Good To Be True?
Len Monheit, President & CEO, Natural
Products Industry Center, Toronto, Ontario
© NPIcenter.com, reprinted with permission.
both praise and skepticism, the FDA is asking for public comment
on how its actions and policies for advertising and labeling should
be reevaluated after recent defeats involving First Amendment Freedom
of Speech issues. This is potentially a wonderful opportunity for
the dietary supplement industry and consumers to provide direct
feedback, and given existing industry relations with the FDA, this
opportunity can't be ignored. Supporters of the call to the public
are eager to influence agency policy. Detractors fear a loosening
of enforcement and FDA powers.
can't help but wonder at what's going on behind the scenes and at
the motivations behind this request. Especially with regulatory
issues, things are rarely exactly as they seem, and this situation
may be too good to be true. Could it be that the FDA, under new
guidance and legal advice finally comprehends the implications of
First Amendment defeats? Could it be that they understand that disclaimer
clauses of several sentences are impractical on small labels? Could
it be that the agency is coming to terms with limited enforcement
resources, and that it doesn't want to wage futile war, fighting
battles like Pearson versus Shalala over and over again? Or could
it be that the FDA wants to alter its image to be more participative
and guiding in its stance to regulate industry and advise consumers?
sample questions the FDA has asked to launch the program do not
indicate much in the way of objectives, at least at face value.
Several relate to social behaviors including the effect of 'commercial
speech' and FDA warnings on consumer behavior. I am sure this data
exists and will be brought to the appropriate attention.
FDA's questions listed at FDA
Seeks Public Comment on First Amendment Limits on Health Claims.)
irony is that many within the FDA have held the agency to be above
both law and public opinion in the enforcement of its mandates.
For it to incorporate public opinion and socio-economic data into
its policies now would be a drastic switch. But maybe the situation
does call for drastic action. We continually hear the cry of 'inadequate
resources' from regulatory agencies around the world attempting
to fulfill their obligations. Cost recovery and fiscal reality has
made an impact on many areas of government, and any way to reduce
cost to allow an increased focus on strategic objectives on the
part of agencies would be good -- or would it? Will the comments
received change agency plans, or will the results support objectives
already in place inside the agency? In fact, having been defeated
on first amendment issues, what is the purpose behind a public comment
period? If the lawmakers and enforcers have already decided that
the FDA's stance runs contrary to constitutional law, what will
public comment, and the interpretation of public comment, change?
Amin, from the Chicago-based law firm of Weaver & Amin comments,
FDA needs to focus on policing and enforcing against companies
making false or misleading claims rather than implementing more
policies and regulations which the Supreme Court already has indicated
treads on violating First Amendment commercial free speech rights
and constitutes unconstitutional and illegal prior restraint of
so many feel FDA has been given its answer by the courts regarding
Freedom of Speech, one can't help but ask how many scarce resources
are going to be allocated to this PR campaign and whether this is
the best use of FDA resources.
the sample FDA questions did not focus solely on dietary supplements,
they did indicate attention placed on the different regulatory environments
among supplements and food and drugs. Given negative comments made
by FDA officials about the dietary supplements industry, it would
not be surprising if part of the objective of the comment period
was to open discussion about DSHEA and the perception that the dietary
supplements industry is not properly regulated or that 'commercial
speech' as presently interpreted in the courts is misleading to
Amin, whose firm has extensive experience in FDA and FTC law and
regulations issues notes,
Food, Drug & Cosmetic Act, which includes DSHEA as an amendment,
and Federal Trade Commission regulations prohibit false or misleading
claims and labeling for any food, drug, and dietary supplement
product including structure-function claims. The FDC Act also
requires all foods and dietary supplements to be safe.
the FDA already has ample ammunition to enforce against companies
distributing unsafe products and/or making any type of false or
misleading claim or in any way mislabeling a product. In other
words, diligent FDA and related regulatory enforcement would benefit
consumers much more than over-regulating."
this comment period is an opportunity to incorporate public opinion
into regulatory policy, it's another example of where our industry
needs to be alert for ulterior motives and a hidden agenda. The
interpretation of the public comment will be critical; this industry
needs to be vocal in order to protect itself.
to submit your comments to FDA]