Botanical (herbal) dietary supplements are more popular than ever, not only for humans but for their pets also.  This popularity and increased sales has sent up a red flag and pharmaceutical groups are wanting a piece of this pie.  So, spin articles are appearing in mass claiming adverse health effects might occur in the population if the FDA doesn't regulate herbal products with a tighter rein.

Under DSHEA, botanical dietary supplements are considered low risk, as are vitamin and mineral supplements, as data acknowledges, and therefore are regulated as foods. At present the FDA has a voluntary system in place for reporting adverse events concerning herbs and supplements, receiving less than 1% associated with dietary supplements. The FDA wants to require mandatory adverse event reporting and have stepped up their efforts to regulate supplements in general with their Operation Cure-All program, at this point, they are mainly warning companies on illegal claims in literature or on websites.

With the ephedra fiasco fueling the fire, "good manufacturing practices" (GMP's) put into place by the FDA to ensure reliable quality, and manufacturers pre-warned that other supplements could follow ephedra's demise, the horizon for herbal products regulation seems a sure bet.  For the FDA to realize their true goal, which is oversight on botanicals, one avenue is the issuing of a guidance document for botanicals used in prescription drugs, which entices companies to be able to eliminate preclinical trials on toxicity if they only take products through the clinical trials towards the efficacy determining stage.  This steering of dietary supplement manufacturers towards the FDA's drug-approval process and standardized methods, with its benefits of premarket approval and benefits claim of product, is their strategy because at this point the FDA cannot require toxicity data on herbal products. They still will regulate if risk is indicated by data, which is why a push towards more federal research on botanical products is their plan and the NIH Office of Dietary Supplements now has a budget of around $ 25 million.

DSHEA has always posed a challenge to the FDA and they are trying to circumvent its restrictions anyway they can. At this point they have no formal plan to determine the risks and benefits of botanical dietary supplements but many of the NIH institutes are currently working on that research. Tighter regulation of herbal supplements seems eminent.