This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
FDA Law Blog reports: "The court rejected the state’s premise that any
use of a defined term inconsistent with the state’s preferred definition
is inherently misleading. “Such a per se rule would eviscerate Central Hudson,
rendering all but the threshold question superfluous.” Instead, the
court reviewed the Webster’s dictionary definition of “skim milk,” and
concluded that consumers did not expect skim milk to meet the state’s
The Decision states: "The State's mandate was clearly more extensive
than necessary to serve its interest in preventing deception and
ensuring adequate nutritional standards..." Ocheese Creamery LLC v Putnam (11th Cir. 2017 - Case 16-12049 - Page 22, Slip Decision of 20 March 2017)*
So the question to ponder is this: if the courts will not show
"deference" to a state government's imposed definition, will they
continue to show deference to Federal Agency definitions of terms, such
as the FDA's regulations that restrict speech based on their own
definitions? Or will the common meaning of words now receive judicial
sanction? Have we now won the right to use, for example, the word
wishing to market cosmetics in the USA and/or European Union are
required to maintain certain records in the Product Information File
is required by US FDA Regulation Sect. 740.10 And EU Regulation Article
7. The Safety Assessment Certification provided by third party
consultants needs to meet the regulation requirements. Our services are
designed to meet these requirements.
FDA on the Prowl...**
"On Tuesday, the agency responsible for policing the American food and drug market issued warning letters
to 14 companies that it says are "illegally selling more than 65
products that fraudulently claim to prevent, diagnose, treat or cure
A word to the wise...
Recently got a call from a client
who may have been pulled into this fracas! She says she hired an SEO
company that put cancer claims in her metatags, about which she had no
prior knowledge. Letting anyone who is not fully trained in the Allowed and Forbidden Words to touch the web site, even the hidden text, is risky.
"[T]ruthful and non-misleading commercial speech is constitutionally protected…"
Off-label pharmaceutical claims get First Amendment protection. What about structure & function or health claims for nutrients?
Can FDA discriminate against nutrients because they are not
FDA-approved, but rather grandfathered under DSHEA? Articles from the
FDA Law Blog and from Nat Law Review explore the Amarin case.
After reviewing the Injunction and several reports on it, I am of the
opinion that “off label” use for Dietary Supplements cannot be prevented
by FDA, so long as the claims are carefully presented as substantiated but not conclusive. That does not mean you can claim to “treat disease.”
It does mean that social media chatter and consumer review marketing can now be a bit more adventurous…
-------------------------------- Voice of America reporting
An end-of-March Cape Town court ruling appears to legalize at-home
cannabis use in South Africa. VoA quoted one of the parties to the law
“So, if you are using cannabis in the privacy of your own home, or
indeed if you have grown cannabis in the privacy of your home and it’s
never left the building, you now have a loophole in the law that if you
do get arrested and you do go in front of a magistrate, you can use the
defense that you are hurting nobody, there was no victim, there was no
crime, there’s no black market, there are no transactions, no one is
making money out of this, you are using the cannabis you grew in the
privacy of your own home,”