Sometimes FDA and other government agencies seem to be a bit
behind the times but just last week FDA published the 19th warning
letter to mention Facebook. Some of these
letters from the past three years have also cited Twitter and Tumblr as sources
of violative claims. While these letters
were primarily directed at dietary supplement companies, food, cosmetic and
even drug companies can easily run afoul of FDA regulations on social media
sites.
The most recent warning letter to mention Facebook, which
was sent to Zarbee’s Inc. of Draper, UT. not only cites the company’s own
Facebook postings but notes that “Zarbees “liked” the following comment...” and
goes on to quote from customer posts noting how well the products worked for
coughs, insomnia and other ailments. In
2012 FDA had disliked the like that AMARC Enterprises, Inc. of El Cajon, CA
gave to one of its customer’s posts about using their dietary supplement
product for cancer.
The concept that testimonials presented on company websites
and in other marketing materials are claims that are subject to regulatory
scrutiny is not new.. In 2009 the Federal Trade Commission (FTC) issued a
guidance document on testimonials and endorsements in advertising http://tinyurl.com/kdxnoqa noting that they, like all marketing claims
must be truthful, not misleading and supported by data. FDA expands requirements for endorsements and
testimonials to require that they comply with regulations on allowable claims.
All companies like positive comments and testimonials from
customers. While consumer comments are
not a new phenomenon, the consumer’s ability to publish their comments to the
world on social media sites is new. So
what is a company to do when a happy customer posts something that makes a
claim that violates the regulations governing the compliant marking of their
product?
Several of the Facebook warning letters included this note
from FDA,
“We advise you review all the
information on your websites, including testimonials, social media websites
(e.g., Facebook and Twitter), product labels, and other labeling and
promotional materials for your products to ensure the claims you make are not
in violation of the FD&C Act. It is your responsibility to assure
compliance with all requirements of federal law and FDA regulations.”
The last sentence makes it clear: Companies must closely
monitor their social media for compliance with FDA regulations. If a post about
a product goes beyond what is allowed by regulation, the posts must be deleted
or edited to become compliant.
·
If you are a dietary supplement company and a
customer posts that your product cured an ailment or relieved pain; your
product just became an unapproved new drug subject to FDA enforcement.
·
If you are a cosmetic company and a happy
customer states that your oil healed their skin condition, that oil just became
an unapproved new drug subject to FDA enforcement.
·
If you are selling an OTC drug and a customer posts
about a use that is not covered in the approved labeling of your product, you
are also subject to FDA enforcement action.
My colleagues and I can help you stay out of trouble by
reviewing or monitoring your website and social media posts, as well as your
product labels and brochures for FDA compliance. Contact us with your questions.
It is my hope that you will find these occasional updates
interesting. If so, you may use this link http://eepurl.com/Imbjv
to subscribe to our occasional email newsletters regarding FDA regulations and
other topics of interest to FDA-regulated companies. We send messages targeted to the dietary
supplement, cosmetic, food, OTC drug and medical device industry sectors. You may subscribe to one or all of the
newsletters and you may unsubscribe at any time. Please post any questions you
may have. My associates and I stand
ready to help you with your FDA regulatory issues.
All the best to you!
Evelyn & Associates
