Thursday, August 16, 2012

08/16/12 - Daily Value and “Excellent Source” Claims; Your PAD App!

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

[1] Daily Value and “Excellent Source” Claims
[2] Yes, You do Need Clinical Trials…

[3] EU Cosmetics Dossier
[4] Vitamin Lawyer Connections: All the Links You Need!

[1] Daily Value and Excellent Source Claims

States FDA in one warning letter: 
“Nutrient content claims that use the defined terms “rich in,” “excellent source,” or “high,” (“superb source” is an unauthorized synonym for “excellent source”) may be used in the labeling of a food only if the food contains 20 percent or more of the daily value (DV) of that nutrient per reference amount customarily consumed (RACC) [21 CFR 101.54(b)(1)].  Such claims may not be made about a nutrient for which there is no established DV…”


[2] Yes, you do need clinical trials! Further Services You Need!

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 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!

[3] 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:
Announcement: For information about the SEC-filed Fund for Natural Solutions: (offering only by Private Placement Memorandum, available upon request: just email me at 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!

[4] Vitamin Lawyer Connections

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.
Trailer: – Airing on:
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ralph …
Ralph Fucetola JD

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