Solving US Hemp Regulatory Problem Will Take Wider View Of FDA Rule – AHPA’s McGuffin
Excluding All Ingredients Used In Drugs Inequitable For Supplement Industry
FDA, along with supplement and food industries, have looked to Congress to authorizing agency to waive exclusion rule for hemp ingredients. Instead, Michael McGuffin recommends amending DSHEA to clarify that the same ingredients at different concentrations can be allowed in supplements and drugs.
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Trade group contends FDA’s misuse of regulation prohibiting any substance studied or approved as a drug in US from being used as dietary ingredients undermines innovation in supplement industry and is detrimental to consumer choice and health.
Busy agenda of disparate topics in one-day meeting likely valuable for informing FDA on safety of hemp ingredients but not for moving toward a regulatory pathway for the ingredients' lawful use in supplements and food.
Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug ingredient. However, NAC supplements, as they have remained since 2020, were available to US consumers when draft was published.