FDA: Hero or Villain?



The FDA is a lot like a traffic cop. It is often unpopular. The average citizen sometimes has less-than charitable things to say about both. But without them, systems we've come to rely upon would slowly slide into self-policing and chaos.

Some Foods For Living shoppers have indicted the FDA for being a typically inefficient government agency, bloated past usefulness by bureaucracy. But the FDA won some hearts and minds in August 2014 when it finally made "gluten-free" mean something. A law passed the year before had finally taken effect, and we semanticists of the world experienced a rare moment of joy.

Like many other food-label terms, "gluten-free" has always been a term defined by the manufacturer. (See also, "all natural," "fresh," "artisan," etc.) A company could create a gluten-free product in a facility that also created gluten-packed products, or had trace amounts of gluten, and it was up to the wary consumer to investigate these claims. As of last August, the definition became very specific: "gluten-free" products cannot contain a detectable amount of gluten, period, or contain wheat, rye, barley, or their derivatives. 

This is a huge win for those with celiac disease, for whom even trace amounts of gluten can be damaging. (For those simply pursuing a gluten-free diet lifestyle, trace amounts wouldn't matter.) The move was praised by the American Celiac Disease Alliance. And we can thank the good ole FDA. This is an example of a government agency protecting consumers.

So why do some people hate the FDA?

Well, for one, they test products on animals, and they source studies by agencies that do the same. Clearly, this is a line which, when crossed, brands the FDA as a villain for some people. They work with Americans for Medical Progress (AMP), whose webpage features a banner with a white mouse that says "research needs advocates." For those against animal testing, the FDA is complicit in untold suffering.

The FDA's legendary inefficiency is another reason some people bristle at the mere mention of the the organization. Stories about the FDA dragging its feet on approving crucial drugs are numerous. Like any large government organization, the FDA is a bureaucracy. The machinery of bureaucracy is inefficient by nature. But only a large organization with the power and reach of the FDA could conceivably police our food and drug supply. The United States has one of the world's safest food supplies. But even with its tremendous power, the FDA may not be doing enough, according to this article from the Daily Beast, which argues that simple food-borne illness isn't our largest dietary threat, but rather the contents of the "nutritionally hollow" modern diet itself. Many nutrition advocates would like to see the FDA take an active role in legislating nutritional guidelines, but this opens a Pandora's box that's already crowded with Michelle Obama's Let's Move program and illegally-sized New York soft drinks.

Of course, the FDA is invisible when it's working properly. There are innumerable cases where the FDA caught a flaw during testing or denied approval to something dangerous. Many of us take for granted the safety of everything we consume, forgetting that safe food is by no means the default setting. Few would argue with setting high standards for food safety.

But there are many gray areas when it comes to protecting people from themselves. Take the case of consumer genomics, for instance. Consumer genomics test kits, such as those manufactured by 23andMe, can provide people with personal genetic data. If a person finds out they have a predisposition to a certain condition, this may allow them to take appropriate (or inappropriate) action. Previously, 23andMe was including recommended actions with its results. The FDA thought this could lead people to take harmful steps, such as unnecessary surgery. The FDA ruled that 23andMe can keep marketing their tests, so long as they do not dispense medical advice alongside them.

The FDA often ends up seeming like a well-intentioned, crippled watchdog. When potentially life-saving drugs are up for the organization's approval process, all eyes are on the FDA, and they receive understandable scrutiny every step of the way. But they are making strides. 2014 saw the FDA hit an 18-year high in drug approvals. (Cue due cynicism regarding Big Pharma.)

The one area where the FDA has remained aloof is the world of dietary supplements.  According to the FDA, manufacturers are responsible for policing their own process and product. If something poisonous or blatantly mislabeled makes it to the shelf, then FDA will step in.

During the sepia-tinged administration of Bill Clinton, in the autumn of 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law. This essentially disengaged the FDA from supplement oversight. Previously, supplements were overseen by the FDA like any other consumable. But in a post '94 world, there is no bureaucratic obstacle to coming out with a Super Goji Inhalant (at least not until after the fact). The only stipulation is a small, ubiquitous label that reads "These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." For better or worse, the world of supplements remains a relatively safe sort of wild west. 

Whether the FDA is a bloated cyclops or a vigilant watchdog is a matter of personal opinion. Even as it stalls approval for life-saving drugs, the FDA is laboring to make our food some of the safest in the world. What do you think?