Using the ephedra ban as a springboard, the nonprofit policy organisation Institute of Medicine (IOM) has released a report calling for an enhanced adverse event reporting (AER) system for dietary supplements and botanicals in particular.
Under the 1994 Dietary Supplement Health and Education Act, supplements are regulated like foods instead of drugs, meaning they are considered safe unless proved otherwise. The ephedra ban—which took the Food and Drug Administration years of data gathering and deliberation before acting—highlighted the need to improve upon the system of assessing supplement safety.
?What the report did was to reiterate what is written in DSHEA,? said IOM committee member Elizabeth Jeffery, a professor of nutrition at the University of Illinois-Urbana. ?That is, that FDA should take action when a supplement presents an unreasonable risk, not wait until a product proves itself harmful by leaving dead bodies in the emergency room.?
The report, sponsored by the FDA, aims to establish a new analytical framework for regulating supplements. It recommends using animal data, in vitro tests and other nonhuman reports to help decide a botanical?s safety.
It says historical use may not be enough by itself to demonstrate a supplement?s safety. Labels should include a toll-free number for consumers and health professionals to call in health problems or concerns. Manufacturers should provide the FDA with all available safety data, pro and con, before marketing a new supplement. And it says reformulating products is grounds for making the reformulation a new dietary ingredient.
?Clearly, the recommendation that talks about reformulation is cause for concern within the industry,? said David Seckman, president of the National Nutritional Foods Association. ?Just because someone changes a formulary, to go through an NDI is not correct or needed.?
AER system is supported
Over the next several months, the FDA will provide additional information to explain and implement the tools available to the agency under DSHEA to act against unsafe supplements and false or misleading labelling claims. This comes in addition to recent good manufacturing practices regulations now being finalised.
?We will support mandatory reporting of serious adverse effects,? said Annette Dickinson, president of the Council for Responsible Nutrition. ?We?re not talking headaches or stomachaches but serious complaints. For 99.9 per cent of our products, this is not a heavy burden.?
While the IOM report is a step toward creating an adverse event reporting system, some in the industry are concerned with what final passage might look like. This is because the FDA has said they will use the approach used to ban ephedra in assaying other supplements.
?I believe the FDA should have acted against ephedra. There isn?t anything wrong with it, but it was misused for 10 years and now they?ve acted in a way that could be damaging to the industry,? said Gerald Kessler, CEO of Nature?s Plus, a supplements maker in New York. ?Even products that are not banned by the FDA could disappear from the market as manufacturers are unable to provide the costly and exhaustive material the FDA could ask for on benefits.?
Is a regime change needed?
An AER regime could help regain consumer confidence in the quality of supplements, and could forestall a greater DSHEA overhaul.
While most bills currently in Congress seek to limit the availability of various substances deemed a threat to public safety, some in the industry point to new regulatory regimes in other countries as a way forward in revitalising the US botanicals market.
The European Directive on Traditional Herbal Medicines is one such scenario. Closer to home, Canada has just overhauled its traditional medicines market.
?What Canada just did is a huge breakthrough. If you?re selling a traditional medicine, you get to call it a medicine, you get to say what the product is used for, even if you cross the ?cure/treat/prevent/mitigate? line,? said Michael McGuffin, president of the American Herbal Products Association. ?That language is no longer the property of pharmaceutical manufacturers.?
Researcher Stephen Bent, a professor at the University of California-San Francisco who has just published a review of herbal medicines in the April American Journal of Medicine, advocates a new regulatory category for herbs that includes pre-market testing to ensure product safety and make botanicals more like over-the-counter drugs.
?Herbs have unique considerations, largely due to the complexity of standardising the mixtures of ingredients, so a separate regulatory system makes sense,? said Bent. ?Since pre-market studies would be a huge cost to the industry and are not likely to happen, improved AERs would help.?