HHS STATEMENT

U.S. Department of Health and Human Services



STATEMENT                                        Print Media:         301-827-6242
February 9, 2000                                 
                                                 Consumer Inquiries:  888-INFO-FDA

FDA STATEMENT CONCERNING STRUCTURE/FUNCTION RULE* AND PREGNANCY CLAIMS

To ensure that careful consideration is given to concerns recently raised regarding how the structure/function rule relates to pregnancy, FDA today is advising dietary supplement manufacturers not to make any claims related to pregnancy on their products based on the agency's recently issued structure/function rule. FDA will issue a Federal Register notice shortly describing these concerns in more detail, stating the agency's intention to fully review these concerns, hold a public meeting related to potential pregnancy related safety concerns, and then issue further guidance. FDA urges all pregnant women to consult their health care provider before taking any dietary supplements or medication.

#### *Citation: 65 FR 1000; January 6, 2000; Docket No. 98N-0044

For more information on this matter, see the Center for Food Safety and Applied Nutrition's Dietary Supplements page.