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Bill on ODIs is probably DOA

A bill put forward by Rep. Dan Burton, (R-IN) to alter a key part of the Dietary Supplement Health and Education Act (DSHEA) has received a lukewarm reaction from industry observers.

One of the sticking points in FDA’s draft guidance on New Dietary Ingredients concerns the subject of Old Dietary Ingredients.  DSHEA, the industry’s overarching regulation, established a date of Oct. 15, 1994.  Ingredients not seen previously in the marketplace and introduced after that date were supposed to go through the NDI filing process to vet their safety.  Ingredients on the market as of that date are categorized as ODIs and are presumed to be safe.

Industry groups had compiled lists of what was on the market in late 1994 and would then qualify as ODIs, but FDA summarily dismissed these lists in the draft guidance.  So, as matters stand now, if a company has an ingredient that was on the market in 1994, it’s up to that company to prove it, via sales receipts, ingredient info sales sheets, testing data, etc.

Burton’s proposed bill, which observers said he doesn’t plan to push further this year, would alleviate much of that documentation burden by changing the ODI grandfather date to Jan. 1, 2007.  That date is significant because it marks the first day that some key features of DSHEA first started to be enforced, namely the Adverse Events Reports (AERs) system and Good Manufacturing Procedures (GMPs) rules and inspections.  So, the presumption is that the data from those systems will reveal what potential safety problems might exist in the marketplace since 2007.  And further, the absence of any significant safety problems with supplements prior to that date (with the exception of ephedra) means it makes sense to put the 1994-2007 ingredients into the ODI category, in which case it would be up to FDA to prove these ingredients are unsafe.

Seems reasonable, yes?  But there’s a catch.

“I certainly understand the appeal of the idea, given the strong record supplements have had regarding safety in the period from DSHEA to 2007,” said John Gay, executive director and CEO of the Natural Products Association.  “But this bill opens DSHEA up. And when you do that, it allows other people who have ideas we don’t think are great to add those to the mix (via possible amendments).  You don’t have any control of the process.”

“From a policy standpoint we think that it makes a lot of sense to move the date forward,” said Steve Mister, president and CEO of the Council for Responsible Nutrition. “But then you have to ask about the political piece of it.  What if some of your critics try to hijack the bill?”

Both Gay and Mister said they are staying focused on FDA and the draft NDI guidance, rather than pushing legislation on Capitol Hill.  And both are hard at work  finishing their organizations’ comments before the filing deadline of December 2. Mister said there is reason to believe that FDA will work with industry to discuss incorporating changes suggested in the comments in the final guidance, citing FDA’s previous willingness to work with industry on the guidance documents that established the AERs and GMPs.

“But,” Mister said, “Burton’s bill is a reminder that there are other options.”

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