06.01.05
FDA’s Office of Nutritional Products, Labeling, and Dietary Supplements recently issued new industry guidelines on dietary supplement labeling. According to the American Herbal Products Association (AHPA), Silver Spring, MD, 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 should also provide a helpful review for established firms.” Major topics in the guide include general dietary supplement labeling, statement of identity, net quantity of contents, nutrition labeling, ingredient labeling, claims, premarket notification of new dietary ingredients (NOIs) and other relevant 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.”