While the new ban concerns only dietary supplements containing ephedra alkaloids, all dietary supplements, not just ephedra, will be subject to a risk/benefit safety analysis for the first time, warns the trade association. In the past, only risk of injury was relevant.
The FDA chose not to use or define the 'significant risk of illness or injury' safety standard under the Dietary Supplement Health and Education Act (DSHEA), relying instead on the 'unreasonable risk' safety standard. In FDA's view, this requires an examination of benefits as well as risk, explains NNFA.
The third safety vehicle provided in DSHEA - an administrative ban - was not used by Health and Human Services.
Most importantly, the ephedra ban demonstrates that DSHEA, passed in 1994, works. But the trade association believes that despite choosing one of the two new, easier DSHEA safety burdens to carry out the industry-wide ban, it involved significant cost and time to issue, largely because of previous FDA actions denying the powers conferred by DSHEA. The agency did not need to examine the benefits of a supplement under this DSHEA safety provision, argues NNFA, and instead could have reached the same result by examining risk alone.
Such long-winded measures may not be needed in future however.
"Industry can expect further rule-making instead of waiting for case-by-case enforcement when a widely publicized ingredient safety issue arises," predicts the association.
The agency has added a new section to the Code of Federal Regulations for 'Dietary Supplements that Present a Significant or Unreasonable Risk'. FDA chose this route to cast a wider net over all purveyors, argues NNFA.
"The bottom line of FDA's lengthy scientific discussion is that it seriously raises the bar on safety substantiation. A key indicator for future supplement challenges is FDA's rejection of the safety studies because they were not designed to detect serious effects in susceptible individuals-and because the studies were too small," it continues.
The background to the regulation can be viewed on the FDA website.