Monday, August 30, 2010

08/30/10 - 60% of FDA Warnings are about SOPs

0.  Blogs & News – FDA Warning Letters; (sic) “Food Safety” bill…
1.  FDA Warning Letter and SOPs
3.  Private Vitamin Lawyer Ad Copy Webinar!
4.  Natural Clinical Trials Center
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 and the FDA Rule regarding “expiration” dates and “best if used by” dates.

Access to the Vitamin Lawyer Webinars and more; videos, major site updates:
www .NaturalHealthOptions .net

News: Senate has not passed the fake “Food Safety” bill, S.510… yet:
URGENT ACTION ITEM; www .healthfreedomusa. org/?p=6269

1. FDA Warning Letters… SOPs

This just in from FDA News:
“What problem is cited in 60% of all FDA warning letters?
Hint #1: It's a process issue — within your power to control and change.
Hint #2: It spans multiple departments or divisions of your company.
Hint #3: It's likely to be something you use every week.

Give up?
It's SOPs. Not the lack of them, but how poorly they're written, communicated, monitored and enforced.
One former top FDA official recalls walking into dozens of companies and being shown stacks of SOPs hot off the photocopier. But when he talked to lab and plant staff, the response was always the same. "What SOPs?" or, "Yeah, we saw them, but we're not sure what they mean." …
It is becoming increasingly clear that FDA and FTC want the Natural Products Industry to conform to standards that are in place for the toxic drug industry. While this level of regulation is neither necessary nor beneficial, companies must begin to “Render unto Caesar…” by having Standard Operating Procedures.
Additionally, having effective SOPs will actually help your company operate more effectively… you might even be able to take a vacation knowing that your staff has a clear set of guidelines to follow…
If you haven’t already engaged me to work with your staff on developing SOPs… it is getting late! Better act now rather than after the FDA visit! FDA agents have been bragging at various industry events that they’ve been given large amounts of “stimulus” money to drastically increase their inspection visits to companies large and small.
If the FDA hasn’t visited you in the past year… they will soon! ACT NOW! Call me: 973.300.4594

2.  New Vitamin Lawyer Ad Copy Webinar – Private for Your Company, via Internet…

I am offering a private, two hour internet webinar, with Powerpoint visual aids and ebook, about writing lawful natural product ad copy, specifically including the new FTC testimonial rule. I will do the presentation over the net and answer any questions from your staff. Email me if your company is interested.

Webinar covers:

DSHEA and Nutrient Claims
Three Levels of Allowed Claims
FDA Guidance on Claims Substantiation
Allowed and Disallowed Terms (detailed lists!)
Common Mistakes
New FTC Testimonial Rule
Varieties of Substantiation
Traditional Uses
Substantiation & Other Resources

Sample: Slide #4

“Dietary Supplement products are governed by a complex of statutes and regulations.  The primary source of marketing rules for nutrient claims is the Dietary Supplement Health & Education Act of 1994 (DSHEA).  This Act is now part of the Food, Drug and Cosmetics Act that empowers the Food and Drug Administration (FDA).  DSHEA codified the right of marketers to make certain kinds of Claims about Dietary Supplements while forbidding others.

In any event, allowable Claims must also be, under Federal Trade Commission (FTC) rules, “truthful and not misleading” which means, there must be a certain level of substantiation for any Claim a marketer wants to make. On the horizon are several layers of international regulations, including the controversial Codex Alimentarius’ Vitamin and Mineral Guidelines that may restrict international trade in supplements and their ingredients.”


3.  Natural Clinical Trials Center

The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials can begin shortly! GET YOURS SCHEDULED NOW. Check out the Videos and PPT Webinar on the Site!

www .NaturalClinicalTrials .org

• 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: 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.
Trailer: 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 .globalhealthfreedom. org

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

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