Drug Administration
5600 Fishers Lane
Room 14B03, HF-7
Rockville, MD 20857

The Office of Management and Budget
725 17th Street, NW
Washington, DC 20503

Subject: Request for Correction (Removal) of Information Found on the OIVD Section of the FDA Web Site.

The following request for removal of inaccurate information from the FDA Web site is made per the Data Quality Act, HHS Information Quality Guidelines and the FDA's Guidelines for Ensuring the Quality of Information Disseminated to the Public.

1. Contact Information:

Jay Davis
Omega Laboratories, Inc.
400 North Cleveland Avenue
Mogadore, Ohio 44260

2. Material In Question

A letter found at the following URL - http://www.fda.gov/cdrh/oivd/letters/120103-omega.html - is inaccurate and should be removed from the FDA Web site.

3. Reasons the information does not meet applicable OMB, HHS, or FDA guidelines

A. There is no regulatory problem with the hair drug testing done by Omega Laboratories, Inc.. The letter in question does not represent accurate information.

B. The URL cited in the letter (http://www.omegalabs.net/abouthairtesting/hairtestingfaq/hairtestingfaq.aspx) is for a Web page that ONLY contains Frequently Asked Questions About Hair Drug Testing and offers NOTHING for sale to the site visitor.

C. The letter claims that "it appears that you offer for sale collection systems intended for use in collecting hair samples." We offer NOTHING for sale on our Web site and there is not, nor ever has been, an ecommerce capability on the Omega Web site.

D. This is not an over-the-counter (OTC) sample collection system as you can see from the attached sample. It is simply a transport device for conveying the sample from the trained specimen collector to the laboratory for testing. I feel Dr. Gutman is mistakenly adding these transport materials to the OTC device category. These FDA Guidelines ARE applicable to home urine test kits which contain screening panels for a "lay purchaser" (per CFR 809.40 (d)) to interpret test results. This point is emphasized on the OIVD section of the FDA Web site (http://www.fda.gov/cdrh/oivd/consumer-otcdatabase.html#2) which reads as follows:

Home-Use Lab Tests 
(also known as Over-The-Counter (OTC) Tests) 

This section contains information about the on-line search for Home Use Lab Tests [Over-the-Counter tests (OTC)] and collection kits that have been cleared or approved by the FDA

What Are Home-Use Tests? 
Home-use tests are test kits that you use at home, without the help of healthcare professional. Most home-use tests are available over the counter (OTC) without a prescription.

(emphasis added)
As you can see the OIVD Web site also emphasizes that "Home-Use Lab Tests" are defined as "used at home", not laboratorytesting as done by Omega Laboratories, Inc..

E. Omega Laboratories, Inc. was inspected by the FDA just two weeks ago and we were found to only require submission of Form 2891. We have submitted the Form and based on the more recent information from the FDA our registration as a Specification Developer" is sufficient to cover the hair sample transport materials. After the visit of FDA Inspector Laureen Geniusz we received the following email:

"As discussed, the plan will be to have your firm register (form #2891) as a specification developer. I will code you in our computer database as a class I, non-sterile, non-high risk specification developer. Please refer to CFR section 864.3260 for a further description. I believe since your product is labeled per 809.40 and 809.10 (f), it does meet the definition of a class I medical device.

You are NOT required per CFR 864.3260 to file a 510(K). You are also exempt from current good manufacturing practices (because your product is not labeled as sterile).

Laureen Geniusz, Investigator
U.S. Food & Drug Administration
Cincinnati-District, Brunswick Resident Post
ph: (330) 273-1038
fax: (330) 225-7477

4. Specific recommendations for correcting the information

Immediate removal of this inaccurate and misleading letter from the FDA Web site is requested. Omega Laboratories, Inc. responded to this letter on December 3, 2003, pointing out the inaccuracies both by telephone to Dr. Gutman and in a seven-page written response (attached). We received no response from the FDA.

5. A description of how the person submitting the complaint is affected by the information error.

This letter is being used by competitors as a sales and marketing tool to imply that Omega Laboratories, Inc. has testing methodology that generates poor quality test results. One competitor claims to customers that they have FDA "approval" and that labs without 510K clearance are operating illegally. We have had, and continue to have potential clients who have been shown this letter and then will not consider Omega for their Hair Drug Testing Programs. The letter has been posted for more than one and one-half years with this misleading information and has caused Omega a great deal of economic harm.

All help to immediately rectify this matter will be greatly appreciated.

Jay Davis
Omega Laboratories, Inc.