Monday, October 25, 2010

10/25/10 - FDA Says: Seizures Replacing Warning Letters

0.  Blogs & News – Planning Trip to Panama in January
1.  New Treaty to Protect Intellectual Property
3.  Cautions for CAM Wellness Practices Webinar Now Archived!
4.  Natural Clinical Trials Center Inspection Tour in January
5.  Vitamin Lawyer connections…

0. Blogs & News –

Recent issues of this Memo have covered such topics as recent Claims Surveys, Trademark “Fair Use”, CCDS (Company Core Data Sheets), Trends in FDA Warning Letters; the new FTC testimonial Rule, the FDA Rule regarding “expiration” dates and “best if used by” dates, and the FTC and POM juice claims...

I’ll be leading a group of interested people to the Natural Solutions Center in Panama from January 19 through 27, 2011. We’ll be there to inspect the Natural Clinical Trials facility, enjoy the eternal Spring weather, participate in seminars led by Dr. Robert H. Sorge ND and Nancy Orlen Weber, RN, among others… If you want to join, please email me ASAP.

Access to the Vitamin Lawyer Webinars and more; videos, major site updates:

Election 2010 Food Freedom Talking Points:

FDA Seizures Replacing Warning Letters!

10.25.10 -- This today from FDA News: “ Last Week, Howard Sklamberg, Director of the Office of Enforcement at FDA said the agency has stopped sending repeat offenders warning letters — instead they are going straight to enforcement! Sklamberg said the agency is targeting seizure of products or sales injunctions as likely punishments.”
A word to the wise: Note that the FDA sees its initial attack as a “punishment” without, of course, the benefit of due process! Now more than ever, “your papers must be in order…”


1. Anti-counterfeiting Accord Compromises on Food Names
By Caroline Scott-Thomas, 11-Oct-2010

“Delegates from 37 countries representing more than half the world’s trade have agreed to an international anti-counterfeiting trade pact designed to protect against illegal copies of foods and other products. The nearly finalized text of the anti-counterfeiting trade agreement (ACTA) follows talks in Tokyo earlier this month, which some US food manufacturers had feared could lead to American parmesan cheese, champagne or gorgonzola being seized as illicit goods by border controls… However, the finalized draft released late last week reached a compromise on the issue, referring to tolerance of existing rights in various countries… The agreement is largely intended to crack down on intellectual property (IP) right infringements, particularly in light of digital piracy and trade in counterfeit goods online.

The consolidated text is available online here:

From the Agreement:

“Counterfeit trademark goods means any goods, including packaging, bearing without authorization a trademark that is identical to the trademark validly registered in respect of such goods, or that cannot be distinguished in its essential aspects from such a trademark, and that thereby infringes the rights of the owner of the trademark…
“Section 1 - General

“1. Parties shall ensure that enforcement procedures are available under their law so
as to permit effective action against any act of infringement of intellectual property
“Section 2 – Civil Enforcement

1. Each Party shall make available to right holders civil judicial procedures
concerning the enforcement of any intellectual property right… Each Party shall provide that, in civil judicial proceedings concerning the enforcement of intellectual property rights, its judicial authorities shall have the authority to issue an order against a party to desist from an infringement… declaratory judgments and adequate compensation shall be available… At least with respect to pirated copyright goods and counterfeit trademark goods, each Party shall provide that in civil judicial proceedings, at the right holder’s request, its judicial authorities shall have the authority to order that such goods be destroyed, except in exceptional circumstances, without compensation of any sort…”


2.  Cautions for CAM Wellness Practices Webinar Now Archived

"Do you have a CAM “Alternative” health practice? Do you provide nutrients, remedies or health related items to clients?

Do you have questions about your legal rights and limits … or need information about how best to run your health care business? Are you aware there are words you cannot use and statements, although true, you cannot safely say to clients?

Hiring an attorney, one on one, to review these issues could cost you hundreds of dollars… making a mistake could cost you thousands. I invite you, instead, to learn from my Webinar, Cautions for CAM Wellness Practices.

I am known as The Vitamin Lawyer, because much of my 36 year legal practice centered around helping people in CAM practices, nutrient purveyors and advanced healthcare teachers. Today I am a Trustee of Natural Solutions Foundation. I can keep you out of trouble and operating smoothly so you can fulfill your mission to help others…"

This $99 PEL Webinar runs about an hour through 32 slides. It includes an 18 page eBook of information and forms all of which would cost over $500 if one on one. This is a Natural Solutions Foundation Benefit Webinar."

3.  Natural Clinical Trials Center

The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials are beginning shortly! GET YOURS SCHEDULED NOW. Check out the Videos and PPT Webinar on the Site!  See Clinical Trial SOPs below. I am leading an inspection tour to Panama in January (see above) and you are invited to see the NCT facility…  

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Center Staff.


4. Vitamin Lawyer Connections…

Do you Skype? If so, free is one of the easiest ways to contact me, no matter where I may be. My Skype handle is: vitaminlawyer

Our new affiliation site:
Do you have an affiliation program? We’d like to list it.

If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.

Follow me on Twitter -  


Ralph Fucetola JD

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) with “Unsubscribe” in the subject line.