The political irony of the natural products business is that Republicans have been more of our Congressional champions whereas Democratic voters tend to be our consumer champions.
Put another way, Republicans are not particularly enamored with the idea of preventive medicine or holistic healing but they are our allies in that they want government regulations to just go away. So in that regard it has helped the industry to not deal with regulations that are too onerous, in particular in the years after the 1994 Dietary Supplements Health and Education Act was signed and liberated the industry.
Democrats, on the other hand, are supportive of preventive medicine—look no further than Obamacare’s preventive benefits such as well-woman visits and gestational diabetes screenings for pregnant women. However, Democrats also have a propensity to come down too hard on the side of government regulating products. There’s no denying that FDA and FTC enforcement actions have accelerated under the Obama administration.
When you look at it through that prism, it can be difficult to say who is better for the industry. Some regulation of the industry is important because you need to have baseline quality standards met. For example, what is in the pill has to match what is listed on the label. There has been case after case of testing agencies looking at this, and the failure rate is unacceptably high.
Of course, sometimes this can be difficult when you’re dealing with complex formulas of inherently variable natural products—not every dandelion in your lawn looks exactly the same. So that’s a challenge for the industry to be sure, and that might be something that we’re never going to overcome, but we’ve got to come closer.
What do we do about this sorry state of affairs from a government perspective? For one, we have Good Manufacturing Practices, and I don’t think anyone in the responsible part of industry is opposed to GMPs.
On the other hand, dietary supplements and nutritional products are a safe class of consumer packaged goods products. Considering the billions of pills that people swallow every year, the adverse events that people experience from these are remarkably low. So there’s something to be said for that, and something to be said for excessively onerous regulations that would unnecessarily stifle the business of the industry of natural products as well as not give consumers all the benefits that they can have from these products. The current NDI rulemaking process is a perfect example of overshooting the mark. European regulations in general are another.
Regulation that crosses party lines
Similarly, there are people who do not like Senator Dick Durbin (D-IL) because he’s tilting at the windmill of caffeinated energy drinks—from wanting labels to include how much caffeine is in the product to getting rid of the category altogether.
At the very least, shouldn’t drinks that contain caffeine as the active ingredient state how much caffeine is in that product? On the one hand, coffee drinks do not have to, though consumers might believe a double caffe latte grande is a little more caffeinated than a run-of-the-mill cup of joe. On the other, energy drinks absolutely should include such information because their target market includes minors. Some energy drink companies assert that the amount of caffeine is a proprietary blend, but experiential alkaloids like caffeine ought to be labeled.
So the tension between the parties and the debate over who’s better for the industry will continue. It pays for all of us to have clear-headed thinking to go with political advocacy. Some regulation certainly is appropriate: like the banking industry, wherein if you don’t have any regulations you might collapse the economy, or in oil drilling, wherein if you don’t have the right kind you’ll end up with the BP oil volcano.
Natural products are a remarkably safe category with very little adverse events, though a report due out in March 2013 from the Government Accountability Office (GAO) at the behst of Senator Durbin and Congressman Henry Waxman (D-CA) will probably have just enough in it to stir up regulatory passions of Democrats. Balance will be key—these are products that people consume, which is why these products are appropriately regulated as foods, not drugs.
Now, at certain therapeutic dosage levels you can sometimes get drug-like effects, and so maybe that’s the future direction of legislation—to be able to acknowledge that you can have products that, just like foods, can indeed prevent or treat or cure diseases. And if they do you ought to be able to say that, not say the only thing that can possibly do that is a drug. It’s just wrong to not be able to so much as even register a study if you have a disease end point in mind. This is the sort of advocacy that ought to resonate with both political parties—pharmaceutical industry lobbying and donations notwithstanding.