FDA Admits Its Rules Don’t Make Sense

Food And Drug Administration

If you’re familiar with the dietary supplement industry, you’re familiar with the Food and Drug Administration (FDA).  For those who aren’t familiar, the FDA is a federal agency tasked with approving or denying new drugs in the pharmaceutical space as well as issuing guidance for all dietary supplements.  Dietary supplements, unlike drugs, are not subject to an approval process by the FDA, but are instead required to follow a set up guidelines created and randomly updated by the agency from time to time.

Those who operate within the supplement industry are probably aware that FDA guidance often times isn’t all too clear and now it appears that even the FDA itself is ready to admit it.

According to a recent article by NaturalProductInsider, an FDA official went on record saying “it became clear that there was considerable misunderstanding about parts of the draft guidance and that, in some cases, our views were not stated clearly.”

This is the first time the FDA, an agency which has spent more time creating new laws and banning substances than enforcing the laws and bans they already have in place, has admitted fault like this.

Much of the confusion stems from the most recent gudiance for New Dietary Ingredients (NDI).  These are simply ingredients which are not currently being sold as supplements.  Naturally, an supplement company looking to get ahead may want to introduce NDI’s from time to time, but the rules are tough to follow.

According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), a new dietary ingredient is considered adulterated (and therefore not fit for sale) unless it “contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered” or if the FDA receives some sort of data indicating that the NDI is “reasonably expected to be safe”.

Needless to say, this is about as ambiguous as it gets.

The majority of NDI submissions have been rejected by the agency for seemingly arbitrary reasons, leading to the increase in “adulterated” supplements in recent years.  In reality, the FDA has positioned itself directly at odds with the majority of supplement companies at this point, and guidance that isn’t meant to be followed is clearly an indication that the agency has lost site of why it exists in the first place.

The FDA’s job is not to jam up supplement companies like they jam up pharmaceutical companies.  Surely we can all agree that the fact that it takes 10 years a billions of dollars to start selling a drug that could potentially save/improve lives is a joke.  But until this recent admission, it did not appear as though the FDA was aware that creating unnecessary barriers for businesses isn’t the best way to acheive it’s purpose of keeping the general public safe and informed.

The FDA has become to the supplement industry what the SEC is to the finance industry: a joke.  In fact, it’s lost so much credibility in recent years with its “ban first, research later” approach that some companies have simply stopped listening to what it has to say.

The truth is, the FDA is run by people who have no interest in research or science.  They just want to regulate.  And while some government regulation is certainly needed in the developed world, it’s getting to the point where they’re making laws just to make laws, not to keep people safe.  Is the supplement industry filled with a bunch of crooks and scammers looking to rip people off and introduce dangerous ingredients in to the marketplace?  Absolutely, and something needs to be done about it.  Making laws that are difficult to follow on purpose just to jam companies up doens’t seem like the way to go though… exists to educate the supplement community and seperate the science from the hype.

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