Ullman Comments on Future Results of FDA Policy on NAC

April 29, 2022 | Compliance Investigations & White Collar

Marc Ullman commented on how the FDA’s recent enforcement discretion of NAC will bring some certainty to the market in NutraIngredientsUSA article, “Enforcement discretion gives some solace to NAC space, observers say.”

Ullman stated, “FDA enforcement discretion on matters like NAC should be fairly reliable in the absence of any data emerging indicating a potential public health risk.  While enforcement discretions are subject to change without notice, it would be extraordinarily unusual for FDA to turn on a dime — especially where there is a potentially serious economic impact to a reversal.”

“Most recently, FDA issued a spate of enforcement discretions related to products like hand sanitizers it believes to be important for combatting COVID.  Most prominently for the Supplement Industry are the series of enforcement discretions issued in connection with qualified health claims.  Many of these have been long standing and companies have been able to rely on them for marketing purposes with confidence,”​ he said.

Ullman said the history of DSHEA makes it clear in his mind that its framers did not intend for it to be used for historical fishing expeditions. ‘Legislative intent,’ however, can be a slender reed when it comes to dealing with the more recent policies of regulatory agencies, so he said it might be something that will have to adjudicated in the future.

“​The primacy of the exclusionary clause or the grandfather date is an interesting one.  Given that DSHEA’s intent was to expand access to dietary supplements and the legislative history showing that the exclusionary clause was a late addition to the statute, I would argue that the grandfather clause should prevail.  FDA, which is always interested in expanding its powers and has never liked DSHEA (also two reasons why I am opposed to a mandatory product listing) is taking the opposite position.  This presents an interesting legal question that may have to be settled in court one of these days,”​ Ullman commented.

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