This formulation leaves out the central First Amendment consideration, which is clarification of
the disclaimer language needed to make a less-than-perfect claim not misleading, in order to
get the existing information out to the public. In fact, the new Guidance goes so far as to
eliminate separate review of “qualified” health care claims based on its conclusion that the
standard is essentially the same as for any health care claim.
The impact of this regulatory change remains to be seen as new petitions are reviewed, but it
assures that for now, data about CAM treatments for mental health conditions will not
become widely available because the FDA review process itself will curtail availability of
information from product labels. This situation underlies the need for this outline.
According to Berkeley Wellness, there have been numerous reports of dietary supplements
containing much less, or much more, than what’s listed on the labels. To address these
concerns, the FDA issued final rules in 2007 that require dietary supplement makers to follow
more extensive “good manufacturing practices” (GMPs) to ensure the identity, purity, strength
and composition of their products.
The 2007 GMPs are specific for dietary supplements and impose higher standards on these
products than food GMPs do. For example, companies are supposed to test all raw materials,
set expiration dates based on documented science, ensure that workers are appropriately
trained and follow proper procedures, and keep more extensive records, subject to FDA
inspection. But the final rules were watered down from the original proposals. Not surprisingly,
manufacturers fought against measures that would increase costs. What’s more, the FDA,
despite increased funding and a pledge to substantially increase inspections, still lacks the
resources to fully monitor compliance, which is done primarily through inspection of
paperwork, not facilities.
In particular, the provision to test finished products was dropped in the final rule. Though the
GMPs for dietary supplements are supposed to ensure that products contain what their labels
say, manufacturers are required only to test raw ingredients—and they can still cut corners and
make poor-quality products. The FDA has also been criticized for allowing some companies to