The “Wild West” of Supplement SafetyMarch 20, 2012
The episode, which aired this past Sunday, was mainly about a vitamin and mineral concoction called Total Body Formula that was sold four years ago by a store in Georgia. After several users reported horrific reactions—hair falling out completely, fingernails falling off, etc.—an investigation revealed that the formula contained extraordinarily high levels of selenium.
It turns out the manufacturer misread the formula when creating the supplement, resulting in selenium levels 200 times higher than the amount indicated on the label. On top of that, the supplement was produced using methods that no reputable manufacturer would use—for example, they strained the mixture through pantyhose!
To add insult to injury, an analysis by the product’s certification lab, Atlas Bioscience, didn’t even detect those dangerous selenium levels. So Dateline launched one of their famous sting operations where they submitted to the same lab two “new supplements” which had been secretly (but deliberately) spiked with arsenic and lead, and even asked the lab to check for them specifically—and once again the lab didn’t detect the dangerous chemicals: the lab had clearly fabricated its results.
Happily, Dateline got good quotes from the Council for Responsible Nutrition and the Natural Products Association, both of whom underscored the fact that the vast majority of supplements are safe. On the downside, the report clearly implied that giving FDA approval power over supplements would make them safer, which is false.
The fact is, FDA approval does not, and cannot, prevent contamination or adulteration. It certainly hasn’t done so for FDA-approved drugs! Supplement quality is maintained through strict adherence to Current Good Manufacturing Practices (CGMPs), which the FDA already has in place, and which are extremely stringent.
In particular because of the CGMPs, but even without the CGMPs, the FDA has full authority to enforce against contamination and adulteration. In this case, the FDA issued an official warning, and the manufacturer voluntarily recalled the toxic product to avoid lawsuits. The problem is not a lack of regulation but a lack of enforcement. As FDA’s Daniel Fabricant confirmed in the interview, it’s partly a matter of resources: FDA has only 22 agents working on supplements, and this is a $28 billion industry.
There is also a widespread belief that at least in the past the agency deliberately decided to minimize enforcement of supplements with the expectation that doing so would lead to a crisis, and a crisis would bring supplements more fully under FDA control. This may sound like a conspiracy theory, but there is evidence to support it.
FDA pre-approval would not only fail to make supplements safer; it would also threaten our access to supplements. And as we have seen with the FDA’s draft guidance for New Dietary Ingredients, a pre-approval system would greatly diminish access to supplements by removing many of them from the market, and also make the remaining supplements far more expensive.
Dateline’s piece paints the regulation of supplements as being like “the Wild West”—that is, without any reliable controls. But FDA certification for laboratories that test supplements is exactly the same as for those that test drugs and food. In both cases, it is a voluntary process.
And more to the point, only one certification lab out of all the labs Dateline investigated, the aforementioned Atlas Bioscience, was alleged to be guilty of being a “dry lab”—that is, of providing fraudulent data. One should not use the actions of one rogue laboratory to draw conclusions about the entire industry.
The burden is on the supplement manufacturer to ensure that the testing is reliable because ultimately, it is the manufacturer who is answerable. The same goes for food and drug manufacturers. As in all industries, there are bad actors, but as the episode points out, the majority of supplement manufacturers provide products that are safe and consumers use them to stay healthy.
Supposed “exposés” like this one never seem to point out that the percentage of adverse event reports for nutritional supplements is much, much lower than those for pharmaceutical drugs and vaccines. If the supplement industry is alleged to be “the Wild West,” what are we to make of the shocking number of deaths and injuries from drugs and biologics? Nobody says that these are unregulated industries.