Food and Drug Administration (FDA) regulations require that dietary supplement labels include a descriptive name of the product, the name and place of business of the manufacturer, packer, or distributor, a list of ingredients, and the net content of the product. In addition to generating more informed consumers, creating an FDA-compliant supplement label protects your company from FDA compliance action that can be costly to correct and that will tarnish your company's reputation. In this dietary supplement labeling guide, we'll discuss in detail the FDA supplement labeling regulations, format options, and the next steps to take when considering creating your own dietary supplement labels. It's important to understand some of the common terms used on supplement labels when choosing the right product for you.
Popular supplements include vitamins D and B12; minerals such as calcium and iron; herbs such as echinacea and garlic; and products such as glucosamine, probiotics and fish oils. Manufacturers can say, for example, that a supplement promotes health or supports a body function (such as immunity or heart health). This means that there is no guarantee that a supplement will be produced according to specific quality standards or that it will remain consistent from batch to batch. The FDA doesn't regulate the safety or efficacy of supplements as strictly as it regulates medications, so it's important to carefully review the label when buying supplements.
The net quantity of the content is defined as the amount of supplement in the package or package and can be expressed as weight, measurement, numerical, or both. Nutritional information is provided in the form of a panel with information about supplements, including the serving size of the product, the amount and the percentage of the daily value, if established, of each dietary ingredient. Avoid supplements that make these fraudulent claims or claim that they can treat a long list of health problems. Supplement labels often contain terms such as “all natural” or “organic”, which can be confusing for consumers.
Some supplements are advertised as free or non-GMO, meaning they are produced without any genetically modified ingredients. In addition to vitamins, dietary supplements may contain minerals, herbs or other botanical ingredients, amino acids, enzymes, and many other ingredients. The term “supplements” includes a variety of products, including vitamins, minerals, probiotics, herbal extracts, amino acids, enzymes, and more. If you think you have had an adverse reaction to a dietary supplement, tell your healthcare provider.
Be sure to contact an experienced FDA lawyer who understands the ins and outs of dietary supplement labeling. The Office of Dietary Supplements website has a useful form - My Dietary Supplement and Medicine Record - which you can print and complete at home. It's important to practice reading labels when buying supplements to ensure you're getting the highest quality product possible. Is it a jungle out there or comply or die? Well, on the bright side strengthen your compliance and mitigate compliance risk.
The FDA can take a variety of compliance measures not limited to warning letters.
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