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The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law

[DOI] [PMC free article] [PubMed] [Google Scholar] [26].Ingold I, Aichler M, Yefremova E, et al

While the results of the study point to clear dietary signals, most included studies were observational or high-risk clinical trials, and outcome measures varied widely