First, the FDA has issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained by the Dietary Supplement Health and Education Act (DSHEA). As you may recall, DSHEA said that supplements already on sale prior to the passage of the act were "grandfathered" in, and did not have to be reviewed by the FDA. New supplements developed after the Act have been in a kind of limbo waiting for the FDA to spell out the procedures to be followed.
These new supplements have always been at risk because of the uncertainly surrounding their regulatory status. And many of these new supplements are extremely important for our health. We won't name them, because to do would be to put a bull’s-eye on them for the FDA to shoot at, but you would recognize many of them and may be currently taking them.
DSHEA was passed in 1994. The FDA has thus taken seventeen years to provide regulatory guidance for these new supplements. Now a draft version of guidance is here, and it isn't good. It is just another effort by the FDA to suffocate the supplement industry so that everything—supplements and drugs alike—will go through the vastly expensive drug approval process, a process that pays for FDA salaries.
We have said it before and we will say it again. Supplements cannot usually be patented. No non-patentable substance can be taken through a drug approval process that on average costs a billion dollars. If supplements are treated like drugs, there simply won't be any supplements. The FDA knows this perfectly well.
The new draft guidance is written in the usual regulatory non-English, but buried within it are definitions of "new supplements" that will make more and more supplements subject to the new rules. The rules themselves are designed to make it harder and harder to market new supplements, all of which will need to submit notification to an agency that is fundamentally hostile to the supplement industry. Not only does each supplement require its own notification, a separate notification must be submitted by each company that offers it. Additionally, notification must be submitted again if the supplement is reformulated in any way or offered in combination with any other supplement or ingredient. Based on what the FDA has done in the past, many more applications will be rejected than accepted and the cost of the whole process will be high.
The FDA is required to give us 90 days to comment on their proposed guidance. Our experts are busy analyzing the proposal in all its detail and we will report on it again and provide an Action Alert in our next newsletter right after the holiday. We already know this needs to be stopped. With your help we will do everything we can to change it. Your ability to use supplements not already documented as having been on the market under the same exact name and formulation prior to 1994 will depend on it.
As we mentioned above, Sen. Durbin’s much-feared Dietary Supplement Labeling Act of 2011 (S.1310) has been formally introduced in Congress.
The Alliance for Natural Health USA