Friday, June 3, 2011

06/03/11 - Vitamin Lawyer Update eMemo – 6.3.2011

Welcome to our June edition of the Update eMemo.
First, I invite you to watch my YouTube interview with Dr. Ron Paul regarding his Raw Milk Commerce Bill, HR 1830:
Second: here are several excerpts from a very important article, which I received from Natural Products Association, regarding FDA contract manufacturer requirements:
Recent GMP Audits of Supplement Makers Reveal Common Compliance ProblemsBy: Caren Baginski
… Through its audits of supplement manufacturers, the FDA has pinpointed [a] kind of adulteration that is pervading industry: companies not meeting supplement Good Manufacturing Practices (GMPs).
… 25 percent of the dietary supplements manufacturers inspected by the agency in 2010 had significant GMP deficiencies. These deficiencies occurred in small, medium and large companies… The problems being identified by FDA are many. Recent GMP audits reveal companies' failure to:

- Perform required identity testing on incoming dietary ingredients
- Set appropriate specifications for components and dietary supplements
- Adopt written procedures as required in the rule
- Prepare and follow Master Manufacturing Records and/or Batch Production Records for manufacture of dietary supplements
- Provide quality personnel to conduct required material reviews and make disposition decisions
Companies that do not comply with GMPs could meet serious action from FDA beginning with a warning letter… product seizure or an injunction could prevent companies from continuing to produce until the violations have been corrected….
Some companies have seen this coming and are prepared. Last year, contract manufacturers told Functional Ingredients that GMP compliance is the most important criteria to look for in a contract manufacturer—and that audits are occurring regularly.
"We've definitely seen the majority of our customers become more aware of and demand compliance with the current GMPs," said Steve Holtby, president and CEO of Soft Gel Technologies, a contract manufacturer in Los Angeles, California. "In fact, some of our customers require us to undergo periodic internal and third-party audits to confirm GMP compliance." …
Above all, be sure to adopt FDA's written procedures, because when it comes to GMPs, if it isn't documented, it didn't happen. "It's an amazing amount of documentation that we have to do," said Beth Lambert, CEO of Herbalist & Alchemist.
"It's also important to remember that GMPs are the minimum standard a manufacturer must meet in order to ensure its product is not adulterated," said [FDA’s] Williams. "Hopefully a manufacturer is looking at ways to continually improve the safety and quality of their product, utilizing appropriate preventive control measures." …
Source URL:

Warnings for Natural Product Companies!
Several clients are raising funds to invest in Clinical Trials or Clinical Studies; I was asked to prepare a “Comfort Letter” for the clients to use with their potential investors. If you would like a copy addressed to your Company, to raise the funds you need to invest to stay in the market, please email me!

The Red Letter warnings I sent you in recent months from the NPA & ASA urgently restate what I’ve been telling my perceptive clients regarding the vitamin or natural products companies. Are you ready for the FDA inspectors?  I told you the 4 essential steps you must take in the last issue of the VL Update. Here, I add estimates of what these essential steps will cost your company. You need to budget now and start to do what you can to be prepared.
HHS Secretary Sibelius admitted that she has a $16 Billion slush fund under Obamacare that can be used to fund activities like the FDA’s 4,000 new inspectors… and FDA has already dramatically increased inspections, without those new bureaucrats!
What do you need to survive an FDA inspection? I’ve told you several times!

  1. Standard Operating Procedures – in place and up-to-date -from $500. The SOP document not only satisfies FDA, but also helps you organize your business!
  2. Product Substantiation Notebook – in place and up-to-date –from $500 plus your research time; this Notebook is a MUST if you get inspected! Part of the Notebook includes copies of the Structure and Function Claims Notices companies are required to file with the FDA within 30 days of marketing any claim. The cost for these notices is from $340.
  3. Copy-writers who know how to avoid Red Flag claims & Illegal Testimonials! My webinar on these issues is inexpensive. $99 for the archived CAM Webinar; a private copywriter webinar just for your company copywriters will cost above $500 (the webinar includes an eBook specially written for your company).
  4. A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients – This can cost up to several hundred thousand dollars. NCT offers a Minimal Clinical Trial from $35,000.
WHAT SHOULD YOU DO? Contact me NOW!  973.300.4594
The longer you put off addressing any of the above issues,
the more at-risk is your company!
Archived Cautions for CAM Wellness Practices
"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."
NCT Clinical Trials Center
The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials are beginning shortly! GET YOURS SCHEDULED NOW. The cost of a basic 12-person, one month Clinical Trial with a formal Report signed-off by credentialed professionals is about $40,000.
Prof. Udani on Clinical Trials - If you haven't seen it before, I urge you to watch the short video from Prof. Udani, who says that you need to get your Clinical Trials done if you want to remain in business! See his video from Expo West here:
NCT Web Site:
Important Videos on the above web site:
Meet Drs. Laibow and Goodman.
• 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.
“In my opinion, over the next two to three years a company that still wants to be on the market and on the shelves needs to start investing in clinical trials today,” said Dr Udani.
Vitamin Lawyer Connections…
Notice of Fee Increase: New rates: $340 standard and $285 discounted.
Do you Skype? I
f so, free is one of the easiest ways to contact me, no matter where I may be.

My Skype handle is: vitaminlawyer
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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.
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Ralph Fucetola JD
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