In late April, acting FDA Commissioner, Dr. Lester Crawford, outlined the agency’s science-based approach to protecting American consumers from unsafe dietary supplements. Dr. Crawford said FDA would soon provide further details about its plan to ensure that the consumer protection provisions of DSHEA are used effectively and appropriately. Specifically he said, “Unlike most foods, some dietary supplements are pharmacologically active. And we have seen over the last 10 years a huge growth in the dietary supplement industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose.” Dr. Crawford spoke of these plans before an audience at the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences. FDA claims it has stepped up its enforcement efforts over the last six months by inspecting 180 domestic dietary supplement manufacturers; sending 119 warning letters to dietary supplement distributors; refusing entry to 1171 foreign shipments of dietary supplements and seizing or supervising the voluntary destruction of almost $18 million worth of mislabeled or adulterated products. FDA says it will provide additional information to explain and implement the tools available to the agency under DSHEA to act against unsafe dietary supplements and false or misleading supplement labeling claims. To support its consumer protection actions, the agency is developing approaches to systematically review the evidence about the safety of individual dietary supplements. FDA expects to evaluate the available pharmacology, published literature (including animal, in vitro, epidemiological and clinical trial data), evidenced-based reviews and adverse event information, which is identical to the approach that formed the scientific foundation for FDA’s recent rulemaking on ephedra. Some of the supplements in question include kava, usnic acid and bitter orange (citrus aurantium). Whether or not these supplements will face an ephedra-like fate, Dr. Crawford indicated it was too early to tell.