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NPA Finds Fault in AER Labeling

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By: Sean Moloughney

Editor, Nutraceuticals World

The Natural Products Association (NPA), Washington, D.C., is encouraging members to submit company-specific comments to FDA once the agency officially publishes a Federal Register notice about dietary supplement labeling and adverse event reporting. FDA released and then withdrew a pre-publication notice to the Office of Management and Budget (OMB) for future publication. NPA has raised several concerns about the draft guidance published in January, arguing that it would impose a financial burden on the industry. The association also contends the requirement that labels contain a full U.S. mailing address or a telephone number, is not required by law and should not be mandated in the final guidance. The 30-day comment period begins immediately after the FDA publishes the draft in the Federal Register

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