Volume 108 Number 2
AJHM Summer2015 61
Homeopathic Product Regulation
that
all
homeopathic drugs were prescription only. That
position was substantially tempered by the fact that FDA
didn’t actually enforce it very often and virtually never
against domestic manufacturers. It did, however, episodi-
cally enforce the Rx-only rule against imported products.
An industry coalition met with the agency and noted that
the agency’s enforcement against importers
only
probably
violated U.S. trade treaty obligations. At the same time,
the agency, in language quite similar to that in the Federal
Register notice announcing this hearing, said that home-
opathy was growing and that it was time to reexamine how
it was regulated.
That initial meeting lead to a series of discussions which
resulted in the issuance of the current compliance policy
guide, CPG 400.400,
Conditions Under Which Homeo-
pathic Drugs May Be Marketed
. One immediate impact
of the issuance of the CPG was the establishment of a very
cooperative working relationship between the agency and
the homeopathic community. When the agency had ques-
tions about the propriety of certain claims, it could and did
pick up a phone and ask. And industry took advantage of
that relationship to file trade complaints against companies
that did not follow the requirements of the CPG with some
hope of agency enforcement action in response. That co-
operative approach lasted for about 15 years, but is sadly
no longer the case. I believe that both industry and the
agency would benefit from a reinvigorated relationship,
one that will result in a greater understanding of homeo-
pathic medicine.
FDA’s stated reasons for this hearing involved what it
called the explosive growth in the market for homeopathic
drugs and purported safety concerns. I believe that the
claimed safety issues are not real and have been adequately
addressed by others. Similarly, the explosive growth that
seems to trouble the agency is based on numbers which
the homeopathic manufacturers can only dream about. In
fact, the market is about one-third of what FDA cites. So
if things have not really changed that much, why should
we spend the time and energy to consider any substantial
revision to the current CPG?
That FDA calls homeopathic drugs unapproved new
drugs sounds scary, but actually puts them into excellent
company, with several thousand unapproved prescription
drugs on the market today and many allopathic OTC drugs
not subject to final monographs.
The real issue is not whether homeopathic drugs are un-
approved new drugs, which is a statutory term of art, but
rather the process the agency must engage in for a binding
determination of their status. That issue goes back to 1962,
when Congress adopted the Drug Amendments of 1962,
which, for the first time, added the efficacy requirement
to the new drug approval criteria. Faced with examining
thousands of pre-1962 drugs, FDA first reviewed prescrip-
tion drugs through a contract with the National Academy
of Sciences-National Research Council. Over 50 years
later, that review is on-going, if not moribund, with several
thousand drugs never fully upgraded as safe and effective
nor removed from the market.
When FDA turned to examining OTC drugs, it decided
to take a different approach. Rather than review drugs in-
dividually, as it had done in the DESI Review, it decided
to review them by therapeutic category. In announcing the
OTC Review in 1972, FDA said that it was taking this ap-
proach for several reasons:
1. The agency’s limited resources would be overwhelmed
by trying to review each OTC drug individually.
2. Litigation to remove violative drugs would have to
be on a case-by-case basis, another enormously
resource-intensive approach.
3. Litigation concerning the scope of the 1938 and 1962
grandfather clauses “would more than exhaust all
present resources of the agency.” 37 Fed. Reg. 85,
at 86 (Jan. 3, 1972).
As noted by the agency in the Federal Register notice
announcing this hearing, homeopathic OTC drugs were
excluded from the OTC Review and were supposed to be
the subject of a separate review to follow the completion of
the OTC Review. As we all know, the OTC Review is far
from over and we have little reason to expect that an OTC
review of homeopathic drugs is on the horizon.
In the absence of a homeopathic OTC review, it is fair to
ask what changes, if any, to the current compliance policy
guide would both advance the public health while not tak-
ing a disproportionate investment of agency resources. I
believe that the data that have been and will be presented
at this hearing show that homeopathic drugs are extremely
safe. Given the low levels of active ingredients present
in these products, that is not surprising. So the real ques-
tion is how much time and energy the agency is willing to
commit to reviewing homeopathic drugs. As the agency
recognized in 1972 when it adopted the OTC Review pro-
cedures, the FD&C Act does not empower FDA to wave a
magic wand and remove drugs from the market.
In view of the very low incidence of serious adverse
events associated with homeopathic products, it is dif-
ficult to see how the public health would benefit from a
significant investment of FDA resources in the creation and
implementation of a new regulatory approach. I believe
that the risk-benefit calculus the agency adopted in 1988 is
essentially unchanged today.
The Federal Register notice raised the issue of OTC
homeopathic drugs carrying what the agency considers Rx
claims and asked about an appropriate review process. The
supposed Rx claims fall into three categories. The first
category consists of claims which FDA and most of the in-
dustry would agree are Rx. Most of these claims are made
by companies I consider outliers, which do most of their
marketing by the Internet, and which have little history in
the homeopathic community. And most of these products
go away when the manufacturers receive warning letters.
The second category consists of a very small handful of
