The FDA issued New Dietary Ingredient (NDI) notification protocols, the rules under which the supplement industry can innovate and create new supplements. The new guidelines come as a the result of the recent mandates in the recent Food Safety Modernization Act.
Currently, the FDA has the power to pull any unsafe drug or supplement from the market if they do not comply with Good Manufacturing Practices or other specific rules. However, the new regulations allows the FDA to arbitrarily ban any supplement, particularly new ones developed after 1994.
In general, the new regulations create a burdensome and redundant process. For example, the FDA the NDI notification specific to the manufacturer, not the ingredient. So if two manufacturers are marketing the same ingredient, at the same quantity, they must each submit an NDI notification. They can’t hire a third party to do it for them as a group.
The FDA also expects a different notification for the same ingredient for every different version of the supplement it is in. For example, the same ingredient at a higher concentration needs a separate notification/approval. Or the same ingredient in a different combination of ingredients requires yet another notification/approval.
Other regulations impose extensive paperwork and testing for each supplement, including those that have been on the market for years without negative incidents.
Such regulations will cause higher prices for the consumer, and if manufacturers deem the new regulations too onerous, they may cease production altogether.
At the end of the day, certain supplements that we rely upon to maintain our health, may become unavailable over the counter. While we may still be able to purchase them as prescription drugs, they will be far more expensive. All of which leads me to wonder if the prescription drug industry is behind all this.