FDA will continue safety campaign, says official
products, warned an FDA official at SupplySide yesterday, and while
the agency is not expecting to take an ephedra-type action in the
near future, it has numerous ingredients on its radar.
"We want to see compliance with the science, and while enforcement is one aspect of this, industry can certainly take their own actions to ensure this is achieved," said David Elder, director of the office of enforcement in the Food and Drug Administration's office of regulatory affairs.
Elder, replacing associate commissioner for regulatory affairs John Taylor who was called to a government meeting, added that while it may appear that FDA has taken a more aggressive stance on supplements in recent months, "there is nothing new about FDA's approach to enforcement".
In a speech to supplement and ingredient manufacturer executives, Elder listed agency actions taken over recent years, including the recent ban on ephedra, the first outright ban of a dietary supplement since 1994's Dietary Supplement Health and Education Act (DSHEA) was passed.
FDA has also recently backed a crackdown on products containing androstenedione, which acts like a steroid but is generally marketed as a dietary supplement, as well as a number of supplements making claims that cannot be supported by available science, such as SeaSilver, which was subject to a seizure of $5 million worth of products.
Earlier this year previous commissioner of FDA Mark McClellan cited herbals such as bitter orange as products that would come under investigation in the future.
But Elder told NutraIngredientsUSA.com that while 'stimulant products' were particularly likely to be watched by the regulators, "we are nowhere near the ephedra stage with these. There simply isn't enough science yet."
He added that FDA may look at the regulation on 'new dietary ingredients' as an area of enforcement "that we could do much more with". This would involve checking for ingredients that had been refused approval under the rule - part of DSHEA that requires pre-market notification of an ingredient not previously found in foods or supplements - but are still on the market.
However the agency's action on ephedra, much criticised by industry for taking several years to come about, is unlikely to make similar enforcement quicker in the future.
"It was the first time we had taken an action like this and we were learning. But every decision we take has to be based on strong science, so we can't guarantee that it will be faster next time round. It will take as long as it takes to evaluate the science," Elder told the audience.
He also said that the "Administration is not looking for any changes to DSHEA, or to reopen" the legislation.
