Volume 108 Number 2
62 AJHM Summer 2015
Homeopathic Product Regulation
claims which the agency considers Rx but are claims upon
which reasonable people could differ. Warning letters cit-
ing these claims usually prompt a detailed documented
response from the manufacturer. Again, this is a small
universe.
The third category of claims the agency considers Rx
are based more on the differences between allopathic and
homeopathic medicine than on any actual need for phy-
sician intervention. Since homeopathy is traditionally
a symptom-based approach, it uses words which are not
generally used on allopathic labels. These terms usually
show up not as indication/uses, but in the purposes section
of the drugs fact panel. They also show up as symptom
indications for single ingredients products, products which
are typically purchased by sophisticated consumers. These
allegedly Rx claims include words such as “bleeding,”
“inflammation,” “burning runny nose,” and “gum disease.”
In addition, some FDA compliance personnel have taken
the position that no indication which does not appear in
the OTC Review can be used on homeopathic products. I
suggest that is simply not the law.
The agency asked whether there is information regard-
ing the regulation of homeopathic drugs in other countries
that can inform FDA’s consideration. Without going into
detail, it is worth noting here that any other system involves
a much greater investment of government resources while
still generally relying on homeopathic literature to permit
marketing. One may wonder how those systems are an ad-
vance over the CPG approach.
Finally, the agency asked whether there are areas of
the current CPG that could benefit from additional clarity.
There has been a lot of discussion about combining homeo-
pathic actives and diet supplements. The CPG states that:
“Drug products containing homeopathic ingredients in
combination with non-homeopathic active ingredients are
not homeopathic drug products.” In 1988, that was clearly
understood to prohibit mixing allopathic and homeopathic
active ingredients in the same product. That is a position
that the majority of the industry has always endorsed. At
some point in the past, the agency began to interpret that
sentence to also bar the combination of homeopathic active
ingredients and diet supplement ingredients in the same
product. I do not believe that is what the sentence says.
The sentence bars only the mixture of “non-homeopathic
active ingredients” with homeopathic actives. Only allo-
pathic drugs can be “non-homeopathic active ingredients,”
not diet supplements, which by definition are foods, not
drugs. Furthermore, there is nothing in the statute which
bars combination products, and the agency recognizes the
appropriateness of cosmetic-drug combinations and others.
So, while I disagree with the agency’s interpretation of that
sentence, I believe that the language should be revised to
accurately reflect the agency’s position.
Another topic of discussion is the appearance of new ho-
meopathic active ingredients. The CPG, in language that
is not eloquent, deals with this by essentially shifting the
burden of proof to the manufacturer to demonstrate that the
product is homeopathic. It does not, however, specify how
that occurs.
There is another change to the current CPG that I believe
is both responsible and reasonable. Yesterday, the Ameri-
canAssociation of Homeopathic Pharmacists explained the
new disclaimer that is a part of its voluntary advertising
and labeling guideline: “These statements have not been
reviewed by the Food and Drug Administration.” That
statement should alert most consumers that these drugs are
different than traditional allopathic drugs. According to the
AAHP, most of its members are rolling out the use of this
disclaimer. It certainly adds clarity and fairness to the CPG
if the agency were to require the use of that statement by
all parties.
I fully understand that the agency’s responsibilities con-
stantly expand while its resources continually lag behind.
That inevitably results in prioritizing efforts. I feel reason-
ably confident that an assessment of the status of homeo-
pathic drugs can only lead to the conclusion that there are
many issues and products more deserving of FDA’s time
and attention than the demonstrably safe homeopathic
medicines which consumers demand and expect.
Thank you very much for your attention.
Alvin J Lorman, Esq.
