Threats to DSHEA: Chicken or the EggThreats to DSHEA: Chicken or the Egg
John Shaw, CEO and executive director of the Natural Products Association, doesnt have much time to wax nostalgic on DSHEAs 20th anniversary. Hes too busy worried about industry non-compliance, a draggy FDA, and an indifferent media.
January 10, 2014
As we come up on the 20th anniversary of the Dietary Supplement Health and Education Act (DSHEA), I cant help but think about the law itself. As the leading trade association defending the dietary supplement industry, NPA believes we must protect DSHEA from the threats that crop up. One danger we cannot ignore is the message from major media outlets that were an unregulated or under-regulated industry. Frankly, those terms get my blood boiling every time I hear it and, unfortunately, Ive heard it a lot over the past year.
In fact, NPA will be undertaking a revitalized mainstream media campaign in 2014 to change that message. And why is this message such a threat to DSHEA? Because it leads to continued focus on our industry by congressional opponents like Sen. Dick Durbin, D-Ill., and provides justification for major modifications to DSHEA.
But where does this idea that were unregulated come from? Its a message that is promulgated by major media outlets, but why? If you ask me, its because theyre only getting half the story they arent hearing about all the good our industry is doing. To dig into the why of this story, Im going to get a little philosophical. I think were really asking the age-old question: which came first, the chicken or the egg? And to ask in terms of todays topic: which came first, industrys non-compliance or the Food and Drug Administrations (FDA) inaction?
Lets further explain the notion of industrys non-compliance. This is, by no means, representative of the entire industry--in fact, there are plenty of companies which invest resources in ensuring they are compliant with the facility registration requirement under the Bioterrorism Act, Good Manufacturing Practice (GMP) regulation, New Dietary Ingredient (NDI) Notifications, Adverse Event Report (AER) submissions, and more. But there are also plenty of companies struggling to comply with all the dietary supplement-specific regulations that are in place. Unfortunately, there are also some companies in this space that are outright disregarding the laws and regulations. And these two groups are providing fodder for the impression that the industry is un- or under- regulated.
Now lets consider the other side of that philosophical question: what about the FDAs inaction? Now dont get me wrong, NPA is very supportive of the enforcement actions the FDA has taken over the past three years. While it may hurt now, we do believe itll make the industry stronger in the long run--demonstrating we are, in fact, regulated.
But what about the first 10 to 15 years of DSHEA?
Of those regulations mentioned above, it took the FDA 13 years to draft and finalize the GMP Rule for dietary supplements. In that time, NPA drafted our own GMP standard and was certifying manufacturers to it for seven years. Additionally, industry asked for guidance on the NDI notification rule for years before receiving it and it was a good thing we asked because as we all saw from the FDAs draft NDI guidance two and a half years ago, they had drastically different expectations regarding NDIs than the industry. But even with the regulations this industry operates under, the FDA is constantly under-resourced. This doesnt just affect the amount of time it takes to get regulations or guidance documents written; this affects the amount of enforcement the FDA can undertake. This is in reference to the earlier comment that our industry will be stronger as the FDA continues to enforce. This industry doesnt need additional regulationswe need full enforcement of the current law.
So what came first, the chicken (industrys non-compliance) or the egg (FDAs inaction)? I dont carelets fix them both. The natural products industry needs to rise to the occasion, no more intentional or unintentional non-compliance. There are resources available for all sides of the industry, for all sizes of companies who make all kinds of products. NPA has our GMP certification program along with intensive workshops that cover the entire GMP Rule. We also offer web-based education on any number of topics. And with consultants and other groups offering the same, there is no excuse for this non-compliance. NPA also advocates for additional resources for the FDA to ensure they have the funding and manpower to regulate our industry.
Self-regulatory efforts only go so far: having FDA at full capacity to oversee this industry is as important to changing that message with the media as our internal efforts.
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