Adverse Event Reporting
Chester J. Zelasko, Ph.D. | January 10, 2007

The Congress of the United States seems to get more done in the last hours of a session than in all the previous months. The Dietary Supplement and Nonprescription Drug Consumer Protection Act falls into that category of bills passed in a marathon session of Congress (1). The bill was signed into law by the President. For those of us who take dietary supplements, it leads to several questions. This Newsletter will examine some of the questions raised by this new law. For brevity, I’ll refer to the law simply as AER.

What does AER say?
Stated as simply as possible, AER mandates that a manufacturer, packer, or distributor of a dietary supplement must provide a mechanism (phone number or address) for a consumer to report any suspected adverse event resulting from using the supplement, and the company must keep records of these events for six years. Any serious adverse event must be reported to the Food and Drug Administration within 15 days.

Serious adverse events are clear. They include death, a life-threatening experience, hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or any medical intervention required to prevent these events after taking the dietary supplement. This part of the law seems to be in direct response to the deaths associated with ephedra several years ago.

Another section of the law addresses other adverse events. The law defines adverse events as “any health-related event associated with the use of a dietary supplement that is adverse.” This seems as wishy-washy as a definition can get, and it will take time to determine what this language really means.

Does an upset stomach constitute an adverse event? Maybe, maybe not. The problem is that inevitably some people will get upset stomachs when ingesting something new, whether it’s a dietary supplement or a new food--that’s to be expected. But if a pattern emerges suggesting that the use of a product causes stomach upset of a severe nature or for many people, it seems prudent to let people know that it’s a possible side effect.

Is AER necessary?
Critics of the law say that there’s already a method for reporting adverse events. That’s true, but just try to find it on the FDA website (2). It’s at least three links--if you select the right starting point--so it’s there, but reporting isn’t easy. A toll-free number on a supplement label will make it easier.

Making the reporting easier also means that consumers will report experiences that were incidental and may not be related to the supplement use. The new system errs on the conservative side; while inconvenient from a record-keeping perspective, it seems like a small price for legitimate companies to pay.

AER also legitimizes the supplement industry. One of the past criticisms of the industry is that it’s an unregulated industry. That’s not true--I’ve written before about the Dietary Supplement Health Education Act, DSHEA. But taking this additional step allows a degree of oversight that should satisfy at least some of the critics.

Compared to pharmaceuticals, dietary-supplement makers get a pass because they don’t have to prove a product benefit before it’s introduced; that’s one of the reasons dietary supplements are often criticized by the medical and nutrition communities. But supplement makers are very limited on what can be said about their product. Even if there are clinical trials that suggest a product may lower cholesterol or reduce joint pain, those claims cannot be stated outright because the product has not passed the FDA-approval process for drugs. It would seem that a system for reporting adverse events is a step toward quelling the critics of dietary supplements.

Will this law impact our ability to purchase dietary supplements in the future?
Probably not--at least not legitimate products that are safe for consumption. But if a new herb or other supplement that was touted as being the next best thing for your health actually had serious side effects, wouldn’t you want those to be reported, investigated, and if warranted, have the product removed from the market? I think you would.

It would be nice if laws were not necessary to protect consumers, but that’s simply not possible in this age of internet consumerism. AER seems to be a step in the right direction for our health and safety. As always, time will tell.

References:
  1. S.3546 Dietary Supplement and Nonprescription Drug Consumer Protection Act (Enrolled as Agreed to or Passed by Both House and Senate)
  2. www.fda.gov
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