01.01.04
In late November, FDA issued an advanced notice of proposed rulemaking (ANPR) to request comments on alternatives for regulating qualified health claims in the labeling of conventional human foods and dietary supplements. FDA is also seeking comments on the appropriateness and nature of dietary guidance statements on conventional food and dietary supplement labels, as well as any policy initiatives that will help consumers make wise food choices.
According to the ANPR, FDA is currently considering three alternatives:
• Incorporate interim procedures and evidence-based ranking system into a regulation;
• Reinterpret the Significant Scientific Agreement (SSA) standard to apply to the accuracy of the characterization of the evidence supporting the claim, instead of the underlying substance-disease relationship, and subject qualified health claims to notice-and-comment rulemaking;
• Regulate qualified health claims solely on a postmarket basis, if they are false or misleading.
FDA is also seeking comment on each of the options described above, including comments about the strengths and weaknesses of each option from the perspective of public health, policy, law and practicality; and which is the best option and why. The agency is also requesting comments that suggest additional options for regulating qualified health claims, together with an analysis of the strength and weaknesses of each suggested alternative from the perspective of public health, policy, law and practicality.
Written or electronic comments will be accepted for a period of 60 days. Electronic comments can be sent to www.fda.gov/dockets/ecomments and written comments can be sent to Food & Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
According to the ANPR, FDA is currently considering three alternatives:
• Incorporate interim procedures and evidence-based ranking system into a regulation;
• Reinterpret the Significant Scientific Agreement (SSA) standard to apply to the accuracy of the characterization of the evidence supporting the claim, instead of the underlying substance-disease relationship, and subject qualified health claims to notice-and-comment rulemaking;
• Regulate qualified health claims solely on a postmarket basis, if they are false or misleading.
FDA is also seeking comment on each of the options described above, including comments about the strengths and weaknesses of each option from the perspective of public health, policy, law and practicality; and which is the best option and why. The agency is also requesting comments that suggest additional options for regulating qualified health claims, together with an analysis of the strength and weaknesses of each suggested alternative from the perspective of public health, policy, law and practicality.
Written or electronic comments will be accepted for a period of 60 days. Electronic comments can be sent to www.fda.gov/dockets/ecomments and written comments can be sent to Food & Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.