Answer: There is no legal requirement to pre-clear recycled plastics with FDA, provided the underlying resin complies with existing clearances (regulations and FCNs) and provided the material is of a suitable purity for the intended use.
When requests for a status determination on a recycled polymer have been sought in the past, they have been for customer assurance purposes only. FDA has no current plans to accept FCNs for new recycling technologies. The agency will continue, upon request, to issue letters stating the agency's non-objection to the use of the technology. However, rather than refer to these letters as "no objection" letters, as the agency has done in the past, FDA is now referring to these as "opinion letters."
The agency has on several occasions noted its intent to publish rules that will specify a testing protocol for recycling processes that produce food-contact materials.
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