In last month's column, I worried about how the political change of 2006 might impact the politics of alternative medicine. I made a tacit assumption that Democrats might push for more regulations of alternative medical practices and nutritional medicine, repudiating the laissez-faire style of the Republicans. We didn't really need to wait long. In December, even before the freshmen Democrats took office, and while Republican office staff were huddled in the Congressional basement putting out classified ads for new employment, both the Senate and the House passed legislation regulating over-the-counter drugs and nutritional supplements.

In a report by Steve Myers of the Natural Products Insider, posted on 12/16/06 at www.naturalproductsinsider.com, the House passage of the Adverse Effects Reporting Bill for nutritional supplements was announced with unabated excitement. The bipartisan bill was initially proposed early in the summer by Senators Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), and Richard Durbin (D-Illinois). The Dietary Supplement and Non Prescription Drug Consumer Protection Act (S. 3546) requires reporting of serious adverse effects (AERs) of both over-the-counter drugs and nutritional supplements. Manufacturers would be required to report within 15 days any adverse effect or incident (AER) to the FDA.

According to Myers, nutritional supplement manufacturers, consumer advocacy groups, and herbals organizations lauded the passage of this legislation. David Seckman, executive director of the Natural Products Association, stated that "we have long said passing this legislation is the responsible, right thing to do for both the industry and consumers." Seckman thanked his membership, who sent thousands of letters to Congressmen supporting the passage of this legislation. Michael McGuffin, president of the American Herbal Products Association (AHPA), noted that the Senate passed the billed unanimously and the House supported it by a 2 to 1 vote. Myers reported that the Council for Responsible Nutrition (CRN)'s president, Steven Mister, praised the legislation: "With this law, consumers can be assured that if they report to a manufacturer a serious adverse event they believe may be associated with a supplement product, the agency that regulates this industry – FDA – will be made aware of that report." Mister further thought the regulation will offer consumers greater confidence when using nutritional supplements. "We are confident that ultimately the AER system will highlight the strong safety record of dietary supplements and allow consumers to feel increased confidence about the choices they make when taking dietary supplements." The chairman of the consumer group Citizens for Health, attorney James S. Turner, noted, "this is a very important piece of legislation that advances consumer interests within a safe, credible dietary supplement marketplace."

Curiously, Myer did not report that some alternative medical groups did not share the same viewpoint. The American Association for Health Freedom (AAHF) encouraged its membership to contact their congressmen and women to defeat this legislation. Executive Director Brenna Hill of the AAHF worried that passage of this legislation would undo freedoms Americans now have under the Dietary Supplement Health and Education Act (DSHEA) of 1994 to freely obtain and use nutritional supplementation without restriction from government agency oversight. The National Health Federation (NHF) was also concerned that the passage of S.3546 would be detrimental to consumers' free use of supplements and would pose a serious threat to the manufacture and distribution of supplements. The National Health Federation did a policy analysis, which determined that the AER reporting system would obligate the FDA to engage in greater enforcement actions with nutritional supplement manufacturers as well as distributors of such supplements.

It is difficult at this juncture to determine if this legislation will substantially change the marketplace for nutritional supplements and consumer access to such products. It is of interest that legislation for AER reporting of nutritional supplements has been considered numerous times over the past ten years. The DSHEA legislation argued against AER regulation and effectively blocked passage of similar bills. Increasing concerns with adulterated drugs (which I will discuss next issue) may have tipped the balance in favor of a consumer protection act for nutritional supplements. Still, it is interesting that this legislation's passage followed the November landslide election for Democrats.

Our February/March 2007 issue focuses on the best of naturopathic medicine. We congratulate the naturopathic students, faculty, and clinicians who are winners in our second annual competition, and we thank all the entrants. In general, submissions for this competition were thoughtful and well-researched. Bastyr student David Graves' essay, for instance, on Latent Autoimmune Diabetes of Adults (LADA), considers the presentation of that frequently misdiagnosed form of diabetes mellitus and reviews possible adjunctive naturopathic treatment therapies. And in his well-detailed article on hypothyroidism, Martin Milner, ND, presents a compelling case for slow-release, compounded thyroid replacement. Award-winners Jonathan Prousky, ND, ("The Orthomolecular Treatment of Schizophrenia") and Ani Hawkinson, UBCNM, ("Nutrigenomics and Nutrigenetics in Whole Food Nutritional Medicine") also offer noteworthy essays. In addition, we are pleased to present two companion essays to our prize-winners in which the deans of National College of Naturopathic Medicine (essay) and Southwest College of Naturopathic Medicine present their visions for naturopathic education in 2007 and the future. We thank the many individuals who helped to facilitate our competition, including the deans of naturopathic education at Bastyr University, Bridgeport University College of Naturopathic Medicine, Canadian College of Naturopathic Medicine, National College of Naturopathic Medicine, and Southwest College of Naturopathic Medicine. We would like to encourage all interested students, faculty, and practicing physicians to submit articles for our next biannual "Best of Naturopathic Medicine" issue.

Jonathan Collin, MD