Tag Archives: FDA

What a row: FDA’s New Dietary Ingredients draft guidance

December 2 was the deadline for comments on the FDA’s new draft guidance on New Dietary Ingredients, a set of new guidelines for supplement manufacturers on adhering to the Dietary Supplement Health and Education Act (DSHEA) of 1994.

The supplements industry is deeply troubled by the draft, which they feel would drastically increase the cost of proving the safety of their products without actually increasing the safety of supplements. Individual NDI filings will have to be submitted for each challenged ingredient, which at a cost of tens of thousands of dollars for each filing will be disastrous for smaller companies.

Just a few of the issues: synthetic versions of botanicals — lycopene from a tomato, say — would disqualify a product as a dietary supplement. Small changes in the manufacturing process will require a new NDI filing. Old lists of accepted ingredients proven as safe are dismissed, meaning a new NDI filing would be required for almost every product.

Jarrow Formulas (who make my favorite vitamin B12) was so incensed they submitted a Freedom of Information Act request for background on the development of the draft.

The draft does nothing to allay fears about a pharmaceutical industry campaign to reduce the supplement industry’s lobbying strength and increase public perception of supplements as unsafe in the hands of unguided consumers, and thus reduce resistance to the idea of patenting supplement ingredients for exclusive use in pharmaceuticals.

The FDA draft is covered extensively at New Hope 360, which seems to aggregate articles from the magazines Delicious Living, Functional Ingredients, Natural Foods Merchandiser, and Nutrition Business Journal.