MarkerTest Distribution
The FDA and UR Code
Polyethylene Glycols (PEG) are on the FDA list of inactive ingredients. They do not have side effects and are completely safe.
In 2011, Marker-Test Diagnostics (under the name “RUMA Marker System”) submitted to the FDA’s “Center for Devices and Radiological Health” and FDA’s “Center for Drug Evaluation and Research” a request for review and concurrence determination.
On December 29, 2011, the FDA stated that the UR Code does not meet the definitions of a Device under Section 513(g) or a Drug under Section 201(g) as those terms that are defined by the Federal Food, Drug and Cosmetic Act. Therefore since UR Code is not "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals it is our opinion that the [Marker Test System], as described in your submissions, should not be regulated as a Drug.
As the product is not regulated as a Drug or as a Device in the U.S., no specific approvals are required from the FDA.
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See Also:
Polyethylene Glycols are found in these common everyday products that we use. They have been used for over 50 years.