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!
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[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…”

 
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm239410.htm

 





[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: 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!


[4] Vitamin Lawyer Connections


Vitamin Lawyer Connections…
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.
Trailer:
www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesllc.com – Airing on: www.telostv.com
Follow me on Twitter - www.twitter.com/healthfreedomus  
ralph …
Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org

Click here to unsubscribe from the Health Freedom Action eAlerts: http://www.demaction.org/dia/organizations/healthfreedomusa/unsubscribe.jsp
We respect your right to privacy. View our policy.





Wednesday, August 1, 2012

08/01/12 - FDA Warning about Dietary Supplement Batch Testing



Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...
 
[0] FDA Warning About DS Batch Testing
[1] When Does a Dietary Supplement Company Have to Report an Adverse Event?
[2] Roehr’s Patented Medical Food & Dietary Supplement Delivery System
[3] Yes, You do Need Clinical Trials…
[4] Vitamin Lawyer Connections: All the Links You Need!
--------------------------

HEADS’ UP! This just in from an industry maven: The FDA may be changing its rule relative to Proprietary Blends. Currently, if a dietary ingredient has a DV (Daily Value) you have to list it separately “in the box” on the label, and cannot include it in the Proprietary Blend. Apparently FDA is considering a change that any ingredient present at less than 2% of DV cannot be listed separately in the Supplement Facts Box. Therefore, it could be included in the Proprietary Blend portion of the label.

 
[0] FDA Warning about Dietary Supplement Batch Testing


The FDA provided this warning to a dietary supplement company regarding the requirement to batch test.

"Your firm failed to verify that your finished batch of dietary supplements met established product specifications for purity and strength, as required by 21 CFR 111.75(c). You must establish product specifications for each dietary supplement you manufacture (21 CFR 111.70(e)), and determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with testing requirements in 21 CFR 111.75(c). Specifically, you provided our investigator with finished assay test data on the products you manufacture, including assay data on product FaBB (batch# 030013 and 030014). However, our review of the assay data revealed that they were insufficient to meet this requirement. Your assay data did not provide quantitative data to determine if the specifications for your finished products were met. Further, the concentration (strength) for the referenced standards was not provided."


http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm284400.htm






[1] When Does a Dietary Supplement Company Have to Report an Adverse Event?

While the FDA has issued an updated guidance on adverse event reporting, the underlying Statutory Rule
remains unchanged. If a company is not sure whether an adverse event needs to be reported, the Vitamin Lawyer Consultancy is prepared to provide independent third-party advise and written opinion regarding the application of the law to particular situations.
 
The Statute provides that only a “serious” event needs to be reported.
A “serious adverse event” is defined by law as: “The term “serious adverse even” is an adverse event that-- (A) results in-- (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).”

The Vitamin Lawyer Consultancy includes standard procedures for AER processing in the Standard Operating Procedures (SOPs) document available from this office. Just email ralph.fucetola@usa.net with “SOP” in the subject line to start the process. I estimate an hour to set up your SOPs and a couple hours to fine-tune them to your actual operations.


Guidance Summary: "the guidance recommends that the responsible person keep the following other records:


(1) Communications between the responsible person and the initial reporter
of the adverse event and between the responsible person and any other person(s) who provided information about the adverse event,


(2) the responsible person's serious adverse event report to FDA with attachments,


(3) any new information about the adverse event received by the responsible person,
and


(4) any reports to FDA of new information related to the serious
adverse event report."

http://www.gpo.gov/fdsys/pkg/FR-2012-05-29/html/2012-12878.htm




Vitamin Lawyer Connections…
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.
Trailer:
www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesinc.net/store.html
Follow me on Twitter - www.twitter.com/healthfreedomus  
ralph …
Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org

Click here to unsubscribe from the Health Freedom Action eAlerts: http://www.demaction.org/dia/organizations/healthfreedomusa/unsubscribe.jsp
We respect your right to privacy. View our policy.