Durbin reaches for premarket approval with reintroduction of labeling bill, trade groups say

By Hank Schultz

- Last updated on GMT

Related tags: Dietary supplements, Dietary supplement

Durbin reaches for premarket approval with reintroduction of labeling bill, trade groups say
A bill reintroduced by Senators Dick Durbin, D-Il and Richard Blumenthal, D-CT to require registration of all dietary supplements with FDA is a solution in search of a problem, according to trade organizations.

The act, called the Dietary Supplements Labeling Act, has been introduced by the two senators before.  The present version seems indentical to those previous go rounds, accordoing to Michael McGuffin, executive director of the American Herbal Products Association and is identical in its intent. In his view, “registration” is tantamount to “premarket approval.”

“I think it’s no secret what Dick Durbin thinks is appropriate for this class of goods. It’s premarket approval,”​ McGuffin told NutraIngredients-USA. “He’d like the FDA to be able to say you may or may not sell that product.”

Labeling requirements

Durbin’s bill would also amend certain labeling requirements.  In particular, it would require lot numbers on all supplement labels, something many companies are already doing though they are not required to do so under law, McGuffin said.

“The fact that this bill would require ever dietary supplement to have a lot number on it, they almost all do already. The normal industry practice to put a lot number on labels,”​ he said. “There isn’t a real good reason to pass a law requiring us to do something that we already do.”

Steve Mister, president and CEO of the Council for Responsible Nutrition, said his group opposes the proposed law because it would do nothing to better protect public safety.

“We oppose the Dietary Supplement Labeling Act of 2013 because it creates added burdens for both FDA and companies already following the law, but does not address the problem of those companies that are disregarding the law. Without robust enforcement, companies who look for loopholes and disregard their legal obligations will continue to ignore new requirements,”​ Mister said.

Rather than nipping at the edges of the issue, Congress should drive right to the heart and give FDA enough funding to fully enforce the laws already on the books, Mister said.

“Rather than creating new laws, our industry needs a renewed commitment from Congress to provide FDA with additional funding and resources so the agency can use the ample enforcement tools already at its disposal to take aim at companies that do not comply with the regulations currently in place,”​ he said.

Loren Israelsen, president of the United Natural Products Alliance concurred, saying: "As drafted (the bill) would not solve the problems it seeks to address.  In fact, it would likely impede progress on cracking down on unlawful operators by adding a series of unfunded mandates to an already underfunded FDA dietary supplement enforcement effort."

Safety questions

McGuffin said Durbin had called into question the safety of dietary supplements, and implied that situation was worsening.

“His press release was focused on a lot on the significant increase of adverse event reports as the reason that this law is needed. He knows as I know and as his staff knows that an adverse event is not evidence of harm.  It is only evidence that a company received a call that there is a temporal association between the use of a product and an adverse experience,”​ he said.

To address this concern, Durbin’s bill would call for warning labels on supplements connected to the reports of adverse events.  This is a nonstarter, as far as Mister is concerned.

“We cannot support legislation that directs FDA to require warning labels for products or ingredients that ‘could cause’ adverse events or potential risks as this is a case of the precautionary principle run amok. While the premise may be well intentioned, in practice this requirement would lead to confusing and unnecessary label instructions likely to deter consumers from using beneficial dietary supplements based on uncommon or minuscule risks,”​ Mister said.

Communicate through constituents

As far as the bill’s chance of passage, McGuffin was unwilling to speculate.  But he said AHPA will pursue a similar strategy to what it has employed before, and that is encourage members to communicate with their elected representatives and to reiterate a message they’ve delivered before.

“Sen. Durbin is a very smart lawmaker.  He is in a position of some significant authority in the Democratic Party. We certainly can’t dismiss it.  We will maintain our attention and vigilance.  More than anything we will work with the constituents of Senators.

“We’ve got a law (DSHEA) that works.  We’ve got a well-regulated class of goods,”​ McGuffin said.

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