Herbs and drugs: labelling or liability?

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Related tags: Food and drug administration, Over-the-counter drug, Mark blumenthal

Last week's WHO guidelines on dietary supplements reinvigorated the
debate about how manufacturers can direct attention to the effects
herbal supplements may have on prescription drugs. Philippa
Nuttall spoke to Mark Blumenthal, founder and executive
director of the American Botanical Council (ABC) to gauge his
thoughts.

ABC decided to tackle this issue last year by teaming up with Pharamvite, makers of Nature's Resource herbs, to launch the safety labeling program(SLP). This was designed to provide "quality, science-based safety information on specific herbs to manufacturers to provide the basis for warnings and directions on their product labels."​ It was hoped the system would benefit consumers and healthcare professionals.

Blumenthal told NutraIngredientsusa.com that the scheme had proved a success since its inception.

"Focus groups and consumer surveys have been overwhelmingly positive about the SLP; nobody is going to say that there is too much information on supplement labels,"​ he said.

However, at the moment only Pharamvite and a handful of other manufacturers have signed up to the SLP.

With all the evidence suggesting a clamour from consumers and health care officials for more information about supplements, the reason for this may be purely financial. Blumenthal noted that the scheme probably adds 80 cents to $1 to the cost of a bottle of supplements.

"The manufacturer would need to buy labels that are about 8 cents more expensive than they normally buy and they have to subscribe with the ABC to get the labels,"​ he said.

Blumenthal explained that subscriptions cost about $3000 per herb for those herbs for which ABC have already developed safety information sheets; for non-documented products the cost can rise to $6500-$7000.

He says the investment has been worthwhile for Pharmavite, which has been able to hold its share in a market in which many companies are suffering.

But there are also less romantic reasons why manufacturers need to make sure consumers know exactly what supplements they are taking and if there are any potential risks; liability law.

Last week, a Crosby woman who suffered brain damage in a stroke after taking the now banned dietary supplement ephedra received a $7.4 million jury award. A Southeast Texas jury awarded Rhea McAllister $2.4 million for damage caused by the supplement Metabolife and $5 million in punitive damages.

"We believe herbs are safe, but they need to be treated with the same respect as over-the-counter drugs,"​ said Blumenthal. "The supplements industry has to take responsibility and disclose potential effects. We can mitigate the risk of liable action if we put these possibilities on product labels."​Indeed, if the Texan case is to set a precedent, increasing the risk of liability, it may become preferable for supplement manufacturers to pay for a recognised standard of labeling to minimise the likelihood of becoming embroiled in million dollar lawsuits.

Related topics: Regulation

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