• FDA Regulated Nutrients

  • Determining Functionality and Bioavailability for Supplement Labeling

  • Optimizing Supplement Formulation

FDA Regulated Nutrients

FDA defines dietary ingredients as vitamins, minerals, botanicals, amino acids, or dietary substances to supplement the diet (or concentrates, metabolites, constituents, or extracts of those substances). Dietary supplements, therefore, are products intended to be ingested by man and contain one or more dietary ingredients, the purpose of which is to supplement the diet. Intended use drives the formulation of a supplement by determining the dietary ingredients to use, the quantity of data needed to support any claims, and the labeling of a supplement.

FDA-regulated vitamin and mineral supplements have perhaps the simplest intended uses; they are designed to provide a vitamin/mineral. They are generally the simplest to market since robust data is available for these nutrients, so maintaining data to support claims is relatively easy. FDA prescribes the labeling of these nutrients, including the name, order, and units to be used in the Supplement Facts Panel (SFP).

Determining Functionality and Bioavailability for Supplement Labeling

Dietary supplements designed to deliver relatively simple synthetic or purified compounds like amino acids may be generally simpler to design, use, and label as well. For dietary ingredients like amino acids that have an extensive research background, manufacturers likely will not struggle to maintain documentation for associated claims, and FDA provides some guidance on the labeling of amino acids and nutrients associated with them.

On the other hand, determining the use and labeling of botanical dietary ingredients is more complicated. Botanical ingredients, which include algae, fungi, and plants, may have one primary constituent that produces an effect or many constituents that interact with one another to produce an effect. Further, testing out the influence of compounds within a botanical is only one challenge; botanicals may interact with human physiology in varied ways, and may have limited bioavailability unless combined with other dietary ingredients. For example, one study found that while curcumin from turmeric generally has poor bioavailability, its bioavailability was increased by 154% when administered with piperine (a component of black pepper). Generally speaking, once a manufacturer has a defined intended use for a developing product, an extensive literature review on botanicals and their effects will elucidate some of the primary qualities to be highlighted in the product formulation and on the label. Unfortunately, lesser-known botanicals may not have as wide a dataset to draw from. In that event, a manufacturer may need to perform independent studies on safety, bioavailability, and physiological results. Studies on safety include toxicological and mutagenicity studies. Studies on physiological results may need to be performed to determine the biological effects of constituents, any metabolites produced, and any physiological adaptations over time to the intake of the dietary ingredient(s).

Optimizing Supplement Formulation

Once the manufacturer has adequate data on safety, functionality, bioavailability, and physiological effects, the formulation can be optimized to deliver dietary ingredients that will have the greatest effect while maintaining safety. Generally speaking, the literature and data support will guide both the SFP and the claims that a manufacturer can use.

For botanical supplements that have less data available or that may rely on dozens of chemical compounds to work synergistically to produce an effect, it may be beneficial to list the botanicals by their species and part only. The effects may be too broad to pinpoint to certain compounds, and the claims made about the effects will by necessity be broader.

However, for botanical supplements where one or several nameable constituent compounds are producing an effect, it is beneficial on several levels to both test for those compounds individually and list those compounds individually with their quantitative amounts on the label. This not only shows that identity and potency testing has been performed – key markers of both a compliant (i.e., meeting FDA supplement GMPs) and a high-quality product – but also helps justify the manufacturer’s dosage and can encourage customers to further explore literature on the supplement’s dietary ingredients and potential effects.

What Can Mérieux Nutrisciences Do For You?

Mérieux Nutrisciences provides a wide array of testing services that can help you optimize the development and support claims for your dietary supplement. We also provide labeling support to assist you with compliance with FDA regulation. 


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