The diet supplement industry has used innumerable methods of staying ahead of the posse (the FDA, the FTC, State AGs, and the courts). They have simply outrun regulation, and outfoxed the regulators. The industry has outlobbied the regulators, as well. Despite decades of scientific data and media disclosures, the industry is virtually unregulated, and the consumer still cannot trust that a diet supplement purchased on the open market is safe, effective, or unadulterated. “Caveat emptor, baby, caveat emptor” was also the chant of the Bush Administration in its approach to these issues.
A new report by the FDA asks the simple question whether the FDA is up to the challenge of regulating engineered nanoparticles in diet supplements. Without reading the report, we know the answer to be “no.” The FDA is not set up to litigate, it has not been given a true mandate to regulate this industry, it is underfunded, and its scientists are squelched. But let’s see what they say. “It is not clear that the supplement industry is conducting the rigorous testing needed either to understand the effects of nanoscale ingredients in its products or to back up product claims.” We had to pay for a study to get to this conclusion? The industry doesn’t do “rigorous testing”. It doesn’t on anything it sells, because it isn’t legally required to do so. Instead, the industry does “rigorous marketing”.
As for whether the agency is “up to the challenge,” the report concludes: “The short answer is no.” Three reasons are given: 1.) the agency doesn’t have the capacity to identify nano-based supplements; 2.) the agency has little regulatory authority over such supplements; and 3.) the agency lacks the scientific expertise and resources to effectively regulate these supplements. The report recommends what has been obvious for decades now–increase the agency’s regulatory authority, and increase its resources.
The report provides a summary of the regulatory history that brings us to the current DMZ of DSHEA, and it even tackles summarizing the regulatory efforts aimed at corralling ephedra. It provides a disturbing summary of the increased budget and mandate of the agency in inverse proportions to the number of agency employees expected to accomplish the agency’s goals.
Ultimately, the report recommends that rational steps be taken, such as product registration, safety standards, market review, pre-market testing, adverse events reporting, and increased resources.
The report’s appendix contains a list of over 40 supplements using nanoparticles, but it does not articulate the safety risks the consumer faces. These risks include not only the direct risk to consumers, but also to those manufacturing the products, and the risk to the water supply, the environment, and animals.
One has to appreciate the efforts of the agency to articulate this nano-concern, but the report merely states the obvious as to the flagrant regulatory gaps that have been with us for decades now. The agency has to step up to the plate, as does Congress. The Obama administration’s stated goals suggest a new direction for the agency, and a return to science and consumer-based regulatory purposes. This will require that America step back from the gluttony of unbridled capitalism and the ritualistic zeal of woo. Perhaps we can, but I wouldn’t bet on it.