Label Review Tools Part I

By Curtis Walcker, M.S.
August 10, 2014

toolsIf you are a frequent reviewer of dietary supplement labels, you have probably found that your speed and efficiency increase when you have your “tools” readily accessible. This month we have prepared a two-part series focusing on a selection of the important tools of our trade. If you are not currently using some of these, we help direct you to where you may find them.

Tool #1 – The regulations and guidance documents

These can be located on the FDA’s website. One of the best ways to use the regulations and guidance documents is to bookmark them in your browser. When a label issue arises, you can go straight to the page(s) to look for the answer. Many of the documents are large, so effective word searching is essential to make the task a breeze. The more you access these documents, the quicker you will be able to pinpoint specific regulations.

Tool #2 – A calculator

But not just any calculator – a percent Daily Value calculator. If you are currently using a regular calculator for determining your declarations, you are wasting far too much time. Using a program such as Microsoft Excel, you can create your own spreadsheet, where you can enter in the label values for nutrients and it will give you the percentages. A proper and efficient one will be built so that all of the nutrients are already in the order that they must be declared on the label, the correct nomenclature is used, the defined units of measure are used, and the numbers are automatically rounded to the nearest whole percentages. Not up to building one or just need a better one? Download one that can do all of the above for free here.

Tool #3 – The FDA Warning Letters

If you currently are not reviewing the FDA Warning Letters to dietary supplement companies posted each week, you are truly missing out on one of life’s great pleasures. Not only can they be entertaining, they can also expose you to regulations you may not have been aware of, remind you of regulations you have forgotten about, and help you gather regulatory intelligence regarding trends in what the FDA is looking at. The Warning Letters are a great tool for continually self-auditing your own skills and improving your label review expertise. Visit the FDA Warning Letters page to access past Warning Letters and sign up for e-mail updates so you never forget. Access and cite these when needing to support your assessments and edits.

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