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."

[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 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,

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

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