# Microbiome-Based Interventions for Food Safety and Environmental Health
## 5 Challenges and Limitations Associated with MBT
### Regulatory and Safety Concerns
In consideration of this input from major stakeholders, the FDA eventually allowed \"enforcement discretion\" for FMT to treat CDI that was not responding to standard antibiotic therapies without requiring them to submit an IND application, resulting in most physicians and stool banks not obtaining IND approval for such treatments [116; 117]. The agency, however, insisted that an IND application would be necessary if FMT were to be used for research purposes or to treat ailments other than CDI [122]. The FDA classifies products based on the claims made by the manufacturer, not their ingredients or properties [116]. Ethical and socioeconomic factors significantly influence the design, implementation, and outcomes of microbiome research. For instance, in FMT trials, stringent donor screening is required to minimize the risk of transmitting infectious agents. However, inconsistent regulatory frameworks across countries raise ethical concerns regarding patient safety and data privacy [113]. Socioeconomic factors also impact the accessibility of microbiome-based interventions [123]. Additionally, ethical considerations extend to data privacy in large-scale microbiome studies. For example, in human gut microbiome sequencing projects, ensuring participant consent and data security is paramount. To prevent privacy breaches while maintaining data transparency and reproducibility, it is essential to de-identify microbiome data. For instance, [PERSON] and [PERSON] [124] discuss the privacy risks associated with microbiome data and suggest that adopting well-known anonymization techniques can help protect participant privacy in microbiome studies. Additionally, [PERSON] et al. [125] propose the use of secure computation methods to enable comparative analysis over combined microbiome datasets without revealing individual sample information, thereby addressing privacy concerns in microbiome research. If a product, including a probiotic, is claimed to cure, mitigate, treat, or prevent disease, it is classified as a drug, thereby requiring a costly IND application. Similarly, human studies investigating these claims also require an IND application, which poses barriers for researchers due to the need to provide proprietary manufacturing information [126]. The \"locked-in\" rule, which forbids marketing a substance as a food product if it is first examined as an IND, even if the study is intended to encourage usage of that product as a food rather than a medication, increases limitations to high-quality clinical research on probiotics [126]. Considering that these substances can be marketed as a dietary supplement or food before conducting an IND application, the FDA inadvertently provides a loophole that allows marketing a substance as a dietary supplement or food before seeking an IND approval, preserving the option to continue marketing it in those forms even if substantial clinical investigations show no benefit [126]. This has discouraged manufacturers and researchers from rigorously evaluating probiotic claims, contributing to the FDA not approving any probiotic products as live biotherapeutic agents [116; 126].