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The FDA only evaluates foods and drugs, not supplements like these products

Clarke R, Lewington S, Sherliker P, Armitage J (2007) Effects of B-vitamins on plasma homocysteine concentrations and on risk of cardiovascular disease and dementia

The impact of leucine supplementation on body composition and glucose tolerance following energy restriction: an 8-week RCT in adults at risk of the metabolic syndrome

However, the evidence for superiority over subcutaneous administration remains unclear, and the increased complexity and discomfort of IM injection discourages its use for most individuals

Regulatory status for compounded substances can change which is one reason clinical observers caution against building long-term treatment plans around compounds that lack formal approval