DSHEA's Architect Hosts NDI Town Hall

I had the opportunity to participate last week in a Town Hall Meeting for the Utah Dietary Supplement Industry sponsored by Sen. Orrin Hatch. It was a great example of the two-way communication that can occur when members of Congress sit down with their constituents. Sen. Hatch was able to convey to industry members the impact that decisions in Washington can have on their businesses in Utah, and they were able to express their anxiety about such issues as the New Dietary Ingredient (NDI) Draft Guidance and ask for his help.

At the risk of appearing too patronizing of Sen. Hatch, it’s worth acknowledging what a critical role he plays in the NDI discussion. When FDA issues a guidance—as it did in July—that misinterprets the Dietary Supplement Health & Education Act (DSHEA) in a manner that is contrary to Congress’ original intent, having one of the primary architects of that law in your corner is pretty remarkable. Sen. Hatch, better than almost anyone else, knows what the law that he co-authored was intended to do and what Congress meant on matters like the new dietary ingredient process.

Here’s a sampling of a variety of concerns I heard being raised about the draft guidance:

Utah businesses expressed concern about the position FDA has taken that NDI notifications should be filed for each new formulation that includes a new dietary ingredient. This interpretation is contrary to FDA’s earlier pronouncements about the NDI provision, and would vastly multiply the burdens of the NDI notification process. Instead of filing the notification once, FDA would require notifications for each new “product” using that ingredient.

Company reps voiced frustration about FDA’s interpretation that even grandfathered ingredients may be transformed into new dietary ingredients if changes in the manufacturing process change the structure of the final ingredient. If industry took FDA’s directive literally and began filing NDIs on all these “new” ingredients, it could overwhelm the agency, and result in trusted ingredients with strong safety records being removed from the market until FDA reviews the notice and responds.

The amount of safety data FDA is requesting to meet the burden of demonstrating a reasonable expectation of safety is entirely too high for what DSHEA intended. In the years just before DSHEA was enacted, FDA tried to hold dietary ingredients to the standards for food additives, demanding the same level of data for supplements as it requires for chemical colorants and preservatives added to food. DSHEA rejected that and created a new one. Now FDA has used this guidance to redefine a “reasonable expectation of safety” as almost the same as the food additive petition. FDA is essentially equating the two standards—which is exactly what DSHEA endeavored to prevent.

Even the fact that FDA offers up the GRAS (generally recognized as safe) self-affirmation process as an alternative route to marketing a new dietary ingredient is a Trojan Horse. To go that route of a GRAS petition and forsake the NDI process, which is a more cumbersome requirement, is to accept a burden of proof that DSHEA was enacted to reject.

And finally, there was dismay at FDA’s position that synthetic versions of dietary ingredients are not dietary ingredients at all. FDA has used the NDI guidance to articulate a view that a synthetically produced version of a constituent of a plant can not be a dietary ingredient, even though it is bio-identical to the constituent.

Today there are any number of dietary supplements on the market that contain a synthetically produced version of a botanical ingredient. This may be because it’s more commercially viable, because it’s more environmentally sustainable, or because a synthetic version provides more consistency and uniformity of the finished product. But FDA would halt that.

What’s particularly troubling is that this isn’t even a question of safety. To FDA, it’s definitional—if the ingredient is produced in a lab, no matter how bio-identical it is—it can’t be used in a dietary supplement, period. And no amount of safety data appears that it will change the agency’s mind.

Sen. Hatch listened attentively to these constituent discussions and vowed to protect industry and supplement consumers from changes that would limit access to safe products. He stopped short of offering a “legislative fix,” saying we should focus the energy now in trying to change FDA’s mind and working with the agency to influence the guidance, rather than plotting to revise the law. He’s absolutely right, but it sure is nice to know he’s watching our back.