The FDA doesnt require even drug company to have certification…
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you can try to self regulate but when the FDA walks in your door one day which I’m sure will happen it happens to all manufacturers in all industries, I personally would want to have a third party audit on my side but to each their own. 
Third party audit isn’t going to prevent you from getting a 483, or a warning letter, or a consent decree.
All it will do is tell you what you might want to improve.
Having a quality culture - with a foundation in GMP - and people who know why they are doing what they are doing. With an eye on the patient/customer and trained hands on the wheel is the only way to really see success under the feds.
I’ve worked for those third party auditors. Some times people listen. Most of the time they don’t. And they think just because we have been there - that somehow makes it okay. I’ve been at places that had third party groups on site and still ended up with warning letters.
Such is life. Give those third parties your money - they need to feed their fam too! And you can always call and ask the regulators for help - they are more helpful than people seem to think.
Either way we have audited or had third party audits of soooo many labs that are “cMGP” or “have cGMP protocols in place” that couldn’t even pass a third party audit let alone an audit from the FDA, and these are some of the top/largest manufacturers in the industry. you can think you can do it alone all day but I have found that not to be the case personally.
Me too! All day. Its crazy!
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https://www.sos.state.co.us/CCR/RegisterPdfContents.do?publicationDay=01/10/2021
Pages 80-128 Is mainly the Colorado documentation that pertains to the hemp industry. Maybe this is a basic question but it seems slightly different than the document posted. Many sections highlighted in red, as well as no “Adopted by the Board of Health on February 17, 2021; effective, April 14, 2021”. On the top. Did this go back into review? Anyone know where one can find the most updated official Colorado documents? Not doubting any authenticity, just trying to keep up-to-date.
You can follow all the happenings for the CDPHE here.
At least the public happenings. This includes the announcement for the hearing that happened on 2/17/21 - and a follow-up from the attorney generals office. There’s even an opportunity to provide feedback on the redline changes, as well as, talk at the hearing or at least ask questions. That time has passed for this specific notice of rulemaking.
If you want a more specific/personal update on what’s happening post hearing - you should reach out to:
That’s the person listed as responsible on all the public notices.
That already happened -
Figured I’d pop this link into this thread. Looks like the FDA is starting to cite GMP violations in their new warning letters.
FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief | FDA
Looks like the FDA is starting to cite GMP violations in their new warning letters.
This is a result of companies marketing CBD as a drug product, they were making health claims about specific conditions, and using red flag words like “pain” and “inflammation”. As soon as you make those claims, your product is regulated as an OTC drug, requiring an FDA monograph to be approved for any active ingredients.
As the FDA said, they were “CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act”
Letters of legal opinion from qualified lawyers save businesses!! Your company’s packaging is a great example of what clear, compliant packaging should look like and say.
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If you read the letters they specifically site GMP violations “This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211)”
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Yes, that’s because the health claims they were making made the production of the CBD products fall into finished pharmaceutical regulation. There’s approved pain creams that use lidocaine and histamine dihydrochloride, but they’re bound by cGMP practices for OTC drugs. If they didn’t make health claims then it wouldn’t have fallen into that category of regulation.
The problem here is more on the side of the marketing of the product, which made it fall into OTC cGMP rules + regulations. Even if they did have a cGMP manufacturing facility, they would still be cited for marketing a non-approved substance without an FDA monograph. The fact that they’re not in compliance with OTC drug manufacturing regulations is just the cherry on top of the problem, if they didn’t make health claims about their products then they wouldn’t have been in this situation.
I have intimate experience with how careful a company has to be with marketing claims when in the OTC drug arena, my experience lies specifically among 505(b)(2) approvals.
I have a feeling we’ll be seeing more punitive FDA action against companies that fall into making drug claims. I’m impressed how many companies have been getting away with marketing CBD topicals as “pain creams” or “anti-inflammatory”.
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I’m looking for a consultant to ensure compliance. Anyone available?
Our farmtofinish.us platform is setup for this to enable full lot and batch tracking as well as full recall and traceability support.
Built it a while ago knowing things was where the industry was headed. Dm for details.