In today’s video, we return to FTC substantiation
rules and talk about the dilemma substantiation
causes for dietary supplement and cosmetics
companies, as well as how to break through.
I’m Michael H. Cohen, founding attorney
of the Cohen Healthcare Law Group.
We’ve advised over a thousand healthcare
industry clients on healthcare and FDA legal
issues, including many companies with medical
devices, dietary supplements, cosmetics, and
OTC drugs. We’ve counseled companies on
how to position their marketing claims so
as to mitigate the risk of FDA and FTC enforcement,
and we’ve counseled them when they have
run afoul of FDA and FTC rules.
As we’ve said, when it comes to compliance
with legal advertising rules, dietary supplement,
cosmetics and marketing companies face a dilemma.
The more aggressive the marketing, the bigger
the likely compliance challenges; and the
stricter the compliance, the less effective
the marketing.
Today we’ll discuss three things:
1. The notion of “100% compliant.”
2. The scope of enforcement and its consequences.
3. Some high-danger claims.
First, the notion of 100% compliant.
Some healthcare industry clients say they
want to be “100% compliant,” but they
don’t always mean that. If you’re a physician
in a small clinical practice, you might want
to be as compliant as possible, and reduce
the risk of potential Medical Board discipline
and lawsuits; and as legal counsel we can
help you mitigate risk.
If, on the other hand, you’re a healthcare
startup, you might be more industry in pushing
the industry envelope, and, keeping up with
your competitors. We advise these clients
as well.
And some of our large dietary supplement and
cosmetics and medical device clients feel
the FDA is just plain evil – like Evil Corp
in Mr. Robot – the rules suck, the Agency
sucks, they aren’t going to pay attention,
and if they get a warning letter from FDA,
well, so be it, at least they are being true
to what they believe.
We can certainly empathize. Yet, from a risk
management perspective, the best quote here
is from Clint Eastwood in Dirty Harry, when
he says: …. “Are you feeling lucky?"
Don't try to get lucky with FDA. Now let's talk about FDA enforcement and its consequences.
As we’ve said before, FDA can choose not
to give you a warning letter, and to step
up enforcement instead. And even the FDA warning
letter will require you to take huge compliance
steps, which could well tank your current
marketing plans. As well, other enforcement
agencies as well as private plaintiffs can
piggyback off the FDA warning letter with
their own actions.
FTC’s penalties are often even more draconian.
In a settlement with Skechers USA, the FTC
charged that the company made deceptive claims
that its sneakers would help consumers lose
weight and strengthen and tone various body
parts. According to the FTC, those claims
lacked substantiation by randomized, controlled
clinical trials.
The settlement: 40 million dollars.
Last, some high-danger claims.
Here are some of the claims FTC says will
likely incur extra enforcement scrutiny:
• Claims that the product is 'clinically
proven.'
• Claims about evidence (and the evidences
do not meet FDA's rigorous criteria above).
• Claims about expected results.
• Claims about mechanism or scientific process.
So, for example, before you put on your product
website, “clinically proven,” take a pause
and realize you are upping the likelihood
of federal enforcement.
And if you think you’re making things better
by proclaiming all the scientific benefits
of your health and wellness product, you might
actually be making things worse. If you cannot
back up these claims by competent and reliable
scientific evidence, FTC may find a substantiation
issue. And, the more you try to explain the
mechanism of action—how ingredient X causes
result Y—the greater the potential gap between
your explanation and what FTC requires for
you to substantiate the claim.
Thanks for watching. If you still have questions,
click on the link below,
cohenhealthcarelaw.com/contact-us,
to send us a message or book an appointment.
Here’s to the success of your healthcare venture,
we look forward to working with you soon
