Tuesday, May 9, 2017

First Amendment Food Claim

Fed Appeals Court Supports
First Amendment Food Claim

The 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 “alternative definition.”"

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 "heal"?

I recently wrote about Judicial Deference to agency determinations, and about Judge (now Justice) Gorsuch's pro-freedom views on this issue. The blog entry was written before Gorsuch was nominated to the Supreme Court. You can read it here: http://vitaminlawyerarchives.blogspot.com/2017/01/house-passes-h5-to-redress-judicial.html


Cosmetic Dossiers
The Essential FDA/EU Service
Companies wishing to market cosmetics in the USA and/or European Union are required to maintain certain records in the Product Information File (Dossier). This 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 cancer.""

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.

This may mean a new FDA push against nutrient remedies is ramping up.  We need to keep the pressure up -- http://tinyurl.com/NaturalRemedyFreedom

Countering this are recent court cases giving more leeway to "off label uses" I wrote about that last year:  http://vitaminlawyerarchives.blogspot.com/2016/01/off-label-marketing-of-dshea-products.html

That article explained:

"[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…

** http://www.cnn.com/2017/04/25/health/cancer-treatments-illegal-fraudulent-misleading-fda/?iid=ob_homepage_showcase_pool-test

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 suit,

“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,”


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