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Dietary Supplements and cGMP

Kapmcrunk

The Kaptain (40g)
KavaForums Founder
CFR-2021-TITLE 21 PART 111
Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements.

*Note: This document is so large I personally haven’t had the time to fully read and understand it all, so please refer any direct questions to the sources themselves. In short, I’m not an expert, but these rules should be available for us all to see even if they look like they’re written in another language.


Who do these rules apply to?

  • This document applies to any exporter of kava into the United States, or any repackager of kava for sale in the United States.

Who do these rules NOT apply to?

  • These rules do not apply if you’re simply holding the supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. You won’t be opening or repackaging any product received from the exporter/manufacturer. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.

What’s my risk of getting caught and what are my penalties if I don’t observe these rules?

  • They (FDA) seem to only come at you when you’re at your most vulnerable. So if you’ve been exporting kava into the US for a while now, but have not had to deal with the FDA, it’s simply only a matter of time until they ring you up for an inspection.
  • If your company or exporter is “FDA Registered” it means absolutely nothing in regards to good manufacturing practices. Essentially you’ve just given the FDA an address for which to inspect.
  • Violation penalties.
    • Penalties range from $250.00 up to $10,000,000.00 [1,2], and generally end up on the higher side for serious infractions.
    • They retain the option of issuing an import restriction on your firm until you can get your procedural documentation in order.
  • Trending and common cGMP violations [3,4]
    • Equipment and facilities aren’t properly designed or maintained to meet construction or sanitation requirements
    • Pharmaceutical contamination from lack of oversight to follow the mandated operational checkpoints or by non-approved personnel
    • Production and process controls don’t follow the mandated guidelines, which can invalidate all records that don’t adhere
    • Plant and Grounds violations that allow or have the potential to harbor pests
    • Defects and complaints don’t meet guidelines to determine either cause or impact
    • For pharmaceuticals, having products that differ in strength, purity or quality being released
    • Not following testing or inspection requirements or not documenting testing properly, which can lead to an inconsistent product
    • Failure to establish and follow written procedures for QC operations
    • Lack of an accurate temperature monitoring/reporting device in each freezer or cold storage compartment, leading to potential for decay, mold growth or cross-contamination.
    • Insufficient standard operating procedures (SOPs) and documentation.
    • Underqualified personnel (particularly software vendors) performing sensitive functions.
    • Insufficient external training for employees.

It’s important to remember that the FDA can classify your product as adulterated “If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling” [5].

[1] Code of federal regulations. govinfo.gov. (2021, March 17). Retrieved January 26, 2022, from https://www.govinfo.gov/content/pkg/CFR-2012-title21-vol1/pdf/CFR-2012-title21-vol1-chapI.pdf

[2] Legal Information Institute. (n.d.). 21 U.S. Code § 333 - Penalties. Legal Information Institute. Retrieved January 26, 2022, from https://www.law.cornell.edu/uscode/text/21/333

[3] CGMP requirements and common violations. Rite. (n.d.). Retrieved January 26, 2022, from https://www.ritehite.com/en/am/news/2019/blog/cgmp-regulations-and-common-violations

[4] Gregor, M. (2007, September 17). cGMP Violations: Beware Complacency. Pharmamanufacturing.com. Retrieved January 26, 2022, from https://www.pharmamanufacturing.com/articles/2007/138/

[5] Code of federal regulations. govinfo.gov. (2021, March 17). Retrieved January 26, 2022, from https://www.govinfo.gov/content/pkg...SCODE-2011-title21-chap9-subchapIV-sec342.pdf
 

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kasa_balavu

Yaqona Dina
@Michael those cGMP rules apply to all manufacturers of kava destined for sale in the US, whether or not the manufacturing and packing happens in the US or not.
 
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