The FDA has issued an advance 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. The Agency is also seeking 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.
Written or electronic comments will be accepted for a sixty day period. (Electronic comments to: http://www.fda.gov/dockets/ecomments.)
According to the ANPR, FDA is considering three alternatives:
Option 1—incorporate interim procedures and evidence-based ranking system into a regulation
Option 2—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;
Option 3—Regulate qualified health claims solely on a postmarket basis, if they are false or misleading.
FDA is seeking comment on each of these options from the perspective of public health, policy, law, and practicality.
Complete ANPR: http://www.fda.gov/OHRMS/DOCKETS/98fr/cf0362.pdf