“Efficacy and Safety Claims Are Held to Same Standard as Other OTC
On November 15, 2016, the Federal Trade Commission announced a new "Enforcement
Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs. This news bulletin is reproduced here in its entirety:
The policy statement was informed by an FTC workshop held last year to
examine how such drugs are marketed to consumers. The FTC also released
its staff report on the workshop, which summarizes the panel presentations
and related public comments in addition to describing consumer research
commissioned by the FTC.
The policy statement explains that the FTC will hold efficacy and safety
claims for OTC homeopathic drugs to the same standard as other products
making similar claims. That is, companies must have competent and reliable
scientific evidence for health-related claims, including claims that a
product can treat specific conditions. The statement describes the type
of scientific evidence that the Commission requires of companies making
such claims for their products.
Homeopathy, which dates back to the 1700s, is based on the theory that disease symptoms can be treated by minute
doses of substances that produce similar symptoms when provided in larger
doses to healthy people. Many homeopathic products are diluted to such
an extent that they no longer contain detectable levels of the initial
substance. According to the policy statement, homeopathic theories are
not accepted by most modern medical experts.
For the vast majority of OTC homeopathic drugs, the policy statement notes,
"the case for efficacy is based solely on traditional homeopathic
theories and there are no valid studies using current scientific methods
showing the product's efficacy." As such, the marketing claims
for these products are likely misleading, in violation of the FTC Act.
However, the policy statement also notes that "the FTC has long recognized
that marketing claims may include additional explanatory information to
prevent the claims from being misleading. Accordingly, it recognizes that
an OTC homeopathic drug claim that is not substantiated by competent and
reliable scientific evidence might not be deceptive if the advertisement
or label where it appears effectively communicates that: 1) there is no
scientific evidence that the product works; and 2) the product's claims
are based only on theories of homeopathy from the 1700s that are not accepted
by most modern medical experts.
The policy statement notes that any such disclosures should stand out and
be in close proximity to the product's efficacy message and might
need to be incorporated into that message. It also warns marketers not
to undercut a disclosure with additional positive statements or consumer
endorsements reinforcing a product's efficacy. The statement warns
that the FTC will carefully scrutinize the net impression of OTC homeopathic
marketing claims and that if an ad conveys more substantiation than a
marketer has, it will violate the FTC Act.
The Commission vote approving the enforcement policy statement and issuance
of the staff report on the Homeopathic Medicine & Advertising Workshop was 3-0.
“Efficacy and safety claims for homeopathic drugs are held to the
same standards as similar claims for non-homeopathic drugs.” This
statement is not unreasonable, on the face of it. The dilemma, of course,
lies in the definition of “competent and reliable scientific evidence”
as defined by one’s definition of “qualified persons”,
and who makes up the profession. If we are talking about qualified homeopaths,
then there is no problem. If we are talking about those who have no knowledge
or experience of homeopathy, then obviously there will not be agreement.
Like everything we do, our claims are based on the “proof of the
pudding being in the eating” principle, and those who hate homeopathy
with a passion will use this to vilify the whole philosophy. Those who
are open-minded or who have experienced the benefits of homeopathy will
continue to be open-minded. My patients who have chest ports placed will
continue to use arnica to help with post-traumatic bleeding and bruising
– we don’t have to claim that it cures anything, just that
some people have found it helpful, and have found that they don’t
bruise as much as other people who have undergone the same procedure.
There are many published articles on the use of arnica for bruising injuries. A
Google Scholar search gives 2,460 results, most of them in the peer-reviewed literature and
indexed in MedLine.
The “scientific” mind is sometimes closed to other options.
It’s a shame, but we are not going to change them by vituperating
or forcing them to change. They will eventually come to realize the limits
of their philosophy – or they won’t – and nothing that
we do will make much difference until they are ready to change. We can
knock at the door all we like, but either we are compelled to break it
down (the more Newtonian principle) or we wait, and allow the door is
opened by those who are inside – when and if they choose to open it.
The FTC statement goes on to read: “truthful, non-misleading, effective
disclosure of the basis for an efficacy claim may be possible. The approach
outlined in this Policy Statement is therefore consistent with the First
Amendment, and neither limits consumer access to OTC homeopathic products
nor conflicts with the FDA’s regulatory scheme. It would allow a
marketer to include an indication for use that is not supported by scientific
evidence so long as the marketer effectively communicates the limited
basis for the claim in the manner discussed above.” We are not trying
to persuade people that homeopathic remedies work – we all know
that their effect can be very powerful. We are just offering options and
alternatives which some people have found to be helpful.
I personally choose not to attempt to break down the door. There is no
fire, there is no immediate threat to life or limb. The only threat to
homeopathy is if we allow it to be a threat. We don’t have to claim
to cure anything, as I said. We can say that many people find this remedy
helpful for whatever symptoms we are wanting to treat – and leave
it at that. No claims, just an offer of assistance.
 Samuel Hahneman was born in 1755 in Germany and died in 1843 in Paris.
He enrolled at the University of Leipzig to study medicine, and transferred
to the University of Vienna because the first school had neither hospital
nor clinic available for students. He finally registered at the University
of Erlangen and finished his schooling. He moved to Dresden in 1784 and
became a translator of medical texts. For the next 20 years he moved from
place to place, working as a translator and not practicing medicine at
all. During this time he was able to learn about every system of medicine,
because of his translation wok. In 1790 he made his first experiment with
the medicine called Cinchona, given as a specific for malaria at the time.
He disagreed with the conventional wisdom that the medicine worked because
it tonified the stomach. He decided to take the medicine himself, and
observe the effects on himself. To his great surprise, he observed symptoms
very similar to malaria including intermittent fever. Over the next fifteen
years he developed a large collection of effects of different herbal and
natural medications when given to healthy volunteers (mostly his family).
In 1804 he began to write about the experience. He began to develop a
system of medicine which relied on single drugs in harmless doses, based
on observation and experiment.
In 1812 he moved back to Leipzig, with the intention of taking on the medical
establishment. Unfortunately he fell into the habit of haranguing the
establishment, and lost his student following. Orthodox medicine began
increasingly coordinated attacks on the form of medicine that Hahneman
was teaching. The government decreed that doctors were no longer allowed
to make or dispense their own medications, thus barring him from the legal
practice of medicine.
In 1820 he moved to Coethen where he was allowed to prepare his own medicines,
and where his continued to update the Organon and Materia Medica. He developed
the theory of miasms during this period. His wife died.
In 1834 he met his (soon to be) second wife, Melanie. She became his patient
and eventually his wife, exposing Hahneman once again to vilification
– not unlike what would happen today, where sexual relations with
a patient are considered to be unprofessional conduct by almost all the
licensed healing professions. In Hahneman’s case, after moving to
Paris with his new wife, he became a celebrity, the preferred physician
of the rich and famous. With the help of his new wife, the Materia Medica
and the Organon were completed. [information 04-02-17 from