Senator Markey Questions the FDA over Self-Determined GRAS Ingredients

When a manufacturer of a unique ingredient wants to release that product, and it has never been sold before, they need to file a 75 day notice with the FDA informing them of their intent to sell a New Dietary Ingredient. Many companies (illegally) choose not to do this, and some attempt to avoid notifying the FDA entirely, through a process called Self-Determined GRAS (Generally Regarded As Safe).

However, this is not a legally valid strategy. Daniel Fabricant, PhD (then of the FDA), has stated:

“If the ingredient has GRAS status (with or without FDA notification) then the statute states that it needs to have been previously used in foods [and a company should not think that] “GRAS gets submitted and it goes in a supplement…”

But that’s exactly what many companies think, and have done, in an effort to circumvent the NDI process (and avoid their ingredient being rejected). But the party may be over now, as there is senatorial oversight on the FDA, who have been allowing this to happen, in flagrant violation of the law.

In fact…I can think of an ingredient that was rejected by the FDA, and later self-determined as GRAS. Again, in flagrant violation of the law.

Now, Senator Ed Markey of Massachusetts, has raised concerns and questions, and directed a letter to the FDA which makes a very strong case against companies declaring their own products to be safe.

Check it out: