A new guide, Regulations on Statements Made for Dietary Supplements Concerning the Effect on the Structure or Function of the Body, has been issued by the US Food and Drug Administration (FDA) and the Department of Health and Human Services.
The guide defines the types of statements which can be made by manufacturers when promoting the effect of dietary supplement products in line with regulations drawn up in January 2000.
The new law, which came into force in February 2000, also clarified the types of claim which may be made by manufacturers. For example, claims that the product can diagnose, cure, mitigate, treat or prevent disease are prohibited by the Dietary Supplement Health and Education Act.
It also sets out which types of claim can be made for dietary supplements without prior review by the FDA and which require prior authorisation as health claims or drug claims.
The guide has been issued because the FDA found that the changes to the regulations could have a significant economic impact on a large number of small companies manufacturing and selling dietary supplements. The guide is meant to explain the new regulations in simple English in order to facilitate compliance.
The FDA stressed that the method of compliance set out in the guide was not the only one, and that an alternative approach could be adopted provided the regulations were satisfactorily applied.