Congressmen Jason Chaffetz (R-UT) and Jared Polis (D-CO) have introduced a bill in Congress that seeks to let a little light into the box that dietary supplements and functional foods find themselves in. Whether it has a chance of passage, or whether it could accomplish its goals if it did, are matters of debate.
As more and more studies pile up about the benefits of dietary supplements and the functional ingredients in foods it's a source of much frustration in the industry that many of these findings cannot be communicated legally to consumers. Chaffetz' and Polis' bill, called The Free Speech About Science Act (HR1364) seeks to change that.
"It is important for individuals and families to take charge of their personal health by making the right decisions to get and stay healthy," said Chaffetz. "This includes accessing information so that individuals can adjust habits, eat healthy and take appropriate dietary supplements to prevent and even treat health conditions. The Free Speech About Science Act helps insure their access to legitimate scientific research to make the necessary decisions to improve their personal health and the health of their families."
"Today's science has shown that vitamins and nutritional supplements can offer successful, natural alternatives to drugs," said Polis. "As we begin to reform our nation's healthcare system, supplements are an innovative way to help reduce costs."
"You can see how companies would be incredibly frustrated by not being able to give people credible science information," said Washington, D.C.-based attorney Ivan Wasserman. "The courts have repeatedly held that speech about the sale of products can be regulated, and the FDA has taken the position that it ultimately has the right to decide what can and can't be said about food and drugs."
Why the bill might not change much
The bill, which is identical to a bill introduced last year and has been submitted to the Energy and Commerce Committee, has little chance of passage, observers say. And at least one observer, Virginia-based attorney Jonathan Emord, said it makes little difference whether the bill passes or dies in committee, as it did last year.
"If it were enacted, it would do nothing to change existing law," Emord said.
In effect, the bill is structured as a series of amendments to paragraphs of the federal Food Drug and Cosmetic Act. The bill would allow a manufacturer to mention the effect his product has a specific disease condition, provided there exists "legitimate scientific research" to back up the claim. If the bill were passed and were to have its intended effect, it would obviate the second clause of the DSHEA boilerplate language, the one that starts with, "This product is not intended to diagnose, treat, etc." The bill also lays out definitions for what kind of research can be construed as "legitimate."
But it's the vagueness of terms like "legitimate" that lies at the heart of the issue, Emord said. Because the bill amends, but does not replace existing law, it gives the FDA great latitude for interpretation. "Who's going to determine was 'legitimate scientific research' is? The FDA. And it would, by default, use its existing system of assessment (the significant scientific agreement standard)," he said.
Emord noted that language in Chaffetz' and Polis' bill is very similar to language that existed already in the Dietary Supplement Health and Education Act in the section dealing with "third party literature." FDA had already circumvented that language, Emord said, and he has no doubts the agency would do the same with Chaffetz' and Polis' bill.
"It’s unfortunate, because I think they are well intentioned," he said.