Senators John McCain (R-AZ) and Byron Dorgan (R-ND) may have withdrawn their recent proposal to increase the FDA’s regulatory powers over the dietary supplement industry, but leaders in the field of integrative medicine predict that increased regulation is inevitable in the coming years. And that might not be a bad thing.
Speaking at a panel on policy and legislation at the 2010 Integrative Healthcare Symposium, thought-leaders in the field voiced their views and concerns about a host of issues, including the oversight of the dietary supplement or “nutraceuticals” industry. The issue has profound significance for integrative physicians because many of them routinely use nutritional products and botanical medicines to treat their patients.
Although holistic and integrative physicians are by and large highly supportive of nutritional supplementation, herbs, homeopathic remedies and many other natural products, they are concerned about gaps in quality. After all, it’s their patients who will be hurt by inferior products or false claims, and their butts that can end up in court if they recommend or sell a product that ends up injuring someone.
“If it’s not the McCain proposal, it will be something else,” predicted Wayne Jonas, MD, director of the Samueli Institute, an Alexandria, VA-based think-tank on integrative medical practice and policy. Dr. Jonas was also the former director of the federal Office of Alternative Medicine, now known as the National Center for Complementary & Alternative Medicine (NCCAM) within NIH. He believes regulatory change is bound to happen one way or another, “because there is a real need for some change.”
The McCain proposal, loudly shouted down by many in the industry and advocates of “health freedom,” would have revised the definition of new dietary ingredients (NDIs) according to an FDA-generated positive list of allowed ingredients; required that even minor supplement-associated adverse events be reported to FDA annually; obliged downstream manufacturers and retailers to obtain written confirmation from ingredient suppliers or brand marketers, of compliance with facility registration and product notification rules; and increased FDA authority to remove products that are adulterated, misbranded or present serious health risks.
Sens. McCain and Dorgan say they were motivated largely by the desire to restrict the number of drug-containing “performance enhancement” products illegally being sold as dietary supplements.
Dr. Jonas believes the move reflects a broader dissatisfaction in Washington with the current supplement regulatory systems (or lack there of), and he holds that many of their concerns are legitimate.
“We need to pay attention to the drivers of this (the McCain bill), among them the issues of quality, safety, science, or lack thereof, and issues of how claims are made.” He and several other speakers echoed Congress’ worries about, among other things, the presence of steroids or other drugs in products sold as sports performance enhancement supplements. There are also issues of poor quality raw materials entering the supply stream, witting or unwitting false labeling, exaggerated claims, borrowed science and product inconsistency, all of which worry doctors who utilize supplements in their clinical practices.
Dr. Jonas urged leaders in the supplement industry, companies that have firm commitments to quality control and the integrative healthcare community to become involved in the policy-making process. He predicted that sooner or later, there will be a re-writing of the Dietary Supplement Health Education Act (DSHEA). The real question is, “What do we want it to look like?”
Mark Hyman, MD, one of the country’s most prominent integrative physicians and noted author of several popular books, including the best-selling UltraMind and UltraMetabolism series, agreed that there are reasonable concerns about supplement safety and quality. But he believes the McCain-Dorgan proposal, had it passed, would have severely and inappropriately restricted public access to supplements, and could have been a serious blow to the further evolution of integrative medicine.
“Calling it a ‘Safety Act’ is a joke. It is a pharmaceutical industry-driven initiative,” said Dr. Hyman, calling attention to what he believes is the barely hidden agenda lying underneath the generally reasonable public health wording of the bill.
Therein lies the challenge for the natural products industry and the integrative medical community alike: how to envision and establish a regulatory system that truly ensures quality and safety and protects the public without completely “pharmaceuticalizing” the marketplace, making nutraceuticals into prescription-only products, restricting access, or unfairly penalizing companies that already have long-standing commitments and investments in the highest possible quality, safety and efficacy standards.
If we’re honest with ourselves, we as an industry will admit the idea “the industry can self-regulate” is nonsense. Perhaps it can, but it seems rather unwilling to do so, as even a casual stroll down the aisles of ExpoWest will show. At the same time, the oft-heard accusations that this industry is entirely lawless and wholly unethical are also false—as can also be proven by a day on the floor at ExpoWest. The number of companies investing heavily in quality control, clinical research and farm-to-shelf tracking is heartening and inspiring.
The bottom line is that the companies and industry leaders who’ve made that commitment need to stand up, demonstrate what they do and lead the way toward a more intelligent regulatory system that enables this industry to thrive in a healthful and ethical manner, while protecting the public from the very real parasites, large and small, looking to make a quick buck on a popular trend.
Failure to take the lead on new and better regulation could prove very dangerous to the industry in the long haul. As Drs. Hyman, Jonas and others ably pointed out, there are a lot of lawmakers and medical opinion leaders who have serious concerns about the quality of nutritional products. Some of their concerns are real, and it won’t work to dodge issues with deflective maneuvers like, “Well, what about the thousands of deaths each year caused by prescription medications?”
True enough. But that argument isn’t going to fly. It won’t mollify those who seek to increase regulation, and it doesn’t obviate the natural product industry’s obligation to take greater responsibility. All the signs indicate that greater regulation is coming—maybe not this year, but sometime soon. We either get involved and try to shape new policy so it reflects and nurtures what’s best and brightest about our movement, or we bitch about how we got screwed later on.
Unfortunately, no one’s yet invented a supplement or drug to treat “Missed Opportunity Syndrome.”
Erik Goldman is the co-founder and editor of Holistic Primary Care-News for Health & Healing, a quarterly medical news publication reaching 80,000 primary care MDs, NDs and DOs , and covering the wide spectrum of natural healthcare. Before launching Holistic Primary Care in October 2000, he was the New York Bureau Chief for International Medical News Group, a well-established medical publishing company that produces clinical news publications for various medical specialties. He has been writing for medical audiences about clinical practice and socioeconomic trends in medicine for 20 years. He can be reached at 212-406-8957; Fax: 212-406-8959; E-mail: firstname.lastname@example.org; Website: www.holisticprimarycare.net.
Healthcare Practitioner Corner: Integrative Medicine Leaders Sound Off on Regulation
Experts agree increased regulation is on the horizon, but to what degree can and should be determined by industry.
By Erik Goldman
Published May 3, 2010