While the New Dietary Ingredient (NDI) draft guidance will dominate the regulatory picture, other issues, such as adverse event reporting, will compete for attention this year.
On the legislative front, two longtime opponents of the dietary supplement industry, Sen. Richard Durbin (D-IL) and Rep. Henry Waxman (D-CA), have directed the Government Accountability Office (GAO) to review the adverse event reports (AER) system. Among other things, they asked GAO to call out which supplements are reported on the most and to assess whether companies are complying with the AER requirement, which became law in 2007. Whether GAO officials will be called forth to testify in a Capitol Hill hearing remains to be seen.
We can also expect more vigorous enforcement of the GMP standards, which for the most part is to the good. In November two executives of a New Jersey supplement manufacturer were sent to prison over GMP violations. Another GMP violator was slapped with a permanent injunction.
And enforcement of health claims will continue apace, too. Products were seized in November from a Wisconsin manufacturer who was alleged to have been making illegal disease claims.
Looming over the whole affair are possible budget cuts at FDA, which will likely cause the agency to focus on the areas of greatest risk.
Hank Schultz is the Managing Editor of Functional Ingredients magazine.