Improving childhood vaccination rates.

391 cause the FDA is holding supplements to the same safety standards as food additives — which was not Congress’s intent when drafting DSHEA. Industry advocates are correct insofar as DSHEA does not hold established (pre-1994) supplement ingredients to the same safety standards as food additives: a chemical preservative sprayed inside a can of tomato soup or the purple dye in Jell-O requires much more evidence of safety than ingredients used in supplements. However, the industry’s argument is flawed with respect to new supplement ingredients. The FDA’s legal authority over new products is generally greater than that over established products,5 and this also applies to supplements. DSHEA explicitly requires the FDA to assess the reasonable expectation of safety of new ingredients, and it is impossible to do so scientifically without experimental data. If the FDA succumbs to industry pressure, the public health consequences will be significant, as hundreds of thousands of Americans continue to turn to new supplements to sustain their health and treat their ailments. By insisting on scientific evidence to demonstrate the expectation of safety, the FDA will not only improve the safety of new supplements but also create a database of evidence that scientists, physicians, regulators, and consumers can tap to help make informed decisions about the use of supplements in the future.5 But even if the guidance is strengthened and aggressively implemented, fundamental flaws in DSHEA, such as the lack of a preapproval review process for all supplements, will continue to limit the FDA’s ability to ensure that dietary supplements are safe. Disclosure forms provided by the author are available with the full text of this article at NEJM.org.