Tuesday, February 14, 2012

02/14/12 - The Cost of GMP Compliance

Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...

[1] The Cost of GMP Compliance
[2] Social Networking
[3] Yes, You do Need Clinical Trials…
[4] Vitamin Lawyer Connections: All the Links You Need!


New Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from NCT! Please take a look at our new Webinar linked from this web page: http://www.naturalclinicaltrials.com/NCT-EU-Cosmetics.php.

Announcement: For information about the SEC-filed Fund for Natural Solutions: wwwFundforNaturalSolutions.org (offering only by Private Placement Memorandum, available upon request: just email me at ralph.fucetola@usa.net with “Fund” in the subject line). Our first proposed investment: an off-shore (Panama/Hong Kong) compounding pharmacy. Doing good while doing well… think about the possibilities!

[1] The Cost of GMP Compliance!

This from the Natural Products Association’s recent article on the costs of complying with FDA GMP rules.

“…FDA likely underestimated the cost very small- and small companies (fewer than 500 employees) would face to achieve compliance. In its 2003 proposal, FDA estimated this cost to be about $100,000 per year, but many industry members disagreed, especially in the area of testing ingredients and finished products. In its final supplement GMP rule issued years later, FDA in fact amended its cost estimates to $46,000 per year for very small companies (fewer than 20 employees) and $184,000 per year for small companies (more than 20, fewer than 500 employees).
“Another change FDA made in its cost analysis in the final rule was to amend its estimates for the average number of batches per year per company size category; industry heavily criticized FDA's 2003 estimates as too low in each category and illogical in estimating more batches for small companies (554 batches) than for large companies (309). FDA changed this to 444 for very small; 2,436 for small; and 1,164 for large firms. The reason for the persistent discrepancy between small and large estimates, according to FDA, was information from self-proclaimed small companies that said they produce more batches of smaller size than do large firms, due to differences in equipment capacity. This increase in batch estimates across the board is one reason why overall cost estimates rose, as testing batches is a primary cost in GMP compliance. 

“In amending its projections, FDA acknowledged numerous comments submitted by industry detailing the "burdensome" testing requirements and warning the GMPs, as proposed in 2003, would drive small companies out of business and push the price of supplements up possibly over the price of some drugs. In the final rule, the agency also noted compliance efforts may steal companies' resources from areas such as worker safety, product development, marketing and voluntary product testing. This is an often overlooked cost of becoming GMP compliant, especially for companies on tight and small budgets, which includes just about every company in this current economy…”
Are you prepared for the inevitable FDA inspection?

[2] Social Networking is the New “Google”!

From a savvy marketing mavin: “With Facebook now receiving more traffic than Google, it is arguably one of the most important marketing tools for any business. In fact, CNN says 43% of businesses are using custom Facebook pages to gain new business.”

So I looked on the Internet for further information about the power of social networks.
“The most influential news-sharers, and the group which shared 87% of the stories in the survey, only accounted for 27% of all the users - tallying with previous definitions of a minority of highly active web web users that contribute a majority of content online.

“The big social networks - Facebook Twitter, YouTube and MySpace, accounted for 43% of all links shared, email 30%, SMS 15% and instant messenger 12%. “Researchers identified three primary motivations for sharing, which differed around the world. In Europe and North America, users had more altruistic reasons for sharing stories that would be useful to friends or family, European users tend to share more work-related stories and Asia-Pacific readers were more likely to 'status' broadcast - share things that underline or reinforce their own knowledge and identity.” http://www.guardian.co.uk/media/pda+cnn
“Google, the monolithic search engine that spreads traffic across the web like Congress spreads stimulus funds, now gets less traffic than that stupid website you joined so you could see what your kids are doing when they're not home. Of course, smart marketers know that neither of those characterization is correct anymore. Google is still a huge source of traffic, but the web is now bigger than just Google. And while Facebook may have started on college campuses it long since graduated. Hitwise's numbers reflect this change. According to their report, the market share of visits to Facebook.com increased 185% last week from the same week in 2009. And Google? Well, they grew, but only 9%.

Marketers, ignore Facebook at your own peril.”
Read more: http://blog.hubspot.com/blog/tabid/6307/bid/5739/What-Gets-More-Traffic-Than-Google-Now-Facebook.aspx#ixzz1gXNrsBUl

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[3] Yes, you do need clinical trials!

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. The 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!

[4] Vitamin Lawyer Connections
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."

Vitamin Lawyer Connections…
Notice of Fee Increase: 2011 Rates: $340 standard and $285 discounted.
Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be.
My Skype handle is: vitaminlawyer
Our new affiliation site: www.naturalhealthoptions.net
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.
www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesinc.net/store.html
Follow me on Twitter - www.twitter.com/healthfreedomus  

Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org
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