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February 2021

Why an NDI Doesn’t Equal Safety

There’s some confusion surrounding what a New Dietary Ingredient (NDI) filing means. Make sure patients understand that it’s not an FDA safety approval.

If a dietary supplement includes an ingredient that’s never been used in a supplement before, information proving its safety is legally required to be submitted to the FDA and filed as an NDI at least 75 days prior to its availability on the market. It’s not an approval by the FDA nor an acknowledgement of supplement safety or effectiveness. It’s simply a step mandated by DSHEA requiring that all dietary supplements sold in the US must be reasonably expected to be safe. When filing an NDI, manufacturers must identify the new ingredient and explain why they think it’s reasonably expected to be safe. This will ensure that the FDA does not identify the new ingredient as an adulterated drug. Effectiveness isn’t considered at all for NDI filings.

Some manufacturers ignore these requirements altogether and sell potentially unsafe products to consumers without any consideration for DSHEA or the FDA. Others file an NDI, but when it’s rejected, continue to sell their product anyway – the ingredient apoaequorin in popular memory supplement Pregaven is a good example of this. While apoaequorin hasn’t posed any major safety concerns, other ingredients such as 1,3-DMAA have. The synthetic stimulant was marketed in products such as OxyElite Pro and Jack3d. The ingredient never received an NDI and products like OxyElite Pro were ultimately pulled from the market due to safety issues.

Keep in mind that when the FDA does accept an NDI, some manufacturers may portray it as meaning more than it does. Even if an ingredient receives an NDI, the FDA can still take steps in the future to remove it from the market if safety concerns emerge. The bottom line is, an NDI does not mean the FDA has completed a thorough safety evaluation as it does with drugs. Patients and providers should be cautious with unfamiliar dietary ingredients.

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The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2021 Natural Medicines Inc. Commercial distribution or reproduction prohibited. Natural Medicines is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.