Loren Israelsen, executive director of the Salt Lake City-based United Natural Products Alliance and president of the LDI Group, a consulting firm that specializes in dietary supplements, functional foods and phytomedicine issues, visited NFM’s offices yesterday to share his thoughts on the state and future of the Dietary Supplement Health and Education Act of 1994. He pointed out that in the 15 years since DSHEA passed, the legislation has never been amended. That’s incredible.
But under the Obama administration, which has pumped more money into the FDA partly for enforcement, Israelsen expects a few key changes that may affect the way we do business. “DSHEA is a good law,” said Israelsen, “but it needs to be enforced to be a good law.” When is the leash tight enough to promote good behavior and when does it get so tight that it strangles the industry? The line is a fine one.
Here’s what Israelsen outlined for 2010.
Current good manufacturing practices (CGMP). The CGMP rule will be rolled out to smaller companies by June 25, 2010. Will bad players get weeded out in the process?
New dietary ingredients (NDI). Today, only new ingredients need FDA registration and approval before sale. Ingredients used prior to 1994 are grandfathered in. Israelsen expects the FDA to announce a new guidance (followed by enforcement) in 2010 that will require manufacturers to prove that what they are selling today is the same as what they sold before 1994. If they changed a solvent for extraction, for example, does that change the resulting ingredient?
Adverse event reporting (AER). Considering the recent enforcement actions surrounding hydroxycut, no one can predict how the FDA will use adverse event reports to develop policies or to take actions against supplement companies.
Spiking. Israelsen calls adulteration and spiking “the bane of the industry.” The question is: How can retailers help consumers choose trusted brands? How can anyone truly know if a product has been spiked with a pharmaceutical ingredient if that ingredient is no longer recognizable after processing? What role do third-party certifiers play in monitoring the integrity of products?
Share your thoughts on these upcoming issues below. And check out our Legislation Guide for details on current regulations for supplements as well as organics and food safety.