Waiting on the Food and Drug Administration (FDA) is nothing new for the U.S. dietary supplement industry. Supplement suppliers, companies and their trade associations waited 13 years after the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994 for the agency to publish the good manufacturing practice (GMP) rules mandated by the law. It took another three years for the rules to be fully implemented. Other pieces of DSHEA also remained inactive for long periods of time, due in large part to inadequate funding of the bill.
Now, once again, the industry is waiting for the agency to publish rules that have been deemed essential by Congress and that could dramatically influence consumer access to supplements. This time those rules will lay out what the FDA expects from the supplement industry in terms of new dietary ingredients, or NDIs.
What’s an NDI? It’s a supplement ingredient that came onto the U.S. market after October 1994, when Congress passed DSHEA. Any company that brought a supplement ingredient to market after this date is required by law to file an NDI application with the FDA. This application is intended to enable the agency to conduct a safety review of the ingredient. Supplement ingredients that were on the market prior to the passage of DSHEA are considered “grandfathered in” and safe and, thus, do not require an NDI application.
The problem, however, is that the current rules governing NDI applications have been confusing to supplement manufacturers, which have struggled to pass the agency’s NDI safety threshold. This struggle, coupled with the fact that the FDA has been woefully lax in its enforcement of supplement regulation, have created an environment where too many supplement companies do not feel it’s important to file NDIs—even if they know they are technically using ingredients that were not on the market prior to DSHEA. That’s why the supplement industry has pleaded for FDA to provide greater explanation of who the agency expects to file NDIs, as well as what it expects to see in an NDI application.
Of course, this seems to be one of those situations where industry should be careful of what it asks for, because now the fear is that FDA is going to take a very broad view of what specifically would constitute a new dietary ingredient. In other words, some believe the agency will view ingredients that were on the market prior to DSHEA as new dietary ingredients if those ingredients are synthetic versions of natural ingredients or have undergone new forms of extraction or processing.
The FDA had been stalling on releasing its NDI guidance for years, but now—thanks to the passage of the Food Safety Modernization Act (FSMA) at the beginning of this year—Congress has set a deadline for when the agency must unveil the guidance. That deadline is July 5, 2011.
As the deadline approaches, agitation and fear of the worst have been building within the U.S. dietary supplement industry. “This could be a real game changer,” Douglas ‘Duffy’ Mackay, who heads up scientific and regulatory affairs at the Council for Responsible Nutrition, told attendees at the SupplySide East ingredient supply show this week.
Bill Frankos, the former director of the Division of Dietary Supplement Programs at the FDA, told the Salt Lake Tribune that, once published, the agency’s NDI guidance could throw the supplement industry into turmoil and add to the hostility that has existed between the government and supplement companies for decades. “That is the shoe that could drop and be a problem,” said Frankos, who now works for the multi-level marketing supplement company Herbalife. “I think that will put a huge amount of tension on the agency and the industry.”
If you aren’t familiar with the intricacies of how supplement products are regulated by the FDA, this impending NDI guidance probably sounds a bit ho hum and bureaucratic. In reality, however, it has the potential to force hundreds, if not thousands, of supplement products off the market. Or, at least that is the concern that has been spreading throughout the supplement industry over the last several years.
If you sell or take dietary supplements, you should care about all of this. Of course, such drama makes good fodder for blog posts like this, but it also represents the real apprehension supplement makers and suppliers feel regarding their longtime tenuous relationship with FDA. Tension is nothing new, and even though the agency’s dietary supplements division is now being overseen by a former supplement spokesman—Daniel Fabricant, PhD, vice president of global government and scientific affairs at the Natural Products Association (NPA)—many are predicting that a new era of increased strife between government and dietary supplements is approaching.
Are you ready?