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Critics point to abstainer bias (non-drinkers may include former heavy drinkers who appear sicker) and confounding lifestyle factors

Prolonged poor glycaemic control increases the risk of both acute complications (such as hyperosmolar hyperglycaemic state, or HHS, which is the typical hyperglycaemic emergency in type 2 diabetes) and long-term microvascular and macrovascular complications affecting the eyes, kidneys, nerves, and cardiovascular system

Both participants and study staff were blinded to treatment assignment

Using FDA-approved language to market it for general fat loss or body composition is a direct misrepresentation that appears in multiple recent warning letters