FDA publishes supplements labeling guide
manufacturers label products in an appropriate, consumer-friendly
way and conform to requirements.
The online document entitled A Dietary Supplement Labeling Guide consists of eight chapters and two appendices presenting information on size and placement of words, statement of identity, quantity of contents, nutrition and ingredient labeling, defining health and structure/function claims and premarket notification of new dietary ingredients.
The FDA said the document is intended to describe its current thinking on the subject and does not establish legally enforceable responsibilities.
"[Companies] can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations," it said. Industry members are invited to contact the authors if they wish to discuss alternatives.
The document does draw attention to specific regulatory or statutory requirements where they exist, however.
The publication has been welcomed by the American Herbal Products Association.
"This guidance document appears to be a very thorough review of the federal regulations that need to be considered when labeling a dietary supplement product," said president Michael McGuffin.
"This new guidance should be especially useful to companies that are new to the trade, but will also provide a helpful review for established firms."
