00-4946. Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure of Function of the Body; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of January 6, 2000 (65 FR 1000). The document issued final regulations defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body.

DATES:

The final rule is effective February 7, 2000.

FOR FURTHER INFORMATION CONTACT:

LaJuana D. Caldwell, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION:

In FR Doc. 00-53 appearing on page 1000 in the Federal Register of Thursday, January 6, 2000, the following corrections are made:

1. On page 1034, in the 3d column, in the 2d full paragraph, beginning in the 16th line, the phrase “The agency also notes that as discussed” is corrected to read “The agency also notes that as discussed in comment 95 of section III.A of this document”.

2. On page 1046, in the 2d column, in the 28th line, the sentence is corrected to read “Even this 62 percent figure is too high, however, because RTI over-sampled herbal products, which have a higher probability of claims. Thus, FDA believes that the true percentage of dietary supplement products with claims would not exceed 60 percent and has used this figure as its final estimate.”

3. On page 1047, in the 2d column, in the 2d full paragraph, in the 14th line “not” is corrected to read “now”.

Dated: February 25, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.