Nutraceuticals, such as functional foods, dietary supplements, and therapeutic foods, are crucial for
fostering health and averting illness. However, a number of nutraceutical bioactive chemicals' quick
metabolism, low bioavailability, poor stability, and poor water solubility limit their therapeutic efficacy.
Because nanoformulation techniques enhance the bioavailability, stability, controlled release, and
targeted administration of nutraceutical components, they have become a viable means of overcoming
these constraints. In this assessment, the regulatory environment around nutraceuticals is critically
examined, with a focus on goods that are enabled by nanotechnology. Significant regulatory obstacles
include the lack of agreed-upon terminology, ambiguity in the classification of food and medication
categories, issues in verifying health claims, inconsistent labeling standards, and post-market
surveillance constraints. We address common nanoencapsulation technologies utilized in nutraceuticals,
including polymer-based systems, solid lipid nanoparticles, liposomes, and nanosuspensions, utilizing
omega-3 fatty acids, curcumin, and coenzyme Q10 as sample examples. Concerns about long-term
safety, toxicity specific to nanoparticles, and irregularities in analytical and regulatory evaluation
techniques persist despite the substantial functional benefits that nanoformulations provide. For the
development of nano-nutraceuticals to be safe and successful, the review emphasizes the necessity of
strong scientific evidence and standardized international regulatory frameworks.
Keywords: Nutraceuticals; Nanoformulation; Regulatory challenges; Bioavailability; Safety
Publication date: 2026/10/01
https://www.ijbpas.com/pdf/2026/October/MS_IJBPAS_2026_10525.pdf
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doi.org/10.31032/IJBPAS/2026/15.10.10525
