Referencing recent warning letters from FDA to 10 firms regarding the use of 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine, Dr Welch, Director of FDA’s Office of Dietary Supplement Programs, noted that, in some cases, the ingredients are new dietary ingredients for which FDA has not received a notification. In other cases, the ingredients are unsafe food additives.
“The definition of dietary supplement is very ingredient specific,” said Dr Welch at last week’s GRMA Summit in Chicago, “and the products we identified with these violative ingredients are a product integrity problem, if not also a consumer safety problem.”
Industry can often voice frustrations that warning letters cite ingredients that have been the subject of previous warning letters, suggesting to some stakeholders that FDA’s actions are not as effective as desired.
“That frustration – the idea that FDA is sending yet another warning [about the same ingredient] – is warranted,” said Dr Welch. “It’s something we in the Agency struggle with as well.
“Looking back over the past seven or eight years, we’ve spent time and resources evaluating various ingredients and describing how they’re not appropriate for use in dietary supplements. Usually, we communicate this through warning letters. But we have to come back to the same ingredient time and again because we keep finding more products containing these ingredients.”
DMAA
Dr Welch highlighted the case of DMAA, which was the subject of numerous warning letters as early as 2012. Products containing the ingredient have been the subject of seizures over the years.
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