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Once FDA establishes the intended use, FDA can review its own records to determine that the company is not registered with FDA and/or has no drug approval, at which point the product is an unapproved new drug. Adulteration and misbranding violations follow in line, both of which are based on statutes carrying civil and criminal penalties

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The results of a cohort study with 70 participants (42 men and 28 women) who consumed baobab fruit pulp and another 70 participants (44 men and 26 women) who did not, showed that the baobab fruit users had significantly lower levels of low-density lipoprotein cholesterol, triglycerides, and total cholesterol (Ahmed et al., 2022)

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Blinding and allocation concealment are often inadequately reported, increasing the risk of bias