FDA rejects two NDI filings on full spectrum hemp extracts

Jonathan Miller, an attorney in the firm Frost Brown Todd and the chief legal officer of the US Hemp Roundtable, said his organization is preparing a detailed position statement on the situation to be released tomorrow.  But as a snap reaction, he said the import of the rejections is clear.

Clear message:  Legislation only way to break logjam

“This makes it absolutely crystal clear how important it is that we pass legislation in Congress to find a legal pathway for CBD,”​ Miller told NutraIngredients-USA.

Steve Mister, president and CEO of the Council for Responsible Nutrition, concurred.  CRN had filed a Citizen’s Position with FDA last year​ providing what the organization believed to be a reasonable roadmap for a way forward for CBD in supplements.  Mister said he’s disappointed that the NDI rejections show the Agency has hardly budged on the issue in the intervening year.

“This situation is very disturbing to us and provides more than ever a clear indication that Congress is going to have to step in and solve this problem,”​ he said.

“FDA has had ample opportunities to find a way forward on this issue and they continue to reject the opportunities handed to them,”​ Mister added.

Federal law provides that New Dietary Ingredients that were not on the market prior to Oct. 15, 1994 must file a notification with FDA demonstrating that the ingredient is ‘reasonably expected to be safe.’  Experts note that this was meant to be a different and somewhat lesser standard of proof than that required for food additives.  Unlike substances added to foods, which would be consumed frequently as part of the diet, supplements are consumed in far lesser quantities and less often, hence the reasoning for the differing safety standards.



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