Two to Three years the eliquid/ecig industry has had the opportunity to start self regulating and updating their manufacturing process to some type of standard , at the very least, approaching cGMP.
Here's a copy of a portion of the now infamous FDA letter(s) sent to Johnson Creek(who have touted themselves as having FDA registry and highly tuned Quality control/ Quality assurance measures already in place - well it seems a somewhat recent inspection-within the past year- tells a different story):
Additionally, during our September 1-25, 2009, inspection of your manufacturing facility, Johnson Creek Enterprises, LLC, located at 320 N. Watertown Street, Suite F, Johnson Creek, Wisconsin, investigator(s) from the FDA identified significant violations of Current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s), as described above, to be adulterated within the meaning of section 501(a)(2)(B) of the Act (21 U.S.C. § 351 (a)(2)(B)) in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP. Specific violations observed during the inspection include, but are not limited, to the following:
CGMP Violations
Your firm has not established a quality control unit having the responsibility and authority to approve and reject all components, drug product containers, closure, in-process materials, packaging materials, labeling and drug products, and the authority to review production records to assure that no errors have occurred (21 C.F.R. § 211.22(a)). For example, your firm has not established a quality control unit. Personnel with quality control unit responsibility have not been designated.
1. Your firm does not test each batch of drug product to determine conformance with final specifications (21 C.F.R. § 211.165(a)). Specifically, your firm does not test each batch of drug product prior to release.
2. Your firm has not established written procedures designed to prevent microbiological contamination of drug products not required to be sterile (21 C.F.R. § 211.1 13(a)). For example, your firm has not set microbial limits for your firm's oral liquid drug products, nor have you demonstrated preservative effectiveness.
3. Your firm has not conducted specific identification testing when components are accepted based on the supplier's report of analysis (21 C.F.R. § 211.84(d)(2)). For example, your firm accepts a Certificate of Analysis (COA) from the supplier of components. However, your firm does not conduct identity testing on your components or appropriate verification of the supplier's test results.
4. Your firm does not have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expirations dates (21 C.F.R. § 211.166(a)). For example, your firm does not have a stability testing program for your firm's components and finished drug products.
5. Your firm's drug products do not bear an expiration date determined by appropriate stability data to ensure they meet applicable standards of identity, strength, quality and purity at the time of use (21 C.F.R. § 211.137(a)). For example, your firm does not have the stability data to support expiration dating for these products.
Please be aware that the FDA has issued a letter addressed to the Electronic Cigarette Association (ECA) which explains in detail how the electronic cigarette industry can begin the drug approval process. For your convenience, we have enclosed a copy of that letter and encourage you to follow through with the recommendations.
They don't even have a QC unit(or person apparently) specifically tasked with any QC matters- No recordkeeping, no product testing before release, no initial testing of incoming supplies, no formal operating procedure, etc... As a healthcare professional who has worked in the industry and is familiar with cGMP and minimal QC standards, this is very disturbing. And if you read the specific violations(which are just SOME of the violations found) you'll see I've addressed everyone of them in previous posts in a myriad of threads. And this company is supposed to be one of the BEST in terms of QC/QA standards in the US eliquid industry - Yikes, I can only imagine the "homebrewer's" standards. I only hope, NOW, that JC and other manufacturers will start "following the recommendations" and working to legitimize the industry. You've now had 3 years of "cottage industry playtime". Unfortunately for vapers everywhere, playtime is over... The sad thing is, it didn't have to be this way.
P.S. I just threw out the one 15ml bottle of JC TC and the sampler pack I had. I refuse to do business with a company that misrepresents itself so blatantly and obviously cares so little about consumer product safety.
Here's a copy of a portion of the now infamous FDA letter(s) sent to Johnson Creek(who have touted themselves as having FDA registry and highly tuned Quality control/ Quality assurance measures already in place - well it seems a somewhat recent inspection-within the past year- tells a different story):
Additionally, during our September 1-25, 2009, inspection of your manufacturing facility, Johnson Creek Enterprises, LLC, located at 320 N. Watertown Street, Suite F, Johnson Creek, Wisconsin, investigator(s) from the FDA identified significant violations of Current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s), as described above, to be adulterated within the meaning of section 501(a)(2)(B) of the Act (21 U.S.C. § 351 (a)(2)(B)) in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP. Specific violations observed during the inspection include, but are not limited, to the following:
CGMP Violations
Your firm has not established a quality control unit having the responsibility and authority to approve and reject all components, drug product containers, closure, in-process materials, packaging materials, labeling and drug products, and the authority to review production records to assure that no errors have occurred (21 C.F.R. § 211.22(a)). For example, your firm has not established a quality control unit. Personnel with quality control unit responsibility have not been designated.
1. Your firm does not test each batch of drug product to determine conformance with final specifications (21 C.F.R. § 211.165(a)). Specifically, your firm does not test each batch of drug product prior to release.
2. Your firm has not established written procedures designed to prevent microbiological contamination of drug products not required to be sterile (21 C.F.R. § 211.1 13(a)). For example, your firm has not set microbial limits for your firm's oral liquid drug products, nor have you demonstrated preservative effectiveness.
3. Your firm has not conducted specific identification testing when components are accepted based on the supplier's report of analysis (21 C.F.R. § 211.84(d)(2)). For example, your firm accepts a Certificate of Analysis (COA) from the supplier of components. However, your firm does not conduct identity testing on your components or appropriate verification of the supplier's test results.
4. Your firm does not have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expirations dates (21 C.F.R. § 211.166(a)). For example, your firm does not have a stability testing program for your firm's components and finished drug products.
5. Your firm's drug products do not bear an expiration date determined by appropriate stability data to ensure they meet applicable standards of identity, strength, quality and purity at the time of use (21 C.F.R. § 211.137(a)). For example, your firm does not have the stability data to support expiration dating for these products.
Please be aware that the FDA has issued a letter addressed to the Electronic Cigarette Association (ECA) which explains in detail how the electronic cigarette industry can begin the drug approval process. For your convenience, we have enclosed a copy of that letter and encourage you to follow through with the recommendations.
They don't even have a QC unit(or person apparently) specifically tasked with any QC matters- No recordkeeping, no product testing before release, no initial testing of incoming supplies, no formal operating procedure, etc... As a healthcare professional who has worked in the industry and is familiar with cGMP and minimal QC standards, this is very disturbing. And if you read the specific violations(which are just SOME of the violations found) you'll see I've addressed everyone of them in previous posts in a myriad of threads. And this company is supposed to be one of the BEST in terms of QC/QA standards in the US eliquid industry - Yikes, I can only imagine the "homebrewer's" standards. I only hope, NOW, that JC and other manufacturers will start "following the recommendations" and working to legitimize the industry. You've now had 3 years of "cottage industry playtime". Unfortunately for vapers everywhere, playtime is over... The sad thing is, it didn't have to be this way.
P.S. I just threw out the one 15ml bottle of JC TC and the sampler pack I had. I refuse to do business with a company that misrepresents itself so blatantly and obviously cares so little about consumer product safety.
Last edited:
