By Richard Jaffe, Esq.

I am a big supporter of chiropractors working in the nutrition field. In fact, I represent the Clinical Nutrition Certification Board, which offers an advanced training and continuing education program in clinical nutrition for practitioners. More than half of the group’s members are chiropractors.

Nationally, it appears that most chiropractors offer some form of nutritional counseling.¹ Nutritional counseling almost invariably involves the recommendation and sale of dietary supplements (except in New Jersey, where, for some reason, it’s illegal for chiropractors to sell supplements). So, chiropractors have a strong interest in following the regulation and availability of dietary supplements.

Americans have it good when it comes to access to dietary supplements–too good, some would argue. In comparison to most other industrialized countries, there are virtually no restrictions on the type or strength of nutritional supplements that can be purchased in the United States. The only significant limitation on the sale of supplements is that disease- and cure-related claims cannot be made by supplement manufacturers without FDA approval. But of course, that does not hinder or affect a practitioner such as a chiropractor from recommending a supplement for a disease or condition (subject, of course, to whatever limitations non-MD practitioners have on practicing medicine without a medical license under state law).

The situation is much worse in the rest of the world, and especially in Europe. Many European countries have adopted the highly restrictive Codex standards for dietary supplements. Codex standards all but eliminate the consumer’s ability to purchase dietary supplements in therapeutic or meaningful preventive dosages. The net effect of Codex is that useful dietary supplements will be as hard to get as prescription drugs in many European countries. In fact, it might be a lot harder to obtain real dietary supplements in Europe, because Codex likely will squash the demand and cause manufacturers to simply withdraw from these unprofitable markets.

There has been much written and debated during the past few years about whether Codex is coming to the U.S. It seems to me that as long as key members of Congress continue to support the consumer’s broad right of access to these products, we should be safe from a direct application of Codex to supplements in the U.S. That does not mean dietary supplements will not receive increased federal regulatory attention.

In December 2006, Congress passed and President Bush signed the “Dietary Supplement and Nonprescription Drug Consumer Protection Act.” The bill requires dietary supplement manufacturers to put on the supplement label a telephone number for consumers to report a “serious adverse event.” The law will take effect in 2008. Only a “serious adverse event” needs to be reported. That means basically death or a life-threatening experience that normally would require hospitalization and/or medical or surgical intervention to prevent death. Only the manufacturer (or by agreement with the manufacturer, a distributor of a privately labeled supplement) has the responsibility of reporting the “serious adverse event” to the FDA. Retailers and other providers of supplements, such as chiropractors and other health care practitioners, have no reporting obligation under the new law. I suppose the big question is whether there will be a flood of “adverse events” reports. This is not an academic question because even under the Dietary Supplement Health and Education Act (DSHEA), the FDA does have the power to pull a supplement off the market if it determines the supplement is dangerous.

My inclination, based on my work in the supplement field, representing practitioners and supplement companies, would be to say that there are relatively few serious side effects caused by supplements. But the new adverse event reporting law does not limit adverse events to events actually caused by the supplements. Under the law, all adverse events that “may” be caused or are in any way temporally associated with the ingestion of a supplement have to be reported by the manufacturer. I suppose the FDA will then determine whether the supplement in question actually was the cause of the event. That could be a problem in years to come, since it is no secret the FDA opposed DSHEA, and I believe it has been behind the scenes in recent attempts to limit or rescind DSHEA. Therefore, it is conceivable the FDA might attempt to use the new law to limit or eliminate access to some supplements; or more broadly, use the adverse event data to build a case for increased regulation of dietary supplements.

A harbinger of things to come might be an anti-dietary supplement and anti-supplement industry book that has just been published. The title pretty much sums up its point of view: Natural Causes: Death, Lies, and Politics in America’s Vitamin and Herbal Supplement Industry. And here’s the teaser: Behind its carefully crafted image, a $20 billion business that sells “safe and natural” products that are untested, unproven, and often tragically unsafe.² The book discusses in painstaking detail all of the horrible side effects of certain supplements; how supplements have maimed and killed countless Americans. It also reports on the tens of thousands of adverse effects from supplements that have been reported to state and federal poison or disease-control entities. Fair and balanced, it is not. But the book might be used as part of an anti-supplement PR campaign. And lest we forget, Congress now is controlled by the Democrats, some of whom have unfavorable opinions about unfettered access to dietary supplements.

All in all, I would say the next few years will present interesting challenges to the dietary supplement industry and, by extension, to practitioners such as chiropractors who make use of them in their practice.

References

1. See the NBCE Job Analysis of Chiropractic, as discussed in “FDA Proposes New Standards for Labeling and Manufacturing of Dietary Supplements.” Dynamic Chiropractic, May 5, 2003. For what it is worth, in my opinion, the basic nutrition coursework offered at most chiropractic colleges is insufficient to provide chiropractors with the skills necessary to integrate nutrition into their practice. I think any chiropractor considering or involved in providing nutritional counseling should take an advanced certification program, such as what is offered by the CNCB or other such advanced programs.
2. The author is Dan Hurley, who is a journalist with no stated medical or scientific education.

Editor’s note: For background information on the Codex Guidelines on Vitamin and Mineral Food Supplements, promulgated by the Codex Alimentarius Commission, please visit click here.