Challenges in 2012 for the Dietary Supplement Industry

By Douglas MacKay, ND, vice president, scientific and regulatory affairs, CRN

Sometimes marriages don’t work. And here’s a classic case. For the dietary supplement industry, 2011 was an interesting year. Two issues in particular were hot topics that didn’t go away when we turned the calendar page to January, ensuring that 2012 will be just as interesting, and even more challenging. The issues I’m referring to are: 1) adulterated products masquerading as supplements; and 2) the New Dietary Ingredient (NDI) Draft Guidance. The former issue has been looming over the industry for some time and threatens to explode unless we can get a handle on it. The latter has equally dire implications. But these topics don’t go hand-in-hand and should not be married together, as FDA is trying to do, using adulterated products as a justification for the over-burdensome NDI Draft Guidance document.
 
Certainly, as an industry we have a responsibility to abide by the law—and the law requires both that companies manufacture unadulterated products and submit NDI notifications. This is why all five dietary supplement trade associations, led by the Council for Responsible Nutrition (CRN), participated with FDA in a joint press conference to announce a united front against the intentional adulteration of dietary supplements. That is also why CRN, and others, called for the release of the draft guidance for NDIs. 
 
But these are two separate issues, with separate solutions needed, and it is inappropriate on FDA’s part to attempt to tie in the problem of adulteration as justification for an over-reaching NDI Draft Guidance. To pretend that the adulteration problem will go away because of the NDI notification process is a fantasy. If you’re illegally spiking a product with Viagra, does anyone believe that company will submit an NDI notification for Viagra?!
 
Let’s face it. The companies that are intentionally adulterating products are certainly not going to submit NDIs. So, instead of looking for a real solution to address the serious problem of adulterated dietary supplements, FDA appears to have decided to punish the companies that would like to follow the law—both with regard to NDI notifications and unadulterated products. 
 
FDA officials have been less than welcoming toward industry’s concerns with the pharmaceutical-like draft guidance and many of its provisions. Hopefully as the process continues, the agency will be willing to engage industry as a partner and not a foe on both issues—separately. Whether this happens remains to be seen but in the meantime we should collectively and proactively think about ways to solve the serious problem of adulteration before our industry is irreparably damaged. But first, FDA should divorce its false notion that tying the NDI Draft Guidance to adulteration provides a true solution.

Duffy MacKay, ND, is the vice president of scientific and regulatory affairs at CRN. He can be reached at dmackay@crnusa.org.