1. Are Bar Codes Required for Dietary Supplements?
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1. Are Bar Codes Required for Dietary Supplements?
Our starting point is that at least 1/3 to 1/2 of all dietary supplement bottles on the store shelves include bar codes. Certain distributers and major retailers may require them.
Whether bar codes are required, however, depends on the terms of the FDA's Good Manufacturing Practices for Dietary Supplements (cGMPs) which became finally effective for all vitamin companies, including small entities, in June 2009, having been promulgated during June 2007.
cGMPs - http://edocket.access.gpo.gov/2007/07-3039.htm
Here are some key definitions from the cGMPs:
The cGMPs apply to "...a person who manufactures, packages, labels, or holds dietary supplements."
"Batch means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified time period according to a single manufacturing record during the same cycle
of manufacture."
"Batch number, lot number, or control number means any distinctive group of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacturing, packaging, labeling, and/or holding of a batch or lot of dietary supplements can be determined."
"Lot means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition; or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition."
Here is what the cGMPs say about labels and packaging:
Subpart D 111.80: The Company shall maintain “(e) Representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the finished packaged and labeled dietary supplements meet specifications established in accordance with Sec. 111.70(g), and as applicable, Sec. 111.70(a).”
Subpart F Sec 111.155 - Before using a label, the responsible person at the Company shall (in accordance with Subpart D, Sect. 111.75: (f)(2): “at a minimum, conduct a visual examination of the label and review the supplier's invoice, guarantee, or certification to determine whether label specifications are met” -- (g): “ You must, at a minimum, conduct a visual examination of the packaging and labeling of the finished packaged and labeled dietary supplements to determine whether you used the specified packaging and applied the specified label” -- and (h)(1) “You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods.”
(e) Subpart D 111.80: The Company shall maintain “(e) Representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the finished packaged and labeled dietary supplements meet specifications established in accordance with Sec. 111.70(g), and as applicable, Sec. 111.70(a).”
Without some system such as bar coding, I fail to see how a company can met the cGMP requirements as to tracking. In the event of a recall, being unable to specify the lot and batch will force a total recall, instead of a limited recall.
Therefore, although the FDA does not require bar coding by specific regulation, it is highly advisable that you use bar coding and that the system you employ is sufficiently robust as to be able to not only identify the product run, but also any batch or lot subdivisions. You also need the coding to be able to maintain representative samples of each lot. Modern practices, driven by traceability regulations, are tantamount to requiring bar coding.
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www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .cohttp://www.healthfreedomusa.org/?p=507m