A new administration in Washington doesn't necessarily bespeak a new beginning for our industry in terms of how we are perceived or treated by the government in general and by the Food and Drug Administration (FDA) in particular. Rather, it puts us at another crossroads while giving us an opportunity to help set the direction, tone and, maybe most importantly, how we will be seen and understood by the public over the next four years and beyond.

It doesn't take new laws or changes in existing laws such as DSHEA for the public to have reasonable assurance and confidence that available dietary supplements are safe. As FDA routinely points out, federal law already requires dietary supplement manufacturers to ensure that the products they put on the market are safe, although the FDA's review and approval of supplement ingredients and products is not required before manufacture and marketing. Under DSHEA, only after a dietary supplement is brought to market does FDA have any responsibility for showing that the product could be unsafe before the agency can take action to restrict its use. "The majority of supplement manufacturers are responsible and careful," said Elizabeth Yetley, Ph.D, director of FDA's Office of Special Nutritionals. "But, as with all products on the market, consumers need to be discriminating. FDA and industry have important roles to play but consumers must take responsibility too."

The "important role" the industry has to play must be an active role, not one where we sit back with unwarranted confidence and nod in agreement and say, "Yes, good point, we understand, but let George do it." To those wrapped up in that attitude, I cannot say forcefully enough:We are George. All of us. We must do it for ourselves, actively and aggressively, or we are abdicating the right and the opportunities now open to us. We must do it for ourselves or prepare for any negative consequences that will likely accrue through our own negligence or indifference.

Certainly, there have been similar calls made in the past by other organizations serving our industry, but we have yet to mass as a unified body behind what the Council on Natural Nutrition sees and has consistently advocated as major and meaningful objectives:
1. A program of continuing education, aimed not just at the public, but at the medical profession and the government as well.
2. A "Seal of Quality Assurance" designed, developed, instituted and administered within the industry and ap­plied to existing and new products. These would be products that have undergone or otherwise met a set of rigid research and testing standards created and overseen by industry experts, where appropriate, in conjunction with FDA.
3. Product labeling that clearly and accurately defines the contents of herbal and nutrient packages on the shelf, as a further requirement in being awarded the "Seal of Quality Assurance."
4. A concentrated, highly visible industry push to foster and encourage more doctors to come aboard the concept of "integrated medicine." This concept gives natural nutrient products of proven value and reliability equal standing alongside similarly-valued prescription drugs.

This is a time of great opportunity for our industry, perhaps greater than at any time in any previous year. More and more doctors have seen the wisdom and value in "integrated medicine" since the door was opened to them by the American Medical Association's acknowledgment that there are natural nutrients that offer health benefits to their patients. Moreover, a number of major pharmaceutical companies that once argued for the demise of the industry have joined the industry. These companies have stepped away from the costly, unnecessary battlefield and added various natural nutrients to their product lines, rather than continue to lose out on a market that continues to grow and shows no signs of going away.
Of significant and far reaching importance, leading into the new year FDA was showing an inclination to let experts in our industry take an active role in advising the agency on approvals for herbal and nutrient products, what labels should say and how the study of new products should be designed.

In the past, we were mainly outsiders looking in at a committee process routinely top-heavy with pharmaceutical interests and others with a knee-jerk adverse reaction to anything that remotely suggested a health value to the use of herbals and natural nutrients, including the dozens upon dozens whose quality has been proven by years of successful use by millions of satisfied consumers. (One published report, for example, described how more than half the experts serving on 18 FDA advisory committees had financial ties to pharmaceutical companies.)

The FDA Department of Health & Human Services issued a call to companies in our industry to nominate candidates for a proposed standing subcommittee on dietary supplements that will be part of a new Food Advisory Committee. A short time after that, there was an FDA invitation to the industry to submit candidates for a new committee to work with the National Academy of Science's Institute of Medicine on developing a protocol for reviewing the safety of dietary supplements. When last we looked, the selection process was still in progress, delayed by the national elections, and after that by a need to fill vacancies in FDA, including the post of FDA commissioner. But if there is favorable follow-through, if leaders of our industry are placed on these committees, it will be progress-certainly, far better than our being outsiders looking in-and consistent with the ancient Chinese proverb that holds, "The journey of a million miles begins with one step."

To date, too many inside our industry have talked the talk without taking the walk. It's time, past time, given all these signs of greater acceptance in Washington, for each and every one of us to put on our walking shoes. Stop waiting for George to do it. Be among those who band together and take that first step. Let FDA know that, as an industry, we care. Join with others who share a belief that our future growth, our industry's future overall, is best served by loudly advocating and supporting the concepts of public education, better product testing methods, more informative product labeling, and development of a Seal of Quality Assurance that has weight and meaning to our customers and their good health.

NW

About the author:
Ronald M. Lawrence, M.D., Ph.D, the Council on Natural Nutrition's executive director, is a senior member of the American Academy of Neurology, president and founder of the American Medical Joggers Association, a former member of the President's Council on Physical Fitness and the U.S. Department of Health and Human Services National Advisory Council on Aging. He can reached at P.O. Box 292393, Los Angeles, CA 90029; Fax 323-663-2820; e-mail leviinc@aol.com.