It has to be scary, not knowing what lies ahead. But unfortunately this is how the nutraceuticals industry will exit 2005, without closure to many issues still on the table. First and foremost is the matter of dietary supplement GMPs. One more year gone and still no final rule. However, rumblings within the industry seem to indicate that a final rule is imminent. But haven't we been down this road before? It was exactly a year ago that we all waited anxiously for a final rule in order to prepare for compliance. (Check out my editorial from December 2004-wow, was I off base!) Only this time around, we are missing the support of former FDA Commissioner Dr. Lester Crawford, who indicated a year ago that the industry would be pleased with the final rule.

Speaking of FDA Commissioners, there is a new "sheriff" in town and he knows next to nothing about this industry. In turn, we know next to nothing about him except the fact that he is a cancer survivor and will remain chief of the National Cancer Institute, while he tends to his post at FDA. For now, the fate of GMPs is one big question mark, along with what the new Commissioner has in store for this industry. At the very least, expect the landscape of the dietary supplement industry to change dramatically.

Another issue that is far from resolution is that of qualified health claims. Apparently these types of claims are confusing to consumers, according to research studies carried out by FDA. The fact that consumers find it hard to make sense of qualified health claims is not nearly as shocking as FDA commissioning studies to confirm this fact. You mean to tell me that consumers find it hard to comprehend the following: "Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer." Please don't tell me it took 1920 volunteers recruited from five different shopping malls and taxpayer money to confirm that indeed qualified health claims are hard to understand. And now, in this corner we have the FDA, which holds the title of "Master of the Obvious." (I would like to thank Clare Hasler-see State of the Industry, which starts on page 34-for her inspiration in writing this part of my editorial.)

So what good news can we take with us into 2006? How about the fact that 187 million consumers continue to turn to supplements and healthy ingredients for overall health maintenance. According to a new survey released by the Lewin Group, American adults, as they become more educated about their healthcare options, are choosing supplements to improve their overall health and well-being. The Barometer Survey, a nationwide online poll conducted by the Natural Marketing Institute, reports 85% of the population believes that using nutritional supplements can keep them healthier, while 72% wants to have control over their health decisions, including the kind of supplements they should be able to use. Three-quarters of those polled also believe government should have a role in funding more research, however, seven out of 10 surveyed said its role should not include limiting or restricting access to supplements. (For more information, see Top of the News on page 8.)

So how should the industry prepare for the year ahead? Well, if traditional methods of preparation are not an option, how about simply crossing your fingers and hoping for the best.