Silver Spring, MD (April 21, 2005) -- FDA’s Office of Nutritional Products, Labeling, and Dietary Supplements posted new industry guidelines on its website today. The eight chapters of A Dietary Supplement Labeling Guide cover everything from the size and placement of the words on a dietary supplement label to defining health claims and structure/function claims.
“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 AHPA 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.”
The information is arranged in eight chapters and six appendices:
General Dietary Supplement Labeling
Statement of Identity
Net Quantity of Contents
Premarket Notification of New Dietary Ingredients
Other Labeling Information
The text in each chapter is in a question/answer format, and most answers cite the specific regulations related to each issue. As with all FDA guidance documents, this new publication is identified as representing the Agency’s “current thinking on the topic.” A standard disclaimer states that this “does not create or confer any rights for or on any person and does not operate to bind FDA or the public,” and that firms “can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.”
The document has been posted on the FDA website at: http://www.cfsan.fda.gov/~dms/dslg-toc.html. AHPA has been informed that FDA is considering making the document available within a few weeks in a format that can be more easily downloaded and printed.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org