Adverse Events bill clears Senate by unanimous consent

By Clarisse Douaud

- Last updated on GMT

The United States Senate has passed S 3546, the Dietary Supplement
and Nonprescription Drug Consumer Act, which would require
manufacturers to notify the Food and Drug Administration of all
serious adverse events for dietary supplements.

In June, an amendment to the Food, Drug and Cosmetic Act was introduced that would oblige supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports (AERs). The bill is applauded by industry associations who see it as a means of securing more credibility for the industry as a whole.

While the bill has cleared the Senate, it still has to go through the House of Representatives and is likely to require more muscle work on the part of industry associations before they can claim victory.

"CRN (Council for Responsible Nutrition) strongly encourages the House of Representatives to consider the Senate-passed bill and quickly enact this legislation," CRN president and CEO Steven Mister, said in statement.​ "We urge Congress to make this legislation a reality."

Existing legislation has drawn criticism because it does not require the same pre-market approval for supplements as for prescription drugs. The dietary supplements industry is regulated by DSHEA, the 1994 Dietary Supplements Health and Education Act.

Senate bill 3546 would add an extra post-market precautionary measure by requiring supplement labels to include a telephone number for the reporting of serious advert events, and require supplement companies to pass on these reports to FDA within 15 days.

The supplement industry has attracted media attention in the past when - as in the case of the now banned herbal ephedrine - incidents are not made know to the public until late in the game when a controversy has erupted.

Adverse events are not only associated with safety of specific ingredients, but also supply chain issues, contamination or tampering.

The argument for adverse events reporting is that it would allow FDA to identify patterns leading to the source of a problem being identified, such as tracing it back to a common supplier. Such patterns might not be immediately evident to manufacturers dealing with isolated or few incidences.

"More than 150 million Americans use dietary supplement products and those consumers deserve to know that if they report a serious adverse event they believe may be associated with a supplement product, that the regulatory body that oversees the supplement industry will be made aware of that report,"​ said Mister. "We believe that ultimately such a system will highlight the strong safety record of dietary supplements."

The Natural Products Association (NPA) has also been advocating this bill as a means garnering more perceived credibility for the industry without stifling it industry with over-regulation.

"Contrary to what you may have heard, this legislation will not affect the availability of dietary supplements or lead to closures of health food stores,"​ said NPA in a recent statement calling for support of the bill.

The association explained that any paperwork headaches companies may have initially, as they track all their procedures, will be worth the benefits.

"While the Natural Products Association understands that the mandatory reporting requirements of the AER bill will add to manufacturers' record keeping responsibilities, we believe the bill will benefit the industry in the long run,"​ said NPA.

Related topics: Regulation

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