If FDA does not act to prohibit or modify such a claim, the claim may be used 120 days after receipt of the notification. Subsequently, FDA received several amendments to the notification from Tropicana that modified, among other things, the proposed health claim and clarified the nature of the foods eligible to bear the claim. The combination of a low-sodium, high potassium intake is associated with the lowest blood pressure levels and the lowest frequency of stroke in individuals and populations. Although the effects of reducing sodium intake and increasing potassium intake would vary and may be small in some individuals, the estimated reduction in stroke-related mortality for the population is large.
Potassium supplements are neither necessary nor recommended for the general population.
FDA reviewed the authoritative statements from Diet and Health in their context and in light of existing authorized health claims for hypertension and cardiovascular disease. FDA has not acted to prohibit or modify the claim, as amended. Persons interested in these documents may view them at the Dockets Management Branch from 9 am to 4pm, Monday through Friday. Their address is 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.