New herbal adverse event reporting (AER) legislation

It's been over two years since I saw a notice for a conference entitled, "Developing an Adverse Event Reporting (AER) System for the Dietary Supplement Industry," in St. Paul, MN, sponsored by the Center for Dietary Supplement Safety at the University of Minnesota and the Utah Natural Products Alliance. At this conference, I first heard of the support of the dietary supplement industry for an adverse event reporting system similar to the MedWatch program for prescription drugs.

In general, industry representatives I spoke with justified their support with the expectation that herbal products would prove to be far safer than prescription drugs. In addition, they felt that accepting an AER system would address critics who say that the industry is unregulated.

Well, it has come to pass: in the last session of the 109th Congress last week, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (S. 3546) passed both the Senate and the House, then was signed into law on 22 December. The law will take effect in one year.

The highlights of the reporting, to be administered by the US Food and Drug Administration, are:

• Be limited to serious adverse events only and not require reporting just any complaint
• Include OTC drugs (previously only for OTC drugs that converted from prescription status)
• Not require retailers to report
• Be limited to products sold in the United States
• Allow third parties to report or evaluate claims
• Preempt state AER legislation

Moreover, only "serious adverse events" will be required to be reported, defined as:

• death
• a life-threatening experience
• inpatient hospitalization
• a persistent or significant disability or incapacity
• a congenital anomaly or birth defect
• requires medical or surgical intervention to prevent the above outcomes

I'm of a mixed mind about this whole idea. First, it seems odd to require safety reporting on products for which effectiveness is not required. If the majority of products have no beneficial biological effects, it would then follow that the majority will also appear safe. Second, adverse event reporting does not imply causality. That is, AERs are sentinel reports from which to form hypotheses and investigate causality between an agent and an adverse effect. I also view the exclusion of non-US products as a deficiency; recent reports of high levels of heavy metals in Ayurvedic herbs would not be reported under this system.

Finally, as last year's IOM report indicated, the FDA's AER system for prescription drugs does not work very effectively. Adding another layer to a broken system under a new FDA commissioner seems like a recipe for continued ineffectiveness.

On the other hand, some have raised the point that herbal AER systems might improve the accuracy of prescription drug adverse event reports that might, in fact, be due to confounding issues with herbal products.

However, it still remains unclear how this reporting will be disseminated to the public or medical community and what actions might follow an accumulation of adverse events. Presently, the FDA may only remove an herbal product from the market after safety becomes questionable; how will this law affect how high (or low) the bar is set for product removal.

In the final analysis, the law's usefulness will only become apparent over time. At the very least, the support of the legislation by a large swath of the US dietary supplement industry at least signals the presence of a degree of public responsibility that has been lacking in the past.