On April 29, 2016 the FDA gave the proposed labeling regulations to the Office of Information and Regulatory Affairs (OIRA) (part of the Office of Management and Budget), who will review the guidelines to make sure they are consistent with the applicable law and that they do not conflict with policies and procedures from another agency.
The agency is tasked to finish their review within 90 days (starting from April 29th, 2016), but the timeline can be shorter or longer.
- If OIRA passes the regulations, final labeling regulations will be published in the Federal Register
- According to the timeline in the proposed regulations, the final regulations will become effective 60 days from the Federal Register publication date.
- The proposed regulations state that the compliance date for the final regulations is 2 years after the effective date.
ESHA will continue to monitor the regulations and provide updated information as it’s announced. In the meantime, you may want to start thinking about what you’ll need to do today to be in compliance when the regulations do come out.